AnxietyNCT06715852
Moving on! A Tailored Treatment in a Primary Care Setting for Individuals With Anxiety Disorders?
A study testing PHYSBI: a 12-week physical exercise program and Modified eHealth Lift: a digital, evidence based lifestyle-intervention for health promotion. in people with Anxiety, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The goal of this clinical study is to investigate the effects of two different interventions in patients with anxiety disorder and who seeks help at primary care centers. The participants will choose between two interventions: 1. A 12-week physical exercise program with three training sessions per week, or 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety
- What is being tested?
- PHYSBI: a 12-week physical exercise program and Modified eHealth Lift: a digital, evidence based lifestyle-intervention for health promotion.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteSweden
- Study dates
- 17 Mar 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of anxiety disorder (panic syndrome, 41.0; generalized anxiety, F41.1; mixed anxiety- and depression, F41.2 and F41.3; anxiety not otherwise specified, F41.9).
- Seeking care at primary care centers within the Region Västra Götaland.
- With or without ongoing treatment with psychoactive medication (antidepressants or anxiolytics).
Who cannot join
- Pregnancy
- Physical difficulties in performing a physical exercise program
- Pathological electrocardiogram
- Low BMI (under 17.5)
- Ongoing alcohol/substance abuse
- Ongoing exhaustion disorder or psychotic disorder
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- Newly discovered (within 6 months) atrial fibrillation
- High suicide risk as assessed by the general practitioner
- Limited knowledge in the Swedish language.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
School of Public Health and Community Medicine, Institute of Medicine, University of Gothenburg
Gothenburg, 41320
Maria Åberg, PhD, MD, +46 (0)709668274, maria.aberg@gu.se
Jenny Nyberg, PhD, +46 (0)702180801, jenny.nyberg@neuro.gu.se
About this study
Official title: Moving on! Can a Tailored Treatment in a Primary Care Setting Reduce Symptoms, Healthcare Consumption, Sick Leave and Prevent Pain and Hypertension in Individuals With Anxiety Disorders?
The goal of this clinical study is to investigate the effects of two different interventions in patients with anxiety disorder and who seeks help at primary care centers. The participants will choose between two interventions:
- A 12-week physical exercise program with three training sessions per week, or
- A modified version of eHealth Lift, a digital development of the Health Lift, an evidence based lifestyle-intervention for health promotion and prevention in primary health care.
Read more
The participant will fill in self-assessment scales and questionnaires and also have BMI and blood pressure measured at the start of the study, at 12-weeks after the study start and after 1 year.
The main question the investigators aim to answer is if the interventions are better than treatment as usual for this group of patients regarding:
- symptoms of anxiety and depression
- pain
- sleep
- alcohol habits
- fatigue
- general health
- work ability/sick leave
- physical activity
- perceived quality of life
- BMI and blood pressure
- number of health care contacts
- psychopharmaceuticals and analgesics prescribed
- health literacy
Read the detailed description
Every third patient in the waiting room at a Swedish primary healthcare center is seeking help for common mental disorders including anxiety (1). Anxiety disorders substantially reduce quality of life and daily functioning and are, among mental disorders, the second leading cause of years lived with disability and the sixth-leading cause of disability globally. Anxiety disorders are also associated with elevated risks of pain, cardiovascular disease (CVD) and premature mortality (2), emphasizing the importance of finding effective treatment strategies that can be addressed in primary care.
Specific research questions:
- Can a tailored treatment and secondary prevention in a primary care setting reduce symptoms of anxiety, healthcare consumption, sick leave, pain and prevent hypertension in individuals with anxiety disorders?
- Are there long-term effects at 1 year of follow-up regarding the outcome measures?
- Is the treatment/secondary preventive strategy associated with health economic benefits?
Significance and scientific novelty: Despite the high burden of anxiety, there are major knowledge gaps when it comes to secondary preventive measures. This intervention aims to reduce anxiety, improve the quality of life, work ability and health in primary health care patients with anxiety disorders. Little research has focused on lifestyle improvements or exercise specifically in the treatment of anxiety. In Sweden there are guidelines from The National Board of Health and welfare for treatment of depression with exercise, but guidelines for treatment of anxiety disorders are currently lacking. Also results from this study may extend the current understanding and practice in the field of treatment and secondary prevention of anxiety disorders within primary care.
This project aims to combine evidence-based interventions to tailor a lifestyle intervention with different steps focusing on patient control and participation since the individual chooses the intervention arm. Two evidence-based lifestyle interventions will combined and evaluated: the modified eHealth Lift/Care manager according to regional clinical guidelines and PHYSBI, a promising new strategy with an intensive training program, a new approach for treating anxiety disorders. If a simple intervention program in primary care can alleviate anxiety, improve quality of life, cognitive performance, and work ability, prevent pain and hypertension, this may have a great positive impact both at the individual level and from a societal perspective. The investigators hope to increase the availability of person-centered, evidence-based and cost-effective measures to promote both physical and mental health in patients with anxiety disorders. Moreover, the interventions are designed to easily be implemented in regular primary care activities.
Design of study: A clinical intervention with a matched design with two parallel arms and three assessment points (baseline, post-intervention and 1 year of follow-up).
Setting: Primary care centers in Region Västra Götaland (VGR), Sweden Participants: Patients aged 18-65 diagnosed with anxiety disorders attending 20 primary care centers (PCCs) within the VGR. Participants will be recruited by personnel at the PCCs (doctors, psychologists, nurses), through information material at the PCCs (posters, flyers and handouts) and by using the primary care system Medrave to identify and contact suitable patients. Eligibility criteria can be found elsewhere in the ClinicalTrials.gov protocol. Participants will sign a written informed consent and informed about the possibility to withdraw from the study at any time without disadvantages.
Matching: PCCs connected to a rehabilitation clinic will be assigned as intervention PCCs. Thsese PCCs will be matched for the following variables 1) size of the PCC, 2) socioeconomy as Care Need Index (CNI) and 3). Matching will be executed in order to identify suitable PCCs with care as usual (controls).
The intervention: The 10 PCCs allocated to intervention will offer all patients with a registered anxiety diagnosis in the PCCs electronic patient register as well as patients newly diagnosed with any of the above listed disorders to participate in an intervention program. The patient chooses the intervention arm, and the focus is on person-centredness, control, empowerment and participation.
The two intervention-options are:
- Modified eHealth Lift, a digital development of the Health Lift, an evidence based lifestyle-intervention for health promotion and prevention in primary health care. This intervention will be executed together with care manager contact according to regional clinical guidelines.
- The moderate-high intensity arm of PHYSBI, an individualized 12-week training program for anxiety disorders including 3 occasions/week. The moderate intensity arm of PHYSBI, which also will contain elements of high intensity, corresponds to 3.0-8.9 metabolic equivalents, Borg Rating of Perceived Exertion 12-17 and 60-94% of maximal heart rate. The intervention includes cardiorespiratory and resistance training in a group-session (3). The study physiotherapists design individualized exercise programs during a single one-to-one session with the patients.
CAU (PCCs allocated to non-intervention): At Swedish PCCs, care as usual (CAU) for patients with anxiety disorders can consist of visits to various healthcare professionals (such as physicians, nurses, psychologists, therapists, physiotherapists). The treatment should follow the regional guidelines, which are based on the national evidence-based clinical guidelines for anxiety disorders (National guidelines for care of depression and anxiety disorders, The Swedish National Board of Health and Welfare, Stockholm 2020). These guidelines include psychopedagogic support, psychotherapy (cognitive behavioural therapy (CBT) face-to-face or internet-mediated), psychopharmaceutical treatment and/or sick listing (preferably partial).
Outcome measures: Individual data on symptoms of anxiety, depression, general health, pain, sleep, fatigue, work ability, physical activity and perceived quality of life will be obtained through established self-assessment scales and collected for each intervention arm. Patients will self-report smoking, concurrent illnesses, pain, usage of prescribed drugs and physical activity using a questionnaire designed by the research team. Data will also be obtained from the healthcare database VEGA (Database for health-care consumption in VGR), the national Patient register, the regional prescribed drug register Digitalis, the national Prescribed drug register and the MiDAS database at Försäkringskassan (includes data on sick leave >14 days). Specification of outcomes can be found elsewhere in the ClinicalTrials.gov protocol.
Timeline and Workplan: During 2024 a Clinical Trial registration will be submitted. The investigators already have established contacts with gyms, the PHCRs and the Research and Development primary healthcare centres. During 2024 the collaborations with the primary healthcare organization, the PHCRs and health centres will be further established. A steering committee will be formed and the study procedures tested. During autumn 2024 the PCCs will be invited to participate. At the intervention PCCs, the recruitment of patients will be facilitated through a research nurse. At every PCC, a unique care manager manager which has been implemented at all PCCs in VGR since 2016 (4) handles the modified eHealth Lift, and the physiotherapists implement PHYSBI. The PHCRs will perform the PHYSBI arm and the involved PCCs will implement the modified eHealth Lift arm continuously during the intervention year of 2025. Study start date is anticipated to be in Jan 2025 and primary completion date in Dec 2026 (1 year of follow-up). Outcome data will be collected throughout the period 2025-2026. In 2026-2027 data will be processed, analyzed and scientific papers produced.
Data analysis and statistics: The majority of outcome variables are scale variables that may be treated as continuous variables and therefore primarily modelled using linear regression. These are scales for symptoms of anxiety, depression, pain, sleep, general health, perceived quality of life, sick leave days, number of health care contacts and number and types of psychopharmaceuticals prescribed. Data will be presented using descriptive statistics, including means and standard deviations for continuous variables, and frequencies and percentages for categorical variables Group differences by intervention status (modified eHealth Lift, PHYSBI, or CAU) will be assessed by Kruskal-Wallis test and chi-square tests, respectively. The average change in continuous outcomes will be analyzed using linear regression, with intervention as categorical predictor and baseline levels as covariates.
In the case of count data the investigators will test whether Poisson or negative binomial models are more appropriate than linear regression. The correlation of outcomes between patients from the same PCC will be modelled using a hierarchical linear model including PCC as random effect. A more detailed analysis of the longitudinal change will be based on repeated-measure models that also account for the correlations within individuals. Interaction terms for PCC status and time will test whether time trends differ by intervention status. Binary endpoints such as sick leave will be analyzed using logistic regression with adjustment for correlations as described for the linear models. All regression models will be adjusted for age, sex, as well as for variables on PCC-level such as socioeconomy, number of patients listed per PCC (size), and proportion of patients with anxiety diagnoses.
Power considerations: A power calculations has been performed based on 20 health centres distributed 50:50 i.e. 10 controls and 10 with two interventions. However, as patients are allowed to choose between the two intervention types (modified eHealth Lift or PHYSBI) the investigators will consider an unequal distribution of intervention types, e.g. 70:30 % for the modified eHealth Lift and PHYSBI. As the main outcome measures are continuous, Cohen's d = mean difference/standard deviation is considered as outcome measure, assuming small to medium effect size, i.e. d = 0.2 - 0.5 [51]. Power analysis was performed using a STATA procedure for one-way ANOVA. For a change (baseline to 3 months) effects sizes with d ≥ 0.2 and a power of ≥0.9 (significance level = 0.05) can be observed with a total of 320 individuals, distributed as 160 patients without intervention, 112 with the modified eHealth Lift, and 48 with PHYSBI. The same sample size will yield even larger statistical power if the group size for the modified eHealth Lift and PHYSBI were more alike.
Health-economic analyses: Cost-effectiveness analyses will be performed separately, comparing the two intervention arms to no CAU, including both direct (healthcare and pharmaceutical utilization) and indirect (long-term sickness and absenteeism from work) costs. Cost-effectiveness analyses will be based on the primary data collected within the project and based on a combination of primary data and secondary data from other sources for lifetime time perspectives. The long-term analyses will be performed using a health-economic simulation model projecting the outcomes and cost-effectiveness at the 1-year follow-up to a longer time period (5 years and lifelong).
- Conditions
- Anxiety
- Being tested
- PHYSBI: a 12-week physical exercise program, Modified eHealth Lift: a digital, evidence based lifestyle-intervention for health promotion.
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHYSBI: a 12-week physical exercise programBehavioural
An individualized 12-week training program including 3 occasions/week of moderate-high intensity.
Modified eHealth Lift: a digital, evidence based lifestyle-intervention for health promotion.Behavioural
Through questionnaires, the patients answers questions regarding lifestyle habits and the results are converted into a health profile. A care manager will together with the patient decide appropriate health promoting activities to engage in.
| Study group | Role | What they receive |
|---|---|---|
| PHYSBI: 12-week physical exercise program | Experimental | An individualized 12-week training program including 3 occasions/week of moderate-high intensity. It may also contain elements of high intensity, corresponding to 3.0-8.9 metabolic equivalents (METs), Borg Rating of Perceived Exertion (RPE) 12-17 and 60-94% of maximal heart rate. The intervention includes cardiorespiratory and resistance training where two sessions per week are group-sessions and one session per week is performed individually. A study physiotherapists will design individualized exercise programs during a single one-to-one session with the patients. Receives: Behavioral: PHYSBI: a 12-week physical exercise program |
| Modified eHealth Lift: a digital, evidence based lifestyle-intervention for health promotion. | Experimental | A modified and digital development of the Health Lift, an evidence based lifestyle-intervention for health promotion and prevention in primary health care. This intervention will be executed together with care manager contact according to medical guidelines. The patient receives a material consisting of separate questionnaires dealing with dietary habits, smoking, alcohol habits, physical activity, stress, living conditions, waist-hip-ratio and well-being expressed as a life ladder, present and future. Results are then converted into a health profile and a counsellor indicated what could be offered individually or in groups depending on the participant's wishes. This person-centered method ia based on strengthening the individual's own chosen health promoting activities and support for participation in municipal facilities. Receives: Behavioral: Modified eHealth Lift: a digital, evidence based lifestyle-intervention for health promotion. |
| Care as usual | No intervention | Care as usual for anxiety disorders at the primary care centers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of anxiety - BAI
Established psychiatric self-assessment scale Beck Anxiety Inventory (BAI). BAI is organized in 21 items, with scoring from nothing (0 p), slightly (1 p), moderately (2p) and severely (3p) and total ratings range from nothing, minimal/mild (score 0-15), moderately (score 16-25) and severely (score 26-63).
Measured: At study start
Symptoms of anxiety - BAI
Established psychiatric self-assessment scale Beck Anxiety Inventory (BAI). BAI is organized in 21 items, with scoring from nothing (0 p), slightly (1 p), moderately (2p) and severely (3p) and total ratings range from nothing, minimal/mild (score 0-15), moderately (score 16-25) and severely (score 26-63).
Measured: After 12-weeks intervention
Symptoms of anxiety - BAI
Established psychiatric self-assessment scale Beck Anxiety Inventory (BAI). BAI is organized in 21 items, with scoring from nothing (0 p), slightly (1 p), moderately (2p) and severely (3p) and total ratings range from nothing, minimal/mild (score 0-15), moderately (score 16-25) and severely (score 26-63).
Measured: After one year follow-up
Symptoms of Generalized Anxiety Disorder - GAD-7
An established psychiatric self-assessment scale GAD-7 (Symptoms of Generalized Anxiety Disorder). A 7-item scale where anxiety severity is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21.
0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety
Measured: At study start
Symptoms of Generalized Anxiety Disorder - GAD-7
An established psychiatric self-assessment scale GAD-7 (Symptoms of Generalized Anxiety Disorder). A 7-item scale where anxiety severity is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21.
0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety
Measured: After 12-weeks intervention
Symptoms of Generalized Anxiety Disorder - GAD-7
An established psychiatric self-assessment scale GAD-7 (Symptoms of Generalized Anxiety Disorder). A 7-item scale where anxiety severity is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety
Measured: After one year follow-up
Symptoms of anxiety - HAD
The established psychiatric self-assessment scale HAD (Hospital Anxiety and Depression Scale Symptoms of anxiety) is a scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Score 0-7 = Normal, 8-10 = Borderline abnormal and 11-21 = Abnormal (case).
Measured: At study start
Symptoms of anxiety - HAD
The established psychiatric self-assessment scale HAD (Hospital Anxiety and Depression Scale Symptoms of anxiety) is a scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Score 0-7 = Normal, 8-10 = Borderline abnormal and 11-21 = Abnormal (case).
Measured: After 12-weeks intervention
Symptoms of anxiety - HAD
The established psychiatric self-assessment scale HAD (Hospital Anxiety and Depression Scale Symptoms of anxiety) is a scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Score 0-7 = Normal, 8-10 = Borderline abnormal and 11-21 = Abnormal (case).
Measured: After one year follow-up
Symptoms of inner tension - MADRS-S; question 2
The established psychiatric self-assessment scale MADRS-S (Montgomery-Åsberg Depression Rating Scale); question 2, which asks about inner tension (a proxy for anxiety). The question is scaled from 0 to 6, with higher scores reflecting more severe symptoms.
Measured: At study start
Symptoms of inner tension - MADRS-S; question 2
The established psychiatric self-assessment scale MADRS-S (Montgomery-Åsberg Depression Rating Scale); question 2, which asks about inner tension (a proxy for anxiety). The question is scaled from 0 to 6, with higher scores reflecting more severe symptoms.
Measured: After 12-weeks intervention
Symptoms of inner tension - MADRS-S; question 2
The established psychiatric self-assessment scale MADRS-S (Montgomery-Åsberg Depression Rating Scale); question 2, which asks about inner tension (a proxy for anxiety). The question is scaled from 0 to 6, with higher scores reflecting more severe symptoms.
Measured: After one year follow-up
Secondary outcomes (57)
Symptoms of depression - MADRS-S
The established psychiatric self-assessment scale MADRS-S (Montgomery-Åsberg Depression Rating Scale) contains nine questions. The question are scaled from 0 to 6, with higher scores reflecting more severe symptoms. Ratings can be added to form an overall score (from 0 to 60), with the following cut-offs: 0-6 indicate an absence of symptoms; 7-19 represent mild depression; 20-34 moderate; 35-60 indicate severe depression.
Measured: At study start
Symptoms of depression - MADRS-S
The established psychiatric self-assessment scale MADRS-S (Montgomery-Åsberg Depression Rating Scale) contains nine questions. The question are scaled from 0 to 6, with higher scores reflecting more severe symptoms. Ratings can be added to form an overall score (from 0 to 60), with the following cut-offs: 0-6 indicate an absence of symptoms; 7-19 represent mild depression; 20-34 moderate; 35-60 indicate severe depression.
Measured: After 12-weeks intervention
Symptoms of depression - MADRS-S
The established psychiatric self-assessment scale MADRS-S (Montgomery-Åsberg Depression Rating Scale) contains nine questions. The question are scaled from 0 to 6, with higher scores reflecting more severe symptoms. Ratings can be added to form an overall score (from 0 to 60), with the following cut-offs: 0-6 indicate an absence of symptoms; 7-19 represent mild depression; 20-34 moderate; 35-60 indicate severe depression.
Measured: After one year follow-up
Symptoms of pain - PSQ
The established self-assessment scale PSQ (Pain Sensitivity Questionnaire) with 17 items rated on a 11-point scale with 0 meaning "not painful at all" and 10 meaning "worst pain imaginable." Three items (items 5, 9, and 13) are not normally rated as painful and are not included in scoring. Two scores are obtained from the PSQ. The PSQ-total score is the average of all items, except for the three non-painful items. The PSQ-minor score is the average of items 3, 6, 7, 10, 11, 12, and 14 - items, on average, that are perceived as causing minor pain.
Measured: At study start
Symptoms of pain - PSQ
The established self-assessment scale PSQ (Pain Sensitivity Questionnaire) with 17 items rated on a 11-point scale with 0 meaning "not painful at all" and 10 meaning "worst pain imaginable." Three items (items 5, 9, and 13) are not normally rated as painful and are not included in scoring. Two scores are obtained from the PSQ. The PSQ-total score is the average of all items, except for the three non-painful items. The PSQ-minor score is the average of items 3, 6, 7, 10, 11, 12, and 14 - items, on average, that are perceived as causing minor pain.
Measured: After 12-weeks intervention
Symptoms of pain - PSQ
The established self-assessment scale PSQ (Pain Sensitivity Questionnaire) with 17 items rated on a 11-point scale with 0 meaning "not painful at all" and 10 meaning "worst pain imaginable." Three items (items 5, 9, and 13) are not normally rated as painful and are not included in scoring. Two scores are obtained from the PSQ. The PSQ-total score is the average of all items, except for the three non-painful items. The PSQ-minor score is the average of items 3, 6, 7, 10, 11, 12, and 14 - items, on average, that are perceived as causing minor pain.
Measured: After one year follow-up
Sleep quality - ISI
The established self-assessment scale ISI (Insomnia Severity Index) includes 7 items where responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia. A total score of 0-7 indicates "no clinically significant insomnia," 8-14 means "subthreshold insomnia," 15-21 is "clinical insomnia (moderate severity)," and 22-28 means "clinical insomnia (severe)."
Measured: At study start
Sleep quality - ISI
The established self-assessment scale ISI (Insomnia Severity Index) includes 7 items where responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia. A total score of 0-7 indicates "no clinically significant insomnia," 8-14 means "subthreshold insomnia," 15-21 is "clinical insomnia (moderate severity)," and 22-28 means "clinical insomnia (severe)."
Measured: After 12-weeks intervention
Sleep quality - ISI
The established self-assessment scale ISI (Insomnia Severity Index) includes 7 items where responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia. A total score of 0-7 indicates "no clinically significant insomnia," 8-14 means "subthreshold insomnia," 15-21 is "clinical insomnia (moderate severity)," and 22-28 means "clinical insomnia (severe)."
Measured: After one year follow-up
Alcohol habits - AUDIT
The established self-assessment scale AUDIT (Alcohol Use Disorders Identification Test) including 10 items. Item 1-8 is scored with 0 to 4 points and item 9-10 with 0, 2 or 5 points. A total of 0-40 points can be obtained, where 0 to 7 indicates low risk, 8 to 15 indicates increasing risk, 16 to 19 indicates higher risk, and 20 or more indicates possible dependence.
Measured: At study start
Alcohol habits - AUDIT
The established self-assessment scale AUDIT (Alcohol Use Disorders Identification Test) including 10 items. Item 1-8 is scored with 0 to 4 points and item 9-10 with 0, 2 or 5 points. A total of 0-40 points can be obtained, where 0 to 7 indicates low risk, 8 to 15 indicates increasing risk, 16 to 19 indicates higher risk, and 20 or more indicates possible dependence.
Measured: After 12-weeks intervention
Alcohol habits - AUDIT
The established self-assessment scale AUDIT (Alcohol Use Disorders Identification Test) including 10 items. Item 1-8 is scored with 0 to 4 points and item 9-10 with 0, 2 or 5 points. A total of 0-40 points can be obtained, where 0 to 7 indicates low risk, 8 to 15 indicates increasing risk, 16 to 19 indicates higher risk, and 20 or more indicates possible dependence.
Measured: After one year follow-up
Fatigue - MFS
The established self-assessment scale MFS (Mental Fatigue Scale) includes 14 items. A rating of 0 (no problem) corresponds to normal function and 1 (slight problem), 2 (fairly serious problem) and 3 (serious problem) indicate increasing problem with the symptom. A total score of above 10 implicates problems with mental fatigue and the person should consider the actual situation with work or social life.
Measured: At study start
Fatigue - MFS
The established self-assessment scale MFS (Mental Fatigue Scale) includes 14 items. A rating of 0 (no problem) corresponds to normal function and 1 (slight problem), 2 (fairly serious problem) and 3 (serious problem) indicate increasing problem with the symptom. A total score of above 10 implicates problems with mental fatigue and the person should consider the actual situation with work or social life.
Measured: After 12-weeks intervention
Fatigue - MFS
The established self-assessment scale MFS (Mental Fatigue Scale) includes 14 items. A rating of 0 (no problem) corresponds to normal function and 1 (slight problem), 2 (fairly serious problem) and 3 (serious problem) indicate increasing problem with the symptom. A total score of above 10 implicates problems with mental fatigue and the person should consider the actual situation with work or social life.
Measured: After one year follow-up
Health-related quality of life - EQ-5D
The established self-assessment scale EQ-5D consist of both a visual analogue scale (EQ5D-VAS) and an index score. The EQ5D-VAS records subjective self-rated general well-being on a scale from 0-100, where a higher value corresponds to better health. The index score is derived from the EQ5D-3L survey, including 5 items with three levels of responses (no problems, some problems, and extreme problems).
Measured: At study start
Health-related quality of life - EQ-5D
The established self-assessment scale EQ-5D consist of both a visual analogue scale (EQ5D-VAS) and an index score. The EQ5D-VAS records subjective self-rated general well-being on a scale from 0-100, where a higher value corresponds to better health. The index score is derived from the EQ5D-3L survey, including 5 items with three levels of responses (no problems, some problems, and extreme problems).
Measured: After 12-weeks intervention
Health-related quality of life - EQ-5D
The established self-assessment scale EQ-5D consist of both a visual analogue scale (EQ5D-VAS) and an index score. The EQ5D-VAS records subjective self-rated general well-being on a scale from 0-100, where a higher value corresponds to better health. The index score is derived from the EQ5D-3L survey, including 5 items with three levels of responses (no problems, some problems, and extreme problems).
Measured: After one year follow-up
Work ability - C2WI
The established self-assessment scale C2WI (Capacity to Work Index) including 12 items is an index to assess capacity to work in relation to common mental disorders. The items can be answered with six alternatives: Not at all, To a low degree, To a moderate degree, To a high degree, I do not know and Not relevant.
Measured: At study start
Work ability - C2WI
The established self-assessment scale C2WI (Capacity to Work Index) including 12 items is an index to assess capacity to work in relation to common mental disorders. The items can be answered with six alternatives: Not at all, To a low degree, To a moderate degree, To a high degree, I do not know and Not relevant.
Measured: After 12-weeks intervention
Work ability - C2WI
The established self-assessment scale C2WI (Capacity to Work Index) including 12 items is an index to assess capacity to work in relation to common mental disorders. The items can be answered with six alternatives: Not at all, To a low degree, To a moderate degree, To a high degree, I do not know and Not relevant.
Measured: After one year follow-up
Physical activity - IPAQ
The short form of the established self-assessment scale IPAQ (The International Physical Activity Questionnaires) records the activity of four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting. Frequency and duration are collected separately for each specific type of activity. Both categorical and continuous indicators of physical activity can be obtained. The continuous indicator is presented as median minutes or median MET. Three levels of physical activity categories are recorded: Inactive, Minimally Active and Active.
Measured: At study start
Physical activity - IPAQ
The short form of the established self-assessment scale IPAQ (The International Physical Activity Questionnaires) records the activity of four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting. Frequency and duration are collected separately for each specific type of activity. Both categorical and continuous indicators of physical activity can be obtained. The continuous indicator is presented as median minutes or median MET. Three levels of physical activity categories are recorded: Inactive, Minimally Active and Active.
Measured: After 12-weeks intervention
Physical activity - IPAQ
The short form of the established self-assessment scale IPAQ (The International Physical Activity Questionnaires) records the activity of four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting. Frequency and duration are collected separately for each specific type of activity. Both categorical and continuous indicators of physical activity can be obtained. The continuous indicator is presented as median minutes or median MET. Three levels of physical activity categories are recorded: Inactive, Minimally Active and Active.
Measured: After one year follow-up
Body mass index - BMI
Measured at primary care center as kg/m2
Measured: At study start
Body mass index - BMI
Measured at primary care center as kg/m2
Measured: After 12-weeks intervention
Body mass index - BMI
Measured at primary care center as kg/m2
Measured: After one year follow-up
Blood pressure - mmHg
Measured at primary care center as mmHg.
Measured: At study start
Blood pressure - mmHg
Measured at primary care center as mmHg.
Measured: After 12-weeks intervention
Blood pressure - mmHg
Measured at primary care center as mmHg.
Measured: After one year follow-up
Health care contacts - registry data
Number of health care contacts due to anxiety disorders obtained from registry data in the Swedish National Patient register (hospital outpatient and inpatient care) and VEGA register (primary care data from Region Västra Götaland).
Measured: At study start
Health care contacts - registry data
Number of health care contacts due to anxiety disorders obtained from registry data in the Swedish National Patient register (hospital outpatient and inpatient care) and VEGA register (primary care data from Region Västra Götaland).
Measured: After 12-weeks intervention
Health care contacts - registry data
Number of health care contacts due to anxiety disorders obtained from registry data in the Swedish National Patient register (hospital outpatient and inpatient care) and VEGA register (primary care data from Region Västra Götaland).
Measured: After one year follow-up
Prescribed medication - registry data
Prescribed psychopharmaceuticals and analgesics, obtained from registry data in the Swedish Prescribed drug register and Digitalis register.
Measured: At study start
Prescribed medication - registry data
Prescribed psychopharmaceuticals and analgesics, obtained from registry data in the Swedish Prescribed drug register and Digitalis register.
Measured: After 12-weeks intervention
Prescribed medication - registry data
Prescribed psychopharmaceuticals and analgesics, obtained from registry data in the Swedish Prescribed drug register and Digitalis register.
Measured: After one year follow-up
Sick leave - registry data
Extent of sick leave obtained from registry data in the MiDAS register at the Swedish Social Insurance Agency.
Measured: At study start
Sick leave - registry data
Extent of sick leave obtained from registry data in the MiDAS register at the Swedish Social Insurance Agency.
Measured: After 12-weeks intervention
Sick leave - registry data
Extent of sick leave obtained from registry data in the MiDAS register at the Swedish Social Insurance Agency.
Measured: After one year follow-up
Mental and Physical health - registry data
Diagnoses of mental and physical health as ICD-10 codes (International Classification of Diseases ), obtained from the Swedish National Patient register (hospital outpatient and inpatient care) and VEGA register (primary care data from Region Västra Götaland).
Measured: At study start
Mental and Physical health - registry data
Diagnoses of mental and physical health as ICD-10 codes, obtained from the Swedish National Patient register (hospital outpatient and inpatient care) and VEGA register (primary care data from Region Västra Götaland).
Measured: After 12-weeks intervention
Mental and Physical health - registry data
Diagnoses of mental and physical health as ICD-10 codes, obtained from the Swedish National Patient register (hospital outpatient and inpatient care) and VEGA register (primary care data from Region Västra Götaland).
Measured: After one year follow-up
Sick leave and work ability - questionnaire
Questions regarding extent of sick leave and ability to work in a questionnaire designed by the research team.
Measured: At study start
Sick leave and work ability - questionnaire
Questions regarding extent of sick leave and ability to work in a questionnaire designed by the research team.
Measured: After 12-weeks intervention
Sick leave and work ability - questionnaire
Questions regarding extent of sick leave and ability to work in a questionnaire designed by the research team.
Measured: After one year follow-up
Used psychopharmaceuticals - questionnaire
Questions regarding usage of psychopharmaceuticals in a questionnaire designed by the research team.
Measured: At study start
Used psychopharmaceuticals - questionnaire
Questions regarding usage of psychopharmaceuticals in a questionnaire designed by the research team.
Measured: After 12-weeks intervention
Used psychopharmaceuticals - questionnaire
Questions regarding usage of psychopharmaceuticals in a questionnaire designed by the research team.
Measured: After one year follow-up
Physical activity - questionnaire
Questions regarding physical activity in a questionnaire designed by the research team.
Measured: At study start
Physical activity - questionnaire
Questions regarding physical activity in a questionnaire designed by the research team.
Measured: After 12-weeks intervention
Physical activity - questionnaire
Questions regarding physical activity in a questionnaire designed by the research team.
Measured: After one year follow-up
Pain - questionnaire
Questions regarding pain in a questionnaire designed by the research team.
Measured: At study start
Pain - questionnaire
Questions regarding pain in a questionnaire designed by the research team.
Measured: After 12-weeks intervention
Pain - questionnaire
Questions regarding pain in a questionnaire designed by the research team.
Measured: After one year follow-up
Health care consumption - questionnaire
Questions regarding health care consumption due to mental illness in a questionnaire designed by the research team.
Measured: At study start
Health care consumption - questionnaire
Questions regarding health care consumption due to mental illness in a questionnaire designed by the research team.
Measured: After 12-weeks intervention
Health care consumption - questionnaire
Questions regarding health care consumption due to mental illness in a questionnaire designed by the research team.
Measured: After one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start17 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A clinical intervention with a matched design and parallel arms.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
- Investigators
- Maria Åberg, PhD, MD, Principal investigator, School of Public Health and Community Medicine, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715852
- Sponsor's protocol ID
- Dnr 2024-02725-01
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data generated for the current study is not publicly available for ethical reasons (in order to get ethical approval, only authorized and designated researchers can have access to individual data and are not permitted to share this data), but data on group level are available from the principal investigator on reasonable request.
Publications
Briggs A, Sculpher M, Claxton K. Decision modelling for health economic evaluation: Oup Oxford; 2006.
Drummond MF, Sculpher MJ, Claxton K, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes: Oxford university press; 2015.
Sandheimer C, Bjorkelund C, Hensing G, Mehlig K, Hedenrud T. Implementation of a care manager organisation and its association with antidepressant medication patterns: a register-based study of primary care centres in Sweden. BMJ Open. 2021 Mar 5;11(3):e044959. doi: 10.1136/bmjopen-2020-044959.
PubMed 33674375Nyberg J, Henriksson M, Aberg ND, Wall A, Eggertsen R, Westerlund M, Danielsson L, Kuhn HG, Waern M, Aberg M. Effects of exercise on symptoms of anxiety, cognitive ability and sick leave in patients with anxiety disorders in primary care: study protocol for PHYSBI, a randomized controlled trial. BMC Psychiatry. 2019 Jun 10;19(1):172. doi: 10.1186/s12888-019-2169-5.
PubMed 31182054Batelaan NM, Seldenrijk A, Bot M, van Balkom AJ, Penninx BW. Anxiety and new onset of cardiovascular disease: critical review and meta-analysis. Br J Psychiatry. 2016 Mar;208(3):223-31. doi: 10.1192/bjp.bp.114.156554.
PubMed 26932485A N. 3.5.3 Omfattning - vad går att säga? God och nära vård - Rätt stöd till psykisk hälsa. Betänkande av utredningen Samordnad utveckling för god och nära vård. In: 2021:6 SouS, editor. Stockholm 2021: ISBN 978-91-525-0019-4; 2021. p. 164-6.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moving on! Can a Tailored Treatment in a Primary Care Setting Reduce Symptoms, Healthcare Consumption, Sick Leave and Prevent Pain and Hypertension in Individuals With Anxiety Disorders?
- ClinicalTrials.gov ID
- NCT06715852
- Acronym / sponsor ID
- Dnr 2024-02725-01
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to investigate the effects of two different interventions in patients with anxiety disorder and who seeks help at primary care centers. The participants will choose between two interventions:
- A 12-week physical exercise program with three training sessions per week, or
- A modified version of eHealth Lift, a digital development of the Health Lift, an evidence based lifestyle-intervention for health promotion and prevention in primary health care.
The participant will fill in self-assessment scales and questionnaires and also have BMI and blood pressure measured at the start of the study, at 12-weeks after the study start and after 1 year.
The main question the investigators aim to answer is if the interventions are better than treatment as usual for this group of patients regarding:
- symptoms of anxiety and depression
- pain
- sleep
- alcohol habits
- fatigue
- general health
- work ability/sick leave
- physical activity
- perceived quality of life
- BMI and blood pressure
- number of health care contacts
- psychopharmaceuticals and analgesics prescribed
- health literacy
Detailed description
Every third patient in the waiting room at a Swedish primary healthcare center is seeking help for common mental disorders including anxiety (1). Anxiety disorders substantially reduce quality of life and daily functioning and are, among mental disorders, the second leading cause of years lived with disability and the sixth-leading cause of disability globally. Anxiety disorders are also associated with elevated risks of pain, cardiovascular disease (CVD) and premature mortality (2), emphasizing the importance of finding effective treatment strategies that can be addressed in primary care.
Specific research questions:
- Can a tailored treatment and secondary prevention in a primary care setting reduce symptoms of anxiety, healthcare consumption, sick leave, pain and prevent hypertension in individuals with anxiety disorders?
- Are there long-term effects at 1 year of follow-up regarding the outcome measures?
- Is the treatment/secondary preventive strategy associated with health economic benefits?
Significance and scientific novelty: Despite the high burden of anxiety, there are major knowledge gaps when it comes to secondary preventive measures. This intervention aims to reduce anxiety, improve the quality of life, work ability and health in primary health care patients with anxiety disorders. Little research has focused on lifestyle improvements or exercise specifically in the treatment of anxiety. In Sweden there are guidelines from The National Board of Health and welfare for treatment of depression with exercise, but guidelines for treatment of anxiety disorders are currently lacking. Also results from this study may extend the current understanding and practice in the field of treatment and secondary prevention of anxiety disorders within primary care.
This project aims to combine evidence-based interventions to tailor a lifestyle intervention with different steps focusing on patient control and participation since the individual chooses the intervention arm. Two evidence-based lifestyle interventions will combined and evaluated: the modified eHealth Lift/Care manager according to regional clinical guidelines and PHYSBI, a promising new strategy with an intensive training program, a new approach for treating anxiety disorders. If a simple intervention program in primary care can alleviate anxiety, improve quality of life, cognitive performance, and work ability, prevent pain and hypertension, this may have a great positive impact both at the individual level and from a societal perspective. The investigators hope to increase the availability of person-centered, evidence-based and cost-effective measures to promote both physical and mental health in patients with anxiety disorders. Moreover, the interventions are designed to easily be implemented in regular primary care activities.
Design of study: A clinical intervention with a matched design with two parallel arms and three assessment points (baseline, post-intervention and 1 year of follow-up).
Setting: Primary care centers in Region Västra Götaland (VGR), Sweden Participants: Patients aged 18-65 diagnosed with anxiety disorders attending 20 primary care centers (PCCs) within the VGR. Participants will be recruited by personnel at the PCCs (doctors, psychologists, nurses), through information material at the PCCs (posters, flyers and handouts) and by using the primary care system Medrave to identify and contact suitable patients. Eligibility criteria can be found elsewhere in the ClinicalTrials.gov protocol. Participants will sign a written informed consent and informed about the possibility to withdraw from the study at any time without disadvantages.
Matching: PCCs connected to a rehabilitation clinic will be assigned as intervention PCCs. Thsese PCCs will be matched for the following variables 1) size of the PCC, 2) socioeconomy as Care Need Index (CNI) and 3). Matching will be executed in order to identify suitable PCCs with care as usual (controls).
The intervention: The 10 PCCs allocated to intervention will offer all patients with a registered anxiety diagnosis in the PCCs electronic patient register as well as patients newly diagnosed with any of the above listed disorders to participate in an intervention program. The patient chooses the intervention arm, and the focus is on person-centredness, control, empowerment and participation.
The two intervention-options are:
- Modified eHealth Lift, a digital development of the Health Lift, an evidence based lifestyle-intervention for health promotion and prevention in primary health care. This intervention will be executed together with care manager contact according to regional clinical guidelines.
- The moderate-high intensity arm of PHYSBI, an individualized 12-week training program for anxiety disorders including 3 occasions/week. The moderate intensity arm of PHYSBI, which also will contain elements of high intensity, corresponds to 3.0-8.9 metabolic equivalents, Borg Rating of Perceived Exertion 12-17 and 60-94% of maximal heart rate. The intervention includes cardiorespiratory and resistance training in a group-session (3). The study physiotherapists design individualized exercise programs during a single one-to-one session with the patients.
CAU (PCCs allocated to non-intervention): At Swedish PCCs, care as usual (CAU) for patients with anxiety disorders can consist of visits to various healthcare professionals (such as physicians, nurses, psychologists, therapists, physiotherapists). The treatment should follow the regional guidelines, which are based on the national evidence-based clinical guidelines for anxiety disorders (National guidelines for care of depression and anxiety disorders, The Swedish National Board of Health and Welfare, Stockholm 2020). These guidelines include psychopedagogic support, psychotherapy (cognitive behavioural therapy (CBT) face-to-face or internet-mediated), psychopharmaceutical treatment and/or sick listing (preferably partial).
Outcome measures: Individual data on symptoms of anxiety, depression, general health, pain, sleep, fatigue, work ability, physical activity and perceived quality of life will be obtained through established self-assessment scales and collected for each intervention arm. Patients will self-report smoking, concurrent illnesses, pain, usage of prescribed drugs and physical activity using a questionnaire designed by the research team. Data will also be obtained from the healthcare database VEGA (Database for health-care consumption in VGR), the national Patient register, the regional prescribed drug register Digitalis, the national Prescribed drug register and the MiDAS database at Försäkringskassan (includes data on sick leave >14 days). Specification of outcomes can be found elsewhere in the ClinicalTrials.gov protocol.
Timeline and Workplan: During 2024 a Clinical Trial registration will be submitted. The investigators already have established contacts with gyms, the PHCRs and the Research and Development primary healthcare centres. During 2024 the collaborations with the primary healthcare organization, the PHCRs and health centres will be further established. A steering committee will be formed and the study procedures tested. During autumn 2024 the PCCs will be invited to participate. At the intervention PCCs, the recruitment of patients will be facilitated through a research nurse. At every PCC, a unique care manager manager which has been implemented at all PCCs in VGR since 2016 (4) handles the modified eHealth Lift, and the physiotherapists implement PHYSBI. The PHCRs will perform the PHYSBI arm and the involved PCCs will implement the modified eHealth Lift arm continuously during the intervention year of 2025. Study start date is anticipated to be in Jan 2025 and primary completion date in Dec 2026 (1 year of follow-up). Outcome data will be collected throughout the period 2025-2026. In 2026-2027 data will be processed, analyzed and scientific papers produced.
Data analysis and statistics: The majority of outcome variables are scale variables that may be treated as continuous variables and therefore primarily modelled using linear regression. These are scales for symptoms of anxiety, depression, pain, sleep, general health, perceived quality of life, sick leave days, number of health care contacts and number and types of psychopharmaceuticals prescribed. Data will be presented using descriptive statistics, including means and standard deviations for continuous variables, and frequencies and percentages for categorical variables Group differences by intervention status (modified eHealth Lift, PHYSBI, or CAU) will be assessed by Kruskal-Wallis test and chi-square tests, respectively. The average change in continuous outcomes will be analyzed using linear regression, with intervention as categorical predictor and baseline levels as covariates.
In the case of count data the investigators will test whether Poisson or negative binomial models are more appropriate than linear regression. The correlation of outcomes between patients from the same PCC will be modelled using a hierarchical linear model including PCC as random effect. A more detailed analysis of the longitudinal change will be based on repeated-measure models that also account for the correlations within individuals. Interaction terms for PCC status and time will test whether time trends differ by intervention status. Binary endpoints such as sick leave will be analyzed using logistic regression with adjustment for correlations as described for the linear models. All regression models will be adjusted for age, sex, as well as for variables on PCC-level such as socioeconomy, number of patients listed per PCC (size), and proportion of patients with anxiety diagnoses.
Power considerations: A power calculations has been performed based on 20 health centres distributed 50:50 i.e. 10 controls and 10 with two interventions. However, as patients are allowed to choose between the two intervention types (modified eHealth Lift or PHYSBI) the investigators will consider an unequal distribution of intervention types, e.g. 70:30 % for the modified eHealth Lift and PHYSBI. As the main outcome measures are continuous, Cohen's d = mean difference/standard deviation is considered as outcome measure, assuming small to medium effect size, i.e. d = 0.2 - 0.5 [51]. Power analysis was performed using a STATA procedure for one-way ANOVA. For a change (baseline to 3 months) effects sizes with d ≥ 0.2 and a power of ≥0.9 (significance level = 0.05) can be observed with a total of 320 individuals, distributed as 160 patients without intervention, 112 with the modified eHealth Lift, and 48 with PHYSBI. The same sample size will yield even larger statistical power if the group size for the modified eHealth Lift and PHYSBI were more alike.
Health-economic analyses: Cost-effectiveness analyses will be performed separately, comparing the two intervention arms to no CAU, including both direct (healthcare and pharmaceutical utilization) and indirect (long-term sickness and absenteeism from work) costs. Cost-effectiveness analyses will be based on the primary data collected within the project and based on a combination of primary data and secondary data from other sources for lifetime time perspectives. The long-term analyses will be performed using a health-economic simulation model projecting the outcomes and cost-effectiveness at the 1-year follow-up to a longer time period (5 years and lifelong).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A clinical intervention with a matched design and parallel arms.
| Arm | Type | Receives |
|---|---|---|
| PHYSBI: 12-week physical exercise program | Experimental | Behavioral: PHYSBI: a 12-week physical exercise programAn individualized 12-week training program including 3 occasions/week of moderate-high intensity. It may also contain elements of high intensity, corresponding to 3.0-8.9 metabolic equivalents (METs), Borg Rating of Perceived Exertion (RPE) 12-17 and 60-94% of maximal heart rate. The intervention includes cardiorespiratory and resistance training where two sessions per week are group-sessions and one session per week is performed individually. A study physiotherapists will design individualized exercise programs during a single one-to-one session with the patients. |
| Modified eHealth Lift: a digital, evidence based lifestyle-intervention for health promotion. | Experimental | Behavioral: Modified eHealth Lift: a digital, evidence based lifestyle-intervention for health promotion.A modified and digital development of the Health Lift, an evidence based lifestyle-intervention for health promotion and prevention in primary health care. This intervention will be executed together with care manager contact according to medical guidelines. The patient receives a material consisting of separate questionnaires dealing with dietary habits, smoking, alcohol habits, physical activity, stress, living conditions, waist-hip-ratio and well-being expressed as a life ladder, present and future. Results are then converted into a health profile and a counsellor indicated what could be offered individually or in groups depending on the participant's wishes. This person-centered method ia based on strengthening the individual's own chosen health promoting activities and support for participation in municipal facilities. |
| Care as usual | No intervention | –Care as usual for anxiety disorders at the primary care centers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of anxiety disorder (panic syndrome, 41.0; generalized anxiety, F41.1; mixed anxiety- and depression, F41.2 and F41.3; anxiety not otherwise specified, F41.9).
- Seeking care at primary care centers within the Region Västra Götaland.
- With or without ongoing treatment with psychoactive medication (antidepressants or anxiolytics).
Key exclusion criteria (9 listed)
- Pregnancy
- Physical difficulties in performing a physical exercise program
- Pathological electrocardiogram
- Low BMI (under 17.5)
- Ongoing alcohol/substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHYSBI: a 12-week physical exercise programAn individualized 12-week training program including 3 occasions/week of moderate-high intensity. | Behavioural | PHYSBI: 12-week physical exercise program |
| Modified eHealth Lift: a digital, evidence based lifestyle-intervention for health promotion.Through questionnaires, the patients answers questions regarding lifestyle habits and the results are converted into a health profile. A care manager will together with the patient decide appropriate health promoting activities to engage in. | Behavioural | Modified eHealth Lift: a digital, evidence based lifestyle-intervention for health promotion. |
Primary outcome
Symptoms of anxiety - BAI
Time frame: At study start
Established psychiatric self-assessment scale Beck Anxiety Inventory (BAI). BAI is organized in 21 items, with scoring from nothing (0 p), slightly (1 p), moderately (2p) and severely (3p) and total ratings range from nothing, minimal/mild (score 0-15), moderately (score 16-25) and severely (score 26-63).
Symptoms of anxiety - BAI
Time frame: After 12-weeks intervention
Established psychiatric self-assessment scale Beck Anxiety Inventory (BAI). BAI is organized in 21 items, with scoring from nothing (0 p), slightly (1 p), moderately (2p) and severely (3p) and total ratings range from nothing, minimal/mild (score 0-15), moderately (score 16-25) and severely (score 26-63).
Symptoms of anxiety - BAI
Time frame: After one year follow-up
Established psychiatric self-assessment scale Beck Anxiety Inventory (BAI). BAI is organized in 21 items, with scoring from nothing (0 p), slightly (1 p), moderately (2p) and severely (3p) and total ratings range from nothing, minimal/mild (score 0-15), moderately (score 16-25) and severely (score 26-63).
Symptoms of Generalized Anxiety Disorder - GAD-7
Time frame: At study start
An established psychiatric self-assessment scale GAD-7 (Symptoms of Generalized Anxiety Disorder). A 7-item scale where anxiety severity is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety
Symptoms of Generalized Anxiety Disorder - GAD-7
Time frame: After 12-weeks intervention
An established psychiatric self-assessment scale GAD-7 (Symptoms of Generalized Anxiety Disorder). A 7-item scale where anxiety severity is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety
Symptoms of Generalized Anxiety Disorder - GAD-7
Time frame: After one year follow-up
An established psychiatric self-assessment scale GAD-7 (Symptoms of Generalized Anxiety Disorder). A 7-item scale where anxiety severity is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety
Symptoms of anxiety - HAD
Time frame: At study start
The established psychiatric self-assessment scale HAD (Hospital Anxiety and Depression Scale Symptoms of anxiety) is a scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Score 0-7 = Normal, 8-10 = Borderline abnormal and 11-21 = Abnormal (case).
Symptoms of anxiety - HAD
Time frame: After 12-weeks intervention
The established psychiatric self-assessment scale HAD (Hospital Anxiety and Depression Scale Symptoms of anxiety) is a scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Score 0-7 = Normal, 8-10 = Borderline abnormal and 11-21 = Abnormal (case).
Symptoms of anxiety - HAD
Time frame: After one year follow-up
The established psychiatric self-assessment scale HAD (Hospital Anxiety and Depression Scale Symptoms of anxiety) is a scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Score 0-7 = Normal, 8-10 = Borderline abnormal and 11-21 = Abnormal (case).
Symptoms of inner tension - MADRS-S; question 2
Time frame: At study start
The established psychiatric self-assessment scale MADRS-S (Montgomery-Åsberg Depression Rating Scale); question 2, which asks about inner tension (a proxy for anxiety). The question is scaled from 0 to 6, with higher scores reflecting more severe symptoms.
Symptoms of inner tension - MADRS-S; question 2
Time frame: After 12-weeks intervention
The established psychiatric self-assessment scale MADRS-S (Montgomery-Åsberg Depression Rating Scale); question 2, which asks about inner tension (a proxy for anxiety). The question is scaled from 0 to 6, with higher scores reflecting more severe symptoms.
Symptoms of inner tension - MADRS-S; question 2
Time frame: After one year follow-up
The established psychiatric self-assessment scale MADRS-S (Montgomery-Åsberg Depression Rating Scale); question 2, which asks about inner tension (a proxy for anxiety). The question is scaled from 0 to 6, with higher scores reflecting more severe symptoms.
57 secondary outcomes
Symptoms of depression - MADRS-S
Time frame: At study start
Symptoms of depression - MADRS-S
Time frame: After 12-weeks intervention
Symptoms of depression - MADRS-S
Time frame: After one year follow-up
Symptoms of pain - PSQ
Time frame: At study start
Symptoms of pain - PSQ
Time frame: After 12-weeks intervention
Symptoms of pain - PSQ
Time frame: After one year follow-up
Sleep quality - ISI
Time frame: At study start
Sleep quality - ISI
Time frame: After 12-weeks intervention
Sleep quality - ISI
Time frame: After one year follow-up
Alcohol habits - AUDIT
Time frame: At study start
Alcohol habits - AUDIT
Time frame: After 12-weeks intervention
Alcohol habits - AUDIT
Time frame: After one year follow-up
Fatigue - MFS
Time frame: At study start
Fatigue - MFS
Time frame: After 12-weeks intervention
Fatigue - MFS
Time frame: After one year follow-up
Health-related quality of life - EQ-5D
Time frame: At study start
Health-related quality of life - EQ-5D
Time frame: After 12-weeks intervention
Health-related quality of life - EQ-5D
Time frame: After one year follow-up
Work ability - C2WI
Time frame: At study start
Work ability - C2WI
Time frame: After 12-weeks intervention
Work ability - C2WI
Time frame: After one year follow-up
Physical activity - IPAQ
Time frame: At study start
Physical activity - IPAQ
Time frame: After 12-weeks intervention
Physical activity - IPAQ
Time frame: After one year follow-up
Body mass index - BMI
Time frame: At study start
Body mass index - BMI
Time frame: After 12-weeks intervention
Body mass index - BMI
Time frame: After one year follow-up
Blood pressure - mmHg
Time frame: At study start
Blood pressure - mmHg
Time frame: After 12-weeks intervention
Blood pressure - mmHg
Time frame: After one year follow-up
Health care contacts - registry data
Time frame: At study start
Health care contacts - registry data
Time frame: After 12-weeks intervention
Health care contacts - registry data
Time frame: After one year follow-up
Prescribed medication - registry data
Time frame: At study start
Prescribed medication - registry data
Time frame: After 12-weeks intervention
Prescribed medication - registry data
Time frame: After one year follow-up
Sick leave - registry data
Time frame: At study start
Sick leave - registry data
Time frame: After 12-weeks intervention
Sick leave - registry data
Time frame: After one year follow-up
Mental and Physical health - registry data
Time frame: At study start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- BackgroundBriggs A, Sculpher M, Claxton K. Decision modelling for health economic evaluation: Oup Oxford; 2006.
- BackgroundDrummond MF, Sculpher MJ, Claxton K, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes: Oxford university press; 2015.
- Background: PubMed 33674375Sandheimer C, Bjorkelund C, Hensing G, Mehlig K, Hedenrud T. Implementation of a care manager organisation and its association with antidepressant medication patterns: a register-based study of primary care centres in Sweden. BMJ Open. 2021 Mar 5;11(3):e044959. doi: 10.1136/bmjopen-2020-044959.
- Background: PubMed 31182054Nyberg J, Henriksson M, Aberg ND, Wall A, Eggertsen R, Westerlund M, Danielsson L, Kuhn HG, Waern M, Aberg M. Effects of exercise on symptoms of anxiety, cognitive ability and sick leave in patients with anxiety disorders in primary care: study protocol for PHYSBI, a randomized controlled trial. BMC Psychiatry. 2019 Jun 10;19(1):172. doi: 10.1186/s12888-019-2169-5.
- Background: PubMed 26932485Batelaan NM, Seldenrijk A, Bot M, van Balkom AJ, Penninx BW. Anxiety and new onset of cardiovascular disease: critical review and meta-analysis. Br J Psychiatry. 2016 Mar;208(3):223-31. doi: 10.1192/bjp.bp.114.156554.
- BackgroundA N. 3.5.3 Omfattning - vad går att säga? God och nära vård - Rätt stöd till psykisk hälsa. Betänkande av utredningen Samordnad utveckling för god och nära vård. In: 2021:6 SouS, editor. Stockholm 2021: ISBN 978-91-525-0019-4; 2021. p. 164-6.
- Webpage for the study (in Swedish)Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual data generated for the current study is not publicly available for ethical reasons (in order to get ethical approval, only authorized and designated researchers can have access to individual data and are not permitted to share this data), but data on group level are available from the principal investigator on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Åberg, PhD, MD principal investigator
School of Public Health and Community Medicine, University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHYSBI: a 12-week physical exercise program and Modified eHealth Lift: a digital, evidence based lifestyle-intervention for health promotion. in people with Anxiety, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Åberg, PhD, MD (+46 (0)709668274, maria.aberg@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of anxiety - BAI (time frame: At study start). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06715852, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.