StressNCT04820283
Early Interventions for Primary Care Patients With Stress-related Ill-health: a Non-inferiority RCT
A study testing Care manager intervention (nurse) and CBT in people with Stress, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Stress-related ill-health is rated one of the largest health challenges in the western world. The most empirically supported treatment for stress-related disorders is cognitive behaviour therapy (CBT), but accessibility is low and most patients in primary care do not receive this evidence-based treatment. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Stress
- What is being tested?
- Care manager intervention (nurse) and CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteSweden
- Study dates
- 29 Apr 2021to 7 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At least 16 years of age
- A score of 20 or higher on the Perceived Stress Scale-10
- Stress-related ill-health is the principal problem
- Duration of problems for at least 1 month
- Have symptoms in the mild to moderate range
- Be able to read and write in Swedish
- Have access to a computer with Internet connection
- If the participant is on sick leave then the sick leave period should have a maximum duration of 2 months (full time sick-leave for 2 months is thus allowed)
Who cannot join
- Ongoing other psychological treatment for stress-related problems
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Gustavsbergs Primary Care Center
Gustavsberg, Stockholm County, 134 40
About this study
Official title: Early Interventions for Primary Care Patients With Stress-related Ill-health: a Randomized Controlled Non-inferiority Trial of a Collaborative Care Intervention vs. Cognitive Behavior Therapy
Stress-related ill-health is rated one of the largest health challenges in the western world. The most empirically supported treatment for stress-related disorders is cognitive behaviour therapy (CBT), but accessibility is low and most patients in primary care do not receive this evidence-based treatment. Collaborative care has been shown to be an effective working model for primary care patients with mental health problems. This type of care intervention has however not been compared against CBT, which is arguably the gold standard treatment for this patient group. The overarching purpose of this project is to investigate if implementation of two treatment models - collaborative care and therapist-guided self-help CBT -can be effective as early interventions for primary care patients with stress-related ill-health.
Read the detailed description
Stress-related ill-health is rated one of the largest health challenges in the western world. The most empirically supported treatment for stress-related disorders is cognitive behaviour therapy (CBT), but accessibility is low and most patients in primary care do not receive this evidence-based treatment. Collaborative care has been shown to be an effective working model for primary care patients with mental health problems. In this study collaborative care is conducted by a nurse who provides the patient with self-management support. This intervention has been implemented at Gustavsbergs primary care clinic in Stockholm as a means to increase accessibility and quality of care for the large group of patients with stress-related ill-health. This type of care intervention has however not been compared against CBT, which is arguably the gold standard treatment for this patient group.
Our research group has developed and tested a therapist-guided self-help CBT (SH-CBT) that can be delivered online or as a self-help book with support by a clinician for stress-related ill health, which has been shown to be effective and also potentially very suitable for the primary care context. The overarching purpose of this project is to investigate if implementation of two treatment models - collaborative care and SH-CBT - can be effective as early interventions for primary care patients with stress-related ill-health.
Main research question: Is a brief collaborative care intervention provided by a nurse at least as effective as SH-CBT delivered by a psychologist for primary care patients with mild to moderate symptoms of stress?
Note: In may 2022, the research group made revisions to the study procedures in terms of administration format of CBT and inclusion criteria. These specific changes were made: (1) Participants randomized to SH-CBT are allowed to choose if they want to receive the treatment as therapist-guided online CBT or as therapist-guided bibliotherapy CBT. Participants are exposed to the same treatment content, but in the former case the material is presented on a secure website with asynchronous written therapist support and in the latter case the content is provided through a self-help book and the participant has 2-5 face-to-face appointments with the therapist; (2) It is no longer required that participants has adjustment disorder, instead participants have to have (a) a score on the Perceived Stress Scale-10 of 20 or higher, (b) stress-related ill-health as their principal problem, and (c) a duration of their problems of at least 1 month; (3) The sick-leave criterion is changed so that participants to be included are allowed to have been on full time sick-leave for maximum 2 months (instead of 50% for maximum 1 month).
The revisions described above were made in order to better operationalize the patient population "patients with mild to moderate stress-related ill-health" and to increase the recruitment of participants to the study. When the revisions were implemented approximately 20 participants had been included in the study. The revisions were approved by the Swedish Ethical Review Authority (ID 2022-00990-02).
Note 2: In the autumn of 2023, a new power calculation was conducted where full use of the 5 assessment points between baseline and post-treatment (12 weeks) was taken into account. This new power calculation, based in linear mixed models analysis for longitudinal data, showed that in order to have 80% power to demonstrate non-inferiority (non-inferiority margin d=0.3; one-sided 95% confidence interval) given a true effect difference of 0, approximately 170 participants (85 per treatment arm) will be needed.
- Conditions
- Stress
- Being tested
- Care manager intervention (nurse), CBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care manager intervention (nurse)Behavioural
In this intervention, a primary care nurse provides the participant with self-management support to manage stress-related problems. The participant meets with the nurse face-to-face for typically 2 to 6 sessions.
CBTBehavioural
In this intervention, the participant receives therapist supported self-help CBT. The participant randomized to this arm can choose to receive the treatment via an online treatment platform or via bibliotherapy, i.e., a self-help book.The treatment is comprised of 12 modules or chapters, which entail information about stress management techniques including behavioral activation and exposure. The participant that chooses online CBT is guided by a therapist who provides feedback on homework assignments through written asynchronous text messages; the patient who chooses bibliotherapy is guided by a therapist in typically 2 to 5 face-to-face sessions at a primary care clinic.
| Study group | Role | What they receive |
|---|---|---|
| Care manager intervention (nurse) | Experimental | Not described Receives: Behavioral: Care manager intervention (nurse) |
| Internet-based CBT | Active comparator | Not described Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS-10)
Change in PSS at post-treatment and follow-up compared to baseline (scale range 0-40, higher score means more symptoms)
Measured: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up
Secondary outcomes (8)
Shirom-Melamed Burnout Questionnaire (SMBQ)
Change in SMBQ at post-treatment and follow-up compared to baseline (scale range 1-7, higher score means more symptoms)
Measured: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up
Insomnia Severity Index (ISI)
Change in ISI at post-treatment and follow-up compared to baseline (scale range 0-28, higher score means more symptoms)
Measured: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up
Generalized Anxiety Disorder-7 (GAD-7)
Change in GAD-7 at post-treatment and follow-up compared to baseline (scale range 0-21, higher score means more symptoms)
Measured: Baseline, week 12 (post-treatment), 1-year follow-up
Patient Health Questionnaire-9 (PHQ-9)
Change in PHQ-9 at post-treatment and follow-up compared to baseline (scale range 0-27, higher score means more symptoms)
Measured: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up
Brunnsviken Brief Quality of Life Index (BBQ)
Change in BBQ at post-treatment and follow-up compared to baseline (scale range 0-96, higher score means higher quality of life)
Measured: Baseline, week 12 (post-treatment), 1-year follow-up
EuroQol 5D (EQ5D)
Change in EQ5D at post-treatment and follow-up compared to baseline (the answers will be converted to utility score of health states ranging from 0 to 1 where 0 represents death and 1 full health)
Measured: Baseline, week 12 (post-treatment), 1-year follow-up
Trimbos and Institute of Medical Technology Assessment of Cost Questionnaire for Psychiatry (TIC-P)
The TIC-P enables estimation of costs by collecting information about participant resource utilization and costs related to production loss. Change in costs will be analyzed at post-treatment and follow-up compared to baseline.
Measured: Baseline, week 12 (post-treatment), 1-year follow-up
Sick leave
Sick leave data from the Microdata for Analysis of Social Security (MiDAS) registry. Analyzed as full day equivalents.
Measured: 1 year from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start29 Apr 2021
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled non-inferiority trial with two arms. A non-inferiority margin of Cohen's d 0.3 on the primary outcome Perceived Stress Scale at post-treatment (change from baseline to 12 weeks) will be used. For test of non-inferiority on the primary outcome, a one-sided 95% confidence interval (CI) will be used. If the two-sided 95% CI (exploratory analyses) does not include 0 this will be interpreted as indicating superiority of the corresponding treatment.
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Erik Hedman, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820283
- Sponsor's protocol ID
- Early interventions for stress
- Status last verified
- Sep 2025
- First submitted
- 24 Mar 2021
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Interventions for Primary Care Patients With Stress-related Ill-health: a Randomized Controlled Non-inferiority Trial of a Collaborative Care Intervention vs. Cognitive Behavior Therapy
- ClinicalTrials.gov ID
- NCT04820283
- Acronym / sponsor ID
- Early interventions for stress
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 29 Mar 2021 (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.
Stress-related ill-health is rated one of the largest health challenges in the western world. The most empirically supported treatment for stress-related disorders is cognitive behaviour therapy (CBT), but accessibility is low and most patients in primary care do not receive this evidence-based treatment. Collaborative care has been shown to be an effective working model for primary care patients with mental health problems. This type of care intervention has however not been compared against CBT, which is arguably the gold standard treatment for this patient group. The overarching purpose of this project is to investigate if implementation of two treatment models - collaborative care and therapist-guided self-help CBT -can be effective as early interventions for primary care patients with stress-related ill-health.
Detailed description
Stress-related ill-health is rated one of the largest health challenges in the western world. The most empirically supported treatment for stress-related disorders is cognitive behaviour therapy (CBT), but accessibility is low and most patients in primary care do not receive this evidence-based treatment. Collaborative care has been shown to be an effective working model for primary care patients with mental health problems. In this study collaborative care is conducted by a nurse who provides the patient with self-management support. This intervention has been implemented at Gustavsbergs primary care clinic in Stockholm as a means to increase accessibility and quality of care for the large group of patients with stress-related ill-health. This type of care intervention has however not been compared against CBT, which is arguably the gold standard treatment for this patient group.
Our research group has developed and tested a therapist-guided self-help CBT (SH-CBT) that can be delivered online or as a self-help book with support by a clinician for stress-related ill health, which has been shown to be effective and also potentially very suitable for the primary care context. The overarching purpose of this project is to investigate if implementation of two treatment models - collaborative care and SH-CBT - can be effective as early interventions for primary care patients with stress-related ill-health.
Main research question: Is a brief collaborative care intervention provided by a nurse at least as effective as SH-CBT delivered by a psychologist for primary care patients with mild to moderate symptoms of stress?
Note: In may 2022, the research group made revisions to the study procedures in terms of administration format of CBT and inclusion criteria. These specific changes were made: (1) Participants randomized to SH-CBT are allowed to choose if they want to receive the treatment as therapist-guided online CBT or as therapist-guided bibliotherapy CBT. Participants are exposed to the same treatment content, but in the former case the material is presented on a secure website with asynchronous written therapist support and in the latter case the content is provided through a self-help book and the participant has 2-5 face-to-face appointments with the therapist; (2) It is no longer required that participants has adjustment disorder, instead participants have to have (a) a score on the Perceived Stress Scale-10 of 20 or higher, (b) stress-related ill-health as their principal problem, and (c) a duration of their problems of at least 1 month; (3) The sick-leave criterion is changed so that participants to be included are allowed to have been on full time sick-leave for maximum 2 months (instead of 50% for maximum 1 month).
The revisions described above were made in order to better operationalize the patient population "patients with mild to moderate stress-related ill-health" and to increase the recruitment of participants to the study. When the revisions were implemented approximately 20 participants had been included in the study. The revisions were approved by the Swedish Ethical Review Authority (ID 2022-00990-02).
Note 2: In the autumn of 2023, a new power calculation was conducted where full use of the 5 assessment points between baseline and post-treatment (12 weeks) was taken into account. This new power calculation, based in linear mixed models analysis for longitudinal data, showed that in order to have 80% power to demonstrate non-inferiority (non-inferiority margin d=0.3; one-sided 95% confidence interval) given a true effect difference of 0, approximately 170 participants (85 per treatment arm) will be needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled non-inferiority trial with two arms. A non-inferiority margin of Cohen's d 0.3 on the primary outcome Perceived Stress Scale at post-treatment (change from baseline to 12 weeks) will be used. For test of non-inferiority on the primary outcome, a one-sided 95% confidence interval (CI) will be used. If the two-sided 95% CI (exploratory analyses) does not include 0 this will be interpreted as indicating superiority of the corresponding treatment.
| Arm | Type | Receives |
|---|---|---|
| Care manager intervention (nurse) | Experimental | Behavioral: Care manager intervention (nurse) |
| Internet-based CBT | Active comparator | Behavioral: CBT |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- At least 16 years of age
- A score of 20 or higher on the Perceived Stress Scale-10
- Stress-related ill-health is the principal problem
- Duration of problems for at least 1 month
- Have symptoms in the mild to moderate range
Key exclusion criteria (1 listed)
- Ongoing other psychological treatment for stress-related problems
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 |
|---|---|---|
| Care manager intervention (nurse)In this intervention, a primary care nurse provides the participant with self-management support to manage stress-related problems. The participant meets with the nurse face-to-face for typically 2 to 6 sessions. | Behavioural | Care manager intervention (nurse) |
| CBTIn this intervention, the participant receives therapist supported self-help CBT. The participant randomized to this arm can choose to receive the treatment via an online treatment platform or via bibliotherapy, i.e., a self-help book.The treatment is comprised of 12 modules or chapters, which entail information about stress management techniques including behavioral activation and exposure. The participant that chooses online CBT is guided by a therapist who provides feedback on homework assignments through written asynchronous text messages; the patient who chooses bibliotherapy is guided by a therapist in typically 2 to 5 face-to-face sessions at a primary care clinic. | Behavioural | Internet-based CBT |
Primary outcome
Perceived Stress Scale (PSS-10)
Time frame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up
Change in PSS at post-treatment and follow-up compared to baseline (scale range 0-40, higher score means more symptoms)
8 secondary outcomes
Shirom-Melamed Burnout Questionnaire (SMBQ)
Time frame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up
Insomnia Severity Index (ISI)
Time frame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, week 12 (post-treatment), 1-year follow-up
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up
Brunnsviken Brief Quality of Life Index (BBQ)
Time frame: Baseline, week 12 (post-treatment), 1-year follow-up
EuroQol 5D (EQ5D)
Time frame: Baseline, week 12 (post-treatment), 1-year follow-up
Trimbos and Institute of Medical Technology Assessment of Cost Questionnaire for Psychiatry (TIC-P)
Time frame: Baseline, week 12 (post-treatment), 1-year follow-up
Sick leave
Time frame: 1 year from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care manager intervention (nurse) and CBT in people with Stress, run by Karolinska Institutet 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 8 inclusion and 1 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: finished, as of the sponsor's last update on 15 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS-10) (time frame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2025.