Emotional DisorderPsicAP-Costs2NCT05314920
Cost-effectiveness of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care
A study testing Transdiagnostic cognitive-behavioral therapy (TD-CBT) and Bernstein and Borkovec progressive muscle relaxation (PMR) in people with Emotional Disorder, run by Instituto de Investigación Marqués de Valdecilla at 4 sites in Spain.
Trial summary
The aim of this study is to test the cost-effectiveness and cost-utility of adding a transdiagnostic group cognitive-behavioural therapy (TD-CBT) to treatment as usual (TAU) for emotional disorders in primary care . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Emotional Disorder
- What is being tested?
- Transdiagnostic cognitive-behavioral therapy (TD-CBT) and Bernstein and Borkovec progressive muscle relaxation (PMR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesSpain
- Study dates
- 1 Jan 2020to 1 Jun 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 65, inclusive, who present to the PC centre seeking treatment for anxiety, depressive or somatic symptoms.
- Scores above the predetermined cut-off points on the GAD-7 (>= 10), the PHQ-9 (>= 10) or the PHQ-15 (>=10 plus a score of 2 in three or more somatic symptoms).
- Agreement to participate in the study, with written informed consent.
Who cannot join
- Major depressive disorder (PHQ-9> 24) and/or severe disability (SDS > 25) will be interviewed by a clinician for the presence of any severe mental disorder, including autism spectrum disorders, bipolar disorder, schizophrenia, anorexia nervosa, substance dependence, personality disorder.
- Presence of severe or recent suicide attempts
- Presence of intellectual disability (IQ < 70).
- Be receiving psychological treatment or any type of specialized care related to mental health.
- Insufficient Spanish language skills
Trial locations and contacts
4 sites in 1 country.
Spain4 sites, 4 recruiting
- Recruiting
Centro Sanitario "Sardinero"
Santander, 39005
- Recruiting
Centro Sanitario "Dávila"
Santander, 39006
- Recruiting
Centro Sanitario "Camargo Costa"
Santander, 39600
- Recruiting
Centro Sanitario "Camargo Interior"
Santander, 39600
About this study
Official title: Cost-effectiveness of Transdiagnostic Group Psychological Treatment for Common Mental Disorders in Primary Care (PsicAP-Costs2): a Randomized Controlled Clinical Trial
The aim of this study is to test the cost-effectiveness and cost-utility of adding a transdiagnostic group cognitive-behavioural therapy (TD-CBT) to treatment as usual (TAU) for emotional disorders in primary care . A single-blind randomized controlled clinical trial will be conducted to compare the TD-CBT group therapy plus TAU to progressive muscle relaxation (PMR) group plus TAU in individuals, aged 18 to 65, with emotional disorders in four primary care centres located in Cantabria, Spain. The study will take a societal perspective. Psychological assessments will be carried out at baseline, post-treatment, and 12-months follow-up. The assessments will include measures of clinical symptoms (anxiety, depression, and/or somatic), dysfunction, cognitive-emotional factors (ruminative processes, pathological concern, attentional and interpretative biases, emotion regulation strategies and meta-cognitive beliefs), and satisfaction with the treatment received. Data on health service use, including medication and days of absence from work, will be collected from electronic medical records. The primary outcomes are the incremental cost-effectiveness ratios (ICER) based on the difference in mean costs and effectiveness between interventions and incremental cost-utility ratios (ICURs) based on health-related quality of life at post-treatment and 12-month follow-up. Secondary outcome measures include clinical symptoms, quality of life, functioning and treatment satisfaction. Bootstrap sampling will be used to assess the uncertainty of the results. Secondary moderation and mediation analyses will also be conducted. In addition, in sessions' number 1, 4 and 7 of both treatment arms, two questionnaires will be administered that collect therapeutic alliance and group satisfaction. The main study hypothesis is that adding TD-CBT to TAU in primary care will be more cost-effective than TAU plus PMR. In addition, these gains will be maintained in the 12-month follow-up. If it is successful, the dissemination of cost-effective treatment can help to overcome problems in accessing psychological treatment for emotional disorders in the context of an increasing demand for mental healthcare in primary care.
- Conditions
- Emotional Disorder
- Being tested
- Transdiagnostic cognitive-behavioral therapy (TD-CBT), Bernstein and Borkovec progressive muscle relaxation (PMR)
- Keywords
- transdiagnostic therapy, emotional disorders, primary care, cost-benefit analysis, brief psychological treatments, cognitive behavioral therapy, randomized controlled trial, depression, anxiety disorders, somatoform disorders
- Medical subject headings
- Depression, Anxiety Disorders, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic cognitive-behavioral therapy (TD-CBT)Behavioural
Transdiagnostic cognitive-behavioral therapy (TD-CBT)
Bernstein and Borkovec progressive muscle relaxation (PMR)Behavioural
Bernstein and Borkovec progressive muscle relaxation (PMR)
| Study group | Role | What they receive |
|---|---|---|
| transdiagnostic cognitive-behavioural therapy (TD-CBT) | Experimental | Transdiagnostic cognitive-behavioral group therapy: The psychological interventions will be manualized. Patients assigned to the experimental group will receive 7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals over a 12-week period. Receives: Behavioral: Transdiagnostic cognitive-behavioral therapy (TD-CBT) |
| relaxation therapy | Active comparator | The control group will receive a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure. Patients will receive 7 sessions (1.5 hr/session) in groups of 8-10 individuals over a 12-week period. Receives: Behavioral: Bernstein and Borkovec progressive muscle relaxation (PMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cost-effectiveness data
Cost-effectiveness results will be calculated by the ICER, defined as the difference in mean costs between interventions divided by the difference in their effectiveness according to the symptom questionnaires' mean scores.
The healthcare data collected will be used for cost calculations. To calculate healthcare-related costs, an ad hoc questionnaire will be used to collect emotional disorder-related healthcare data (public and private healthcare consultations, accidents, medical tests, and sick leaves in the past 3 months; psychotropic drugs or other medication, and their posology).
Measured: Baseline, immediately after the intervention, and 12-month follow-up
Change in cost-utility data
Cost-utility will be measured through the healthcare data collected above and the European Quality of Life Scale (EuroQoL, EQ) (The EuroQol Group, 1990), calculating the QALYS and the ICURs, defined as the difference in mean cost divided by the difference in mean QALYs. The Spanish version of the 5-domain, 5-level EuroQol (EQ-5D-5L) (Badia et al., 1999; van Reenen et al., 2019) will be used to assess health status in five dimensions (mobility, self-care, daily activities, pain/unease, and anxiety/depression) with five levels of severity (no problems, slight problems, moderate problems, severe problems, and either extreme problems or unable to perform activity).
Measured: Baseline, immediately after the intervention, and 12 month follow-up
Secondary outcomes (5)
Change in depressive symptoms: Patient Health Questionnaire - 9 item (PHQ-9)
The PHQ-9 (Kroenke et al., 2001) is the depression module of the PHQ (Díez-Quevedo et al., 2001; Spitzer et al., 1999) that scores the 9 DSM-IV depression criteria in the last two weeks. Is a nine item, self-report scale that ranges from 0 to 27 (higher scores means a worse outcome).
Measured: Baseline, immediately after the intervention, and 12 month follow-up
Change in anxiety symptoms: Generalized Anxiety Disorder - 7 item (GAD-7)
The GAD-7 (Spitzer et al., 2006) assesses common anxiety symptoms in the last two weeks. It is composed of seven self-report items ranging from 0 to 21 points. Higher scores means a greater presence of anxiety symptoms.
Measured: Baseline, immediately after the intervention, and 12 month follow-up
Change in somatic symptoms: Patient Health Questionnaire - 15 item (PHQ-15)
The PHQ-15 (Kroenke et al., 2002) is the somatization module of the PHQ and scores symptoms present in the past four weeks. The scale is composed of fifteen self-report items, ranging from 0 to 30. Higher scores means a worse outcome.
Measured: Baseline, immediately after the intervention, and 12 month follow-up
Change in functioning: Sheehan Disability Scale (SDS)
The SDS (Sheehan et al., 1996) is a five item self-reported scale composed of three main domains (work, family and social functioning) and two optional items (perceived stress and perceived social support). It ranges from 0 to 50, with higher scores indicating a worse outcome.
Measured: Baseline, immediately after the intervention, and 12 month follow-up
Change in treatment satisfaction
Posttreatment and 12-month follow-up assessments will also collect an additional question about treatment satisfaction, through a Likert-type question, ranging from 0 to 10.
Measured: Immediately after the intervention and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Jan 2020
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional DisorderStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter randomized controlled trial with pre-post measures and 12-month follow-up.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314920
- Sponsor's protocol ID
- PsicAP-Costs2
- Acronym
- PsicAP-Costs2
- Status last verified
- May 2022
- First submitted
- 25 Jan 2022
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez-Blanch C, Barrio-Martinez S, Priede A, Martinez-Gomez S, Perez-Garcia-Abad S, Miras-Aguilar M, Ruiz-Gutierrez J, Munoz-Navarro R, Ruiz-Rodriguez P, Medrano LA, Prieto-Vila M, Carpallo-Gonzalez M, Aguilera-Martin A, Galvez-Lara M, Cuadrado F, Moreno E, Garcia-Torres F, Vencesla JF, Corpas J, Jurado-Gonzalez FJ, Moriana JA, Cano-Vindel A. Cost-effectiveness of transdiagnostic group cognitive behavioural therapy versus group relaxation therapy for emotional disorders in primary care (PsicAP-Costs2): Protocol for a multicentre randomised controlled trial. PLoS One. 2023 Mar 16;18(3):e0283104. doi: 10.1371/journal.pone.0283104. eCollection 2023.
PubMed 36928238
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of Transdiagnostic Group Psychological Treatment for Common Mental Disorders in Primary Care (PsicAP-Costs2): a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05314920
- Acronym / sponsor ID
- PsicAP-Costs2 / PsicAP-Costs2
- Conditions
- Emotional Disorder
- Keywords
- transdiagnostic therapy, emotional disorders, primary care, cost-benefit analysis, brief psychological treatments, cognitive behavioral therapy, randomized controlled trial, depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 7 Apr 2022 (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 aim of this study is to test the cost-effectiveness and cost-utility of adding a transdiagnostic group cognitive-behavioural therapy (TD-CBT) to treatment as usual (TAU) for emotional disorders in primary care . A single-blind randomized controlled clinical trial will be conducted to compare the TD-CBT group therapy plus TAU to progressive muscle relaxation (PMR) group plus TAU in individuals, aged 18 to 65, with emotional disorders in four primary care centres located in Cantabria, Spain. The study will take a societal perspective. Psychological assessments will be carried out at baseline, post-treatment, and 12-months follow-up. The assessments will include measures of clinical symptoms (anxiety, depression, and/or somatic), dysfunction, cognitive-emotional factors (ruminative processes, pathological concern, attentional and interpretative biases, emotion regulation strategies and meta-cognitive beliefs), and satisfaction with the treatment received. Data on health service use, including medication and days of absence from work, will be collected from electronic medical records. The primary outcomes are the incremental cost-effectiveness ratios (ICER) based on the difference in mean costs and effectiveness between interventions and incremental cost-utility ratios (ICURs) based on health-related quality of life at post-treatment and 12-month follow-up. Secondary outcome measures include clinical symptoms, quality of life, functioning and treatment satisfaction. Bootstrap sampling will be used to assess the uncertainty of the results. Secondary moderation and mediation analyses will also be conducted. In addition, in sessions' number 1, 4 and 7 of both treatment arms, two questionnaires will be administered that collect therapeutic alliance and group satisfaction. The main study hypothesis is that adding TD-CBT to TAU in primary care will be more cost-effective than TAU plus PMR. In addition, these gains will be maintained in the 12-month follow-up. If it is successful, the dissemination of cost-effective treatment can help to overcome problems in accessing psychological treatment for emotional disorders in the context of an increasing demand for mental healthcare in primary care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multicenter randomized controlled trial with pre-post measures and 12-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| transdiagnostic cognitive-behavioural therapy (TD-CBT) | Experimental | Behavioral: Transdiagnostic cognitive-behavioral therapy (TD-CBT)Transdiagnostic cognitive-behavioral group therapy: The psychological interventions will be manualized. Patients assigned to the experimental group will receive 7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals over a 12-week period. |
| relaxation therapy | Active comparator | Behavioral: Bernstein and Borkovec progressive muscle relaxation (PMR)The control group will receive a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure. Patients will receive 7 sessions (1.5 hr/session) in groups of 8-10 individuals over a 12-week period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 to 65, inclusive, who present to the PC centre seeking treatment for anxiety, depressive or somatic symptoms.
- Scores above the predetermined cut-off points on the GAD-7 (>= 10), the PHQ-9 (>= 10) or the PHQ-15 (>=10 plus a score of 2 in three or more somatic symptoms).
- Agreement to participate in the study, with written informed consent.
Key exclusion criteria (5 listed)
- Major depressive disorder (PHQ-9> 24) and/or severe disability (SDS > 25) will be interviewed by a clinician for the presence of any severe mental disorder, including autism spectrum disorders, bipolar disorder, schizophrenia, anorexia nervosa, substance dependence, personality disorder.
- Presence of severe or recent suicide attempts
- Presence of intellectual disability (IQ < 70).
- Be receiving psychological treatment or any type of specialized care related to mental health.
- Insufficient Spanish language skills
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 |
|---|---|---|
| Transdiagnostic cognitive-behavioral therapy (TD-CBT)Transdiagnostic cognitive-behavioral therapy (TD-CBT) | Behavioural | transdiagnostic cognitive-behavioural therapy (TD-CBT) |
| Bernstein and Borkovec progressive muscle relaxation (PMR)Bernstein and Borkovec progressive muscle relaxation (PMR) | Behavioural | relaxation therapy |
Primary outcome
Change in cost-effectiveness data
Time frame: Baseline, immediately after the intervention, and 12-month follow-up
Cost-effectiveness results will be calculated by the ICER, defined as the difference in mean costs between interventions divided by the difference in their effectiveness according to the symptom questionnaires' mean scores. The healthcare data collected will be used for cost calculations. To calculate healthcare-related costs, an ad hoc questionnaire will be used to collect emotional disorder-related healthcare data (public and private healthcare consultations, accidents, medical tests, and sick leaves in the past 3 months; psychotropic drugs or other medication, and their posology).
Change in cost-utility data
Time frame: Baseline, immediately after the intervention, and 12 month follow-up
Cost-utility will be measured through the healthcare data collected above and the European Quality of Life Scale (EuroQoL, EQ) (The EuroQol Group, 1990), calculating the QALYS and the ICURs, defined as the difference in mean cost divided by the difference in mean QALYs. The Spanish version of the 5-domain, 5-level EuroQol (EQ-5D-5L) (Badia et al., 1999; van Reenen et al., 2019) will be used to assess health status in five dimensions (mobility, self-care, daily activities, pain/unease, and anxiety/depression) with five levels of severity (no problems, slight problems, moderate problems, severe problems, and either extreme problems or unable to perform activity).
5 secondary outcomes
Change in depressive symptoms: Patient Health Questionnaire - 9 item (PHQ-9)
Time frame: Baseline, immediately after the intervention, and 12 month follow-up
Change in anxiety symptoms: Generalized Anxiety Disorder - 7 item (GAD-7)
Time frame: Baseline, immediately after the intervention, and 12 month follow-up
Change in somatic symptoms: Patient Health Questionnaire - 15 item (PHQ-15)
Time frame: Baseline, immediately after the intervention, and 12 month follow-up
Change in functioning: Sheehan Disability Scale (SDS)
Time frame: Baseline, immediately after the intervention, and 12 month follow-up
Change in treatment satisfaction
Time frame: Immediately after the intervention and 12-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Derived from this study: PubMed 36928238Gonzalez-Blanch C, Barrio-Martinez S, Priede A, Martinez-Gomez S, Perez-Garcia-Abad S, Miras-Aguilar M, Ruiz-Gutierrez J, Munoz-Navarro R, Ruiz-Rodriguez P, Medrano LA, Prieto-Vila M, Carpallo-Gonzalez M, Aguilera-Martin A, Galvez-Lara M, Cuadrado F, Moreno E, Garcia-Torres F, Vencesla JF, Corpas J, Jurado-Gonzalez FJ, Moriana JA, Cano-Vindel A. Cost-effectiveness of transdiagnostic group cognitive behavioural therapy versus group relaxation therapy for emotional disorders in primary care (PsicAP-Costs2): Protocol for a multicentre randomised controlled trial. PLoS One. 2023 Mar 16;18(3):e0283104. doi: 10.1371/journal.pone.0283104. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic cognitive-behavioral therapy (TD-CBT) and Bernstein and Borkovec progressive muscle relaxation (PMR) in people with Emotional Disorder, run by Instituto de Investigación Marqués de Valdecilla at 4 sites in Spain.
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 5 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: status not confirmed, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact César González-Blanch Bosch, PhD (+34-942-202537, cesar.gonzalezblanch@scsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cost-effectiveness data (time frame: Baseline, immediately after the intervention, and 12-month follow-up). The study lists 2 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 NCT05314920, which also lists 1 linked publication.
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 20 May 2022.