Cost-effectiveness of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care

Study Overview
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Brief Summary
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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.

Official Title
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Cost-effectiveness of Transdiagnostic Group Psychological Treatment for Common Mental Disorders in Primary Care (PsicAP-Costs2): a Randomized Controlled Clinical Trial

Conditions
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Emotional Disorder

Intervention / Treatment
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* Behavioral: Transdiagnostic cognitive-behavioral therapy (TD-CBT)
* Behavioral: Bernstein and Borkovec progressive muscle relaxation (PMR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter randomized controlled trial with pre-post measures and 12-month follow-up.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transdiagnostic cognitive-behavioural therapy (TD-CBT)<br>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. | Behavioral: Transdiagnostic cognitive-behavioral therapy (TD-CBT)<br>* Transdiagnostic cognitive-behavioral therapy (TD-CBT)<br>|
| Active Comparator: relaxation therapy<br>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. | Behavioral: Bernstein and Borkovec progressive muscle relaxation (PMR)<br>* Bernstein and Borkovec progressive muscle relaxation (PMR)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | Baseline, immediately after the intervention, and 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 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. | 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. | Immediately after the intervention and 12-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transdiagnostic therapy, emotional disorders, primary care, cost-benefit analysis, brief psychological treatments, cognitive behavioral therapy, randomized controlled trial, depression, anxiety disorders, somatoform disorders