A Transdiagnostic Course for Common Mental Health Problems in Primary Care

Study Overview
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Brief Summary
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This study investigates the feasibility of a transdiagnostic course that is intended to work for a large variety of patient groups with clinically significant depression or anxiety in primary care. This is a prospective single-group study where 68 adults with clinically significant symptoms of depression or general anxiety, and up to 25 adults with subclinical symptoms, attend up to 6 weekly structured large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing. If necessary, due to the covid-19 pandemic, the course will be held online.

Detailed Description
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Background: Depression and the common anxiety disorders are highly prevalent and associated with disability and reduced quality of life. There is reason to believe that the majority of these patients are found in primary care. Official Swedish guidelines dictate that primary care clinics are responsible for treating mild to moderate cases, but access to treatment is limited. Transdiagnostic psychological interventions have been found to be efficacious for anxiety and mood disorders, and require a relatively rudimentary pre-treatment assessment. A large-group transdiagnostic course based on cognitive-behavioral principles may constitute an effective use of limited resources to improve access to treatment, and offer a sufficiently effective intervention, for most primary care patients with mild to moderate mental health problems. Aim: To investigate the feasibility and preliminary efficacy of a large-group transdiagnostic intervention for depression and clinically significant anxiety in Swedish primary care. Design: This is a prospective single-group feasibility study where 68 adults with clinically significant symptoms of depression or anxiety, and up to 25 adults with subclinical symptoms, are recruited from Liljeholmen primary care clinic, Stockholm, and offered 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing. If necessary, due to the covid-19 pandemic, the course will be held online. The primary outcome is patient satisfaction. Secondary outcomes include within-group effects on psychiatric symptoms (response rates), adherence rates, need for additional treatment, and adverse events.

Official Title
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Single-Arm Feasibility Study of a Transdiagnostic Course for Common Mental Health Problems in Primary Care

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Behavioral: Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 8 points on the GAD-7 or 10 points on the PHQ-9 (N=68; up to 25 subclinical participants may also take part in the study) At least 18 years old Exclusion Criteria: At least one severe mental health problem such as suicidal ideation, a bipolar disorder, or psychosis Non-stable antidepressant medication (dosage changed during the past 6 weeks) Planned absence for 2 weeks or more of the intended treatment period

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective single-group cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Large-group transdiagnostic course<br>6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing | Behavioral: Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material<br>* Primarily standard cognitive-behavioral strategies to reduce common psychiatric symptoms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with treatment as indicated by a mean Client Satisfaction Questionnaire (CSQ-8) score of at least 22 | Theoretical range: 8-32, higher score indicates higher satisfaction. This sum score is based on 8 items, each scored 1-4. The original preregistered range of 7-28 was an erratum. | Post-treatment assessment (immediately after treatment, completed within 45 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence operationalized as the average number of completed sessions | Session attendance registered once each week by a clinician during the treatment period | From week 1 to week 6 | 
| At least 1/3 patients reporting a clinically significant improvement in symptoms of depression | Dichotomous outcome (Jacobson & Truax, 1991) based on the Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, higher score indicates more symptoms of depression) | Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days) | 
| At least 1/3 patients reporting a clinically significant improvement in symptoms of general anxiety | Dichotomous outcome (Jacobson & Truax, 1991) based on the GAD-7 (theoretical range: 0-21, higher score indicates more general anxiety) | Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days) | 
| Change in lifestyle behaviors |  | Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days) | 
| Number of adverse events | Weekly question: Since the last assessment, have you experienced any adverse event, side effect, or unwanted effect of your participation in this study? | From week 1 to week 6 | 
| Proportion of patients in need of additional treatment | Clinical interview | Post-treatment assessment (within 45 days after treatment) | 
| Average change in symptoms of depression | Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, higher score indicates more symptoms of depression) | Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days) | 
| Average change in general anxiety | GAD-7 (theoretical range: 0-21, higher score indicates more general anxiety) | Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days) | 
| Average change in perceived stress | Perceived Stress Scale, 10-item version (PSS-10, theoretical range: 0-40, higher score indicates more perceived stress) | Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days) | 
| Average change in disability | World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2, theoretical range: 0-100, higher score indicates more disability) | Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transdiagnostic, Primary care, Feasibility