A Transdiagnostic Course for Common Mental Health Problems in Primary Care

Not Applicable

Completed

• Conditions: Depression; Anxiety
• Interventions: Behavioral: Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material

• Registration Number: NCT04522713
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-20
• Study First Posted: 2020-08-21
• Study Start: 2020-09-01
• Primary Completion: 2021-12-03
• Study Completion: 2021-12-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Large-group transdiagnostic course	Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material	6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing

Primary Outcome Measures

Name	Time	Method
Satisfaction with treatment as indicated by a mean Client Satisfaction Questionnaire (CSQ-8) score of at least 22	Post-treatment assessment (immediately after treatment, completed within 45 days)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Liljeholmen primary care clinic; 🇸🇪 Stockholm, Sweden

Karolinska Institutet; 🇸🇪 Stockholm, Sweden