Clinical Trial of a Group Self-management Support Program for Anxiety Disorders

Study Overview
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Brief Summary
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Background. Self-management support is a complementary approach to treatment that aims to educate participants on the nature of anxiety and to improve their strategies to manage symptoms and well-being, thus presenting the potential to enhance recovery, improve outcomes, reduce recurrence rates and lower health care costs. There is limited evidence to support the effectiveness of group self-management support for anxiety disorders in community-based care. Objectives. This study aims at examining the effectiveness of a virtual group self-management support program (SMS) for anxiety disorders as an add-on to treatment-as-usual (TAU) in community-based care settings. We will also assess the incremental cost/effectiveness ratio and the implementability of the intervention. Methods. The trial is a multicentre pragmatic randomized controlled trial with a pre-treatment, post-treatment (4-month post-randomization), and follow-ups at 8, 12 and 24-months. Intervention. The experimental condition will consist of a 10-week SMS program for anxiety disorders in addition to TAU. The control condition will receive TAU without restrictions for anxiety disorders. Inclusion criteria will comprise being 18 years old or older, French-speaking, and meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for anxiety disorders: Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder. Patients will be recruited within four regions in Quebec (Canada). Outcome measures: The primary outcome measure is the Beck Anxiety Inventory (BAI). The secondary outcome measures include self-reported instruments for anxiety and depressive symptoms, recovery, self-management, quality of life, and service utilisation. Statistical analysis: Intention-to-treat analysis. A mixed effects regression model will be used to account for between and within-subject variations in the analysis of the longitudinal effects of the intervention. Expected outcomes. The rigorous evaluation of the SMS intervention in the real world will provide information to decision makers, health care managers, clinicians and patients regarding the added value of group SMS for patients with anxiety disorders. Widespread implementation of this intervention could lead to more efficient mental health care services, to better long-term outcomes and to a significant reduction in the extensive social and economic burden of anxiety disorders.

Official Title
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A Pragmatic Randomized Controlled Trial of a Group Self-management Support Program Versus Treatment-as-usual for Anxiety Disorders

Conditions
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Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: Group self-management support program for anxiety disorders


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) aged 18 and over, (2) fluent in spoken and written French, (3) meeting DSM-5 diagnostic criteria for at least one of the following anxiety disorders: Panic Disorder, Agoraphobia, Generalized Anxiety Disorder, Social Anxiety Disorder. The clinical assessment is based on a customized version of the Mini International Neuropsychiatric Interview (M.I.N.I.). (4) access to a computer or tablet connected to the internet with microphone and video camera Exclusion Criteria: (1) previous enrolment in the SMS intervention provided by Relief (2) active suicidal intentions, (3) severe depressive symptoms, (4) active substance-related and addictive disorder, (5) cognitive impairment

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group self-management support<br>Group self-management support program for anxiety disorders developped by Relief (https://myrelief.ca/). | Behavioral: Group self-management support program for anxiety disorders<br>* The group SMS manualized program for anxiety disorders (https://monrelief.ca) aims at improving self-management capabilities through weekly 2.5-hours sessions with 10-15 patients over a 10-week period.This trial will focus solely on the virtual format of the program. The SMS program covers the following themes: getting to know your anxiety; building self-awareness; reconsidering your lifestyle habits; adopting a problem-solving method; avoidance and exposure; acceptance and committed action; seeing things differently; managing your emotions; receiving support from others; and consolidating your toolkit.<br>* Other names: SMS+TAU;|
| No Intervention: Treatment-as-usual<br>Treatment-as-usual and a delayed intervention (if desired by participants) after the 12-month follow up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Beck Anxiety Inventory (BAI) |  | Baseline and post-treatment (4-month post-randomization) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Beck Anxiety Inventory |  | Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups | 
| Change in Generalised Anxiety Disorder-7 |  | Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups | 
| Change in Patient Health Questionnaire-9 |  | Baseline, post-treatment,12-month and 24-month post-randomization follow-ups | 
| Change in Recovery Assessment Scale - Revised |  | Baseline, post-treatment,12-month and 24-month post-randomization follow-ups | 
| Change in Mental Health Self-Management Questionnaire |  | Baseline, post-treatment,12-month and 24-month post-randomization follow-ups | 
| Change in Assessment of Quality of Life - 6 Dimensions |  | Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups | 
| Change in Health care use and indirect costs | Health care costs for other mental health consultations (e.g. type of professional, duration, costs), psychotherapy experience (including CBT) and psychotropic medication. | Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups | 
| Change in Administrative databases records | Data will be obtained from provincial administrative databases for medical and biopsychosocial services, hospitalization's registry, and medication data. | Starting 12 months prior to participant enrolment up to the 24-month post-randomization follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder, Anxiety disorders, Self-management support