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

Sponsor

Université de Sherbrooke (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05124639

Collaborator

Canadian Institutes of Health Research (CIHR) (Other), Relief (Other)

414

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Panic Disorder Agoraphobia Social Anxiety Disorder Generalized Anxiety Disorder	Behavioral: Group self-management support program for anxiety disorders	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

414 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group self-management support Group self-management support program for anxiety disorders developped by Relief (https://myrelief.ca/).	Behavioral: Group self-management support program for anxiety disorders 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. Other Names: SMS+TAU
No Intervention: Treatment-as-usual Treatment-as-usual and a delayed intervention (if desired by participants) after the 12-month follow up

Arm

Intervention/Treatment

Experimental: Group self-management support

Group self-management support program for anxiety disorders developped by Relief (https://myrelief.ca/).

Behavioral: Group self-management support program for anxiety disorders

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.

Other Names:

SMS+TAU

No Intervention: Treatment-as-usual

Treatment-as-usual and a delayed intervention (if desired by participants) after the 12-month follow up

Outcome Measures

Primary Outcome Measures

Change in Beck Anxiety Inventory (BAI) [Baseline and post-treatment (4-month post-randomization)]

Secondary Outcome Measures

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 [Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups]
Health care costs for other mental health consultations (e.g. type of professional, duration, costs), psychotherapy experience (including CBT) and psychotropic medication.
Change in Administrative databases records [Starting 12 months prior to participant enrolment up to the 24-month post-randomization follow-up]
Data will be obtained from provincial administrative databases for medical and biopsychosocial services, hospitalization's registry, and medication data.

Other Outcome Measures

Gross Cohesion Scale [During the 10-week SMS program, after sessions 3 and 8 (for experimental arm participants)]
Working Alliance Inventory [During the 10-week SMS program, after sessions 3 and 8 (for experimental arm participants)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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