NCT05124639

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 414 (actual)
• Sponsor: Université de Sherbrooke · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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 presenting symptoms of anxiety disorders based on self-reported validated assessment scales. Patients will be recruited in the province of 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.

Conditions

• Panic Disorder
• Agoraphobia
• Social Anxiety Disorder
• Generalized Anxiety Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-06
• Primary completion: 2024-03-16
• Completion: 2026-12-21
• First posted: 2021-11-18
• Last updated: 2024-05-09

Locations

1 site across 1 country: Canada