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

Université de Sherbrooke

Status: Active, not recruiting

Conditions: Panic Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder; Agoraphobia

Treatments: Behavioral: Group self-management support program for anxiety disorders

Study type: Interventional

Funder types: Other

Identifiers

NCT05124639

PJT-169163

Details and patient eligibility

About

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.

Enrollment: 414 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (1) aged 18 and over,
• (2) fluent in spoken and written French,
• (3) presence of symptoms of anxiety disorders based on self-reported validated assessment scales and semi-structured assessment interview,
• (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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414 participants in 2 patient groups

Group self-management support

Experimental group

Description:

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

Treatment:

Behavioral: Group self-management support program for anxiety disorders

Treatment-as-usual

No Intervention group

Description:

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