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

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05124639
• Other study ID #: PJT-169163
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2022
• Est. completion date: June 2025

Study information

• Verified date: December 2021
• Source: Université de Sherbrooke
• Contact: Pasquale Roberge, Ph.D.
• Phone: 1-819-821-8000
• Email: pasquale.roberge[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 414
• Est. completion date: June 2025
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Agoraphobia
• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder
• Panic Disorder
• Phobia, Social
• Social Anxiety Disorder

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Université de Sherbrooke	Canadian Institutes of Health Research (CIHR), Relief

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gross Cohesion Scale		During the 10-week SMS program, after sessions 3 and 8 (for experimental arm participants)
Other	Working Alliance Inventory		During the 10-week SMS program, after sessions 3 and 8 (for experimental arm participants)
Primary	Change in Beck Anxiety Inventory (BAI)		Baseline and post-treatment (4-month post-randomization)
Secondary	Change in Beck Anxiety Inventory		Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
Secondary	Change in Generalised Anxiety Disorder-7		Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
Secondary	Change in Patient Health Questionnaire-9		Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
Secondary	Change in Recovery Assessment Scale - Revised		Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
Secondary	Change in Mental Health Self-Management Questionnaire		Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
Secondary	Change in Assessment of Quality of Life - 6 Dimensions		Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
Secondary	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
Secondary	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

External Links

•   Developper of the SMS-A program
•   Nominated principal investigator's [PR] laboratory website.