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
1 other identifier
interventional
414
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2021
CompletedFirst Posted
Study publicly available on registry
November 18, 2021
CompletedStudy Start
First participant enrolled
October 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2026
ExpectedMay 9, 2024
May 1, 2024
1.4 years
October 27, 2021
May 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Beck Anxiety Inventory (BAI)
Baseline and post-treatment (4-month post-randomization)
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Other Outcomes (2)
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)
Study Arms (2)
Group self-management support
EXPERIMENTALGroup self-management support program for anxiety disorders developped by Relief (https://myrelief.ca/).
Treatment-as-usual
NO INTERVENTIONTreatment-as-usual and a delayed intervention (if desired by participants) after the 12-month follow up
Interventions
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.
Eligibility Criteria
You may qualify if:
- (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
You may not qualify if:
- (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Université de Sherbrookelead
- Canadian Institutes of Health Research (CIHR)collaborator
- Reliefcollaborator
Study Sites (1)
Université de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Related Publications (1)
Roberge P, Houle J, Provost JR, Coulombe S, Beaudin A, Bower P, Lemyre FC, Drapeau M, Drouin MS, Hudon C, Provencher MD, Vasiliadis HM. A pragmatic randomized controlled trial of a group self-management support program versus treatment-as-usual for anxiety disorders: study protocol. BMC Psychiatry. 2022 Feb 21;22(1):135. doi: 10.1186/s12888-021-03675-4.
PMID: 35189848DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pasquale Roberge, Ph.D.
Université de Sherbrooke
- PRINCIPAL INVESTIGATOR
Janie Houle, Ph.D.
Université du Québec a Montréal
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2021
First Posted
November 18, 2021
Study Start
October 6, 2022
Primary Completion
March 16, 2024
Study Completion (Estimated)
December 21, 2026
Last Updated
May 9, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
The data that support the findings of this study will be available on request from the nominated principal investigator \[PR\]. The data will not be publicly available due to ethics approval restrictions.