Clinical Trial of a Group Self-management Support Program for Anxiety Disorders
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|ClinicalTrials.gov Identifier: NCT05124639|
Recruitment Status : Not yet recruiting
First Posted : November 18, 2021
Last Update Posted : December 16, 2021
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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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||414 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||A Pragmatic Randomized Controlled Trial of a Group Self-management Support Program Versus Treatment-as-usual for Anxiety Disorders|
|Estimated Study Start Date :||January 2022|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2025|
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 Name: SMS+TAU
No Intervention: Treatment-as-usual
Treatment-as-usual and a delayed intervention (if desired by participants) after the 12-month follow up
- Change in Beck Anxiety Inventory (BAI) [ Time Frame: Baseline and post-treatment (4-month post-randomization) ]
- Change in Beck Anxiety Inventory [ Time Frame: Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups ]
- Change in Generalised Anxiety Disorder-7 [ Time Frame: Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups ]
- Change in Patient Health Questionnaire-9 [ Time Frame: Baseline, post-treatment,12-month and 24-month post-randomization follow-ups ]
- Change in Recovery Assessment Scale - Revised [ Time Frame: Baseline, post-treatment,12-month and 24-month post-randomization follow-ups ]
- Change in Mental Health Self-Management Questionnaire [ Time Frame: Baseline, post-treatment,12-month and 24-month post-randomization follow-ups ]
- Change in Assessment of Quality of Life - 6 Dimensions [ Time Frame: Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups ]
- Change in Health care use and indirect costs [ Time Frame: 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 [ Time Frame: 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.
- Gross Cohesion Scale [ Time Frame: During the 10-week SMS program, after sessions 3 and 8 (for experimental arm participants) ]
- Working Alliance Inventory [ Time Frame: During the 10-week SMS program, after sessions 3 and 8 (for experimental arm participants) ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- (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
- (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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05124639
|Contact: Pasquale Roberge, Ph.D.||1-819-821-8000 ext email@example.com|
|Contact: Annie Benoit, M.Sc.||1-819-821-8000 ext firstname.lastname@example.org|
|Principal Investigator:||Pasquale Roberge, Ph.D.||Université de Sherbrooke|
|Principal Investigator:||Janie Houle, Ph.D.||Université du Québec a Montréal|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Université de Sherbrooke|
|Other Study ID Numbers:||
|First Posted:||November 18, 2021 Key Record Dates|
|Last Update Posted:||December 16, 2021|
|Last Verified:||December 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Social Anxiety Disorder
Generalized Anxiety Disorder