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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Relief | UNKNOWN |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group self-management support | Experimental | Group self-management support program for anxiety disorders developped by Relief (https://myrelief.ca/). |
|
| Treatment-as-usual | No Intervention | Treatment-as-usual and a delayed intervention (if desired by participants) after the 12-month follow up |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group self-management support program for anxiety disorders | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Beck Anxiety Inventory (BAI) | Baseline and post-treatment (4-month post-randomization) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pasquale Roberge, Ph.D. | Université de Sherbrooke | Principal Investigator |
| Janie Houle, Ph.D. | Université du Québec a Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35189848 | Derived | 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. |
| Label | URL |
|---|---|
| Developper of the SMS-A program | View source |
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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.
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| ID | Term |
|---|---|
| D016584 | Panic Disorder |
| D000379 | Agoraphobia |
| D000072861 | Phobia, Social |
| D000098647 | Generalized Anxiety Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
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| 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 |
| Change in Assessment of Quality of Life - 6 Dimensions | Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups |
| 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 |
| 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 |
| Nominated principal investigator's \[PR\] laboratory website. | View source |
| Published study protocol in BMC Psychiatry | View source |