An interventional study of Group self-management support program for anxiety disorders in Panic Disorder, Agoraphobia and Social Anxiety Disorder, sponsored by Université de Sherbrooke. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Treatment
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.
270 studies on the registry are indexed under Panic Disorder; 37 are open to participants now.
This study's enrollment of 414 is above the median of 77 across 215 interventional studies indexed under Panic Disorder.
Browse Panic Disorder studies →Université de Sherbrooke is the lead sponsor of 295 studies on the registry; 65 are open to participants now.
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Exclusion Criteria:
Group self-management support program for anxiety disorders developped by Relief (https://myrelief.ca/).
Behavioral: Group self-management support program for anxiety disorders
Treatment-as-usual and a delayed intervention (if desired by participants) after the 12-month follow up
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.
Also known as: SMS+TAU
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
Health care costs for other mental health consultations (e.g. type of professional, duration, costs), psychotherapy experience (including CBT) and psychotropic medication.
Time frame: 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.
Time frame: Starting 12 months prior to participant enrolment up to the 24-month post-randomization follow-up
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)
Plan to share: Yes — 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.
Supporting information: Study protocol
Ran from Oct 2022 to primary completion in Mar 2024, 17 months.
Of 87 non-industry interventional studies with no phase under Panic Disorder, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 63. This study's 17 months is below that.
Counting every sponsor, half of 87 studies reached it within 38 months; a quarter within 21 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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