Clinical trial NCT05124639: Clinical Trial of a Group Self-management Support Program for Anxiety Disorders
Official title: A Pragmatic Randomized Controlled Trial of a Group Self-management Support Program Versus Treatment-as-usual for Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Panic Disorder
Agoraphobia
Social Anxiety Disorder
Generalized Anxiety Disorder
Keywords: Panic Disorder
Agoraphobia
Social Anxiety Disorder
Generalized Anxiety Disorder
Anxiety disorders
Self-management support
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Relief
First posted: 2021-11-18
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* (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

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

Primary outcomes:
measure: Change in Beck Anxiety Inventory (BAI)
timeFrame: Baseline and post-treatment (4-month post-randomization)
Secondary outcomes:
measure: Change in Beck Anxiety Inventory
timeFrame: Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
measure: Change in Generalised Anxiety Disorder-7
timeFrame: Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
measure: Change in Patient Health Questionnaire-9
timeFrame: Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
measure: Change in Recovery Assessment Scale - Revised
timeFrame: Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
measure: Change in Mental Health Self-Management Questionnaire
timeFrame: Baseline, post-treatment,12-month and 24-month post-randomization follow-ups
measure: Change in Assessment of Quality of Life - 6 Dimensions
timeFrame: Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
measure: Change in Health care use and indirect costs
timeFrame: Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups
measure: Change in Administrative databases records
timeFrame: Starting 12 months prior to participant enrolment up to the 24-month post-randomization follow-up
Other outcomes:
measure: Gross Cohesion Scale
timeFrame: During the 10-week SMS program, after sessions 3 and 8 (for experimental arm participants)
measure: Working Alliance Inventory
timeFrame: During the 10-week SMS program, after sessions 3 and 8 (for experimental arm participants)
Locations:
city: Sherbrooke
country: Canada
facility: Université de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Pasquale Roberge, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Université du Québec a Montréal
name: Janie Houle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.