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

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.

Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder, Anxiety disorders, Self-management support

Group self-management support program for anxiety disorders developped by Relief (https://myrelief.ca/).

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.

Health care costs for other mental health consultations (e.g. type of professional, duration, costs), psychotherapy experience (including CBT) and psychotropic medication.

Data will be obtained from provincial administrative databases for medical and biopsychosocial services, hospitalization's registry, and medication data.

Inclusion Criteria: (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 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

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.

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.