Agoraphobia, Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder
Conditions
Keywords
Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder, Anxiety disorders, Self-management support
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.
Interventions
BEHAVIORALGroup 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.
Sponsors
Canadian Institutes of Health Research (CIHR)
Relief
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Beck Anxiety Inventory (BAI) | Baseline and post-treatment (4-month post-randomization) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 Health care use and indirect costs | 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 | 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. |
| 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 | — |
Other
| Measure | 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) |
Countries
Canada
Outcome results
None listed