Anxiety disorders are the most common mental disorders in community settings, and they are associated with significant psychological distress, functional and social impairment. Although pharmacological and psychological treatments for anxiety and depression have existed for several years now, only a minority of anxiety disorder sufferers are treated according to guidelines. Cognitive behavior therapy (CBT) is the most consistently efficacious psychological treatment for anxiety disorders, but implementation of CBT in primary care is challenging due to limited resources. Recent studies indicate that transdiagnostic group CBT for multiple anxiety disorders could be a promising alternative to individual CBT in primary care. The aim of the study is to examine the effectiveness of group CBT for anxiety disorders as a complement to usual care. The clinical trial will be conducted in three Health and Social Services Centers in the province of Québec (i.e. Sherbrooke, Laval and Québec). Patients will be French-speaking adults with anxiety disorders, and they will be randomly assigned to one of two treatment conditions: a) Transdiagnostic group CBT (12 weekly 2-hour sessions), b) usual care. The transdiagnostic group CBT will be offered as a differed intervention to participants in the usual care group after the 8-month follow up. Participants in both study arms will undergo a baseline clinical evaluation as well as outcome assessment interviews at post-treatment, 4, 8, and 12 month follow-up time-points. The primary study results will include improvement on a questionnaire on anxiety symptoms. Widespread implementation of group CBT could lead to better outcomes for a large number of patients living with anxiety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
231
Treatment in the Transdiagnostic CBT condition will consist of 12 weekly 2-hour sessions following the manualized treatment protocol including psychoeducation, cognitive restructuring, exposure and relapse prevention.
Centre intégré de santé et de services sociaux de Laval
Laval, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie
Sherbrooke, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale
Québec, Canada
Change in Beck Anxiety Inventory (BAI)
Time frame: Baseline and post-treatment; within two weeks after the 12th treatment session, based on the timeframe of the intervention group (treatment completion)
Change in Clinical Severity Rating from the Anxiety Disorders Interview Schedule for DSM-5 - Adult Version (ADIS-5)
Time frame: Baseline and post-treatment; within two weeks after the 12th treatment session, based on the timeframe of the intervention group (treatment completion) (Outcome 2 added 2017-12-12)
Change in Beck Anxiety Inventory (BAI)
Time frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
Change in Clinical Severity Rating from the Anxiety Disorders Interview Schedule for DSM-5 - Adult Version (ADIS-5)
Time frame: Baseline, post-treatment and 8-month follow-ups
Change in Panic Disorder Severity Scale (Self-Report)
Time frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
Change in Mobility Inventory for Agoraphobia
Time frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
Change in Penn State Worry Questionnaire
Time frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
Change in Social Phobia Inventory
Time frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
Change in Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
Change in EuroQol (EQ-5D-5L)
Time frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
Change in Administrative databases records
Beneficiary registry (sex, birthdate, and death registry), Med-Écho hospitalizations (diagnosis, procedures), medical services (physician, diagnosis, acts, services) and pharmaceutical services (medication, dose, duration).
Time frame: Starting 12 months prior to participant enrollment up to the 12-month follow-up
Change in Anxiety Disorder Diagnostic Questionnaire - weekly version (ADDQ-W)
Time frame: ADDQ-W administered weekly over the course of the 12 weekly group therapy sessions to assess change in anxiety severity.
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