Clinical Trial of Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Pragmatic Randomized Controlled Trial of Group Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders in Primary Care

Conditions
-----------------
Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Behavioral: Transdiagnostic Cognitive-Behavioral Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-65 (upper age limit added 2016-11-18) Fluent in spoken and written French. Meeting DSM-5 diagnostic criteria for at least one of the following anxiety disorders as a primary mental disorder: Panic Disorder, Agoraphobia, Generalized Anxiety Disorder and/or Social Anxiety Disorder according to a clinical rating ≥ 4 for the Anxiety Disorders Interview Schedule for DSM-5 (ADIS-5) administered by a trained PhD-level clinician. Exclusion Criteria: Active suicidal intentions, psychosis, bipolar disorder, active substance-related disorder and addictive disorder in the past 12 months (sections or screening questions in ADIS-5). Marked cognitive impairment [Épreuve des 5 mots (Dubois, 2002) administered in case of doubt by assessor]. Consultation with a psychiatrist in the past 12 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transdiagnostic CBT<br>Group psychotherapy according to the Transdiagnostic Cognitive-Behavioral Therapy treatment protocol (Norton, 2012) | Behavioral: Transdiagnostic Cognitive-Behavioral Therapy<br>* 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.<br>|
| No Intervention: Treatment-as-usual<br>Treatment-as-usual and a differed intervention (if desired by participants) after the 8-month follow up. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Beck Anxiety Inventory (BAI) |  | 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) |  | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Beck Anxiety Inventory (BAI) |  | 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) |  | Baseline, post-treatment and 8-month follow-ups | 
| Change in Panic Disorder Severity Scale (Self-Report) |  | Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups | 
| Change in Mobility Inventory for Agoraphobia |  | Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups | 
| Change in Penn State Worry Questionnaire |  | Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups | 
| Change in Social Phobia Inventory |  | Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups | 
| Change in Patient Health Questionnaire (PHQ-9) |  | Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups | 
| Change in EuroQol (EQ-5D-5L) |  | 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). | Starting 12 months prior to participant enrollment up to the 12-month follow-up | 
| Change in Anxiety Disorder Diagnostic Questionnaire - weekly version (ADDQ-W) |  | ADDQ-W administered weekly over the course of the 12 weekly group therapy sessions to assess change in anxiety severity. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder, Cognitive-Behavioral Therapy