Clinical Trial of Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders

Not Applicable

Completed

• Conditions: Agoraphobia; Social Anxiety Disorder; Generalized Anxiety Disorder; Panic Disorder
• Interventions: Behavioral: Transdiagnostic Cognitive-Behavioral Therapy

• Registration Number: NCT02811458
• Lead Sponsor: Université de Sherbrooke

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-23
• Study Start: 2016-09-12
• Primary Completion: 2018-06-15
• Study Completion: 2019-07-10
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-13
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transdiagnostic CBT	Transdiagnostic Cognitive-Behavioral Therapy	Group psychotherapy according to the Transdiagnostic Cognitive-Behavioral Therapy treatment protocol (Norton, 2012)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in Administrative databases records	Starting 12 months prior to participant enrollment up to the 12-month follow-up	Beneficiary registry (sex, birthdate, and death registry), Med-Écho hospitalizations (diagnosis, procedures), medical services (physician, diagnosis, acts, services) and pharmaceutical services (medication, dose, duration).
Change in Beck Anxiety Inventory (BAI)	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 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 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 Social Phobia Inventory	Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
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.
Change in Penn State Worry Questionnaire	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

Trial Locations

Locations (3)

Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale; 🇨🇦 Quebec, Canada

Centre intégré universitaire de santé et de services sociaux de l'Estrie; 🇨🇦 Sherbrooke, Quebec, Canada

Centre intégré de santé et de services sociaux de Laval; 🇨🇦 Laval, Quebec, Canada