Clinical Trial of Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders (T-CBT)

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

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 Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder; Agoraphobia
• Intervention / Treatment: Behavioral: Transdiagnostic Cognitive-Behavioral Therapy

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1C3S2
    • Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale-Nationale
  • Quebec
    • Laval, Quebec, Canada, H7M3L9
      • Centre intégré de santé et de services sociaux de Laval
    • Sherbrooke, Quebec, Canada, J1G1B1
      • Centre integre universitaire de sante et de services sociaux de l'Estrie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transdiagnostic CBT; Group psychotherapy according to the Transdiagnostic Cognitive-Behavioral Therapy treatment protocol (Norton, 2012)	Behavioral: Transdiagnostic Cognitive-Behavioral Therapy; 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.
No Intervention: Treatment-as-usual; 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	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.

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Canadian Institutes of Health Research (CIHR); Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke; CISSS de Laval; Integrated University Health and Social Services Center of the Capitale-Nationale
• Investigators: Principal Investigator: Pasquale Roberge, Ph.D., Universite de Sherbrooke; Principal Investigator: Martin D. Provencher, Ph.D., Laval University

Publications and helpful links

General Publications

• Roberge P, Provencher MD, Gosselin P, Vasiliadis HM, Gaboury I, Benoit A, Antony MM, Chaillet N, Houle J, Hudon C, Norton PJ. A pragmatic randomized controlled trial of group transdiagnostic cognitive-behaviour therapy for anxiety disorders in primary care: study protocol. BMC Psychiatry. 2018 Oct 3;18(1):320. doi: 10.1186/s12888-018-1898-1.

Helpful Links

• BMC Psychiatry

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2016
• Primary Completion (Actual): June 15, 2018
• Study Completion (Actual): July 10, 2019

Study Registration Dates

• First Submitted: May 24, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (Estimate): June 23, 2016

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Generalized Anxiety Disorder; Panic Disorder; Cognitive-Behavioral Therapy; Social Anxiety Disorder; Agoraphobia
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Phobic Disorders; Disease; Anxiety Disorders; Phobia, Social; Panic Disorder; Agoraphobia
• Other Study ID Numbers: CIHR-340410; CIHR-334091 (Other Grant/Funding Number: Canadian Institutes of Health Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No