Clinical Trial of Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders

NCT02811458 | Completed DMC

• 2 other identifiers: CIHR-340410CIHR-334091
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 3

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.

Conditions

Panic Disorder; Agoraphobia; Social Anxiety Disorder; Generalized Anxiety Disorder

Keywords

Panic Disorder; Agoraphobia; Social Anxiety Disorder; Generalized Anxiety Disorder; Cognitive-Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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

Study Arms (2)

Transdiagnostic CBT

EXPERIMENTAL

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

Behavioral: Transdiagnostic Cognitive-Behavioral Therapy

Treatment-as-usual

NO INTERVENTION

Treatment-as-usual and a differed intervention (if desired by participants) after the 8-month follow up.

Interventions

Transdiagnostic Cognitive-Behavioral Therapy BEHAVIORAL

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.

Transdiagnostic CBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke: collaborator
• CISSS de Laval: collaborator
• Integrated University Health and Social Services Center of the Capitale-Nationale: collaborator

Study Sites (3)

Centre intégré de santé et de services sociaux de Laval

Laval, Quebec, H7M3L9, Canada

Location

Centre intégré universitaire de santé et de services sociaux de l'Estrie

Sherbrooke, Quebec, J1G1B1, Canada

Location

Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale

Québec, G1C3S2, Canada

Location

Related Publications (2)

• 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.

  PMID: 30285672 BACKGROUND

• Chapdelaine A, Vasiliadis HM, Provencher MD, Norton PJ, Roberge P. Moderators of the cost-effectiveness of transdiagnostic CBT for anxiety disorders over an 8-month time horizon using a net-benefit regression framework. BMC Health Serv Res. 2023 Jun 8;23(1):596. doi: 10.1186/s12913-023-09468-7.

  PMID: 37291599 DERIVED

Related Links

• BMC Psychiatry

MeSH Terms

Conditions

Panic Disorder; Agoraphobia; Phobia, Social; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Phobic Disorders

Study Officials

• Pasquale Roberge, Ph.D.

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

• Martin D. Provencher, Ph.D.

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 23, 2016
• Study Start: September 12, 2016
• Primary Completion: June 15, 2018
• Study Completion: July 10, 2019
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)