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

This study is currently recruiting participants.
Verified April 2017 by Université de Sherbrooke
Sponsor:
ClinicalTrials.gov Identifier:
NCT02811458
First Posted: June 23, 2016
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Canadian Institutes of Health Research (CIHR)
CIUSSS de l'Estrie - CHUS
CISSS de Laval
CIUSSS de la Capitale-Nationale
Information provided by (Responsible Party):
Université de Sherbrooke
  Purpose
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.

Condition Intervention
Panic Disorder Agoraphobia Social Anxiety Disorder Generalized Anxiety Disorder Behavioral: Transdiagnostic Cognitive-Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pragmatic Randomized Controlled Trial of Group Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders in Primary Care

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Change in Beck Anxiety Inventory (BAI) [ Time Frame: Baseline and post-treatment follow-up ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 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 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. ]

Estimated Enrollment: 211
Actual Study Start Date: September 12, 2016
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18-65.
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811458


Contacts
Contact: Pasquale Roberge, Ph.D. 1-819-821-8000 ext 73814 pasquale.roberge@usherbrooke.ca
Contact: Annie Benoit, M.Sc. 1-819-821-8000 ext 70533 annie.c.benoit@usherbrooke.ca

Locations
Canada, Quebec
Centre intégré de santé et de services sociaux de Laval Recruiting
Laval, Quebec, Canada, H7M3L9
Centre intégré universitaire de santé et de services sociaux de l'Estrie Recruiting
Sherbrooke, Quebec, Canada, J1G1B1
Canada
Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale Recruiting
Quebec, Canada, G1C3S2
Sponsors and Collaborators
Université de Sherbrooke
Canadian Institutes of Health Research (CIHR)
CIUSSS de l'Estrie - CHUS
CISSS de Laval
CIUSSS de la Capitale-Nationale
Investigators
Principal Investigator: Pasquale Roberge, Ph.D. Université de Sherbrooke
Principal Investigator: Martin D. Provencher, Ph.D. Laval University
  More Information

Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02811458     History of Changes
Other Study ID Numbers: CIHR-340410
First Submitted: May 24, 2016
First Posted: June 23, 2016
Last Update Posted: November 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Université de Sherbrooke:
Panic Disorder
Agoraphobia
Social Anxiety Disorder
Generalized Anxiety Disorder
Cognitive-Behavioral Therapy

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Panic Disorder
Phobia, Social
Agoraphobia
Pathologic Processes
Mental Disorders
Phobic Disorders