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NCT Number: NCT02811458

Clinical Trial of Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre intégré de santé et de services sociaux de Laval, Laval, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Beck Anxiety Inventory (BAI)

    Time frame: Baseline and post-treatment; within two weeks after the 12th treatment session, based on the timeframe of the intervention group (treatment completion)

  2. Change in Clinical Severity Rating from the Anxiety Disorders Interview Schedule for DSM-5 - Adult Version (ADIS-5)

    Time frame: 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

  1. Change in Beck Anxiety Inventory (BAI)

    Time frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups

  2. 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

  3. Change in Panic Disorder Severity Scale (Self-Report)

    Time frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups

  4. Change in Mobility Inventory for Agoraphobia

    Time frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups

  5. Change in Penn State Worry Questionnaire

    Time frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups

  6. Change in Social Phobia Inventory

    Time frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups

  7. Change in Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups

  8. Change in EuroQol (EQ-5D-5L)

    Time frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups

  9. 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).

  10. 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.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

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

Registry information

Official study title

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

Acronym: T-CBT

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jun 23, 2016
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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