ClinicalTrials.gg
CompletedNCT02811458T-CBTUpdated Sep 17, 2019

Clinical Trial of Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders

An interventional study of Transdiagnostic Cognitive-Behavioral Therapy in Panic Disorder, Agoraphobia and Social Anxiety Disorder, sponsored by Université de Sherbrooke. Completed at 3 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-09-17.

Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
231
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Panic Disorder
  • Agoraphobia
  • Social Anxiety Disorder
  • Generalized Anxiety Disorder

Keywords

  • Panic Disorder
  • Agoraphobia
  • Social Anxiety Disorder
  • Generalized Anxiety Disorder
  • Cognitive-Behavioral Therapy
03

In context

Panic Disorder

270 studies on the registry are indexed under Panic Disorder; 37 are open to participants now.

This study's enrollment of 231 is above the median of 77 across 215 interventional studies indexed under Panic Disorder.

Browse Panic Disorder studies →

Lead sponsor

Université de Sherbrooke is the lead sponsor of 295 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 18-65 (upper age limit added 2016-11-18)
  • Fluent in spoken and written French.
  • Meeting 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
231 participants (actual)

Study arms

  • Experimental
    Transdiagnostic CBT

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

    Behavioral: Transdiagnostic Cognitive-Behavioral Therapy

  • No intervention
    Treatment-as-usual

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

Interventions

  • BehavioralTransdiagnostic 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.

06

What researchers measure

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

    Beneficiary registry (sex, birthdate, and death registry), Med-Écho hospitalizations (diagnosis, procedures), medical services (physician, diagnosis, acts, services) and pharmaceutical services (medication, dose, duration).

    Time frame: Starting 12 months prior to participant enrollment up to the 12-month follow-up

  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.

07

Study locations

3 sites
  • Centre intégré de santé et de services sociaux de Laval
    Laval, Quebec H7M3L9, Canada
  • Centre intégré universitaire de santé et de services sociaux de l'Estrie
    Sherbrooke, Quebec J1G1B1, Canada
  • Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale
    Quebec, G1C3S2, Canada
08

References and documents

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. PubMed 30285672 ↗

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02811458
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
Responsible party
Sponsor
First posted
Jun 23, 2016
Start date
Sep 12, 2016
Primary completion
Jun 15, 2018
Completion
Jul 10, 2019
Last update
Sep 17, 2019

Study contacts

Pasquale Roberge, Ph.D.
principal investigator · Université de Sherbrooke
Martin D. Provencher, Ph.D.
principal investigator · Laval University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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