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Panic DisorderT-CBTNCT02811458

Clinical Trial of Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders

A study testing Transdiagnostic Cognitive-Behavioral Therapy in people with Panic Disorder and Agoraphobia, run by Université de Sherbrooke at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Transdiagnostic Cognitive-Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
231 participants
Where
3 sitesCanada
Study dates
12 Sep 2016to 10 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Centre intégré de santé et de services sociaux de Laval

    Laval, Quebec, H7M3L9

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

    Québec, G1C3S2

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

    Sherbrooke, Quebec, J1G1B1

Other trials in Canada

About this study

Official title: 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.

Being tested
Transdiagnostic Cognitive-Behavioral Therapy
Keywords
Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder, Cognitive-Behavioral Therapy
Medical subject headings
Panic Disorder, Agoraphobia, Phobia, Social, Generalized Anxiety Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transdiagnostic Cognitive-Behavioral TherapyBehavioural

    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.

Study groups in NCT02811458
Study groupRoleWhat they receive
Transdiagnostic CBTExperimentalGroup psychotherapy according to the Transdiagnostic Cognitive-Behavioral Therapy treatment protocol (Norton, 2012)
Receives: Behavioral: Transdiagnostic Cognitive-Behavioral Therapy
Treatment-as-usualNo interventionTreatment-as-usual and a differed intervention (if desired by participants) after the 8-month follow up.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Beck Anxiety Inventory (BAI)

    Measured: 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)

    Measured: 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)

  1. Change in Beck Anxiety Inventory (BAI)

    Measured: 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)

    Measured: Baseline, post-treatment and 8-month follow-ups

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

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

  4. Change in Mobility Inventory for Agoraphobia

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

  5. Change in Penn State Worry Questionnaire

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

  6. Change in Social Phobia Inventory

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

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

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

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

    Measured: 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).

    Measured: 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)

    Measured: ADDQ-W administered weekly over the course of the 12 weekly group therapy sessions to assess change in anxiety severity.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2016 (estimated)
  2. Study start12 Sep 2016
  3. Primary completion15 Jun 2018
  4. Study completion10 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02811458
Sponsor's protocol ID
CIHR-340410
Other IDs
CIHR-334091
Acronym
T-CBT
Status last verified
Sep 2019
First submitted
24 May 2016
Last updated
17 Sep 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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

  • 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.

    PubMed 37291599

Questions about this trial

What is this clinical trial studying?

A study testing Transdiagnostic Cognitive-Behavioral Therapy in people with Panic Disorder and Agoraphobia, run by Université de Sherbrooke at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02811458, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.

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