Clinical Trial of Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders

Generalized Anxiety Disorder Clinical Trial

— T-CBT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811458
• Other study ID #: CIHR-340410
• Secondary ID: CIHR-334091
• Status: Completed
• Phase: N/A
• Start date: September 12, 2016
• Est. completion date: July 10, 2019

Study information

• Verified date: September 2019
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: July 10, 2019
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Agoraphobia
• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder
• Panic Disorder
• Phobia, Social
• Social Anxiety Disorder

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre intégré de santé et de services sociaux de Laval	Laval	Quebec
Canada	Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale	Quebec
Canada	Centre intégré universitaire de santé et de services sociaux de l'Estrie	Sherbrooke	Quebec

Sponsors (5)

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

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Change in Beck Anxiety Inventory (BAI)		Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
Secondary	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
Secondary	Change in Panic Disorder Severity Scale (Self-Report)		Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
Secondary	Change in Mobility Inventory for Agoraphobia		Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
Secondary	Change in Penn State Worry Questionnaire		Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
Secondary	Change in Social Phobia Inventory		Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
Secondary	Change in Patient Health Questionnaire (PHQ-9)		Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
Secondary	Change in EuroQol (EQ-5D-5L)		Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
Secondary	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).	Starting 12 months prior to participant enrollment up to the 12-month follow-up
Secondary	Change in Anxiety Disorder Diagnostic Questionnaire - weekly version (ADDQ-W)		ADDQ-W administered weekly over the course of the 12 weekly group therapy sessions to assess change in anxiety severity.

External Links

•   BMC Psychiatry