Clinical trial NCT02811458: Clinical Trial of Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders
Official title: A Pragmatic Randomized Controlled Trial of Group Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Panic Disorder
Agoraphobia
Social Anxiety Disorder
Generalized Anxiety Disorder
Keywords: Panic Disorder
Agoraphobia
Social Anxiety Disorder
Generalized Anxiety Disorder
Cognitive-Behavioral Therapy
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
name: CISSS de Laval
name: Integrated University Health and Social Services Center of the Capitale-Nationale
First posted: 2016-06-23
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Beck Anxiety Inventory (BAI)
timeFrame: Baseline and post-treatment; within two weeks after the 12th treatment session, based on the timeframe of the intervention group (treatment completion)
measure: Change in Clinical Severity Rating from the Anxiety Disorders Interview Schedule for DSM-5 - Adult Version (ADIS-5)
timeFrame: 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:
measure: Change in Beck Anxiety Inventory (BAI)
timeFrame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
measure: Change in Clinical Severity Rating from the Anxiety Disorders Interview Schedule for DSM-5 - Adult Version (ADIS-5)
timeFrame: Baseline, post-treatment and 8-month follow-ups
measure: Change in Panic Disorder Severity Scale (Self-Report)
timeFrame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
measure: Change in Mobility Inventory for Agoraphobia
timeFrame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
measure: Change in Penn State Worry Questionnaire
timeFrame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
measure: Change in Social Phobia Inventory
timeFrame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
measure: Change in Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
measure: Change in EuroQol (EQ-5D-5L)
timeFrame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups
measure: Change in Administrative databases records
timeFrame: Starting 12 months prior to participant enrollment up to the 12-month follow-up
measure: Change in Anxiety Disorder Diagnostic Questionnaire - weekly version (ADDQ-W)
timeFrame: ADDQ-W administered weekly over the course of the 12 weekly group therapy sessions to assess change in anxiety severity.
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Centre intégré de santé et de services sociaux de Laval
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre intégré universitaire de santé et de services sociaux de l'Estrie
state: Quebec
city: Quebec
country: Canada
facility: Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale
Study officials:
affiliation: Université de Sherbrooke
name: Pasquale Roberge, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Martin D. Provencher, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.