Clinical Trial: Clinical Trial of Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Université de Sherbrooke

Current Primary Outcome: Change in Beck Anxiety Inventory (BAI) [ Time Frame: Baseline and post-treatment follow-up ]

Original Primary Outcome: Change in Beck Anxiety Inventory (BAI) [ Time Frame: Initial assessment (T0) and 4-month post-assignment follow-up ]

Current Secondary Outcome:

  • Change in Beck Anxiety Inventory (BAI) [ Time Frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups ]
  • 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 ]
  • Change in Panic Disorder Severity Scale (Self-Report) [ Time Frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups ]
  • Change in Mobility Inventory for Agoraphobia [ Time Frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups ]
  • Change in Penn State Worry Questionnaire [ Time Frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups ]
  • Change in Social Phobia Inventory [ Time Frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups ]
  • Change in Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups ]
  • Change in EuroQol (EQ-5D-5L) [ Time Frame: Baseline, post-treatment, 4-month, 8-month and 12-month follow-ups ]
  • 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).
  • 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. ]


Original Secondary Outcome:

  • Change in Beck Anxiety Inventory (BAI) [ Time Frame: Initial assessment (T0), 4-month [*primary outcome],12-month and 16-month post-assignment follow-ups ]
  • Change in Clinical Severity Rating from the Anxiety Disorders Interview Schedule for DSM-5 - Adult Version (ADIS-5) [ Time Frame: Initial assessment (T0), 4-month,12-month and 16-month post-assignment follow-ups ]
  • Change in Panic Disorder Severity Scale (Self-Report) [ Time Frame: Initial assessment (T0), 4-month,12-month and 16-month post-assignment follow-ups ]
  • Change in Mobility Inventory for Agoraphobia [ Time Frame: Initial assessment (T0), 4-month,12-month and 16-month post-assignment follow-ups ]
  • Change in Penn State Worry Questionnaire [ Time Frame: Initial assessment (T0), 4-month,12-month and 16-month post-assignment follow-ups ]
  • Change in Social Phobia Inventory [ Time Frame: Initial assessment (T0), 4-month,12-month and 16-month post-assignment follow-ups ]
  • Change in Patient Health Questionnaire (PHQ-9) [ Time Frame: Initial assessment (T0), 4-month,12-month and 16-month post-assignment follow-ups ]
  • Change in Short Form Health Survey (SF-6D) [ Time Frame: Initial assessment (T0), 4-month, 8-month (telephone),12-month and 16-month post-assignment follow-ups ]
  • Change in Administrative databases records [ Time Frame: Starting 12 months prior to participant enrollment up to 16 months post-assignment. ]
    Beneficiary registry (sex, birthdate, and death registry), Med-Écho hospitalizations (diagnosis, procedures), medical services (physician, diagnosis, acts, services) and pharmaceutical services (medication, dose, duration).
  • 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. ]


Information By: Université de Sherbrooke

Dates:
Date Received: May 24, 2016
Date Started: September 12, 2016
Date Completion: December 2018
Last Updated: May 8, 2017
Last Verified: April 2017