Comparative Trial of a Mindfulness-based Intervention Versus Cognitive Behavior Therapy for Social Anxiety Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Social Anxiety Disorder
- Sponsor
- Hopital Montfort
- Enrollment
- 97
- Locations
- 2
- Primary Endpoint
- Liebowitz Social Anxiety Scale
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
To conduct a prospective, randomized trial to compare the efficacy of a group mindfulness-based intervention adapted for social anxiety disorder (MBI-SAD) versus cognitive behavior group therapy (CBGT).
Detailed Description
The main aim of this comparative trial is to determine if the MBI-SAD will be noninferior to CBGT in improving core symptoms of social anxiety disorder, depressive symptoms, self, esteem, disability and quality of life. A secondary aim is to examine whether treatment gains are maintained over a 6-month period. Exploratory aims of the study are to: 1) determine if the MBI-SAD enhances self-compassion and mindfulness relative to CBGT; 2) determine if changes in self-compassion and mindfulness mediate the clinical response to the MBI-SAD; and 3) explore moderators of treatment response.
Investigators
Diana Koszycki
Professor and Research Chair in Mental Health
Hopital Montfort
Eligibility Criteria
Inclusion Criteria
- •DSM-5 diagnosis of social anxiety disorder (SAD) of at least moderate severity
- •Montgomery Asberg Depression Rating Scale score ≤ 25
- •Comorbid depressive disorders, panic disorder, agoraphobia, generalized anxiety disorder, specific phobias, eating disorders are allowed as long as the SAD is primary and predominates the clinical picture.
Exclusion Criteria
- •Coexisting Axis I disorders excluding those listed in the inclusion criteria
- •Coexisting medical conditions that can alter the clinical presentation of SAD (e.g. Parkinson's disease)
- •Lifetime history of bipolar disorder or psychotic symptoms
- •Substance-related disorders in the last 12 months
- •Acutely suicidal or history of suicide attempt in the past five years
- •History of non-suicidal self-injurious behavior in the last 12 months
- •Currently receiving psychotherapy
- •Currently engaged in a regular meditation or yoga practice
- •Unable to attend weekly group sessions
Outcomes
Primary Outcomes
Liebowitz Social Anxiety Scale
Time Frame: Change from baseline to week 12 and 6-month follow-up
A 24-item clinician-rated scale that assesses fear and avoidance of social performance and social situations.
Secondary Outcomes
- Beck Depression Inventory(Change from baseline to week 12 and 6-month-follow-up)
- Social Adjustment Scale-Self Report Revised(Change from baseline to week 12 and 6-month follow-up)
- Satisfaction with Life Questionnaire(Change from baseline to week 12 and 6-month follow-up)
- Clinical Global Impression Improvement Ratings(Change from baseline to week 12 and 6-month follow-up)
- Rosenberg Self-Esteem Scale(Change from baseline to week 12 and 6-month follow-up)
- Social Phobia Inventory(Change from baseline to week 12 and 6-month follow-up)