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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
97
Twelve week group intervention that includes training in mindfulness meditation, self-compassion and mindful exposure.
Twelve week group intervention that focuses on the interaction between thoughts, feelings, and behaviors.
Hopital Montfort
Ottawa, Ontario, Canada
Montfort Hospital
Ottawa, Ontario, Canada
Liebowitz Social Anxiety Scale
A 24-item clinician-rated scale that assesses fear and avoidance of social performance and social situations.
Time frame: Change from baseline to week 12 and 6-month follow-up
Social Phobia Inventory
A 17-item self-report scale that assesses symptom domains of social anxiety.
Time frame: Change from baseline to week 12 and 6-month follow-up
Clinical Global Impression Improvement Ratings
A 7-point clinician-rated scale that assesses level of clinical improvement.
Time frame: Change from baseline to week 12 and 6-month follow-up
Beck Depression Inventory
A 21-item self-report measure of severity of depressive symptoms.
Time frame: Change from baseline to week 12 and 6-month-follow-up
Social Adjustment Scale-Self Report Revised
A 49-item self-report scale that assesses functional impairment in multiple roles.
Time frame: Change from baseline to week 12 and 6-month follow-up
Rosenberg Self-Esteem Scale
A 10-item self-report measure of self-esteem.
Time frame: Change from baseline to week 12 and 6-month follow-up
Satisfaction with Life Questionnaire
A 5-item self-report scale that assesses overall satisfaction with life.
Time frame: Change from baseline to week 12 and 6-month follow-up
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