Mindfulness-based Intervention Versus CBT for Social Anxiety Disorder

Study 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.

Official Title
-----------------
Comparative Trial of a Mindfulness-based Intervention Versus Cognitive Behavior Therapy for Social Anxiety Disorder

Conditions
-----------------
Social Anxiety Disorder

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-based Intervention
* Behavioral: Cognitive Behavior Group Therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Intervention<br>Participants in the mindfulness-based intervention arm will receive 12 weekly sessions of 2 to 2.5 hours duration. The intervention will be delivered in a group format. Participants will be assigned weekly homework. | Behavioral: Mindfulness-based Intervention<br>* Twelve week group intervention that includes training in mindfulness meditation, self-compassion and mindful exposure.<br>|
| Active Comparator: Cognitive Behavior Group Therapy<br>Participants in the cognitive behavior group therapy arm will receive 12 weekly sessions of 2 to 2.5 hours in duration. Participants will be assigned weekly homework. | Behavioral: Cognitive Behavior Group Therapy<br>* Twelve week group intervention that focuses on the interaction between thoughts, feelings, and behaviors.<br>* Other names: CBGT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liebowitz Social Anxiety Scale | A 24-item clinician-rated scale that assesses fear and avoidance of social performance and social situations. | Change from baseline to week 12 and 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Phobia Inventory | A 17-item self-report scale that assesses symptom domains of social anxiety. | 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. | 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. | 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. | Change from baseline to week 12 and 6-month follow-up | 
| Rosenberg Self-Esteem Scale | A 10-item self-report measure of self-esteem. | 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. | Change from baseline to week 12 and 6-month follow-up |