Mindfulness-based Intervention Versus CBT for Social Anxiety Disorder

Not Applicable

Completed

• Conditions: Social Anxiety Disorder
• Interventions: Behavioral: Cognitive Behavior Group Therapy; Behavioral: Mindfulness-based Intervention

• Registration Number: NCT02490189
• Lead Sponsor: Hopital Montfort

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.

Study Timeline

• Study First Submitted: 2015-06-30
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-03
• Study Start: 2015-07-25
• Primary Completion: 2017-12-15
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Study Completion: 2018-02-21
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavior Group Therapy	Cognitive Behavior Group Therapy	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.
Mindfulness-Based Intervention	Mindfulness-based Intervention	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.

Primary Outcome Measures

Name	Time	Method
Liebowitz Social Anxiety Scale	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 Outcome Measures

Name	Time	Method
Beck Depression Inventory	Change from baseline to week 12 and 6-month-follow-up	A 21-item self-report measure of severity of depressive symptoms.
Social Adjustment Scale-Self Report Revised	Change from baseline to week 12 and 6-month follow-up	A 49-item self-report scale that assesses functional impairment in multiple roles.
Satisfaction with Life Questionnaire	Change from baseline to week 12 and 6-month follow-up	A 5-item self-report scale that assesses overall satisfaction with life.
Clinical Global Impression Improvement Ratings	Change from baseline to week 12 and 6-month follow-up	A 7-point clinician-rated scale that assesses level of clinical improvement.
Rosenberg Self-Esteem Scale	Change from baseline to week 12 and 6-month follow-up	A 10-item self-report measure of self-esteem.
Social Phobia Inventory	Change from baseline to week 12 and 6-month follow-up	A 17-item self-report scale that assesses symptom domains of social anxiety.

Trial Locations

Locations (2)

Hopital Montfort; 🇨🇦 Ottawa, Ontario, Canada

Montfort Hospital; 🇨🇦 Ottawa, Ontario, Canada