Mindfulness-based Intervention Versus CBT for Social Anxiety Disorder

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

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).

Study Overview

• Status: Completed
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Behavioral: Mindfulness-based Intervention; Behavioral: Cognitive Behavior Group Therapy

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 Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1K 0T1
      • Montfort Hospital
    • Ottawa, Ontario, Canada, K1K 0T1
      • Hopital Montfort

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Mindfulness-based Intervention; Twelve week group intervention that includes training in mindfulness meditation, self-compassion and mindful exposure.
Active Comparator: 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.	Behavioral: Cognitive Behavior Group Therapy; Twelve week group intervention that focuses on the interaction between thoughts, feelings, and behaviors.; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Compassion Scale-Short Form	A 12-item self-report scale that captures how respondents perceive their actions towards themselves in difficult times.	Change from baseline to week 12 and 6-month follow-up
Five-Facet Mindfulness Questionnaire	A 39-item self-report inventory that assesses different facets of mindfulness.	Change from baseline to week 12 and 6-month follow-up

Collaborators and Investigators

• Sponsor: Hopital Montfort
• Collaborators: University of Ottawa; Ontario Mental Health Foundation
• Investigators: Principal Investigator: Diana Koszycki, PhD, Hopital Montfort

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2015
• Primary Completion (Actual): December 15, 2017
• Study Completion (Actual): February 21, 2018

Study Registration Dates

• First Submitted: June 30, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 20, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: DK-27-02-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No