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Mindfulness-based Intervention Versus CBT for Social Anxiety Disorder

Primary Purpose

Social Anxiety Disorder

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Mindfulness-based Intervention

Cognitive Behavior Group Therapy

About this trial

This is an interventional treatment trial for Social Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hopital Montfort
Montfort Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-Based Intervention

Cognitive Behavior Group Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Liebowitz Social Anxiety Scale

A 24-item clinician-rated scale that assesses fear and avoidance of social performance and social situations.

Secondary Outcome Measures

Social Phobia Inventory

A 17-item self-report scale that assesses symptom domains of social anxiety.

Clinical Global Impression Improvement Ratings

A 7-point clinician-rated scale that assesses level of clinical improvement.

Beck Depression Inventory

A 21-item self-report measure of severity of depressive symptoms.

Social Adjustment Scale-Self Report Revised

A 49-item self-report scale that assesses functional impairment in multiple roles.

Rosenberg Self-Esteem Scale

A 10-item self-report measure of self-esteem.

Satisfaction with Life Questionnaire

A 5-item self-report scale that assesses overall satisfaction with life.

Full Information

NCT ID

NCT02490189

First Posted

June 30, 2015

Last Updated

February 20, 2018

Sponsor

Hopital Montfort

Collaborators

Ontario Mental Health Foundation, University of Ottawa

1. Study Identification

Unique Protocol Identification Number

NCT02490189

Brief Title

Mindfulness-based Intervention Versus CBT for Social Anxiety Disorder

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

July 25, 2015 (Actual)

Primary Completion Date

December 15, 2017 (Actual)

Study Completion Date

February 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hopital Montfort

Collaborators

Ontario Mental Health Foundation, University of Ottawa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Social Anxiety Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness-Based Intervention

Arm Type

Experimental

Arm Description

Arm Title

Cognitive Behavior Group Therapy

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness-based Intervention

Intervention Description

Twelve week group intervention that includes training in mindfulness meditation, self-compassion and mindful exposure.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavior Group Therapy

Other Intervention Name(s)

CBGT

Intervention Description

Twelve week group intervention that focuses on the interaction between thoughts, feelings, and behaviors.

Primary Outcome Measure Information:

Title

Liebowitz Social Anxiety Scale

Description

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

Secondary Outcome Measure Information:

Title

Social Phobia Inventory

Description

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

Title

Clinical Global Impression Improvement Ratings

Description

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

Title

Beck Depression Inventory

Description

A 21-item self-report measure of severity of depressive symptoms.

Time Frame

Change from baseline to week 12 and 6-month-follow-up

Title

Social Adjustment Scale-Self Report Revised

Description

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

Title

Rosenberg Self-Esteem Scale

Description

A 10-item self-report measure of self-esteem.

Time Frame

Change from baseline to week 12 and 6-month follow-up

Title

Satisfaction with Life Questionnaire

Description

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

Other Pre-specified Outcome Measures:

Title

Self-Compassion Scale-Short Form

Description

A 12-item self-report scale that captures how respondents perceive their actions towards themselves in difficult times.

Time Frame

Change from baseline to week 12 and 6-month follow-up

Title

Five-Facet Mindfulness Questionnaire

Description

A 39-item self-report inventory that assesses different facets of mindfulness.

Time Frame

Change from baseline to week 12 and 6-month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diana Koszycki, PhD

Organizational Affiliation

Hopital Montfort

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hopital Montfort

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1K 0T1

Country

Canada

Facility Name

Montfort Hospital

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1K 0T1

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

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Mindfulness-based Intervention Versus CBT for Social Anxiety Disorder

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