Mindfulness-based Intervention Versus CBT for Social Anxiety Disorder

Social Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02490189
• Other study ID #: DK-27-02-15
• Status: Completed
• Phase: N/A
• First received: June 30, 2015
• Last updated: February 20, 2018
• Start date: July 25, 2015
• Est. completion date: February 21, 2018

Study information

• Verified date: February 2018
• Source: Hopital Montfort
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: February 21, 2018
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• Mindfulness-based Intervention
Twelve week group intervention that includes training in mindfulness meditation, self-compassion and mindful exposure.
• Cognitive Behavior Group Therapy
Twelve week group intervention that focuses on the interaction between thoughts, feelings, and behaviors.

Locations

Country	Name	City	State
Canada	Hopital Montfort	Ottawa	Ontario
Canada	Montfort Hospital	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Hopital Montfort	Ontario Mental Health Foundation, University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rosenberg Self-Esteem Scale	A 10-item self-report measure of self-esteem.	Change from baseline to week 12 and 6-month follow-up
Secondary	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