Efficacy of a Mindfulness Meditation Program for Social Anxiety Disorder

Not Applicable

Completed

• Conditions: Social Anxiety Disorder

• Registration Number: NCT01914874
• Lead Sponsor: Hopital Montfort

Brief Summary

The aim of this study is to evaluate the feasibility and initial efficacy of an enhanced mindfulness-based program that includes "mindful exposure" to reduce anxiety and avoidance of social situations, and the Buddhist practice of self-compassion aimed at reducing harsh judgment and self-criticism that is characteristic of people with social anxiety disorder.

Detailed Description

The purpose of this pilot study is to evaluate the feasibility and initial efficacy of an enhanced mindfulness-based intervention for SAD (MIND-SAD) that incorporates the following components: training in classical mindfulness, including concentration and insight (vipassana) meditation; training in self-compassion; and mindful exposure. An exploratory aim of the study is to evaluate the effects of the mindfulness intervention on biological markers of stress reactivity, including salivary cortisoland salivary alpha-amylase. The study is a two-arm, parallel design, prospective study comparing 12 weekly sessions of MIND-SAD delivered in a group format versus a wait-list control (WLC).

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-02
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-29
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Primary diagnosis of Social Anxiety Disorder; Baseline score of 30 or higher on the Liebowitz Social Anxiety Scale; Baseline score of 4 or higher on the Clinical Global Impression of Severity

Exclusion Criteria

• Lifetime history of psychosis or bipolar disorder; substance abuse in the past 12 months; diagnosis of borderline or antisocial personality disorder; serious suicide risk; currently in psychotherapy; regular meditation or yoga practice in the past 12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Social Phobia Inventory	change from baseline at weeks 6, 12 and 3 months follow-up
Clinician-rated Liebowitz Social Phobia Scale	change from baseline at weeks 6, 12 and 3 months follow-up

Secondary Outcome Measures

Name	Time	Method
CGI-Severity of Illness	change from baseline at weeks 6, 12 and 3 months follow-up
Self-Compassion Scale	change from baseline at weeks 6, 12 and 3-months follow-up
Beck Depression Inventory	change from baseline at weeks 6, 12 and 3 months follow-up
Social Adjustment Scale-Self-Report	change from baseline at weeks 6 and 12 and 3 months follow-up
Five Facet Mindfulness Questionnaire	change from baseline at weeks 6, 12 and 3 months follow-up

Trial Locations

Locations (1)

Montfort Hospital; 🇨🇦 Ottawa, Ontario, Canada