Efficacy of a Mindfulness Meditation Program for Social Anxiety Disorder

Not Applicable

Completed

• Conditions: Social Anxiety Disorder
• Interventions: Behavioral: Mindfulness Meditation

• 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

Arm && Interventions

Group	Intervention	Description
Mindfulness Meditation	Mindfulness Meditation	12 weekly sessions in group format

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