Efficacy of a Mindfulness Meditation Program for Social Anxiety Disorder

Study Overview
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Brief Summary
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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
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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).

Official Title
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Efficacy of an Enhanced Mindfulness-based Intervention for Social Anxiety Disorder: A Pilot Feasibility Randomized Controlled Trial

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Behavioral: Mindfulness Meditation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Meditation<br>12 weekly sessions in group format | Behavioral: Mindfulness Meditation<br> <br> |
| No Intervention: Wait-list<br>Patients will receive the mindfulness intervention after a 12-week wait period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician-rated Liebowitz Social Phobia Scale |  | change from baseline at weeks 6, 12 and 3 months follow-up | 
| Social Phobia Inventory |  | change from baseline at weeks 6, 12 and 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Five Facet Mindfulness Questionnaire |  | change from baseline at weeks 6, 12 and 3 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community Sample