Efficacy of a Mindfulness Meditation Program for Social Anxiety Disorder

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

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Behavioral: Mindfulness Meditation

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1K 0T1
      • Montfort Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
Study compliance: attendance and homework	compliance will be assessed at each week during the 12-week mndfulness meditation program
Salivary cortisol	change from baseline at week 12
Salivary alpha-amylase	change from baseline at week 12

Collaborators and Investigators

• Sponsor: Hopital Montfort
• Investigators: Principal Investigator: Diana Koszycki, PhD, Montfort Hospital and University of Ottawa

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: July 30, 2013
• First Submitted That Met QC Criteria: July 31, 2013
• First Posted (Estimate): August 2, 2013

Study Record Updates

• Last Update Posted (Estimate): July 1, 2015
• Last Update Submitted That Met QC Criteria: June 29, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Community Sample
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: DK-05-02-13