Efficacy of a Mindfulness Meditation Program for Social Anxiety Disorder

Social Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914874
• Other study ID #: DK-05-02-13
• Status: Completed
• Phase: N/A
• First received: July 30, 2013
• Last updated: June 29, 2015
• Start date: July 2013
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: Hopital Montfort
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Montfort Hospital
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobic Disorders
• Social Anxiety Disorder

Intervention

Behavioral:
• Mindfulness Meditation

Locations

Country	Name	City	State
Canada	Montfort Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Montfort

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Study compliance: attendance and homework		compliance will be assessed at each week during the 12-week mndfulness meditation program	No
Other	Salivary cortisol		change from baseline at week 12	No
Other	Salivary alpha-amylase		change from baseline at week 12	No
Primary	Clinician-rated Liebowitz Social Phobia Scale		change from baseline at weeks 6, 12 and 3 months follow-up	No
Primary	Social Phobia Inventory		change from baseline at weeks 6, 12 and 3 months follow-up	No
Secondary	Beck Depression Inventory		change from baseline at weeks 6, 12 and 3 months follow-up	No
Secondary	Social Adjustment Scale-Self-Report		change from baseline at weeks 6 and 12 and 3 months follow-up	No
Secondary	CGI-Severity of Illness		change from baseline at weeks 6, 12 and 3 months follow-up	No
Secondary	Self-Compassion Scale		change from baseline at weeks 6, 12 and 3-months follow-up	No
Secondary	Five Facet Mindfulness Questionnaire		change from baseline at weeks 6, 12 and 3 months follow-up	No