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Completed

NCT Number: NCT01914874

Efficacy of a Mindfulness Meditation Program for Social Anxiety Disorder

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.

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montfort Hospital

Ottawa, Ontario, K1K 0T1, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Meditation

Behavioral

Primary outcomes

  1. Clinician-rated Liebowitz Social Phobia Scale

    Time frame: change from baseline at weeks 6, 12 and 3 months follow-up

  2. Social Phobia Inventory

    Time frame: change from baseline at weeks 6, 12 and 3 months follow-up

Secondary outcomes

  1. Beck Depression Inventory

    Time frame: change from baseline at weeks 6, 12 and 3 months follow-up

  2. Social Adjustment Scale-Self-Report

    Time frame: change from baseline at weeks 6 and 12 and 3 months follow-up

  3. CGI-Severity of Illness

    Time frame: change from baseline at weeks 6, 12 and 3 months follow-up

  4. Self-Compassion Scale

    Time frame: change from baseline at weeks 6, 12 and 3-months follow-up

  5. Five Facet Mindfulness Questionnaire

    Time frame: change from baseline at weeks 6, 12 and 3 months follow-up

Other outcomes

  1. Study compliance: attendance and homework

    Time frame: compliance will be assessed at each week during the 12-week mndfulness meditation program

  2. Salivary cortisol

    Time frame: change from baseline at week 12

  3. Salivary alpha-amylase

    Time frame: change from baseline at week 12

Sponsors and collaborators

Lead sponsor

Hopital Montfort

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 2, 2013
Registry last updated
Jul 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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