Efficacy of an Enhanced Mindfulness-based Intervention for Social Anxiety Disorder: A Pilot Feasibility Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hopital Montfort
- Enrollment
- 39
- Locations
- 2
- Primary Endpoint
- Social Phobia Inventory
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Social Phobia Inventory
Time Frame: change from baseline at weeks 6, 12 and 3 months follow-up
Clinician-rated Liebowitz Social Phobia Scale
Time Frame: change from baseline at weeks 6, 12 and 3 months follow-up
Secondary Outcomes
- 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)
Investigators
Diana Koszycki
Research Chair In Mental Health/Senior Scientist
Hopital Montfort