Clinical trial NCT01914874: Efficacy of a Mindfulness Meditation Program for Social Anxiety Disorder
Official title: Efficacy of an Enhanced Mindfulness-based Intervention for Social Anxiety Disorder: A Pilot Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: Community Sample
Lead sponsor: Hopital Montfort
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Clinician-rated Liebowitz Social Phobia Scale
timeFrame: change from baseline at weeks 6, 12 and 3 months follow-up
measure: Social Phobia Inventory
timeFrame: change from baseline at weeks 6, 12 and 3 months follow-up
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: change from baseline at weeks 6, 12 and 3 months follow-up
measure: Social Adjustment Scale-Self-Report
timeFrame: change from baseline at weeks 6 and 12 and 3 months follow-up
measure: CGI-Severity of Illness
timeFrame: change from baseline at weeks 6, 12 and 3 months follow-up
measure: Self-Compassion Scale
timeFrame: change from baseline at weeks 6, 12 and 3-months follow-up
measure: Five Facet Mindfulness Questionnaire
timeFrame: change from baseline at weeks 6, 12 and 3 months follow-up
Other outcomes:
measure: Study compliance: attendance and homework
timeFrame: compliance will be assessed at each week during the 12-week mndfulness meditation program
measure: Salivary cortisol
timeFrame: change from baseline at week 12
measure: Salivary alpha-amylase
timeFrame: change from baseline at week 12
Locations:
city: Ottawa
country: Canada
facility: Montfort Hospital
state: Ontario
Study officials:
affiliation: Montfort Hospital and University of Ottawa
name: Diana Koszycki, PhD
role: PRINCIPAL_INVESTIGATOR
References: