Efficacy of a Mindfulness Meditation Program for Social Anxiety Disorder
Primary Purpose
Social Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness Meditation
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Community Sample
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
Sites / Locations
- Montfort Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness Meditation
Wait-list
Arm Description
12 weekly sessions in group format
Patients will receive the mindfulness intervention after a 12-week wait period
Outcomes
Primary Outcome Measures
Clinician-rated Liebowitz Social Phobia Scale
Social Phobia Inventory
Secondary Outcome Measures
Beck Depression Inventory
Social Adjustment Scale-Self-Report
CGI-Severity of Illness
Self-Compassion Scale
Five Facet Mindfulness Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01914874
Brief Title
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
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hopital Montfort
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
Community Sample
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Meditation
Arm Type
Experimental
Arm Description
12 weekly sessions in group format
Arm Title
Wait-list
Arm Type
No Intervention
Arm Description
Patients will receive the mindfulness intervention after a 12-week wait period
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Meditation
Primary Outcome Measure Information:
Title
Clinician-rated Liebowitz Social Phobia Scale
Time Frame
change from baseline at weeks 6, 12 and 3 months follow-up
Title
Social Phobia Inventory
Time Frame
change from baseline at weeks 6, 12 and 3 months follow-up
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Time Frame
change from baseline at weeks 6, 12 and 3 months follow-up
Title
Social Adjustment Scale-Self-Report
Time Frame
change from baseline at weeks 6 and 12 and 3 months follow-up
Title
CGI-Severity of Illness
Time Frame
change from baseline at weeks 6, 12 and 3 months follow-up
Title
Self-Compassion Scale
Time Frame
change from baseline at weeks 6, 12 and 3-months follow-up
Title
Five Facet Mindfulness Questionnaire
Time Frame
change from baseline at weeks 6, 12 and 3 months follow-up
Other Pre-specified Outcome Measures:
Title
Study compliance: attendance and homework
Time Frame
compliance will be assessed at each week during the 12-week mndfulness meditation program
Title
Salivary cortisol
Time Frame
change from baseline at week 12
Title
Salivary alpha-amylase
Time Frame
change from baseline at week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Koszycki, PhD
Organizational Affiliation
Montfort Hospital and University of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montfort Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1K 0T1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Efficacy of a Mindfulness Meditation Program for Social Anxiety Disorder
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