Efficacy of a Mindfulness Meditation Program for Social Anxiety Disorder

NCT01914874 | Completed

• 1 other identifier: DK-05-02-13
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder

Keywords

Community Sample

Outcome Measures

Primary Outcomes (2)

• Clinician-rated Liebowitz Social Phobia Scale

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

• Social Phobia Inventory

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

Secondary Outcomes (5)

• 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

• 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

• Five Facet Mindfulness Questionnaire

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

Other Outcomes (3)

• Study compliance: attendance and homework

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

• Salivary cortisol

  change from baseline at week 12

• Salivary alpha-amylase

  change from baseline at week 12

Study Arms (2)

Mindfulness Meditation

EXPERIMENTAL

12 weekly sessions in group format

Behavioral: Mindfulness Meditation

Wait-list

NO INTERVENTION

Patients will receive the mindfulness intervention after a 12-week wait period

Interventions

Mindfulness Meditation BEHAVIORAL

Mindfulness Meditation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Montfort: lead

Study Sites (1)

Montfort Hospital

Ottawa, Ontario, K1K 0T1, Canada

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Diana Koszycki, PhD

  Montfort Hospital and University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Chair In Mental Health/Senior Scientist

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 2, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 1, 2015

Record last verified: 2015-06

Locations

CA (1)