Mindfulness-based Intervention Versus CBT for Social Anxiety Disorder
Study Details
Study Description
Brief Summary
To conduct a prospective, randomized trial to compare the efficacy of a group mindfulness-based intervention adapted for social anxiety disorder (MBI-SAD) versus cognitive behavior group therapy (CBGT).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The main aim of this comparative trial is to determine if the MBI-SAD will be noninferior to CBGT in improving core symptoms of social anxiety disorder, depressive symptoms, self, esteem, disability and quality of life. A secondary aim is to examine whether treatment gains are maintained over a 6-month period. Exploratory aims of the study are to: 1) determine if the MBI-SAD enhances self-compassion and mindfulness relative to CBGT; 2) determine if changes in self-compassion and mindfulness mediate the clinical response to the MBI-SAD; and 3) explore moderators of treatment response.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mindfulness-Based Intervention Participants in the mindfulness-based intervention arm will receive 12 weekly sessions of 2 to 2.5 hours duration. The intervention will be delivered in a group format. Participants will be assigned weekly homework. |
Behavioral: Mindfulness-based Intervention
Twelve week group intervention that includes training in mindfulness meditation, self-compassion and mindful exposure.
|
| Active Comparator: Cognitive Behavior Group Therapy Participants in the cognitive behavior group therapy arm will receive 12 weekly sessions of 2 to 2.5 hours in duration. Participants will be assigned weekly homework. |
Behavioral: Cognitive Behavior Group Therapy
Twelve week group intervention that focuses on the interaction between thoughts, feelings, and behaviors.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Liebowitz Social Anxiety Scale [Change from baseline to week 12 and 6-month follow-up]
A 24-item clinician-rated scale that assesses fear and avoidance of social performance and social situations.
Secondary Outcome Measures
- Social Phobia Inventory [Change from baseline to week 12 and 6-month follow-up]
A 17-item self-report scale that assesses symptom domains of social anxiety.
- Clinical Global Impression Improvement Ratings [Change from baseline to week 12 and 6-month follow-up]
A 7-point clinician-rated scale that assesses level of clinical improvement.
- Beck Depression Inventory [Change from baseline to week 12 and 6-month-follow-up]
A 21-item self-report measure of severity of depressive symptoms.
- Social Adjustment Scale-Self Report Revised [Change from baseline to week 12 and 6-month follow-up]
A 49-item self-report scale that assesses functional impairment in multiple roles.
- Rosenberg Self-Esteem Scale [Change from baseline to week 12 and 6-month follow-up]
A 10-item self-report measure of self-esteem.
- Satisfaction with Life Questionnaire [Change from baseline to week 12 and 6-month follow-up]
A 5-item self-report scale that assesses overall satisfaction with life.
Other Outcome Measures
- Self-Compassion Scale-Short Form [Change from baseline to week 12 and 6-month follow-up]
A 12-item self-report scale that captures how respondents perceive their actions towards themselves in difficult times.
- Five-Facet Mindfulness Questionnaire [Change from baseline to week 12 and 6-month follow-up]
A 39-item self-report inventory that assesses different facets of mindfulness.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
DSM-5 diagnosis of social anxiety disorder (SAD) of at least moderate severity
-
Montgomery Asberg Depression Rating Scale score ≤ 25
-
Comorbid depressive disorders, panic disorder, agoraphobia, generalized anxiety disorder, specific phobias, eating disorders are allowed as long as the SAD is primary and predominates the clinical picture.
Exclusion Criteria:
-
Coexisting Axis I disorders excluding those listed in the inclusion criteria
-
Coexisting medical conditions that can alter the clinical presentation of SAD (e.g. Parkinson's disease)
-
Lifetime history of bipolar disorder or psychotic symptoms
-
Substance-related disorders in the last 12 months
-
Acutely suicidal or history of suicide attempt in the past five years
-
History of non-suicidal self-injurious behavior in the last 12 months
-
Currently receiving psychotherapy
-
Currently engaged in a regular meditation or yoga practice
-
Unable to attend weekly group sessions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hopital Montfort | Ottawa | Ontario | Canada | K1K 0T1 |
| 2 | Montfort Hospital | Ottawa | Ontario | Canada | K1K 0T1 |
Sponsors and Collaborators
- Hopital Montfort
- Ontario Mental Health Foundation
- University of Ottawa
Investigators
- Principal Investigator: Diana Koszycki, PhD, Hopital Montfort
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DK-27-02-15