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| Name | Class |
|---|---|
| Ontario Mental Health Foundation | OTHER_GOV |
| University of Ottawa | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Intervention | Experimental | 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. |
|
| Cognitive Behavior Group Therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based Intervention | Behavioral | Twelve week group intervention that includes training in mindfulness meditation, self-compassion and mindful exposure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liebowitz Social Anxiety Scale | A 24-item clinician-rated scale that assesses fear and avoidance of social performance and social situations. | Change from baseline to week 12 and 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Social Phobia Inventory | A 17-item self-report scale that assesses symptom domains of social anxiety. | Change from baseline to week 12 and 6-month follow-up |
| Clinical Global Impression Improvement Ratings |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Compassion Scale-Short Form | A 12-item self-report scale that captures how respondents perceive their actions towards themselves in difficult times. | Change from baseline to week 12 and 6-month follow-up |
| Five-Facet Mindfulness Questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana Koszycki, PhD | Hopital Montfort | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Montfort | Ottawa | Ontario | K1K 0T1 | Canada | ||
| Montfort Hospital |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Cognitive Behavior Group Therapy | Behavioral | Twelve week group intervention that focuses on the interaction between thoughts, feelings, and behaviors. |
|
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A 7-point clinician-rated scale that assesses level of clinical improvement.
| Change from baseline to week 12 and 6-month follow-up |
| Beck Depression Inventory | A 21-item self-report measure of severity of depressive symptoms. | Change from baseline to week 12 and 6-month-follow-up |
| Social Adjustment Scale-Self Report Revised | A 49-item self-report scale that assesses functional impairment in multiple roles. | Change from baseline to week 12 and 6-month follow-up |
| Rosenberg Self-Esteem Scale | A 10-item self-report measure of self-esteem. | Change from baseline to week 12 and 6-month follow-up |
| Satisfaction with Life Questionnaire | A 5-item self-report scale that assesses overall satisfaction with life. | Change from baseline to week 12 and 6-month follow-up |
A 39-item self-report inventory that assesses different facets of mindfulness.
| Change from baseline to week 12 and 6-month follow-up |
| Ottawa |
| Ontario |
| K1K 0T1 |
| Canada |