Social Anxiety Disorder
Conditions
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).
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.
Interventions
BEHAVIORALMindfulness-based Intervention
Twelve week group intervention that includes training in mindfulness meditation, self-compassion and mindful exposure.
BEHAVIORALCognitive Behavior Group Therapy
Twelve week group intervention that focuses on the interaction between thoughts, feelings, and behaviors.
Sponsors
Ontario Mental Health Foundation
University of Ottawa
Hopital Montfort
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Outcome results
None listed