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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Meditation | Experimental | 12 weekly sessions in group format |
|
| Wait-list | No Intervention | Patients will receive the mindfulness intervention after a 12-week wait period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Meditation | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana Koszycki, PhD | Montfort Hospital and University of Ottawa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montfort Hospital | Ottawa | Ontario | K1K 0T1 | Canada |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 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 |
| Salivary alpha-amylase |
| change from baseline at week 12 |