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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH062547 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will determine whether people with social phobia are deficient in certain social skills.
Social phobia is a debilitating condition that can cause severe social, emotional, educational, and occupational functioning problems. Evidence suggests that individuals with social phobia are deficient in social skills, but the exact skills deficits have not been elucidated. This study will comprise two substudies: one will examine social skills deficits in social phobics and determine how they differ from those of people without social phobia; the other will determine if skills deficits in social phobics can be improved and whether improvements will affect overall social functioning.
Participants in this study will be randomly assigned to one of three groups for 16 weeks: an exposure group, a social skills training and exposure (SET) group, or a wait-list control group. Interviews, self-reports, and simulated role plays will be used to assess the social skills of participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Social skills training and exposure |
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| 2 | Active Comparator | Exposure treatment |
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| 3 | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social Skills Training | Behavioral | Social skills training once per week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Social Phobia Remission | Measured at Month 12 | |
| Social Phobia Remission Rate at 6 Month Follow-up | Lack of SocialPhobia Diagnosis at 6 month follow-up | 6 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Score on the SPAI | Measured at Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
There were two studies contained in this grant. Study 1 was an assessment study and consisted of 379 participants - 200 normal controls and 179 participants with social phobia. Study 2 was a treatment study that consisted of 106 participants with social phobia. That is the study described below.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1Social Effectiveness Therapy | Social skills training and exposure therapy - each conducted once per week. Social Skills was conducted in groups of 4-6 participants. Exposure was individual therapy conducted weekly. |
| FG001 | 2Imaginal and In Vivo Exposure | Exposure treatment - imaginal and in vivo exposure conducted twice per week for entire study. Imaginal was instituted first followed by in vivo exposure in the form of programmed practice |
| FG002 | 3Attention Placebo | Placebo - attention placebo control condition consisting of weekly telephone contact of ten minutes during which clinical status, particularly level of depression was assessed. There was no other contact |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1Social Effectiveness Therapy | Social skills training and exposure therapy - each conducted once per week. |
| BG001 | 2Imaginal and in Vivo Exposure | Exposure treatment - imaginal and in vivo exposure conducted twice per week |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Social Phobia Remission | Not Posted | Measured at Month 12 | |||||||||||||
| Secondary | Score on the SPAI | Not Posted | Measured at Month 12 | |||||||||||||
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Social Effectiveness Therapy | Social skills training and exposure therapy - each conducted once per week. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah C. Beidel, Ph.D. | University of Central Florida | 407-823-3254 | deborah.beidel@ucf.edu |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| D010698 | Phobic Disorders |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Exposure Treatment |
| Behavioral |
Exposure once per week |
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| Placebo | Behavioral | Placebo |
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| BG002 | Attention Placebo Control | Placebo - attention placebo control condition consisting of weekly telephone contact |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Primary |
| Social Phobia Remission Rate at 6 Month Follow-up |
Lack of SocialPhobia Diagnosis at 6 month follow-up |
| Posted |
| Number |
| participants |
| 6 month follow up |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Imaginal and In Vivo Exposure | Exposure treatment - imaginal and in vivo exposure conducted twice per week | 0 | 41 | 0 | 41 |
| EG002 | Attention Placebo Control | Placebo - attention placebo control condition consisting of weekly telephone contact | 0 | 19 | 0 | 19 |
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