Social Phobia
Conditions
Keywords
Phobic Disorders
Brief summary
This study will determine whether people with social phobia are deficient in certain social skills.
Detailed description
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.
Interventions
BEHAVIORALSocial Skills Training
Social skills training once per week
BEHAVIORALExposure Treatment
Exposure once per week
BEHAVIORALPlacebo
Placebo
Sponsors
National Institute of Mental Health (NIMH)
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of Social Phobia
Exclusion criteria
* Axis II diagnosis of schizoid or schizotypal personality disorder or paranoia * Axis II diagnosis of mental retardation, obsessive-compulsive disorder, and personality disorders, except for avoidant personality disorder * Instability on any antidepressants * Psychotic disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Social Phobia Remission | Measured at Month 12 | — |
| Social Phobia Remission Rate at 6 Month Follow-up | 6 month follow up | Lack of SocialPhobia Diagnosis at 6 month follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Score on the SPAI | Measured at Month 12 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 1Social Effectiveness Therapy Social skills training and exposure therapy - each conducted once per week. | 46 |
| 2Imaginal and in Vivo Exposure Exposure treatment - imaginal and in vivo exposure conducted twice per week | 41 |
| Attention Placebo Control Placebo - attention placebo control condition consisting of weekly telephone contact | 19 |
| Total | 106 |
Baseline characteristics
| Characteristic | 2Imaginal and in Vivo Exposure | Attention Placebo Control | 1Social Effectiveness Therapy | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 19 Participants | 45 Participants | 105 Participants |
| Age Continuous | 36.1 years STANDARD_DEVIATION 13.8 | 36.4 years STANDARD_DEVIATION 14.2 | 36.7 years STANDARD_DEVIATION 14.4 | 36.3 years STANDARD_DEVIATION 13.9 |
| Region of Enrollment United States | 41 participants | 19 participants | 46 participants | 106 participants |
| Sex: Female, Male Female | 18 Participants | 12 Participants | 25 Participants | 55 Participants |
| Sex: Female, Male Male | 23 Participants | 7 Participants | 21 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 41 | 0 / 19 |
| serious Total, serious adverse events | 0 / 46 | 0 / 41 | 0 / 19 |
Outcome results
Primary
Social Phobia Remission
Time frame: Measured at Month 12
Primary
Social Phobia Remission Rate at 6 Month Follow-up
Lack of SocialPhobia Diagnosis at 6 month follow-up
Time frame: 6 month follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Social Effectiveness Therapy | Social Phobia Remission Rate at 6 Month Follow-up | 29 participants |
| Imaginal and In Vivo Exposure | Social Phobia Remission Rate at 6 Month Follow-up | 23 participants |
| Attention Placebo Control | Social Phobia Remission Rate at 6 Month Follow-up | NA participants |
Secondary
Score on the SPAI
Time frame: Measured at Month 12