Social PhobiaNCT00073333
Assessment and Treatment of Social Skills Deficits in Individuals With Social Phobia
A study testing Social Skills Training and Exposure Treatment in people with Social Phobia, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This study will determine whether people with social phobia are deficient in certain social skills. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Phobia
- What is being tested?
- Social Skills Training and Exposure Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 379 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Mar 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Social Phobia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Social Phobia: Assessment and Treatment of Social Skills
This study will determine whether people with social phobia are deficient in certain social skills.
Read the 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.
- Conditions
- Social Phobia
- Being tested
- Social Skills Training, Exposure Treatment, Placebo
- Keywords
- Phobic Disorders
- Medical subject headings
- Phobia, Social, Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Skills TrainingBehavioural
Social skills training once per week
Exposure TreatmentBehavioural
Exposure once per week
PlaceboBehavioural
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Social skills training and exposure Receives: Behavioral: Social Skills Training |
| 2 | Active comparator | Exposure treatment Receives: Behavioral: Exposure Treatment |
| 3 | Placebo comparator | Placebo Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Phobia Remission
Measured: Measured at Month 12
Social Phobia Remission Rate at 6 Month Follow-up
Lack of SocialPhobia Diagnosis at 6 month follow-up
Measured: 6 month follow up
Secondary outcomes (1)
Score on the SPAI
Measured: Measured at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2003 (estimated)
- Study startDec 2002
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Social PhobiaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Deborah C. Beidel, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073333
- Sponsor's protocol ID
- R01MH062547
- Other IDs
- R01MH062547
- Status last verified
- Jul 2013
- First submitted
- 19 Nov 2003
- Last updated
- 18 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Phobia: Assessment and Treatment of Social Skills
- ClinicalTrials.gov ID
- NCT00073333
- Acronym / sponsor ID
- R01MH062547
- Conditions
- Social Phobia
- Keywords
- Phobic Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2002
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 21 Nov 2003 (estimated)
- Results
- Posted 2 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Social Skills TrainingSocial skills training and exposure |
| 2 | Active comparator | Behavioral: Exposure TreatmentExposure treatment |
| 3 | Placebo comparator | Behavioral: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Social Phobia
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Skills TrainingSocial skills training once per week | Behavioural | 1 |
| Exposure TreatmentExposure once per week | Behavioural | 2 |
| PlaceboPlacebo | Behavioural | 3 |
Primary outcome
Social Phobia Remission
Time frame: Measured at Month 12
Social Phobia Remission Rate at 6 Month Follow-up
Time frame: 6 month follow up
Lack of SocialPhobia Diagnosis at 6 month follow-up
1 secondary outcome
Score on the SPAI
Time frame: Measured at Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Skills Training and Exposure Treatment in people with Social Phobia, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Phobia Remission (time frame: Measured at Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2013.