NCT00073333

Brief Summary

This study will determine whether people with social phobia are deficient in certain social skills.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
379

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

July 2, 2013

Completed
Last Updated

July 18, 2013

Status Verified

July 1, 2013

Enrollment Period

5.3 years

First QC Date

November 19, 2003

Results QC Date

May 14, 2013

Last Update Submit

July 1, 2013

Conditions

Social Phobia

Keywords

Phobic Disorders

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (1)

  • Score on the SPAI

    Measured at Month 12

Study Arms (3)

1

ACTIVE COMPARATOR

Social skills training and exposure

Behavioral: Social Skills Training

2

ACTIVE COMPARATOR

Exposure treatment

Behavioral: Exposure Treatment

3

PLACEBO COMPARATOR

Placebo

Behavioral: Placebo

Interventions

Social Skills TrainingBEHAVIORAL

Social skills training once per week

1
Exposure TreatmentBEHAVIORAL

Exposure once per week

2
PlaceboBEHAVIORAL

Placebo

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Social Phobia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Phobia, SocialPhobic Disorders

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Results Point of Contact

Title
Deborah C. Beidel, Ph.D.
Organization
University of Central Florida
deborah.beidel@ucf.edu
407-823-3254

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 19, 2003

First Posted

November 21, 2003

Study Start

December 1, 2002

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

July 18, 2013

Results First Posted

July 2, 2013

Record last verified: 2013-07

Locations

US(1)