Trial Outcomes & Findings for Assessment and Treatment of Social Skills Deficits in Individuals With Social Phobia (NCT NCT00073333)

NCT ID: NCT00073333

Last Updated: 2013-07-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 379 participants
• Primary outcome timeframe: Measured at Month 12
• Results posted on: 2013-07-18

Participant Flow

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.

Participant milestones

Measure	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.	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	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
Overall Study STARTED	46	41	19
Overall Study COMPLETED	32	27	19
Overall Study NOT COMPLETED	14	14	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment and Treatment of Social Skills Deficits in Individuals With Social Phobia

Baseline characteristics by cohort

Measure	1Social Effectiveness Therapy n=46 Participants Social skills training and exposure therapy - each conducted once per week.	2Imaginal and in Vivo Exposure n=41 Participants Exposure treatment - imaginal and in vivo exposure conducted twice per week	Attention Placebo Control n=19 Participants Placebo - attention placebo control condition consisting of weekly telephone contact	Total n=106 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=93 Participants	41 Participants n=4 Participants	19 Participants n=27 Participants	105 Participants n=483 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Age Continuous	36.7 years STANDARD_DEVIATION 14.4 • n=93 Participants	36.1 years STANDARD_DEVIATION 13.8 • n=4 Participants	36.4 years STANDARD_DEVIATION 14.2 • n=27 Participants	36.3 years STANDARD_DEVIATION 13.9 • n=483 Participants
Sex: Female, Male Female	25 Participants n=93 Participants	18 Participants n=4 Participants	12 Participants n=27 Participants	55 Participants n=483 Participants
Sex: Female, Male Male	21 Participants n=93 Participants	23 Participants n=4 Participants	7 Participants n=27 Participants	51 Participants n=483 Participants
Region of Enrollment United States	46 participants n=93 Participants	41 participants n=4 Participants	19 participants n=27 Participants	106 participants n=483 Participants

PRIMARY outcome

Timeframe: Measured at Month 12

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 month follow up

Lack of SocialPhobia Diagnosis at 6 month follow-up

Outcome measures

Measure	Social Effectiveness Therapy n=46 Participants Social skills training and exposure therapy - each conducted once per week.	Imaginal and In Vivo Exposure n=41 Participants Exposure treatment - imaginal and in vivo exposure conducted twice per week	Attention Placebo Control n=19 Participants Placebo - attention placebo control condition consisting of weekly telephone contact
Social Phobia Remission Rate at 6 Month Follow-up	29 participants	23 participants	NA participants Wait list was treated at the end of 12 weeks

SECONDARY outcome

Timeframe: Measured at Month 12

Outcome measures

Outcome data not reported

Adverse Events

Social Effectiveness Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Imaginal and In Vivo Exposure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Attention Placebo Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Deborah C. Beidel, Ph.D.

University of Central Florida

Phone: 407-823-3254

Email: deborah.beidel@ucf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place