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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000370
Other study ID # R29MH057326
Secondary ID R29MH057326DSIR
Status Completed
Phase N/A
First received November 2, 1999
Last updated January 16, 2018
Start date May 1998
Est. completion date February 2003

Study information

Verified date January 2018
Source Boston University Charles River Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Social phobia is a very common and debilitating disorder, with public speaking anxiety being the most common fear. Psychologists have found that treating patients for their fear of public speaking, through cognitive-behavioral treatment (talk-based therapy) or exposure treatment (where participants participate in actual public speaking sessions), not only helps patients overcome this fear but also helps them overcome their more general social fears. However, little is known about how this change occurs during therapy. This study tries to identify the factors that contribute most to successful therapy.

Patients are assigned randomly (like tossing a coin) to 1 of 3 groups. Group 1 will receive cognitive-behavioral treatment and Group 2 will receive exposure treatment. Group 3 will not receive treatment. Study leaders will monitor patient response to treatment through behavioral tests and assessments.

An individual may be eligible for this study if he/she:

Has social phobia with public speaking anxiety.


Description:

The primary goal of the present study is to identify the mediators and moderators of change in the treatment of social phobia and, in so doing suggest a common mechanism of action for all brief psychosocial interventions. Perceived self-efficacy of social behavior, negative cognitive appraisal (estimated social costs), and perceived emotional control will be considered as potential mediators; avoidant personality disorder and the generalized subtype of social phobia will be considered as potential predictors for poor treatment outcome.

Social phobia is a very prevalent and debilitating disorder, with public speaking anxiety being the most common fear among socially phobic individuals. Although there are a number of effective psychosocial treatments for social phobia (e.g., cognitive-behavioral treatments and exposure therapy) very little is known about the underlying mechanism of therapeutic change (i.e., the mediators of change), and the variables that are predictive of treatment outcome (i.e., the moderators of change). Furthermore, it is unclear why treating individuals for their public speaking anxiety can generalize to other untreated social fears.

Patients are randomly assigned to either a comprehensive cognitive-behavioral treatment for social phobia (n=43), a performance-based exposure treatment for public speaking anxiety without cognitive intervention (n=43), or a waitlist control group (n=43). Clinician ratings, behavioral tests, cognitive assessments, subjective ratings, and physiological measures are employed to determine the degree of therapeutic gains in various social phobia domains. The main hypothesis is that perceived emotional control will mediate treatment outcome and generality of effectiveness independent of the specific treatment condition.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date February 2003
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

Patients must have:

Social phobia with public speaking anxiety.

Study Design


Intervention

Behavioral:
Cognitive behavior therapy

Performance-based exposure therapy

Psychosocial intervention


Locations

Country Name City State
United States Center for Anxiety and Related Disorders at Boston University Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Boston University Charles River Campus National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

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