Residential Cognitive and Interpersonal Therapy for Social Phobia

Social Phobia Clinical Trial

Official title:

Residential Cognitive Therapy Versus Residential Interpersonal Therapy for Social Phobia: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326430
• Other study ID #: 1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 15, 2006
• Last updated: May 15, 2006
• Start date: October 2001
• Est. completion date: June 2004

Study information

• Verified date: May 2006
• Source: Modum Bad
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: MedicineNorway: The National and Regional Committees for Medical Research Ethics, NEM and REK
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is twofold: (1) to compare the effectiveness of two promising treatments for social phobia, a new cognitive therapy model (Clark & Wells, 1995; Borge et al., 2001) and interpersonal therapy (Lipsitz, Markowitz, & Cherry, 1997), adapted for inpatient groups; and (2) to study the empirical change processes in these therapies and compare them with the cognitive and interpersonal models of change.

Description:

Social phobia typically leads to severe impairment in work and other social life, and - without treatment - it can persist for decades. Given its prevalence, severity, and chronicity, effective treatment methods are strongly needed. However, traditional psychological and pharmacological treatments have had statistically significant, but clinically limited effects (Taylor, 1996).

Based on an empirical analysis of the cognitive processes in social phobia, Clark and Wells (1995) have developed a new cognitive model. Cognitive therapy (CT) derived from this model has been found to be superior to a combination of fluoxetine and self-exposure (Clark et al., 2003).

Social phobic symptoms may be viewed as a result of more general interpersonal difficulties and interpersonal psychotherapy (IPT) can be a reasonable alternative for social phobia (Lipsitz & Markowitz, 1996). A clinical case series indicates that social phobic patients improve during interpersonal psychotherapy for social phobia (IPT-SP; Lipsitz et al., 1999.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• DSM-IV criteria for social phobia

• the patient consider social phobia as the main current problem

• willingness to suspend use of psychotropic medication, alcohol and other substances

• acceptance of random allocation

• ability to speak Norwegian

• age 18-65 years.

Exclusion Criteria:

• a history of recurrent major depression currently treated sucessfully with antidepressant medications

• has immediate need for additional treatment

• current psychotic disorder or substance abuse

• organic mental disorder

• previously treated with similar models

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phobic Disorders
• Social Phobia

Intervention

Behavioral:
• Cognitive Therapy, Interpersonal Therapy

Locations

Country	Name	City	State
Norway	Modum Bad	Vikersund	Buskerud

Sponsors (1)

Lead Sponsor	Collaborator
Modum Bad

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social Avoidance
Primary	Social Anxiety
Secondary	General Anxiety
Secondary	Depression
Secondary	Interpersonal Problems
Secondary	Personality Disorders