Effectiveness of Cognitive-Affective Behavior Therapy for the Treatment of Somatization Disorder

Phase 2

Completed

• Conditions: Somatization Disorder
• Interventions: Behavioral: Cognitive-Affective Behavior Therapy; Behavioral: Augmented Standard Medical Care

• Registration Number: NCT00149760
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

This study will examine the long-term effect of cognitive-affective behavior therapy on the physical symptoms, functioning, and health care utilization of people with somatization disorder.

Detailed Description

Somatization disorder is a syndrome characterized by the presence of multiple medically unexplained physical symptoms. It often results in substantial functional impairment and the need for extensive medical treatment. Neither pharmacological nor psychosocial treatments for the disease have demonstrated clinical success. People with somatization disorder may benefit from a treatment that integrates emotion-centered strategies into cognitive behavioral therapy. The long-term effectiveness of this treatment has not been established, however. This study will examine the long-term effect of cognitive-affective behavior therapy on the physical symptoms, functioning, and health care utilization of people with somatization disorder.

Participants in this open-label study will be randomly assigned to receive either cognitive-affective behavior therapy (CABT) or standard medical care that is augmented by a psychiatric consultation. Treatment will last 4 months. Assessments of somatic symptomatology, functional impairment, and health care costs will occur at screening, baseline (1 to 2 weeks after screening), and 4, 10, and 16 months after baseline. The visits at 10 and 16 months post-baseline will assess specifically the long-term efficacy of the treatment.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-19
• Last Update Posted: 2014-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Meets DSM-IV criteria for somatization disorder
• Available for follow-up over the ensuing 18 months
• English-speaking

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Exclusion Criteria

• Meets DSM-IV criteria for a psychotic disorder, organic brain syndrome, or psychoactive substance dependence (Other psychiatric comorbidity is not exclusionary)
• Active suicidal ideation
• Unstable major medical condition
• Plans to engage in additional psychotherapy during the first 6 months after enrollment
• Current use of any medication that has not been stabilized for the previous 2 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive-Affective Behavior Therapy	Cognitive-Affective Behavior Therapy	Participants will receive individually administered cognitive-affective behavior therapy as well as augmented standard medical care.
Augmented Standard Medical Care	Augmented Standard Medical Care	Participants will receive standard medical care augmented by a psychiatric consultation letter sent to the participants' primary care physician.

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression Scale for Somatization Disorder	Measured at baseline and Months 4, 10, and 16

Secondary Outcome Measures

Name	Time	Method
Health care utilization	Measured between Months 4 and 16
Physical functioning	Measured at baseline and Months 4, 10, and 16

Trial Locations

Locations (1)

Department of Psychiatry, Robert Wood Johnson Medical School; 🇺🇸 Piscataway, New Jersey, United States