Cognitive Behavior Therapy for Somatization Disorder

Phase 2

Completed

• Conditions: Somatoform Disorders

• Registration Number: NCT00276887
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

Brief Summary

This study will examine the long-term effects of cognitive behavioral therapy on the physical symptoms, functioning, and health care utilization of people with multiple medically unexplained physical symptoms.

Detailed Description

Somatization disorder is a chronic psychological condition that causes numerous physical complaints for which no underlying physical problem can be identified. The disorder often lasts for several years and results in substantial functional impairment. The physical complaints most frequently involve chronic pain and problems with the digestive, nervous, and reproductive systems. Neither pharmacological nor psychosocial treatments for this disorder have been successful in suppressing symptoms. Cognitive behavioral therapy (CBT) is a treatment that focuses on maladaptive patterns of thinking and the beliefs that underlie such thinking. This study will examine the long-term effects of CBT 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 CBT supplemented with augmented standard medical care (ASMC) as indicated by a psychiatric consultation letter or ASMC alone. Participants assigned to CBT plus ASMC will receive CBT for 10 weeks. Somatic symptomatology, functional impairment, and health care costs will be assessed at study visits at baseline and Months 3, 9, and 15. The visits at Months 9 and 15 will assess specifically the long-term efficacy of the treatment.

Study Timeline

• Study Start: 1999-09
• Primary Completion: 2003-04
• Study Completion: 2004-04
• Study First Submitted: 2006-01-11
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-13
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-19
• Last Update Posted: 2014-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Meets DSM-IV criteria for somatization disorder
• Available for follow-up over the ensuing 15 months
• English-speaking

Exclusion Criteria

• Meets DSM-IV criteria for a psychotic disorder, organic brain syndrome, or psychoactive substance dependence
• Active suicidal ideation
• Unstable major medical condition
• Plans to engage in additional psychotherapy during the first 3 months after study entry
• Current use of any medication that has not been stabilized for the 2 months prior to study entry

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Symptoms of somatization disorder
Functioning (measured with the Clinical Global Impression Scale for Somatization Disorder at Months 9 and 15)

Secondary Outcome Measures

Name	Time	Method
Health care utilization (measured the year before baseline and during the year after the 3-month assessment)
Health status (measured by the Medical Outcomes Study, SF-36, at Months 9 and 15)

Trial Locations

Locations (1)

Department of Psychiatry, UMDNJ - RWJ Medical School; 🇺🇸 Piscataway, New Jersey, United States