Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)

Phase 3

Completed

• Conditions: Somatoform Disorders
• Interventions: Behavioral: Cognitive Behavioral Therapy; Behavioral: CBT

• Registration Number: NCT00050583
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

Brief Summary

The purpose of this study is to compare cognitive behavior therapy (CBT) to medical care-as-usual for the treatment of patients with high levels of medically unexplained physical symptoms (Somatization Disorder). A second goal is to examine the effectiveness of CBT in Latinos, since Latinos suffer a relatively high prevalence of Somatization Disorder.

Detailed Description

Patients with Somatization Disorder suffer from medically unexplained physical ailments and experience significant distress and disability. This disorder is an important problem for the primary health care system because patients with Somatization Disorder use health care resources extensively but receive little benefit. To date, no medical or psychiatric intervention has been demonstrated in controlled trials to produce clinically significant and lasting symptom relief or improved functional status in Somatization Disorder patients.

Patients in primary care settings with multiple unexplained symptoms are treated with 10 weekly sessions of CBT or "treatment as usual." Physical symptoms, comorbid psychiatric symptoms, disability, and health care utilization are measured and assessed through a combination of structured interviews and self-reports. Assessments are performed at study start, mid-treatment, end of treatment, and at a 6-month follow-up.

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2002-12-16
• Study First Submitted QC: 2002-12-16
• Study First Posted: 2002-12-17
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Somatization disorder

Exclusion Criteria

• Bipolar disorder
• Schizophrenia or other psychosis
• Major Depression

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cognitive Behavioral Therapy	10 Session modified CBT (including a relaxation component) administered by trained mental health clinicians at the primary care setting
1	CBT	10 Session modified CBT (including a relaxation component) administered by trained mental health clinicians at the primary care setting

Primary Outcome Measures

Name	Time	Method
CGI Improvement	Post Treatment

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression	Post Treatment

Trial Locations

Locations (1)

UMDNJ- Robert Wood Johnson Medical School; Dept. of Psychiatry; 🇺🇸 Piscataway, New Jersey, United States