NCT00050583

Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)

Treatment of Somatization in Primary Care

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: University of Medicine and Dentistry of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Somatoform Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy	Ten Weekly Sessions of Manualized CBT
BEHAVIORAL	CBT	Cognitive Behavioral Therapy

Timeline

• Start date: 2001-02-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2002-12-17
• Last updated: 2014-01-14

Locations

1 site across 1 country: United States