Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1 10 Session modified CBT (including a relaxation component) administered by trained mental health clinicians at the primary care setting |
Behavioral: Cognitive Behavioral Therapy
Ten Weekly Sessions of Manualized CBT
Behavioral: CBT
Cognitive Behavioral Therapy
|
No Intervention: 2 "Treatment as Usual", defined as the use of a consultation letter and traditional primary care management. |
Outcome Measures
Primary Outcome Measures
- CGI Improvement [Post Treatment]
Secondary Outcome Measures
- Hamilton Depression [Post Treatment]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Somatization disorder
Exclusion Criteria:
-
Bipolar disorder
-
Schizophrenia or other psychosis
-
Major Depression
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | UMDNJ- Robert Wood Johnson Medical School; Dept. of Psychiatry | Piscataway | New Jersey | United States | 08855-1392 |
Sponsors and Collaborators
- University of Medicine and Dentistry of New Jersey
- National Institute of Mental Health (NIMH)
- Rutgers, The State University of New Jersey
Investigators
- Principal Investigator: Javier I Escobar, M.D., Rutgers, The State University of New Jersey
- Study Director: Michael A Gara, Ph.D., Rutgers, The State University of New Jersey
Study Documents (Full-Text)
None provided.More Information
Publications
- R01MH060265
- R01MH060265