Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)

Somatoform Disorders Clinical Trial

Official title:

Treatment of Somatization in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050583
• Other study ID #: R01MH060265
• Secondary ID: R01MH060265
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2002
• Last updated: January 10, 2014
• Start date: February 2001
• Est. completion date: July 2005

Study information

• Verified date: January 2014
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Somatization disorder

Exclusion Criteria:

• Bipolar disorder

• Schizophrenia or other psychosis

• Major Depression

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Somatoform Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy
Ten Weekly Sessions of Manualized CBT
• CBT
Cognitive Behavioral Therapy

Locations

Country	Name	City	State
United States	UMDNJ- Robert Wood Johnson Medical School; Dept. of Psychiatry	Piscataway	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	National Institute of Mental Health (NIMH), Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (1)

Escobar JI, Gara MA, Diaz-Martinez AM, Interian A, Warman M, Allen LA, Woolfolk RL, Jahn E, Rodgers D. Effectiveness of a time-limited cognitive behavior therapy type intervention among primary care patients with medically unexplained symptoms. Ann Fam Med. 2007 Jul-Aug;5(4):328-35. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CGI Improvement		Post Treatment	No
Secondary	Hamilton Depression		Post Treatment	No