Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)

This study has been completed.
Sponsor:
Collaborators:
Rutgers, The State University of New Jersey
Information provided by (Responsible Party):
Javier I Escobar MD, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00050583
First received: December 16, 2002
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Somatoform Disorders
Behavioral: Cognitive Behavioral Therapy
Behavioral: CBT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Somatization in Primary Care

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • CGI Improvement [ Time Frame: Post Treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamilton Depression [ Time Frame: Post Treatment ] [ Designated as safety issue: No ]

Enrollment: 172
Study Start Date: February 2001
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Somatization disorder

Exclusion Criteria:

  • Bipolar disorder
  • Schizophrenia or other psychosis
  • Major Depression
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050583

Locations
United States, New Jersey
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
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
  More Information

Publications:
Responsible Party: Javier I Escobar MD, Associate Dean for Global Health, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00050583     History of Changes
Other Study ID Numbers: R01 MH60265, R01MH060265
Study First Received: December 16, 2002
Last Updated: January 10, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Disease
Somatoform Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014