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Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00050583
Recruitment Status : Completed
First Posted : December 17, 2002
Last Update Posted : January 14, 2014
National Institute of Mental Health (NIMH)
Rutgers, The State University of New Jersey
Information provided by (Responsible Party):
Javier I Escobar MD, Rutgers, The State University 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.

Condition or disease Intervention/treatment Phase
Somatoform Disorders Behavioral: Cognitive Behavioral Therapy Behavioral: CBT 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Somatization in Primary Care
Study Start Date : February 2001
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

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.

Primary Outcome Measures :
  1. CGI Improvement [ Time Frame: Post Treatment ]

Secondary Outcome Measures :
  1. Hamilton Depression [ Time Frame: Post Treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Somatization disorder

Exclusion Criteria:

  • Bipolar disorder
  • Schizophrenia or other psychosis
  • Major Depression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00050583

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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
National Institute of Mental Health (NIMH)
Rutgers, The State University of New Jersey
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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
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Responsible Party: Javier I Escobar MD, Associate Dean for Global Health, Rutgers, The State University of New Jersey Identifier: NCT00050583    
Other Study ID Numbers: R01MH060265 ( U.S. NIH Grant/Contract )
R01MH060265 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2002    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Somatoform Disorders
Mental Disorders