Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)

January 10, 2014 updated by: Javier I Escobar MD, University of Medicine and Dentistry of New Jersey

Treatment of Somatization in Primary Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Piscataway, New Jersey, United States, 08855-1392
        • UMDNJ- Robert Wood Johnson Medical School; Dept. of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Somatization disorder

Exclusion Criteria:

  • Bipolar disorder
  • Schizophrenia or other psychosis
  • Major Depression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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: CBT
Cognitive Behavioral Therapy
Behavioral: Cognitive Behavioral Therapy
Ten Weekly Sessions of Manualized CBT
No Intervention: 2
"Treatment as Usual", defined as the use of a consultation letter and traditional primary care management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CGI Improvement
Time Frame: Post Treatment
Post Treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Hamilton Depression
Time Frame: Post Treatment
Post Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

December 16, 2002

First Submitted That Met QC Criteria

December 16, 2002

First Posted (Estimate)

December 17, 2002

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH060265 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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