Cognitive Behavior Therapy for Somatization Disorder

February 19, 2014 updated by: University of Medicine and Dentistry of New Jersey
This study will examine the long-term effects of cognitive behavioral therapy on the physical symptoms, functioning, and health care utilization of people with multiple medically unexplained physical symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Somatization disorder is a chronic psychological condition that causes numerous physical complaints for which no underlying physical problem can be identified. The disorder often lasts for several years and results in substantial functional impairment. The physical complaints most frequently involve chronic pain and problems with the digestive, nervous, and reproductive systems. Neither pharmacological nor psychosocial treatments for this disorder have been successful in suppressing symptoms. Cognitive behavioral therapy (CBT) is a treatment that focuses on maladaptive patterns of thinking and the beliefs that underlie such thinking. This study will examine the long-term effects of CBT on the physical symptoms, functioning, and health care utilization of people with somatization disorder.

Participants in this open label study will be randomly assigned to receive either CBT supplemented with augmented standard medical care (ASMC) as indicated by a psychiatric consultation letter or ASMC alone. Participants assigned to CBT plus ASMC will receive CBT for 10 weeks. Somatic symptomatology, functional impairment, and health care costs will be assessed at study visits at baseline and Months 3, 9, and 15. The visits at Months 9 and 15 will assess specifically the long-term efficacy of the treatment.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2

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, 08540
        • Department of Psychiatry, UMDNJ - RWJ Medical School

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meets DSM-IV criteria for somatization disorder
  • Available for follow-up over the ensuing 15 months
  • English-speaking

Exclusion Criteria:

  • Meets DSM-IV criteria for a psychotic disorder, organic brain syndrome, or psychoactive substance dependence
  • Active suicidal ideation
  • Unstable major medical condition
  • Plans to engage in additional psychotherapy during the first 3 months after study entry
  • Current use of any medication that has not been stabilized for the 2 months prior to study entry

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
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Symptoms of somatization disorder
Functioning (measured with the Clinical Global Impression Scale for Somatization Disorder at Months 9 and 15)

Secondary Outcome Measures

Outcome Measure
Health care utilization (measured the year before baseline and during the year after the 3-month assessment)
Health status (measured by the Medical Outcomes Study, SF-36, at Months 9 and 15)

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)

Investigators

  • Principal Investigator: Lesley A. Allen, PhD, University of Medicine & Dentistry of New Jersey - Robert Wood Johnson Medical School

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

September 1, 1999

Primary Completion (ACTUAL)

April 1, 2003

Study Completion (ACTUAL)

April 1, 2004

Study Registration Dates

First Submitted

January 11, 2006

First Submitted That Met QC Criteria

January 11, 2006

First Posted (ESTIMATE)

January 13, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 20, 2014

Last Update Submitted That Met QC Criteria

February 19, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K08MH001662 (NIH)
  • DSIR AT-CD

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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