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Cognitive Behavior Therapy for Somatization Disorder

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ClinicalTrials.gov Identifier: NCT00276887
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : February 20, 2014
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Somatoform Disorders Behavioral: Cognitive Behavior Therapy Behavioral: Psychiatric Consultation Letter Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Behavior Therapy for Somatization Disorder
Study Start Date : September 1999
Primary Completion Date : April 2003
Study Completion Date : April 2004
Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Symptoms of somatization disorder
  2. Functioning (measured with the Clinical Global Impression Scale for Somatization Disorder at Months 9 and 15)

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

Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00276887

United States, New Jersey
Department of Psychiatry, UMDNJ - RWJ Medical School
Piscataway, New Jersey, United States, 08540
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
National Institute of Mental Health (NIMH)
Principal Investigator: Lesley A. Allen, PhD University of Medicine & Dentistry of New Jersey - Robert Wood Johnson Medical School
More Information

ClinicalTrials.gov Identifier: NCT00276887     History of Changes
Other Study ID Numbers: K08MH001662 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: February 20, 2014
Last Verified: February 2014

Keywords provided by Rutgers, The State University of New Jersey:
Somatization Disorder
Multiple Medically Unexplained Symptoms
Cognitive Behavior Therapy
Mental Health

Additional relevant MeSH terms:
Somatoform Disorders
Pathologic Processes
Mental Disorders