Cognitive Behavior Therapy for Somatization Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00276887
First received: January 11, 2006
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Somatoform Disorders
Behavioral: Cognitive Behavior Therapy
Behavioral: Psychiatric Consultation Letter
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Behavior Therapy for Somatization Disorder

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

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

Secondary Outcome Measures:
  • 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)

Enrollment: 84
Study Start Date: September 1999
Study Completion Date: April 2004
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

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

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
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: NCT00276887

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

Publications:
ClinicalTrials.gov Identifier: NCT00276887     History of Changes
Other Study ID Numbers: K08 MH01662, K08MH001662, DSIR AT-CD
Study First Received: January 11, 2006
Last Updated: February 19, 2014
Health Authority: United States: Federal Government

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:
Disease
Somatoform Disorders
Pathologic Processes
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014