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

January 11, 2006
February 19, 2014
September 1999
April 2003   (final data collection date for primary outcome measure)
  • Symptoms of somatization disorder
  • Functioning (measured with the Clinical Global Impression Scale for Somatization Disorder at Months 9 and 15)
Same as current
Complete list of historical versions of study NCT00276887 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Cognitive Behavior Therapy for Somatization Disorder
Cognitive Behavior Therapy for Somatization Disorder

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Somatoform Disorders
  • Behavioral: Cognitive Behavior Therapy
  • Behavioral: Psychiatric Consultation Letter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
April 2004
April 2003   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00276887
K08 MH01662, K08MH001662, DSIR AT-CD
No
Not Provided
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
Rutgers, The State University of New Jersey
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP