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Effectiveness of Cognitive-Affective Behavior Therapy for the Treatment of Somatization Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149760
First Posted: September 8, 2005
Last Update Posted: February 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
  Purpose
This study will examine the long-term effect of cognitive-affective behavior therapy on the physical symptoms, functioning, and health care utilization of people with somatization disorder.

Condition Intervention Phase
Somatization Disorder Behavioral: Augmented Standard Medical Care Behavioral: Cognitive-Affective Behavior Therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Affective Behavior Therapy for Somatization

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

Primary Outcome Measures:
  • Clinical Global Impression Scale for Somatization Disorder [ Time Frame: Measured at baseline and Months 4, 10, and 16 ]

Secondary Outcome Measures:
  • Physical functioning [ Time Frame: Measured at baseline and Months 4, 10, and 16 ]
  • Health care utilization [ Time Frame: Measured between Months 4 and 16 ]

Enrollment: 88
Study Start Date: August 2003
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Augmented Standard Medical Care
Participants will receive standard medical care augmented by a psychiatric consultation letter sent to the participants' primary care physician.
Behavioral: Augmented Standard Medical Care
Participants' physicians will receive a letter making specific treatment recommendations for primary care treatment.
Other Name: Psychiatric consultation letter sent to primary physician
Experimental: Cognitive-Affective Behavior Therapy
Participants will receive individually administered cognitive-affective behavior therapy as well as augmented standard medical care.
Behavioral: Cognitive-Affective Behavior Therapy
Individually-administered cognitive-behavioral therapy with an emotional focus in addition to augmented standard medical care
Other Name: Emotionally-Focused Cognitive-Behavioral Therapy

Detailed Description:

Somatization disorder is a syndrome characterized by the presence of multiple medically unexplained physical symptoms. It often results in substantial functional impairment and the need for extensive medical treatment. Neither pharmacological nor psychosocial treatments for the disease have demonstrated clinical success. People with somatization disorder may benefit from a treatment that integrates emotion-centered strategies into cognitive behavioral therapy. The long-term effectiveness of this treatment has not been established, however. This study will examine the long-term effect of cognitive-affective behavior therapy 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 cognitive-affective behavior therapy (CABT) or standard medical care that is augmented by a psychiatric consultation. Treatment will last 4 months. Assessments of somatic symptomatology, functional impairment, and health care costs will occur at screening, baseline (1 to 2 weeks after screening), and 4, 10, and 16 months after baseline. The visits at 10 and 16 months post-baseline will assess specifically the long-term efficacy of the treatment.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets DSM-IV criteria for somatization disorder
  • Available for follow-up over the ensuing 18 months
  • English-speaking

Exclusion Criteria:

  • Meets DSM-IV criteria for a psychotic disorder, organic brain syndrome, or psychoactive substance dependence (Other psychiatric comorbidity is not exclusionary)
  • Active suicidal ideation
  • Unstable major medical condition
  • Plans to engage in additional psychotherapy during the first 6 months after enrollment
  • Current use of any medication that has not been stabilized for the previous 2 months
  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): NCT00149760


Locations
United States, New Jersey
Department of Psychiatry, Robert Wood Johnson Medical School
Piscataway, New Jersey, United States, 08854
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Lesley A. Allen, PhD Department of Psychiatry, Robert Wood Johnson Medical School
  More Information

Publications:
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00149760     History of Changes
Other Study ID Numbers: R21MH066831 ( U.S. NIH Grant/Contract )
DAHBR 96-BHC
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: February 20, 2014
Last Verified: February 2014

Keywords provided by Rutgers, The State University of New Jersey:
Cognitive Behavior Therapy
Treatment Outcome
Health Care Utilization
Somatization Disorder
Somatoform Disorder

Additional relevant MeSH terms:
Disease
Somatoform Disorders
Pathologic Processes
Mental Disorders