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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00149760
First received: September 6, 2005
Last updated: February 19, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical functioning [ Time Frame: Measured at baseline and Months 4, 10, and 16 ] [ Designated as safety issue: No ]
  • Health care utilization [ Time Frame: Measured between Months 4 and 16 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 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 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
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: 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
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: R21 MH66831, R21MH066831, DAHBR 96-BHC
Study First Received: September 6, 2005
Last Updated: February 19, 2014
Health Authority: United States: Federal Government

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
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014