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Effectiveness of Cognitive-Affective Behavior Therapy for the Treatment of Somatization Disorder
This study is ongoing, but not recruiting participants.
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00149760
  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
Anxiety Disorders
Somatoform Disorders
Behavioral: Psychiatric consultation letter to primary physician
Behavioral: Cognitive-affective behavior therapy (CABT) plus psychiatric consultation letter to primary physician
Phase II

MedlinePlus related topics: Anxiety
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Cognitive Affective Behavior Therapy for Somatization

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment: 70
Study Start Date: August 2003
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Participants will receive standard medical care augmented by a psychiatric consultation.
Behavioral: Psychiatric consultation letter to primary physician
Participants will receive a letter to give to their primary care physicians making specific treatment recommendations for primary care treatment.
2: Experimental
Participants will receive cognitive-affective behavior therapy.
Behavioral: Cognitive-affective behavior therapy (CABT) plus psychiatric consultation letter to primary physician
CABT is a manualized individual treatment aimed at enhancing participants' behavioral, emotional, and cognitive functioning. Participants will also receive a letter to give to their primary care physicians making specific treatment recommendations for primary care treatment.

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149760

Locations
United States, New Jersey
Department of Psychiatry, UMDNJ-Robert Wood Johnson Medical School
Piscataway, New Jersey, United States, 08854
Sponsors and Collaborators
Investigators
Principal Investigator: Lesley A. Allen, PhD Department of Psychiatry, UMDNJ-Robert Wood Johnson Medical School
  More Information

Publications:
Responsible Party: UMDNJ - Robert Wood Johnson Medical School ( Lesley A. Allen, PhD, Associate Professor of Psychiatry )
Study ID Numbers: R21 MH66831, DAHBR 96-BHC
Study First Received: September 6, 2005
Last Updated: October 16, 2008
ClinicalTrials.gov Identifier: NCT00149760  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Cognitive Behavior Therapy
Treatment Outcome
Health Care Utilization
Somatization Disorder

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Somatoform Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009