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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

September 6, 2005
February 19, 2014
August 2003
February 2010   (final data collection date for primary outcome measure)
Clinical Global Impression Scale for Somatization Disorder [ Time Frame: Measured at baseline and Months 4, 10, and 16 ] [ Designated as safety issue: No ]
Severity of somatization symptoms; measured at baseline, Months 4, 10, and 16
Complete list of historical versions of study NCT00149760 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Functional impairment; measured at baseline, Months 4, 10, and 16
  • Health care utilization; measured during 12-month interval after treatment
Not Provided
Not Provided
 
Effectiveness of Cognitive-Affective Behavior Therapy for the Treatment of Somatization Disorder
Cognitive Affective Behavior Therapy for Somatization

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Somatization Disorder
  • 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
  • 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
  • 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.
    Intervention: Behavioral: Augmented Standard Medical Care
  • Experimental: Cognitive-Affective Behavior Therapy
    Participants will receive individually administered cognitive-affective behavior therapy as well as augmented standard medical care.
    Intervention: Behavioral: Cognitive-Affective Behavior Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00149760
R21 MH66831, R21MH066831, DAHBR 96-BHC
No
Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
National Institute of Mental Health (NIMH)
Principal Investigator: Lesley A. Allen, PhD Department of Psychiatry, 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