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	Behavior: Cognitive-affective behavior therapy  Behavior: Psychiatric consultation to primary physician	Phase II

Further Study Details: 

Primary Outcomes: Severity of somatization symptoms; measured at baseline, Months 4, 10, and 16
Secondary Outcomes: Functional impairment; measured at baseline, Months 4, 10, and 16; Health care utilization; measured during 12-month interval after treatment
Expected Total Enrollment:  70

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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00149760

Lesley A Allen, Ph.D.      732-235-4412    allenla@umdnj.edu

New Jersey
      Department of Psychiatry, UMDNJ-Robert Wood Johnson Medical School, Piscataway,  New Jersey,  08854,  United States; Recruiting

Study chairs or principal investigators

Lesley A Allen, Ph.D.,  Principal Investigator,  Department of Psychiatry, UMDNJ-Robert Wood Johnson Medical School   

Study ID Numbers:  R21 MH 066831
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00149760
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13