Cognitive Affective Behavior Therapy for Somatization
Overview
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Clinical Global Impression Scale for Somatization Disorder
Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Clinical Global Impression Scale for Somatization Disorder
Time Frame: Measured at baseline and Months 4, 10, and 16
Secondary Outcomes
- Health care utilization(Measured between Months 4 and 16)
- Physical functioning(Measured at baseline and Months 4, 10, and 16)