A Phase 2 interventional study of Augmented Standard Medical Care and Cognitive-Affective Behavior Therapy in Somatization Disorder, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-02-20.
Sponsored by Rutgers, The State University of New Jersey · Phase 2, Interventional, and Treatment
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.
402 studies on the registry are indexed under Somatoform Disorders; 80 are open to participants now.
This study's enrollment of 88 is above the median of 57 across 316 interventional studies indexed under Somatoform Disorders.
Browse Somatoform Disorders studies →Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 will receive individually administered cognitive-affective behavior therapy as well as augmented standard medical care.
Behavioral: Cognitive-Affective Behavior Therapy
Participants' physicians will receive a letter making specific treatment recommendations for primary care treatment.
Also known as: Psychiatric consultation letter sent to primary physician
Individually-administered cognitive-behavioral therapy with an emotional focus in addition to augmented standard medical care
Also known as: Emotionally-Focused Cognitive-Behavioral Therapy
Clinical Global Impression Scale for Somatization Disorder
Time frame: Measured at baseline and Months 4, 10, and 16
Physical functioning
Time frame: Measured at baseline and Months 4, 10, and 16
Health care utilization
Time frame: Measured between Months 4 and 16
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Rutgers, The State University of New Jersey