Somatization Disorder Clinical Trial
Official title:
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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