Somatoform Disorders Clinical Trial
Official title:
Cognitive Behavior Therapy for Somatization Disorder
This study will examine the long-term effects of cognitive behavioral therapy on the physical symptoms, functioning, and health care utilization of people with multiple medically unexplained physical symptoms.
Somatization disorder is a chronic psychological condition that causes numerous physical
complaints for which no underlying physical problem can be identified. The disorder often
lasts for several years and results in substantial functional impairment. The physical
complaints most frequently involve chronic pain and problems with the digestive, nervous,
and reproductive systems. Neither pharmacological nor psychosocial treatments for this
disorder have been successful in suppressing symptoms. Cognitive behavioral therapy (CBT) is
a treatment that focuses on maladaptive patterns of thinking and the beliefs that underlie
such thinking. This study will examine the long-term effects of CBT 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 CBT
supplemented with augmented standard medical care (ASMC) as indicated by a psychiatric
consultation letter or ASMC alone. Participants assigned to CBT plus ASMC will receive CBT
for 10 weeks. Somatic symptomatology, functional impairment, and health care costs will be
assessed at study visits at baseline and Months 3, 9, and 15. The visits at Months 9 and 15
will assess specifically the long-term efficacy of the treatment.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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