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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Department of Psychiatry, UMDNJ - RWJ Medical School
Piscataway, New Jersey, United States
Symptoms of somatization disorder
Functioning (measured with the Clinical Global Impression Scale for Somatization Disorder at Months 9 and 15)
Health care utilization (measured the year before baseline and during the year after the 3-month assessment)
Health status (measured by the Medical Outcomes Study, SF-36, at Months 9 and 15)
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