Somatoform Disorders
Conditions
Keywords
Somatization Disorder, Multiple Medically Unexplained Symptoms, Cognitive Behavior Therapy, Mental Health
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCognitive Behavior Therapy
BEHAVIORALPsychiatric Consultation Letter
Sponsors
National Institute of Mental Health (NIMH)
University of Medicine and Dentistry of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Meets DSM-IV criteria for somatization disorder * Available for follow-up over the ensuing 15 months * English-speaking
Exclusion criteria
* Meets DSM-IV criteria for a psychotic disorder, organic brain syndrome, or psychoactive substance dependence * Active suicidal ideation * Unstable major medical condition * Plans to engage in additional psychotherapy during the first 3 months after study entry * Current use of any medication that has not been stabilized for the 2 months prior to study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms of somatization disorder | — |
| Functioning (measured with the Clinical Global Impression Scale for Somatization Disorder at Months 9 and 15) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
United States
Outcome results
None listed