Cognitive Behavior Therapy for Somatization Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cognitive Behavior Therapy for Somatization Disorder

Conditions
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Somatoform Disorders

Intervention / Treatment
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* Behavioral: Cognitive Behavior Therapy
* Behavioral: Psychiatric Consultation Letter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cognitive Behavior Therapy|nan|
|Behavioral: Psychiatric Consultation Letter|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of somatization disorder |  |  | 
| Functioning (measured with the Clinical Global Impression Scale for Somatization Disorder at Months 9 and 15) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Somatization Disorder, Multiple Medically Unexplained Symptoms, Cognitive Behavior Therapy, Mental Health