Effectiveness of Cognitive-Affective Behavior Therapy for the Treatment of Somatization Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cognitive Affective Behavior Therapy for Somatization

Conditions
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Somatization Disorder

Intervention / Treatment
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* Behavioral: Augmented Standard Medical Care
* Behavioral: Cognitive-Affective Behavior Therapy


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 18 months English-speaking Exclusion Criteria: Meets DSM-IV criteria for a psychotic disorder, organic brain syndrome, or psychoactive substance dependence (Other psychiatric comorbidity is not exclusionary) Active suicidal ideation Unstable major medical condition Plans to engage in additional psychotherapy during the first 6 months after enrollment Current use of any medication that has not been stabilized for the previous 2 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Augmented Standard Medical Care<br>Participants will receive standard medical care augmented by a psychiatric consultation letter sent to the participants' primary care physician. | Behavioral: Augmented Standard Medical Care<br>* Participants' physicians will receive a letter making specific treatment recommendations for primary care treatment.<br>* Other names: Psychiatric consultation letter sent to primary physician;|
| Experimental: Cognitive-Affective Behavior Therapy<br>Participants will receive individually administered cognitive-affective behavior therapy as well as augmented standard medical care. | Behavioral: Cognitive-Affective Behavior Therapy<br>* Individually-administered cognitive-behavioral therapy with an emotional focus in addition to augmented standard medical care<br>* Other names: Emotionally-Focused Cognitive-Behavioral Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression Scale for Somatization Disorder |  | Measured at baseline and Months 4, 10, and 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical functioning |  | Measured at baseline and Months 4, 10, and 16 | 
| Health care utilization |  | Measured between Months 4 and 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavior Therapy, Treatment Outcome, Health Care Utilization, Somatization Disorder, Somatoform Disorder