Effectiveness of Cognitive-Affective Behavior Therapy for the Treatment of Somatization Disorder
|ClinicalTrials.gov Identifier: NCT00149760|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : February 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Somatization Disorder||Behavioral: Augmented Standard Medical Care Behavioral: Cognitive-Affective Behavior Therapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cognitive Affective Behavior Therapy for Somatization|
|Study Start Date :||August 2003|
|Primary Completion Date :||February 2010|
|Study Completion Date :||February 2010|
Active Comparator: Augmented Standard Medical Care
Participants will receive standard medical care augmented by a psychiatric consultation letter sent to the participants' primary care physician.
Behavioral: Augmented Standard Medical Care
Participants' physicians will receive a letter making specific treatment recommendations for primary care treatment.
Other Name: Psychiatric consultation letter sent to primary physician
Experimental: Cognitive-Affective Behavior Therapy
Participants will receive individually administered cognitive-affective behavior therapy as well as augmented standard medical care.
Behavioral: Cognitive-Affective Behavior Therapy
Individually-administered cognitive-behavioral therapy with an emotional focus in addition to augmented standard medical care
Other Name: Emotionally-Focused Cognitive-Behavioral Therapy
- Clinical Global Impression Scale for Somatization Disorder [ Time Frame: Measured at baseline and Months 4, 10, and 16 ]
- Physical functioning [ Time Frame: Measured at baseline and Months 4, 10, and 16 ]
- Health care utilization [ Time Frame: Measured between Months 4 and 16 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149760
|United States, New Jersey|
|Department of Psychiatry, Robert Wood Johnson Medical School|
|Piscataway, New Jersey, United States, 08854|
|Principal Investigator:||Lesley A. Allen, PhD||Department of Psychiatry, Robert Wood Johnson Medical School|