Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)
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|ClinicalTrials.gov Identifier: NCT00050583|
Recruitment Status : Completed
First Posted : December 17, 2002
Last Update Posted : January 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Somatoform Disorders||Behavioral: Cognitive Behavioral Therapy Behavioral: CBT||Phase 3|
Patients with Somatization Disorder suffer from medically unexplained physical ailments and experience significant distress and disability. This disorder is an important problem for the primary health care system because patients with Somatization Disorder use health care resources extensively but receive little benefit. To date, no medical or psychiatric intervention has been demonstrated in controlled trials to produce clinically significant and lasting symptom relief or improved functional status in Somatization Disorder patients.
Patients in primary care settings with multiple unexplained symptoms are treated with 10 weekly sessions of CBT or "treatment as usual." Physical symptoms, comorbid psychiatric symptoms, disability, and health care utilization are measured and assessed through a combination of structured interviews and self-reports. Assessments are performed at study start, mid-treatment, end of treatment, and at a 6-month follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Treatment of Somatization in Primary Care|
|Study Start Date :||February 2001|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||July 2005|
10 Session modified CBT (including a relaxation component) administered by trained mental health clinicians at the primary care setting
Behavioral: Cognitive Behavioral Therapy
Ten Weekly Sessions of Manualized CBT
Cognitive Behavioral Therapy
No Intervention: 2
"Treatment as Usual", defined as the use of a consultation letter and traditional primary care management.
- CGI Improvement [ Time Frame: Post Treatment ]
- Hamilton Depression [ Time Frame: Post Treatment ]
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): NCT00050583
|United States, New Jersey|
|UMDNJ- Robert Wood Johnson Medical School; Dept. of Psychiatry|
|Piscataway, New Jersey, United States, 08855-1392|
|Principal Investigator:||Javier I Escobar, M.D.||Rutgers, The State University of New Jersey|
|Study Director:||Michael A Gara, Ph.D.||Rutgers, The State University of New Jersey|