Viewing Study NCT00050583



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Study NCT ID: NCT00050583
Status: COMPLETED
Last Update Posted: 2014-01-14
First Post: 2002-12-16

Brief Title: Treatment of Medically Unexplained Physical Ailments Somatization Disorder
Sponsor: University of Medicine and Dentistry of New Jersey
Organization: Rutgers The State University of New Jersey

Study Overview

Official Title: Treatment of Somatization in Primary Care
Status: COMPLETED
Status Verified Date: 2014-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to compare cognitive behavior therapy CBT to medical care-as-usual for the treatment of patients with high levels of medically unexplained physical symptoms Somatization Disorder A second goal is to examine the effectiveness of CBT in Latinos since Latinos suffer a relatively high prevalence of Somatization Disorder
Detailed Description: 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01MH060265 NIH None httpsreporternihgovquickSearchR01MH060265