Back to resultsTreatment of Medically Unexplained Physical Ailments (Somatization Disorder)
Primary Purpose
Somatoform Disorders
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
CBT
Sponsored by
About this trial
This is an interventional treatment trial for Somatoform Disorders
Eligibility Criteria
Inclusion Criteria: Somatization disorder Exclusion Criteria: Bipolar disorder Schizophrenia or other psychosis Major Depression
Sites / Locations
- UMDNJ- Robert Wood Johnson Medical School; Dept. of Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
10 Session modified CBT (including a relaxation component) administered by trained mental health clinicians at the primary care setting
"Treatment as Usual", defined as the use of a consultation letter and traditional primary care management.
Outcomes
Primary Outcome Measures
CGI Improvement
Secondary Outcome Measures
Hamilton Depression
Full Information
NCT ID
NCT00050583
First Posted
December 16, 2002
Last Updated
January 10, 2014
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Institute of Mental Health (NIMH), Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT00050583
Brief Title
Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)
Official Title
Treatment of Somatization in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Institute of Mental Health (NIMH), Rutgers, The State University of New Jersey
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Somatoform Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
10 Session modified CBT (including a relaxation component) administered by trained mental health clinicians at the primary care setting
Arm Title
2
Arm Type
No Intervention
Arm Description
"Treatment as Usual", defined as the use of a consultation letter and traditional primary care management.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Ten Weekly Sessions of Manualized CBT
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
Cognitive Behavioral Therapy
Primary Outcome Measure Information:
Title
CGI Improvement
Time Frame
Post Treatment
Secondary Outcome Measure Information:
Title
Hamilton Depression
Time Frame
Post Treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Somatization disorder
Exclusion Criteria:
Bipolar disorder
Schizophrenia or other psychosis
Major Depression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier I Escobar, M.D.
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael A Gara, Ph.D.
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Study Director
Facility Information:
Facility Name
UMDNJ- Robert Wood Johnson Medical School; Dept. of Psychiatry
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08855-1392
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17664499
Citation
Escobar JI, Gara MA, Diaz-Martinez AM, Interian A, Warman M, Allen LA, Woolfolk RL, Jahn E, Rodgers D. Effectiveness of a time-limited cognitive behavior therapy type intervention among primary care patients with medically unexplained symptoms. Ann Fam Med. 2007 Jul-Aug;5(4):328-35. doi: 10.1370/afm.702.
Results Reference
background
Learn more about this trial
Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)
We'll reach out to this number within 24 hrs