Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)

• ClinicalTrials.gov Identifier: NCT00050583
• Recruitment Status: Completed
• First Posted: December 17, 2002
• Last Update Posted: January 14, 2014
• Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborators: National Institute of Mental Health (NIMH); Rutgers, The State University of New Jersey
• Information provided by (Responsible Party): Javier I Escobar MD, Rutgers, The State University of New Jersey

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.

Condition or disease	Intervention/treatment	Phase
Somatoform Disorders	Behavioral: Cognitive Behavioral Therapy; Behavioral: CBT	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 172 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; 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; Behavioral: CBT; Cognitive Behavioral Therapy
No Intervention: 2; "Treatment as Usual", defined as the use of a consultation letter and traditional primary care management.

Outcome Measures

Primary Outcome Measures :

1. CGI Improvement [ Time Frame: Post Treatment ]

Secondary Outcome Measures :

1. Hamilton Depression [ Time Frame: Post Treatment ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Somatization disorder

Exclusion Criteria:

• Bipolar disorder
• Schizophrenia or other psychosis
• Major Depression

Contacts and Locations

Locations

United States, New Jersey

UMDNJ- Robert Wood Johnson Medical School; Dept. of Psychiatry

Piscataway, New Jersey, United States, 08855-1392

Sponsors and Collaborators

University of Medicine and Dentistry of New Jersey

National Institute of Mental Health (NIMH)

Rutgers, The State University of New Jersey

Investigators

• 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

More Information

Publications:

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.

• Responsible Party: Javier I Escobar MD, Associate Dean for Global Health, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT00050583
• Other Study ID Numbers: R01MH060265 ( U.S. NIH Grant/Contract ); R01MH060265 ( U.S. NIH Grant/Contract )
• First Posted: December 17, 2002
• Last Update Posted: January 14, 2014
• Last Verified: January 2014

Additional relevant MeSH terms:

Somatoform Disorders; Mental Disorders