Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)

NCT ID: NCT00050583

Last Updated: 2014-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-02-28
• Study Completion Date: 2005-07-31

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.

Conditions

Somatoform Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

10 Session modified CBT (including a relaxation component) administered by trained mental health clinicians at the primary care setting

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Ten Weekly Sessions of Manualized CBT

CBT

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy

2

"Treatment as Usual", defined as the use of a consultation letter and traditional primary care management.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Behavioral Therapy

Ten Weekly Sessions of Manualized CBT

Intervention Type: BEHAVIORAL

CBT

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Somatization disorder

Exclusion Criteria

• Bipolar disorder
• Schizophrenia or other psychosis
• Major Depression

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: collaborator

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Javier I Escobar MD

Associate Dean for Global Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Javier I Escobar, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Michael A Gara, Ph.D.

Role: STUDY_DIRECTOR

Rutgers, The State University of New Jersey

Locations

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

Piscataway, New Jersey, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17664499 (View on PubMed)

Other Identifiers

R01MH060265

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH060265

Identifier Type: NIH

Identifier Source: org_study_id

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