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OpenTrials
Completed

NCT Number: NCT00050583

Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)

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.

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Key information

Conditions

Somatoform Disorders Mental Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Piscataway, New Jersey, 08855-1392, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Somatization disorder

Exclusion criteria

  • Bipolar disorder
  • Schizophrenia or other psychosis
  • Major Depression

Treatment and study plan

Cognitive behavioral therapy

Behavioral

Ten Weekly Sessions of Manualized CBT

CBT

Behavioral

Cognitive Behavioral Therapy

Primary outcomes

  1. CGI Improvement

    Time frame: Post Treatment

Secondary outcomes

  1. Hamilton Depression

    Time frame: Post Treatment

Sponsors and collaborators

Lead sponsor

University of Medicine and Dentistry of New Jersey

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Rutgers, The State University of New Jersey

Registry information

Official study title

Treatment of Somatization in Primary Care

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Dec 17, 2002
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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