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Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)

Treatment of Somatization in Primary Care

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00050583
Enrollment
172
Registered
2002-12-17
Start date
2001-02-28
Completion date
2005-07-31
Last updated
2014-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Somatoform Disorders

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy

Ten Weekly Sessions of Manualized CBT

BEHAVIORALCBT

Cognitive Behavioral Therapy

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Rutgers, The State University of New Jersey
CollaboratorOTHER
University of Medicine and Dentistry of New Jersey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Somatization disorder

Exclusion criteria

* Bipolar disorder * Schizophrenia or other psychosis * Major Depression

Design outcomes

Primary

MeasureTime frame
CGI ImprovementPost Treatment

Secondary

MeasureTime frame
Hamilton DepressionPost Treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026