Treatment of Medically Unexplained Physical Ailments (Somatization Disorder)

University of Medicine and Dentistry of New Jersey

Status and phase: Completed; Phase 3

Conditions: Somatoform Disorders

Treatments: Behavioral: CBT; Behavioral: Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00050583

R01MH060265 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Somatization disorder

Exclusion criteria

• Bipolar disorder
• Schizophrenia or other psychosis
• Major Depression

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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172 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive Behavioral Therapy

Behavioral: CBT

2

No Intervention group

Description:

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