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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH060265 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Rutgers, The State University of New Jersey | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 10 Session modified CBT (including a relaxation component) administered by trained mental health clinicians at the primary care setting |
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| 2 | No Intervention | "Treatment as Usual", defined as the use of a consultation letter and traditional primary care management. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | Ten Weekly Sessions of Manualized CBT |
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| Measure | Description | Time Frame |
|---|---|---|
| CGI Improvement | Post Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression | Post Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier I Escobar, M.D. | Rutgers, The State University of New Jersey | Principal Investigator |
| Michael A Gara, Ph.D. | Rutgers, The State University of New Jersey | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMDNJ- Robert Wood Johnson Medical School; Dept. of Psychiatry | Piscataway | New Jersey | 08855-1392 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17664499 | Background | 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. |
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| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| CBT |
| Behavioral |
Cognitive Behavioral Therapy |
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