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| ID | Type | Description | Link |
|---|---|---|---|
| R21MH066831 | U.S. NIH Grant/Contract | View source | |
| DAHBR 96-BHC |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will examine the long-term effect of cognitive-affective behavior therapy on the physical symptoms, functioning, and health care utilization of people with somatization disorder.
Somatization disorder is a syndrome characterized by the presence of multiple medically unexplained physical symptoms. It often results in substantial functional impairment and the need for extensive medical treatment. Neither pharmacological nor psychosocial treatments for the disease have demonstrated clinical success. People with somatization disorder may benefit from a treatment that integrates emotion-centered strategies into cognitive behavioral therapy. The long-term effectiveness of this treatment has not been established, however. This study will examine the long-term effect of cognitive-affective behavior therapy on the physical symptoms, functioning, and health care utilization of people with somatization disorder.
Participants in this open-label study will be randomly assigned to receive either cognitive-affective behavior therapy (CABT) or standard medical care that is augmented by a psychiatric consultation. Treatment will last 4 months. Assessments of somatic symptomatology, functional impairment, and health care costs will occur at screening, baseline (1 to 2 weeks after screening), and 4, 10, and 16 months after baseline. The visits at 10 and 16 months post-baseline will assess specifically the long-term efficacy of the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Augmented Standard Medical Care | Active Comparator | Participants will receive standard medical care augmented by a psychiatric consultation letter sent to the participants' primary care physician. |
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| Cognitive-Affective Behavior Therapy | Experimental | Participants will receive individually administered cognitive-affective behavior therapy as well as augmented standard medical care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Augmented Standard Medical Care | Behavioral | Participants' physicians will receive a letter making specific treatment recommendations for primary care treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression Scale for Somatization Disorder | Measured at baseline and Months 4, 10, and 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical functioning | Measured at baseline and Months 4, 10, and 16 | |
| Health care utilization | Measured between Months 4 and 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lesley A. Allen, PhD | Department of Psychiatry, Robert Wood Johnson Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, Robert Wood Johnson Medical School | Piscataway | New Jersey | 08854 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11764061 | Background | Allen LA, Woolfolk RL, Lehrer PM, Gara MA, Escobar JI. Cognitive behavior therapy for somatization disorder: a preliminary investigation. J Behav Ther Exp Psychiatry. 2001 Jun;32(2):53-62. doi: 10.1016/s0005-7916(01)00020-9. | |
| 12461199 | Background | Allen LA, Escobar JI, Lehrer PM, Gara MA, Woolfolk RL. Psychosocial treatments for multiple unexplained physical symptoms: a review of the literature. Psychosom Med. 2002 Nov-Dec;64(6):939-50. doi: 10.1097/01.psy.0000024231.11538.8f. |
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| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Cognitive-Affective Behavior Therapy | Behavioral | Individually-administered cognitive-behavioral therapy with an emotional focus in addition to augmented standard medical care |
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| Background | Allen, Lesley A. Short-term therapy for somatization disorder: A cognitive behavioral approach. Journal of Cognitive Psychotherapy. Vol 14(4) Win 2000, 373-380. |
| 16864762 | Background | Allen LA, Woolfolk RL, Escobar JI, Gara MA, Hamer RM. Cognitive-behavioral therapy for somatization disorder: a randomized controlled trial. Arch Intern Med. 2006 Jul 24;166(14):1512-8. doi: 10.1001/archinte.166.14.1512. |