Effectiveness of Cognitive-Affective Behavior Therapy for the Treatment of Somatization Disorder
Cognitive Affective Behavior Therapy for Somatization
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New Jersey
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Piscataway, New Jersey, United States, 08854
- Department of Psychiatry, Robert Wood Johnson Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Meets DSM-IV criteria for somatization disorder
- Available for follow-up over the ensuing 18 months
- English-speaking
Exclusion Criteria:
- Meets DSM-IV criteria for a psychotic disorder, organic brain syndrome, or psychoactive substance dependence (Other psychiatric comorbidity is not exclusionary)
- Active suicidal ideation
- Unstable major medical condition
- Plans to engage in additional psychotherapy during the first 6 months after enrollment
- Current use of any medication that has not been stabilized for the previous 2 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Augmented Standard Medical Care
Participants will receive standard medical care augmented by a psychiatric consultation letter sent to the participants' primary care physician.
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Participants' physicians will receive a letter making specific treatment recommendations for primary care treatment.
Other Names:
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Experimental: Cognitive-Affective Behavior Therapy
Participants will receive individually administered cognitive-affective behavior therapy as well as augmented standard medical care.
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Individually-administered cognitive-behavioral therapy with an emotional focus in addition to augmented standard medical care
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Clinical Global Impression Scale for Somatization Disorder
Time Frame: Measured at baseline and Months 4, 10, and 16
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Measured at baseline and Months 4, 10, and 16
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Physical functioning
Time Frame: Measured at baseline and Months 4, 10, and 16
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Measured at baseline and Months 4, 10, and 16
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Health care utilization
Time Frame: Measured between Months 4 and 16
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Measured between Months 4 and 16
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lesley A. Allen, PhD, Department of Psychiatry, Robert Wood Johnson Medical School
Publications and helpful links
General Publications
- 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.
- 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.
- Allen, Lesley A. Short-term therapy for somatization disorder: A cognitive behavioral approach. Journal of Cognitive Psychotherapy. Vol 14(4) Win 2000, 373-380.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21MH066831 (U.S. NIH Grant/Contract)
- DAHBR 96-BHC (Other Grant/Funding Number: National Institute of Mental Health (NIMH))
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