Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Mental Health (NIMH) |
---|---|
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00149760 |
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.
Condition | Intervention | Phase |
---|---|---|
Anxiety Disorders Somatoform Disorders |
Behavioral: Psychiatric consultation letter to primary physician Behavioral: Cognitive-affective behavior therapy (CABT) plus psychiatric consultation letter to primary physician |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Cognitive Affective Behavior Therapy for Somatization |
Estimated Enrollment: | 70 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Participants will receive standard medical care augmented by a psychiatric consultation.
|
Behavioral: Psychiatric consultation letter to primary physician
Participants will receive a letter to give to their primary care physicians making specific treatment recommendations for primary care treatment.
|
2: Experimental
Participants will receive cognitive-affective behavior therapy.
|
Behavioral: Cognitive-affective behavior therapy (CABT) plus psychiatric consultation letter to primary physician
CABT is a manualized individual treatment aimed at enhancing participants' behavioral, emotional, and cognitive functioning. Participants will also receive a letter to give to their primary care physicians making specific treatment recommendations for primary care treatment.
|
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Department of Psychiatry, UMDNJ-Robert Wood Johnson Medical School | |
Piscataway, New Jersey, United States, 08854 |
Principal Investigator: | Lesley A. Allen, PhD | Department of Psychiatry, UMDNJ-Robert Wood Johnson Medical School |
Responsible Party: | UMDNJ - Robert Wood Johnson Medical School ( Lesley A. Allen, PhD, Associate Professor of Psychiatry ) |
Study ID Numbers: | R21 MH66831, DAHBR 96-BHC |
Study First Received: | September 6, 2005 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00149760 |
Health Authority: | United States: Federal Government |
Cognitive Behavior Therapy Treatment Outcome Health Care Utilization Somatization Disorder |
Anxiety Disorders Mental Disorders Somatoform Disorders |
Pathologic Processes Disease |