Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00149760
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2005-09-06
Brief Title:
Effectiveness of Cognitive-Affective Behavior Therapy for the Treatment of Somatization Disorder
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Cognitive Affective Behavior Therapy for Somatization
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DAHBR 96-BHC | US NIH GrantContract | None | httpsreporternihgovquickSearchR21MH066831 |
| R21MH066831 | NIH | None | None |