Ignite Creation Date:
2024-05-05 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00539279
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2007-10-02
Brief Title:
Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2015-08
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 project represents the first randomized clinical trial of psychotherapy for older veterans with posttraumatic stress disorder PTSD It will compare relaxation training RT to prolonged exposure therapy PE The project will also examine whether cognitive impairment influences psychotherapy outcome
Primary hypotheses 1 Subjects in the PE condition will have significantly less severe PTSD symptoms depressive symptoms and functional impairment than subjects in the RT condition at posttest 2 Executive functioning will modify the response to both treatments such that those with impaired executive functioning will demonstrate a smaller reduction in PTSD symptoms representing less clinically significant change
Primary hypotheses 1 Subjects in the PE condition will have significantly less severe PTSD symptoms depressive symptoms and functional impairment than subjects in the RT condition at posttest 2 Executive functioning will modify the response to both treatments such that those with impaired executive functioning will demonstrate a smaller reduction in PTSD symptoms representing less clinically significant change
Detailed Description:
PTSD is associated with high rates of mortality from suicide and health complications high healthcare costs and diminished health and quality of life Many military veterans have PTSD due to combat and many veterans continue to carry the symptoms of PTSD into late life The percentage of older veterans is expected to increase substantially in coming years especially as Vietnam-era veterans become older adults The psychosocial intervention with the most rigorous empirical support for treating PTSD in the general population is a cognitive-behavioral treatment known as exposure therapy which involves helping patients face feared memories and situations yet there have been no controlled studies of any psychosocial interventions for PTSD in samples of older adults Some have argued that older adults will not respond well to exposure because of their cognitive limitations However several empirical studies have shown exposure therapy to be safe and effective with older adults with anxiety disorders other than PTSD
The current project represents the first randomized clinical trial of psychotherapy for older veterans with posttraumatic stress disorder PTSD It will compare relaxation training RT to prolonged exposure therapy PE The project will also examine whether cognitive impairment influences psychotherapy outcome The five-year Research Plan is divided into three phases Phase 1 Year 1 involves the development of procedures for assessment and preparation for the clinical trial Phase 2 Years 2-4 will entail the first randomized clinical trial of psychosocial treatments for PTSD in late life One hundred veterans aged 60 years or older with chronic PTSD will be recruited from the San Diego VA PTSD Clinical Team and randomly assigned to 12 sessions of PE or 12 sessions of RT Phase 3 Year 5 will be comprised of final data collection scoring and interpretation of all neuropsychological tests data cleaning and analysis and writing for publication of results Primary hypotheses 1 Subjects in the PE condition will have significantly less severe PTSD symptoms depressive symptoms and functional impairment than subjects in the RT condition at posttest 2 Executive functioning will modify the response to both treatments such that those with impaired executive functioning will demonstrate a smaller reduction in PTSD symptoms representing less clinically significant change
The current project represents the first randomized clinical trial of psychotherapy for older veterans with posttraumatic stress disorder PTSD It will compare relaxation training RT to prolonged exposure therapy PE The project will also examine whether cognitive impairment influences psychotherapy outcome The five-year Research Plan is divided into three phases Phase 1 Year 1 involves the development of procedures for assessment and preparation for the clinical trial Phase 2 Years 2-4 will entail the first randomized clinical trial of psychosocial treatments for PTSD in late life One hundred veterans aged 60 years or older with chronic PTSD will be recruited from the San Diego VA PTSD Clinical Team and randomly assigned to 12 sessions of PE or 12 sessions of RT Phase 3 Year 5 will be comprised of final data collection scoring and interpretation of all neuropsychological tests data cleaning and analysis and writing for publication of results Primary hypotheses 1 Subjects in the PE condition will have significantly less severe PTSD symptoms depressive symptoms and functional impairment than subjects in the RT condition at posttest 2 Executive functioning will modify the response to both treatments such that those with impaired executive functioning will demonstrate a smaller reduction in PTSD symptoms representing less clinically significant change
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