Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032617
Status:
COMPLETED
Last Update Posted:
2010-09-24
First Post:
2002-03-27
Brief Title:
A Randomized Clinical Trial of Cognitive-Behavioral Treatment for Post-Traumatic Stress Disorders in Women
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 494 - A Randomized Clinical Trial of Cognitive-Behavioral Treatment for PTSD in Women PTSD
Status:
COMPLETED
Status Verified Date:
2010-09
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:
The purpose of the proposed DVA cooperative study is to evaluate the efficacy of exposure therapy for treating PTSD and associated problems in female veterans and active duty military personnel We propose to compare exposure therapy Prolonged Exposure with a comparison therapy that focuses on current problems Present Centered Therapy
The study is a randomized clinical trial involving 384 female veterans and active duty personnel in 11 VA medical centers and 1 DoD medical center All subjects even self-referrals will enter the study through referrals by mental health clinicians at the participating sites Following informed consent subjects will be screened for inclusion and exclusion diagnoses If they meet these criteria and agree to participate they will be randomly assigned to one of the two treatments which will occur weekly for 10 weeks Subjects will be assessed before treatment immediately following treatment and 3 and 6 months after the end of treatment The primary outcome is PTSD severity Secondary outcomes are anxiety and depression Exploratory outcomes include associated features of PTSD such as dissociation and substance abuse psychosocial functioning quality of life physical health satisfaction with treatment and service utilization Both treatments will be described in detail in a treatment manual and monitored intensively to ensure that they are administered correctly
The study is a randomized clinical trial involving 384 female veterans and active duty personnel in 11 VA medical centers and 1 DoD medical center All subjects even self-referrals will enter the study through referrals by mental health clinicians at the participating sites Following informed consent subjects will be screened for inclusion and exclusion diagnoses If they meet these criteria and agree to participate they will be randomly assigned to one of the two treatments which will occur weekly for 10 weeks Subjects will be assessed before treatment immediately following treatment and 3 and 6 months after the end of treatment The primary outcome is PTSD severity Secondary outcomes are anxiety and depression Exploratory outcomes include associated features of PTSD such as dissociation and substance abuse psychosocial functioning quality of life physical health satisfaction with treatment and service utilization Both treatments will be described in detail in a treatment manual and monitored intensively to ensure that they are administered correctly
Detailed Description:
Intervention Patients will be randomized to one of two interventions Prolonged Exposure PE consisting of 10 weekly treatment sessions that include education about and exposure to the memories of the trauma to which the patient was engaged or Present Center Therapy PCT which will consist of a control therapy of the same duration that will provide emotional support for the trauma victim
Primary Hypothesis Prolonged Exposure PE will be more effective than Present-Centered Therapy PCT for the treatment of PTSD due to military-related trauma in women veterans PE specifically targets PTSD symptoms and the CAPS our primary outcome measure The Clinician Administered PTSD Scale CAPS is considered to be the gold-standard for PTSD assessment
Secondary Hypothesis PE will be more effective than PCT for treating the anxiety and depression that often are comorbid with PTSD
Study Abstract As noted in a recent report on the VA Womens Health Project it is important to study women veterans because they are increasingly seeking VA health care For many women veterans Posttraumatic Stress Disorder PTSD is a specific healthcare concern that is associated with substantial psychosocial and functional disability
The study was proposed in response to the Research Priority Announcement on Posttraumatic Stress Disorder research issued August 1 1997 as a study aimed a special subpopulation of VA patients with PTSD women veterans who have been traumatized during their military service
The first planning meeting for the study was held January 20-21 2000 in Washington DC The protocol was submitted on August 1 2000 it was reviewed and approved by the Cooperative Studies Evaluation Committee on October 10 2000 Intake of training cases is expected to begin 01012002
Primary Hypothesis Prolonged Exposure PE will be more effective than Present-Centered Therapy PCT for the treatment of PTSD due to military-related trauma in women veterans PE specifically targets PTSD symptoms and the CAPS our primary outcome measure The Clinician Administered PTSD Scale CAPS is considered to be the gold-standard for PTSD assessment
Secondary Hypothesis PE will be more effective than PCT for treating the anxiety and depression that often are comorbid with PTSD
Study Abstract As noted in a recent report on the VA Womens Health Project it is important to study women veterans because they are increasingly seeking VA health care For many women veterans Posttraumatic Stress Disorder PTSD is a specific healthcare concern that is associated with substantial psychosocial and functional disability
The study was proposed in response to the Research Priority Announcement on Posttraumatic Stress Disorder research issued August 1 1997 as a study aimed a special subpopulation of VA patients with PTSD women veterans who have been traumatized during their military service
The first planning meeting for the study was held January 20-21 2000 in Washington DC The protocol was submitted on August 1 2000 it was reviewed and approved by the Cooperative Studies Evaluation Committee on October 10 2000 Intake of training cases is expected to begin 01012002
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