Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371644
Status:
COMPLETED
Last Update Posted:
2015-01-15
First Post:
2006-08-31
Brief Title:
Treatment for Veterans With Military Sexual Trauma
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Manualized Treatment for Veterans With Military Sexual Trauma
Status:
COMPLETED
Status Verified Date:
2015-01
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 this study is to evaluate the effectiveness of Cognitive Processing Therapy CPT versus Present-Centered Therapy PCT in treating current post-traumatic stress symptoms associated with sexual assault that occurred while veterans were serving in the military
Detailed Description:
This study is designed to provide insight into effective treatment of veterans with current Post Traumatic Stress Disorder PTSD that resulted from sexual assault that occurred during their active military duty MST This issue is of critical importance as 1 Congress mandated VA to provide counseling to veterans with sexual trauma 2 Based on the national MST surveillance data of 17 million VA patients 22 of women and 1 of men have experienced MST 3 With 20000 Operation Iraqi Freedom OIF veterans having already sought healthcare since deployment VA will begin to serve a higher percentage of women from combat zones where the epidemiology of sexual assault and the efficacy of conventional treatments are essentially unknown Finally 4 findings from our MST-Study of 270 women veterans strongly suggests that MST is clinically different from civilian adult or child sexual trauma bringing into question whether conventional civilian-based treatment will be effective with MST veterans
Cognitive Processing Therapy CPT is a therapy developed to treat civilian rape-related PTSD The efficacy of CPT has been shown with female civilians with sexual assault histories However there has not been any research examining the effectiveness of CPT in treating symptoms associated with sexual assault that occurs in military settings The difference clinically between sexual assault in civilian and military settings is important as revealed by our clinical experience and empirical findings In working with veterans with MST for over 13 years we have noted that the assaults are often perpetrated by trusted military personnel and the victim is often without access to immediate treatment or care Empirically our research demonstrates that MST is associated with higher rates of PTSD compared to civilian sexual assault
The primary goal of the study is to evaluate the effectiveness of CPT treatment versus Present Centered Therapy PCT for PTSD and associated symptoms resulting from MST The study objectives will be met by three levels of hypotheses Hypotheses focus on the primary outcome PTSD symptoms confirmatory outcomes depression symptoms quality of life and exploratory outcomes cost and utilization Based on the results of the study we intend to produce an educational CD-ROM which will include a training manual to educate practitioners on the use of the more effective treatment with veterans It will be designed for administration by clinicians who represent a range of disciplines eg psychologists nurses social workers and levels of training eg bachelor through doctoral degrees
This is a randomized controlled clinical trial involving veterans from the VA North Texas Healthcare System VANTHCS Data will be obtained from face-to-face interview and written questionnaires at baseline treatment completion 2-month 4-month and 6-month follow-ups Patients will be randomized to one of two conditions CPT or PCT Patients will receive biweekly sessions of the respective individual therapy from trained therapists for a 6-week period total of 12 sessions followed by scheduled assessments The primary endpoint is the CAPS score a measure of PTSD severity Secondary endpoints include anxiety depression quality of life and healthcare utilization
Cognitive Processing Therapy CPT is a therapy developed to treat civilian rape-related PTSD The efficacy of CPT has been shown with female civilians with sexual assault histories However there has not been any research examining the effectiveness of CPT in treating symptoms associated with sexual assault that occurs in military settings The difference clinically between sexual assault in civilian and military settings is important as revealed by our clinical experience and empirical findings In working with veterans with MST for over 13 years we have noted that the assaults are often perpetrated by trusted military personnel and the victim is often without access to immediate treatment or care Empirically our research demonstrates that MST is associated with higher rates of PTSD compared to civilian sexual assault
The primary goal of the study is to evaluate the effectiveness of CPT treatment versus Present Centered Therapy PCT for PTSD and associated symptoms resulting from MST The study objectives will be met by three levels of hypotheses Hypotheses focus on the primary outcome PTSD symptoms confirmatory outcomes depression symptoms quality of life and exploratory outcomes cost and utilization Based on the results of the study we intend to produce an educational CD-ROM which will include a training manual to educate practitioners on the use of the more effective treatment with veterans It will be designed for administration by clinicians who represent a range of disciplines eg psychologists nurses social workers and levels of training eg bachelor through doctoral degrees
This is a randomized controlled clinical trial involving veterans from the VA North Texas Healthcare System VANTHCS Data will be obtained from face-to-face interview and written questionnaires at baseline treatment completion 2-month 4-month and 6-month follow-ups Patients will be randomized to one of two conditions CPT or PCT Patients will receive biweekly sessions of the respective individual therapy from trained therapists for a 6-week period total of 12 sessions followed by scheduled assessments The primary endpoint is the CAPS score a measure of PTSD severity Secondary endpoints include anxiety depression quality of life and healthcare utilization
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 |
|---|---|---|---|
| IRB 06-036 | OTHER_GRANT | VA RRD | None |