Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122109
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2005-07-18
Brief Title:
Telemedicine and Anger Management Groups With PTSD Veterans in the Hawaiian Islands
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Telemedicine and Anger Management Groups for PTSD Veterans in the Hawaiian Islands
Status:
COMPLETED
Status Verified Date:
2014-08
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:
Telemedicine has the potential to profoundly influence the delivery of specialized care to the remote veteran population suffering with PTSD Preliminary research supports telemedicine technology as a possible solution to improve access to mental health services for veterans with PTSD The proposed research is a treatment-outcome study that will assess the clinical efficacy of conducting an Anger Management Therapy AMT group treatment intervention using a videoteleconferencing VTC modality as compared to the traditional in-person modality with veterans who have PTSD and reside in remote locations on the Hawaiian Islands AMT is a manual-guided cognitive-behavioral skill based group intervention that has been used nationwide in VA substance abuse programs and most recently has been adopted by many VA PTSD Clinical Teams to treat anger-related to the sequelae of PTSD
Detailed Description:
Background Posttraumatic stress disorder PTSD is a prevalent problem among military troops Recovery from combat-related PTSD is often complicated by problems with anger Veterans with difficulties managing PTSD-related anger may be particularly likely to live in remote geographical regions where access to specialized mental health care is often limited Telemental health TMH has been touted as a potential means of increasing access to care in rural or remote areas Objectives This study compared the effectiveness of group Anger Management Therapy AMT delivered via videoteleconferencing VTC and in-person delivery in a sample of rural combat veterans with PTSD The long-range objective of this project was to develop an empirically sound TMH protocol that will facilitate the extension of manual guided clinical services to remote sites via VTC We hypothesized that providing a manualized group therapy intervention via VTC would result in similar reductions in anger symptoms as obtained from traditional in-person care Further we hypothesized that key process indicators ie attrition adherence satisfaction and therapeutic alliance would not be significantly different between the VTC and in-person conditions The specific objectives of this project were to a determine if group AMT delivered via VTC is as effective as the same intervention delivered in-person on clinical outcomes measuring reductions in anger symptoms and b determine if group AMT delivered via VTC is as effective as the same intervention delivered in-person on group process outcomes Methods A randomized controlled non-inferiority trial of 125 male veterans with PTSD and anger difficulties was conducted at three Department of Veterans Affairs outpatient clinics Participants were randomly assigned to receive AMT delivered in a group setting with the therapist either in-person N 64 or via VTC N 61 Participants were assessed at baseline mid-treatment post-treatment and 3 and 6-months post-treatment The primary clinical outcome was reduction of anger difficulties as measured by the Anger Expression and Trait Anger subscales of the State-Trait Anger Expression Inventory STAXI-2 and the Novaco Anger Total Scale NAS Process variables were measured to assess the feasibility of AMT delivered via VTC SAS MEANS procedure was used to calculate means and standard deviations for change from baseline at subsequent assessment points for both intent-to-treat and per-protocol analysis
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