Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06094933
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-10-16
Brief Title:
Mobile Anger Reduction Intervention
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
A Randomized Controlled Trial of the Mobile Anger Reduction Intervention for Veterans
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
MARI
Brief Summary:
Difficulty controlling anger is the most commonly reported reintegration concern among combat Veterans especially those with a diagnosis of posttraumatic stress disorder PTSD Problematic anger is associated with significant functional impairment In the current project the investigators will compare the Mobile Anger Reduction Intervention MARI with a health education mobile intervention HED among Veterans with PTSD and problematic anger Participants will be randomized to the MARI or HED condition The hypothesis is that participants in the MARI condition will experience greater anger reductions and functional improvements relative to the HED condition
Detailed Description:
Difficulty controlling anger is the most commonly reported reintegration concern among combat Veterans especially those with a diagnosis of posttraumatic stress disorder PTSD In Veterans problematic anger is associated with numerous negative psychosocial outcomes including poor functional outcomes both social and occupational family discord aggression road rage and suicide risk Anger can also impede successful outcomes from PTSD treatment Given the high prevalence of anger problems among Veterans with PTSD and the associated functional impairments there is a clear need to develop innovative and effective anger interventions to improve functional outcomes Use of mobile health mHealth technology could provide a low-cost method to increase the reach of anger management treatments to this high-need group of Veterans
One of the mechanisms associated with problematic anger and aggression is hostile interpretation bias ie a tendency to interpret ambiguous interpersonal situations as hostile By reducing hostile interpretation bias the investigators can reduce problematic anger and aggression and improve functional outcomes A mobile application that uses evidence-based interpretation bias modification techniques to reduce hostile interpretation bias and anger outcomes has been developed and piloted The goal of this project is to evaluate the efficacy of this mobile application among Veterans with PTSD
A randomized controlled trial RCT will be conducted in which 150 Veterans with PTSD and problematic anger will be randomized to either the Mobile Anger Reduction Intervention MARI or a health education condition HED The central hypothesis is that participants in the MARI condition will experience greater anger reductions and functional improvements relative to the HED condition
The proposed research project will address the following Specific Aims Aim 1 To evaluate the efficacy of MARI on anger outcomes eg hostile interpretation bias problematic anger measured at post-treatment 3-months and 6-months post treatment Aim 2 To evaluate the efficacy of MARI on functional improvements ie psychosocial functioning quality of life and self-harm measured at post-treatment 3-months and 6-months post treatment and Exploratory Aim To explore whether changes in hostile interpretation bias proposed treatment mechanism mediate functional improvements
One of the mechanisms associated with problematic anger and aggression is hostile interpretation bias ie a tendency to interpret ambiguous interpersonal situations as hostile By reducing hostile interpretation bias the investigators can reduce problematic anger and aggression and improve functional outcomes A mobile application that uses evidence-based interpretation bias modification techniques to reduce hostile interpretation bias and anger outcomes has been developed and piloted The goal of this project is to evaluate the efficacy of this mobile application among Veterans with PTSD
A randomized controlled trial RCT will be conducted in which 150 Veterans with PTSD and problematic anger will be randomized to either the Mobile Anger Reduction Intervention MARI or a health education condition HED The central hypothesis is that participants in the MARI condition will experience greater anger reductions and functional improvements relative to the HED condition
The proposed research project will address the following Specific Aims Aim 1 To evaluate the efficacy of MARI on anger outcomes eg hostile interpretation bias problematic anger measured at post-treatment 3-months and 6-months post treatment Aim 2 To evaluate the efficacy of MARI on functional improvements ie psychosocial functioning quality of life and self-harm measured at post-treatment 3-months and 6-months post treatment and Exploratory Aim To explore whether changes in hostile interpretation bias proposed treatment mechanism mediate functional improvements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None