Mobile Anger Reduction Intervention

NCT ID: NCT06094933

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2028-03-31

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, i.e., 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 (e.g., 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 (i.e., 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.

Conditions

Posttraumatic Stress Disorder; Anger

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mobile Anger Reduction Intervention (MARI)

Participants in this arm will download the MARI application (app) on their own smart phone device and will use the app for a period of 4 weeks.

Group Type: EXPERIMENTAL

Mobile Anger Reduction Intervention (MARI)

Intervention Type: BEHAVIORAL

This is a mobile intervention that uses interpretation bias modification (IBM) techniques to reduce the hostile interpretation bias. Participants will download the MARI app and be instructed to complete at least 5 treatment sessions each week for a period of 4 weeks. Each session takes approximately 10 minutes. The app also includes a Nightly Diary to track symptoms, a calendar to program session reminders, and a My Progress feature to track use and performance.

Health Education Condition (HED)

Participants in this arm will download the HED application (app) on their own smart phone device and will use the app for a period of 4 weeks.

Group Type: ACTIVE_COMPARATOR

Health Education Condition (HED)

Intervention Type: BEHAVIORAL

This is a mobile application that delivers videos with psychoeducation about healthy habits and selfcare for general wellness. Participants will download the HED app and be instructed to use it at least 5 times a week for a period of 4 weeks.

Interventions

Mobile Anger Reduction Intervention (MARI)

This is a mobile intervention that uses interpretation bias modification (IBM) techniques to reduce the hostile interpretation bias. Participants will download the MARI app and be instructed to complete at least 5 treatment sessions each week for a period of 4 weeks. Each session takes approximately 10 minutes. The app also includes a Nightly Diary to track symptoms, a calendar to program session reminders, and a My Progress feature to track use and performance.

Intervention Type: BEHAVIORAL

Health Education Condition (HED)

This is a mobile application that delivers videos with psychoeducation about healthy habits and selfcare for general wellness. Participants will download the HED app and be instructed to use it at least 5 times a week for a period of 4 weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Veterans diagnosed with PTSD, established via chart review and a score of greater than or equal to 33 on the PTSD Checklist for DSM-5 (PCL-5)
• Reporting a score of greater than or equal to 12 on the 5-item Dimensions of Anger Reactions Scale
• Have not had any changes to type or dose of psychiatric medications for 3 months, with no plans to make adjustments in the next 6 months
• Able to read at least 6th grade level material

Exclusion Criteria

• Currently in a period of active psychosis or mania
• Exhibit current prominent suicidal or homicidal ideation requiring immediate intervention
• Have used the MARI application before as part of another research study
• Receiving (or plan to receive) other anger management psychotherapy or trauma-focused therapy for PTSD (i.e., prolonged exposure, cognitive processing therapy during the course of the study

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirsten H Dillon, PhD

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center, Durham, NC

Locations

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kirsten H Dillon, PhD

Role: CONTACT

Kirsten.Dillon@va.gov

(919) 286-0411

Angela C Kirby, MS

Role: CONTACT

angela.kirby@va.gov

(919) 286-0411 ext. 7456

Facility Contacts

Kirsten H Dillon, PhD

Role: primary

Kirsten.Dillon@va.gov

(919) 286-0411

Other Identifiers

D4561-R

Identifier Type: -

Identifier Source: org_study_id