Mobile Intervention for Veterans With PTSD and Anger

NCT ID: NCT03733028

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2023-06-15

Brief Summary

Anger is the mostly commonly reported reintegration concern among combat Veterans, especially those with PTSD. Problematic anger is associated with significant functional impairment. In the current project, the investigators will pilot-test a newly developed mobile app, entitled Mobile Intervention for Reducing Anger (MIRA), among Veterans with PTSD and problematic anger. The project will compare the MIRA app to a contact control condition. The investigators hypothesize that Veterans with PTSD and problematic anger will find the MIRA app acceptable and will be willing to use it to reduce their anger difficulties and improve psychosocial and occupational functioning.

Detailed Description

Anger is the mostly commonly reported reintegration concern among combat Veterans, especially those with PTSD. Problematic anger is associated with significant functional impairment. 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. The investigator has previously developed and piloted a computer-based interpretation bias modification intervention that successfully reduces both hostile interpretation bias and anger outcomes. In the current project, the investigators will pilot-test a mobile application version of the existing computer-based intervention, entitled Mobile Intervention for Reducing Anger (MIRA), among Veterans with PTSD and problematic anger. The project will compare the MIRA app to a contact control condition to evaluate the feasibility of recruitment, randomization, and retention procedures. The investigators will also utilize psychophysiological and electronic diary monitoring to determine whether this assessment could be used as an outcome or mechanistic variable in a subsequent randomized clinical trial application focused on evaluating the efficacy of the MIRA intervention.

Conditions

Posttraumatic Stress Disorder; Anger

Study Design

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

Study Groups

Mobile Intervention for Reducing Anger (MIRA)

Participants in this arm will be provided with a device that has the MIRA application (app) and asked to use the app for a period of 4 weeks.

Group Type: EXPERIMENTAL

Mobile Intervention for Reducing Anger (MIRA)

Intervention Type: BEHAVIORAL

This is a mobile intervention that uses interpretation bias modification (IBM) techniques to reduce the hostile interpretation bias. Participants will be given a mobile device with the MIRA app and instructed to complete 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.

Mindfulness Intervention

Participants in this arm will be provided with a device that has the Mindfulness application (app) and asked to use the app for a period of 4 weeks.

Group Type: ACTIVE_COMPARATOR

Mindfulness Intervention

Intervention Type: BEHAVIORAL

This is a mobile intervention that uses the Mindful Breathing and Body Scan exercises from the "Mindfulness Coach" app. These audio-guided exercises take approximately 10 minutes each. Participants will be given a mobile device with the Mindfulness app and instructed to complete 5 exercises (i.e., Body Scan or Mindful Breathing) each week for a period of 4 weeks. The app also includes a Nightly Diary to track symptoms, a calendar to program reminders, and a My Progress feature to track use and performance.

Interventions

Mobile Intervention for Reducing Anger (MIRA)

This is a mobile intervention that uses interpretation bias modification (IBM) techniques to reduce the hostile interpretation bias. Participants will be given a mobile device with the MIRA app and instructed to complete 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

Mindfulness Intervention

This is a mobile intervention that uses the Mindful Breathing and Body Scan exercises from the "Mindfulness Coach" app. These audio-guided exercises take approximately 10 minutes each. Participants will be given a mobile device with the Mindfulness app and instructed to complete 5 exercises (i.e., Body Scan or Mindful Breathing) each week for a period of 4 weeks. The app also includes a Nightly Diary to track symptoms, a calendar to program reminders, and a My Progress feature to track use and performance.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Veterans diagnosed with PTSD, established via the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
• Reporting a score of 12 on the 5-item Dimensions of Anger Reactions Scale
• Able to read at least 6th grade level material

Exclusion Criteria

• Expect to be unstable on their medication regimen during the study
• Currently in a period of active psychosis or mania
• Exhibit current prominent suicidal or homicidal ideation requiring immediate intervention
• 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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

D2965-W

Identifier Type: -

Identifier Source: org_study_id