Mobile Intervention for Veterans With PTSD and Anger

NCT03733028 | Completed Results

• 1 other identifier: D2965-W
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder; Anger

Keywords

anger; posttraumatic stress disorder; hostile interpretation bias; mHealth

Outcome Measures

Primary Outcomes (4)

• Feasibility as Measured by Percentage of Recruitment Goal Met

  Patient recruitment goal feasibility goal will be met if recruitment is 75% or greater of recruitment expectation. Recruitment expectation is 20 in each arm.

  Through study completion (approximately 2 years)

• Number of Participants Lost to Attrition During Treatment

  Treatment retention feasibility goal will be met if attrition from MIRA treatment arm is no more than 25%.

  Post-treatment assessment visit (approximately one month after enrollment)

• Number of Participants Who Report Satisfaction With the MIRA App

  Patient satisfaction goal will be met if 80% or greater of participants indicate that they are either "very satisfied" or "mostly satisfied" with the MIRA app on item #7 of the Client Satisfaction Questionnaire.

  Post-treatment assessment visit (approximately one month after enrollment)

• Average Number of Treatment Sessions Completed by MIRA App Users

  Our App utilization goal will be met if MIRA app utilization rates are greater than 50% of expected use. Expected use is defined as 20 sessions completed, and the app utilization goal will be met if participants complete, on average, at least 10 sessions.

  Post-treatment assessment visit (approximately one month after enrollment)

Study Arms (2)

Mobile Intervention for Reducing Anger (MIRA)

EXPERIMENTAL

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.

Behavioral: Mobile Intervention for Reducing Anger (MIRA)

Mindfulness Intervention

ACTIVE COMPARATOR

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.

Behavioral: Mindfulness Intervention

Interventions

Mobile Intervention for Reducing Anger (MIRA) 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.

Mobile Intervention for Reducing Anger (MIRA)

Mindfulness Intervention 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.

Mindfulness Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Angela Kirby
• Organization: Durham VA Health Care System

angela.kirby@va.gov

919-824-7729

Study Officials

• Kirsten H Dillon, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 7, 2018
• Study Start: March 15, 2021
• Primary Completion: April 18, 2023
• Study Completion: June 15, 2023
• Last Updated: July 22, 2025
• Results First Posted: July 5, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)