An interventional study of Mobile Intervention for Reducing Anger (MIRA) and Mindfulness Intervention in Posttraumatic Stress Disorder and Anger, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
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.
2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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
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.
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.
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.
Time frame: 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%.
Time frame: 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.
Time frame: 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.
Time frame: Post-treatment assessment visit (approximately one month after enrollment)
| Milestone | Mobile Intervention for Reducing Anger (MIRA) | Mindfulness Intervention |
|---|---|---|
| Started | 16 | 14 |
| Completed | 16 | 14 |
| Not completed | 0 | 0 |
Patient recruitment goal feasibility goal will be met if recruitment is 75% or greater of recruitment expectation. Recruitment expectation is 20 in each arm.
| participants | Mobile Intervention for Reducing Anger (MIRA) | Mindfulness Intervention |
|---|---|---|
| Feasibility as Measured by Percentage of Recruitment Goal Met | 16 | 14 |
Treatment retention feasibility goal will be met if attrition from MIRA treatment arm is no more than 25%.
| participants | Mobile Intervention for Reducing Anger (MIRA) | Mindfulness Intervention |
|---|---|---|
| Number of Participants Lost to Attrition During Treatment | 0 | 1 |
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.
| participants | MIRA Group/Users Only |
|---|---|
| Number of Participants Who Report Satisfaction With the MIRA App | 14 |
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.
| sessions completed | MIRA Group/Users Only |
|---|---|
| Average Number of Treatment Sessions Completed by MIRA App Users | 17.13 ± 8.79 |
Collected over Adverse events were collected for approximately 17 weeks, from baseline to the 3-month follow-up visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mobile Intervention for Reducing Anger (MIRA) | 0/16 (0%) | 0/16 (0%) | 2/16 (12.5%) |
| Mindfulness Intervention | 0/14 (0%) | 0/14 (0%) | 4/14 (28.6%) |
| Event | Mobile Intervention for Reducing Anger (MIRA) | Mindfulness Intervention |
|---|---|---|
| frustration/discomfort with using the mobile appGeneral disorders | 1/16 | 3/14 |
| Distress upon completing interview about posttraumatic stress disorder symptomsPsychiatric disorders | 1/16 | 1/14 |
| Age, Continuous(years) | Mobile Intervention for Reducing Anger (MIRA) | Mindfulness Intervention | Total |
|---|---|---|---|
| Mean | 51.56 ± 12.82 | 59.29 ± 10.76 | 54.53 ± 11.91 |
| Sex: Female, Male(Participants) | Mobile Intervention for Reducing Anger (MIRA) | Mindfulness Intervention | Total |
|---|---|---|---|
| Female | 2 | 3 | 5 |
| Male | 14 | 11 | 25 |
| Ethnicity (NIH/OMB)(Participants) | Mobile Intervention for Reducing Anger (MIRA) | Mindfulness Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 15 | 14 | 29 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Mobile Intervention for Reducing Anger (MIRA) | Mindfulness Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 12 | 7 | 19 |
| White | 2 | 5 | 7 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Region of Enrollment(Participants) | Mobile Intervention for Reducing Anger (MIRA) | Mindfulness Intervention | Total |
|---|---|---|---|
| United States | 16 | 14 | 30 |
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Stress Disorders, Post-Traumatic→
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