Trial Outcomes & Findings for Mobile Intervention for Veterans With PTSD and Anger (NCT NCT03733028)
NCT ID: NCT03733028
Last Updated: 2025-07-22
Results Overview
Patient recruitment goal feasibility goal will be met if recruitment is 75% or greater of recruitment expectation. Recruitment expectation is 20 in each arm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Through study completion (approximately 2 years)
Results posted on
2025-07-22
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobile Intervention for Veterans With PTSD and Anger
Baseline characteristics by cohort
| Measure |
Mobile Intervention for Reducing Anger (MIRA)
n=16 Participants
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.
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.
|
Mindfulness Intervention
n=14 Participants
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.
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.
|
Total
n=30 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
51.56 years
STANDARD_DEVIATION 12.82 • n=5 Participants
|
59.29 years
STANDARD_DEVIATION 10.76 • n=7 Participants
|
54.53 years
STANDARD_DEVIATION 11.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion (approximately 2 years)Population: 20 participants per arm was the expected number of participants to be recruited.
Patient recruitment goal feasibility goal will be met if recruitment is 75% or greater of recruitment expectation. Recruitment expectation is 20 in each arm.
Outcome measures
| Measure |
Mobile Intervention for Reducing Anger (MIRA)
n=20 Participants
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.
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.
|
Mindfulness Intervention
n=20 Participants
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.
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.
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|---|---|---|
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Feasibility as Measured by Percentage of Recruitment Goal Met
|
16 participants
|
14 participants
|
PRIMARY outcome
Timeframe: Post-treatment assessment visit (approximately one month after enrollment)Population: This population is defined as all participants who began treatment.
Treatment retention feasibility goal will be met if attrition from MIRA treatment arm is no more than 25%.
Outcome measures
| Measure |
Mobile Intervention for Reducing Anger (MIRA)
n=16 Participants
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.
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.
|
Mindfulness Intervention
n=14 Participants
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.
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.
|
|---|---|---|
|
Number of Participants Lost to Attrition During Treatment
|
0 participants
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1 participants
|
PRIMARY outcome
Timeframe: Post-treatment assessment visit (approximately one month after enrollment)Population: These are all participants assigned to the MIRA group who completed treatment.
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.
Outcome measures
| Measure |
Mobile Intervention for Reducing Anger (MIRA)
n=16 Participants
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.
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.
|
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.
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.
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|---|---|---|
|
Number of Participants Who Report Satisfaction With the MIRA App
|
14 participants
|
—
|
PRIMARY outcome
Timeframe: Post-treatment assessment visit (approximately one month after enrollment)Population: These are all participants assigned to the MIRA group who completed treatment. One participant was withdrawn prior to beginning treatment, and another withdrew during treatment.
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.
Outcome measures
| Measure |
Mobile Intervention for Reducing Anger (MIRA)
n=16 Participants
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.
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.
|
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.
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.
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|---|---|---|
|
Average Number of Treatment Sessions Completed by MIRA App Users
|
17.13 sessions completed
Standard Deviation 8.79
|
—
|
Adverse Events
Mobile Intervention for Reducing Anger (MIRA)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Mindfulness Intervention
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mobile Intervention for Reducing Anger (MIRA)
n=16 participants at risk
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.
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.
|
Mindfulness Intervention
n=14 participants at risk
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.
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.
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|---|---|---|
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Psychiatric disorders
Distress upon completing interview about posttraumatic stress disorder symptoms
|
6.2%
1/16 • Number of events 1 • Adverse events were collected for approximately 17 weeks, from baseline to the 3-month follow-up visit.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected for approximately 17 weeks, from baseline to the 3-month follow-up visit.
|
|
General disorders
frustration/discomfort with using the mobile app
|
6.2%
1/16 • Number of events 1 • Adverse events were collected for approximately 17 weeks, from baseline to the 3-month follow-up visit.
|
21.4%
3/14 • Number of events 3 • Adverse events were collected for approximately 17 weeks, from baseline to the 3-month follow-up visit.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place