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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten H Dillon, PhD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705-3875 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 20 participants per arm was the expected number of participants to be recruited. | Posted | Number | participants | Through study completion (approximately 2 years) |
|
Adverse events were collected for approximately 17 weeks, from baseline to the 3-month follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Distress upon completing interview about posttraumatic stress disorder symptoms | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Kirby | Durham VA Health Care System | 919-824-7729 | angela.kirby@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2022 | Mar 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 9, 2022 | Mar 18, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| 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. |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | 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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| Primary | 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%. | This population is defined as all participants who began treatment. | Posted | Number | participants | Post-treatment assessment visit (approximately one month after enrollment) |
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| Primary | 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. | These are all participants assigned to the MIRA group who completed treatment. | Posted | Number | participants | Post-treatment assessment visit (approximately one month after enrollment) |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | sessions completed | Post-treatment assessment visit (approximately one month after enrollment) |
|
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| 0 |
| 16 |
| 0 |
| 16 |
| 2 |
| 16 |
| EG001 | 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. | 0 | 14 | 0 | 14 | 4 | 14 |
| frustration/discomfort with using the mobile app | General disorders | Non-systematic Assessment |
|
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