Anger, Posttraumatic Stress Disorder
Conditions
Keywords
anger, posttraumatic stress disorder, hostile interpretation bias, mHealth
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.
Interventions
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.
BEHAVIORALMindfulness 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as Measured by Percentage of Recruitment Goal Met | Through study completion (approximately 2 years) | Patient recruitment goal feasibility goal will be met if recruitment is 75% or greater of recruitment expectation. Recruitment expectation is 20 in each arm. |
| Number of Participants Lost to Attrition During Treatment | Post-treatment assessment visit (approximately one month after enrollment) | Treatment retention feasibility goal will be met if attrition from MIRA treatment arm is no more than 25%. |
| Number of Participants Who Report Satisfaction With the MIRA App | Post-treatment assessment visit (approximately one month after enrollment) | 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. |
| Average Number of Treatment Sessions Completed by MIRA App Users | Post-treatment assessment visit (approximately one month after enrollment) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | Mobile Intervention for Reducing Anger (MIRA) | Total | Mindfulness Intervention |
|---|---|---|---|
| Age, Continuous | 51.56 years STANDARD_DEVIATION 12.82 | 54.53 years STANDARD_DEVIATION 11.91 | 59.29 years STANDARD_DEVIATION 10.76 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 29 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 19 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 2 Participants | 7 Participants | 5 Participants |
| Region of Enrollment United States | 16 Participants | 30 Participants | 14 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 14 Participants | 25 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 14 |
| other Total, other adverse events | 2 / 16 | 4 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Intervention for Reducing Anger (MIRA) | Average Number of Treatment Sessions Completed by MIRA App Users | 17.13 sessions completed | Standard Deviation 8.79 |
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.
Time frame: Through study completion (approximately 2 years)
Population: 20 participants per arm was the expected number of participants to be recruited.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mobile Intervention for Reducing Anger (MIRA) | Feasibility as Measured by Percentage of Recruitment Goal Met | 16 participants |
| Mindfulness Intervention | Feasibility as Measured by Percentage of Recruitment Goal Met | 14 participants |
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%.
Time frame: Post-treatment assessment visit (approximately one month after enrollment)
Population: This population is defined as all participants who began treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mobile Intervention for Reducing Anger (MIRA) | Number of Participants Lost to Attrition During Treatment | 0 participants |
| Mindfulness Intervention | Number of Participants Lost to Attrition During Treatment | 1 participants |
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.
Time frame: Post-treatment assessment visit (approximately one month after enrollment)
Population: These are all participants assigned to the MIRA group who completed treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mobile Intervention for Reducing Anger (MIRA) | Number of Participants Who Report Satisfaction With the MIRA App | 14 participants |