Mobile Intervention for Veterans With PTSD and Anger
Primary Purpose
Posttraumatic Stress Disorder, Anger
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Intervention for Reducing Anger (MIRA)
Mindfulness Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring anger, posttraumatic stress disorder, hostile interpretation bias, mHealth
Eligibility Criteria
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
Sites / Locations
- Durham VA Medical Center, Durham, NC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mobile Intervention for Reducing Anger (MIRA)
Mindfulness Intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Feasibility of participant recruitment
Patient feasibility goal will be met if recruitment is 75% or greater of recruitment expectation.
Feasibility of treatment retention
Treatment retention feasibility goal will be met if attrition from MIRA treatment arm is no more than 25%.
Patient satisfaction: Client Satisfaction Questionnaire
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.
App utilization
App utilization goal will be met if MIRA app utilization rates are greater than 50% of expected use.
Secondary Outcome Measures
Full Information
NCT ID
NCT03733028
First Posted
November 5, 2018
Last Updated
July 7, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03733028
Brief Title
Mobile Intervention for Veterans With PTSD and Anger
Official Title
Developing a Mobile Intervention for Veterans With PTSD and Problematic Anger
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
April 18, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Anger
Keywords
anger, posttraumatic stress disorder, hostile interpretation bias, mHealth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile Intervention for Reducing Anger (MIRA)
Arm Type
Experimental
Arm Description
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.
Arm Title
Mindfulness Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Intervention for Reducing Anger (MIRA)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of participant recruitment
Description
Patient feasibility goal will be met if recruitment is 75% or greater of recruitment expectation.
Time Frame
Through study completion (approximately 2 years)
Title
Feasibility of treatment retention
Description
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)
Title
Patient satisfaction: Client Satisfaction Questionnaire
Description
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)
Title
App utilization
Description
App utilization goal will be met if MIRA app utilization rates are greater than 50% of expected use.
Time Frame
Post-treatment assessment visit (approximately one month after enrollment)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten H Dillon, PhD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705-3875
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Mobile Intervention for Veterans With PTSD and Anger
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