Mobile Intervention for Veterans With PTSD and Anger

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT03733028
Collaborator
(none)
40
1
2
34.6
1.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mobile Intervention for Reducing Anger (MIRA)
  • Behavioral: Mindfulness Intervention
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Developing a Mobile Intervention for Veterans With PTSD and Problematic Anger
Actual Study Start Date :
Mar 15, 2021
Anticipated Primary Completion Date :
Mar 13, 2023
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.

Active Comparator: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility of participant recruitment [Through study completion (approximately 2 years)]

    Patient feasibility goal will be met if recruitment is 75% or greater of recruitment expectation.

  2. Feasibility of treatment retention [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%.

  3. Patient satisfaction: Client Satisfaction Questionnaire [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.

  4. App utilization [Post-treatment assessment visit (approximately one month after enrollment)]

    App utilization goal will be met if MIRA app utilization rates are greater than 50% of expected use.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Durham VA Medical Center, Durham, NC Durham North Carolina United States 27705

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: Kirsten H Dillon, PhD, Durham VA Medical Center, Durham, NC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT03733028
Other Study ID Numbers:
  • D2965-W
First Posted:
Nov 7, 2018
Last Update Posted:
Mar 14, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2022