Mobile Intervention for Veterans With PTSD and Anger

Posttraumatic Stress Disorder Clinical Trial

Official title:

Developing a Mobile Intervention for Veterans With PTSD and Problematic Anger

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03733028
• Other study ID #: D2965-W
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: June 15, 2023

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 15, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anger
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of participant recruitment	Patient feasibility goal will be met if recruitment is 75% or greater of recruitment expectation.	Through study completion (approximately 2 years)
Primary	Feasibility of treatment retention	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)
Primary	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.	Post-treatment assessment visit (approximately one month after enrollment)
Primary	App utilization	App utilization goal will be met if MIRA app utilization rates are greater than 50% of expected use.	Post-treatment assessment visit (approximately one month after enrollment)