Clinical trial NCT03733028: Mobile Intervention for Veterans With PTSD and Anger
Official title: Developing a Mobile Intervention for Veterans With PTSD and Problematic Anger
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Anger
Keywords: anger
posttraumatic stress disorder
hostile interpretation bias
mHealth
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-11-07
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility as Measured by Percentage of Recruitment Goal Met
timeFrame: Through study completion (approximately 2 years)
measure: Number of Participants Lost to Attrition During Treatment
timeFrame: Post-treatment assessment visit (approximately one month after enrollment)
measure: Number of Participants Who Report Satisfaction With the MIRA App
timeFrame: Post-treatment assessment visit (approximately one month after enrollment)
measure: Average Number of Treatment Sessions Completed by MIRA App Users
timeFrame: Post-treatment assessment visit (approximately one month after enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Kirsten H Dillon, PhD
role: PRINCIPAL_INVESTIGATOR
References: