Clinical trial NCT06094933: Mobile Anger Reduction Intervention
Official title: A Randomized Controlled Trial of the Mobile Anger Reduction Intervention for Veterans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Anger
Keywords: posttraumatic stress disorder
anger
hostile interpretation bias
mHealth
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-10-23
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Difficulty controlling anger is the most commonly reported reintegration concern among combat Veterans, especially those with a diagnosis of posttraumatic stress disorder (PTSD). Problematic anger is associated with significant functional impairment. In the current project, the investigators will compare the Mobile Anger Reduction Intervention (MARI) with a health education mobile intervention (HED) among Veterans with PTSD and problematic anger. Participants will be randomized to the MARI or HED condition. The hypothesis is that participants in the MARI condition will experience greater anger reductions and functional improvements relative to the HED condition.

Detailed description: Difficulty controlling anger is the most commonly reported reintegration concern among combat Veterans, especially those with a diagnosis of posttraumatic stress disorder (PTSD). In Veterans, problematic anger is associated with numerous negative psychosocial outcomes, including poor functional outcomes (both social and occupational), family discord, aggression, road rage, and suicide risk. Anger can also impede successful outcomes from PTSD treatment. Given the high prevalence of anger problems among Veterans with PTSD and the associated functional impairments, there is a clear need to develop innovative and effective anger interventions to improve functional outcomes. Use of mobile health (mHealth) technology could provide a low-cost method to increase the reach of anger management treatments to this high-need group of Veterans.

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. By reducing hostile interpretation bias, the investigators can reduce problematic anger and aggression and improve functional outcomes. A mobile application that uses evidence-based interpretation bias modification techniques to reduce hostile interpretation bias and anger outcomes has been developed and piloted. The goal of this project is to evaluate the efficacy of this mobile application among Veterans with PTSD.

A randomized controlled trial (RCT) will be conducted, in which 150 Veterans with PTSD and problematic anger will be randomized to either the Mobile Anger Reduction Intervention (MARI) or a health education condition (HED). The central hypothesis is that participants in the MARI condition will experience greater anger reductions and functional improvements relative to the HED condition.

The proposed research project will address the following Specific Aims: Aim 1: To evaluate the efficacy of MARI on anger outcomes (e.g., hostile interpretation bias, problematic anger) measured at post-treatment, 3-months, and 6-months post treatment; Aim 2: To evaluate the efficacy of MARI on functional improvements (i.e., psychosocial functioning, quality of life) and self-harm measured at post-treatment, 3-months, and 6-months post treatment; and Exploratory Aim: To explore whether changes in hostile interpretation bias (proposed treatment mechanism) mediate functional improvements.

Eligibility criteria: Inclusion Criteria:

* Veterans diagnosed with PTSD, established via chart review and a score of greater than or equal to 33 on the PTSD Checklist for DSM-5 (PCL-5)
* Reporting a score of greater than or equal to 12 on the 5-item Dimensions of Anger Reactions Scale
* Have not had any changes to type or dose of psychiatric medications for 3 months, with no plans to make adjustments in the next 6 months
* Able to read at least 6th grade level material

Exclusion Criteria:

* Currently in a period of active psychosis or mania
* Exhibit current prominent suicidal or homicidal ideation requiring immediate intervention
* Have used the MARI application before as part of another research study
* 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: number of participants below the clinical cut off for problematic anger
timeFrame: Post-treatment (approx. one month after baseline assessment)
measure: number of participants below the clinical cut off for problematic anger
timeFrame: 6-month follow-up
measure: number of participants below the clinical cut off for problematic anger
timeFrame: 3-month follow-up
measure: number of participants with decreased hostile interpretation bias scores
timeFrame: from baseline to post-treatment assessments (approx. one month after baseline assessment)
measure: number of participants with decreased hostile interpretation bias scores
timeFrame: from baseline to 3-month follow-up
measure: number of participants with decreased hostile interpretation bias scores
timeFrame: from baseline to 6-month follow-up
Secondary outcomes:
measure: number of participants with decreased psychosocial impairment scores
timeFrame: from baseline to post-treatment assessments (approx. one month after baseline assessment)
measure: number of participants with decreased psychosocial impairment scores
timeFrame: from baseline to 3-month follow-up
measure: number of participants with decreased psychosocial impairment scores
timeFrame: from baseline to 6-month follow-up
measure: number of participants with improved quality of life
timeFrame: from baseline to post-treatment assessments (approx. one month after baseline assessment)
measure: number of participants with improved quality of life
timeFrame: from baseline to 3-month follow-up
measure: number of participants with improved quality of life
timeFrame: from baseline to 6-month follow-up
measure: number of participants with reduced suicidal ideation
timeFrame: from baseline to post-treatment assessments (approx. one month after baseline assessment)
measure: number of participants with reduced suicidal ideation
timeFrame: from baseline to 3-month follow-up
measure: number of participants with reduced suicidal ideation
timeFrame: from baseline to 6-month follow-up
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: