Randomized Clinical Trial of MARI

Study Overview
=================
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.

Official Title
-----------------
A Randomized Controlled Trial of the Mobile Anger Reduction Intervention for Veterans

Conditions
-----------------
Posttraumatic Stress Disorder, Anger

Intervention / Treatment
-----------------
* Behavioral: Mobile Anger Reduction Intervention (MARI)
* Behavioral: Health Education Condition (HED)


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Anger Reduction Intervention (MARI)<br>Participants in this arm will download the MARI application (app) on their own smart phone device and will use the app for a period of 4 weeks. | Behavioral: Mobile Anger Reduction Intervention (MARI)<br>* This is a mobile intervention that uses interpretation bias modification (IBM) techniques to reduce the hostile interpretation bias. Participants will download the MARI app and be instructed to complete at least 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.<br>|
| Active Comparator: Health Education Condition (HED)<br>Participants in this arm will download the HED application (app) on their own smart phone device and will use the app for a period of 4 weeks. | Behavioral: Health Education Condition (HED)<br>* This is a mobile application that delivers videos with psychoeducation about healthy habits and selfcare for general wellness. Participants will download the HED app and be instructed to use it at least 5 times a week for a period of 4 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants below the clinical cut off for problematic anger | Measured with the Dimensions of Anger Reactions-5 scale; scores range from 5-25, with higher scores indicating higher levels of problematic anger; the clinical cut off is 12. We will count the number of participants in each group who have a score lower than 12. | Post-treatment (approx. one month after baseline assessment) | 
| number of participants below the clinical cut off for problematic anger | Measured with the Dimensions of Anger Reactions-5 scale; scores range from 5-25, with higher scores indicating higher levels of problematic anger; the clinical cut off is 12. We will count the number of participants in each group who have a score lower than 12. | 6-month follow-up | 
| number of participants below the clinical cut off for problematic anger | Measured with the Dimensions of Anger Reactions-5 scale; scores range from 5-25, with higher scores indicating higher levels of problematic anger; the clinical cut off is 12. We will count the number of participants in each group who have a score lower than 12. | 3-month follow-up | 
| number of participants with decreased hostile interpretation bias scores | Measured with the Word Sentence Association Paradigm-Hostility, hostility subscale. Scores range from 1-6, with higher scores indicating higher levels hostile interpretation bias. We will count the number of participants in each group who have a reduction in scores within the time frame. | from baseline to post-treatment assessments (approx. one month after baseline assessment) | 
| number of participants with decreased hostile interpretation bias scores | Measured with the Word Sentence Association Paradigm-Hostility, hostility subscale. Scores range from 1-6, with higher scores indicating higher levels hostile interpretation bias. We will count the number of participants in each group who have a reduction in scores within the time frame. | from baseline to 3-month follow-up | 
| number of participants with decreased hostile interpretation bias scores | Measured with the Word Sentence Association Paradigm-Hostility, hostility subscale. Scores range from 1-6, with higher scores indicating higher levels hostile interpretation bias. We will count the number of participants in each group who have a reduction in scores within the time frame. | from baseline to 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with decreased psychosocial impairment scores | Measured with the Brief Inventory of Psychosocial Functioning. Scores range from 0-6, with higher scores indicating higher levels of psychosocial impairment. We will count the number of participants in each group who have a reduction of scores within the time frame. | from baseline to post-treatment assessments (approx. one month after baseline assessment) | 
| number of participants with decreased psychosocial impairment scores | Measured with the Brief Inventory of Psychosocial Functioning. Scores range from 0-6, with higher scores indicating higher levels of psychosocial impairment. We will count the number of participants in each group who have a reduction of scores within the time frame. | from baseline to 3-month follow-up | 
| number of participants with decreased psychosocial impairment scores | Measured with the Brief Inventory of Psychosocial Functioning. Scores range from 0-6, with higher scores indicating higher levels of psychosocial impairment. We will count the number of participants in each group who have a reduction of scores within the time frame. | from baseline to 6-month follow-up | 
| number of participants with improved quality of life | Measured with the Quality of Life Inventory. Scores range from -6-6, with higher scores indicating higher levels of satisfaction with life. We will count the number of participants in each group who have an increase in their score within the time frame. | from baseline to post-treatment assessments (approx. one month after baseline assessment) | 
| number of participants with improved quality of life | Measured with the Quality of Life Inventory. Scores range from -6-6, with higher scores indicating higher levels of satisfaction with life. We will count the number of participants in each group who have an increase in their score within the time frame. | from baseline to 3-month follow-up | 
| number of participants with improved quality of life | Measured with the Quality of Life Inventory. Scores range from -6-6, with higher scores indicating higher levels of satisfaction with life. We will count the number of participants in each group who have an increase in their score within the time frame. | from baseline to 6-month follow-up | 
| number of participants with reduced suicidal ideation | Measured with the Columbia- Suicide Severity Rating Scale, suicidal ideation intensity rating. Scores range from 0-25, with higher scores indicating higher intensity of suicidal ideation. We will count the number of participants in each group who have a decrease in their score within the time frame. | from baseline to post-treatment assessments (approx. one month after baseline assessment) | 
| number of participants with reduced suicidal ideation | Measured with the Columbia- Suicide Severity Rating Scale, suicidal ideation intensity rating. Scores range from 0-25, with higher scores indicating higher intensity of suicidal ideation. We will count the number of participants in each group who have a decrease in their score within the time frame. | from baseline to 3-month follow-up | 
| number of participants with reduced suicidal ideation | Measured with the Columbia- Suicide Severity Rating Scale, suicidal ideation intensity rating. Scores range from 0-25, with higher scores indicating higher intensity of suicidal ideation. We will count the number of participants in each group who have a decrease in their score within the time frame. | from baseline to 6-month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
posttraumatic stress disorder, anger, hostile interpretation bias, mHealth