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Randomized Clinical Trial of MARI (MARI)

Primary Purpose

Posttraumatic Stress Disorder, Anger

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Anger Reduction Intervention (MARI)
Health Education Condition (HED)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring posttraumatic stress disorder, anger, hostile interpretation bias, mHealth

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Durham VA Medical Center, Durham, NC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile Anger Reduction Intervention (MARI)

Health Education Condition (HED)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 16, 2023
Last Updated
October 16, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT06094933
Brief Title
Randomized Clinical Trial of MARI
Acronym
MARI
Official Title
A Randomized Controlled Trial of the Mobile Anger Reduction Intervention for Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2024 (Anticipated)
Primary Completion Date
September 30, 2027 (Anticipated)
Study Completion Date
March 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Anger
Keywords
posttraumatic stress disorder, anger, hostile interpretation bias, mHealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mobile Anger Reduction Intervention (MARI)
Arm Type
Experimental
Arm Description
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.
Arm Title
Health Education Condition (HED)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Anger Reduction Intervention (MARI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Education Condition (HED)
Intervention Description
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.
Primary Outcome Measure Information:
Title
number of participants below the clinical cut off for problematic anger
Description
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.
Time Frame
Post-treatment (approx. one month after baseline assessment)
Title
number of participants below the clinical cut off for problematic anger
Description
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.
Time Frame
6-month follow-up
Title
number of participants below the clinical cut off for problematic anger
Description
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.
Time Frame
3-month follow-up
Title
number of participants with decreased hostile interpretation bias scores
Description
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.
Time Frame
from baseline to post-treatment assessments (approx. one month after baseline assessment)
Title
number of participants with decreased hostile interpretation bias scores
Description
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.
Time Frame
from baseline to 3-month follow-up
Title
number of participants with decreased hostile interpretation bias scores
Description
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.
Time Frame
from baseline to 6-month follow-up
Secondary Outcome Measure Information:
Title
number of participants with decreased psychosocial impairment scores
Description
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.
Time Frame
from baseline to post-treatment assessments (approx. one month after baseline assessment)
Title
number of participants with decreased psychosocial impairment scores
Description
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.
Time Frame
from baseline to 3-month follow-up
Title
number of participants with decreased psychosocial impairment scores
Description
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.
Time Frame
from baseline to 6-month follow-up
Title
number of participants with improved quality of life
Description
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.
Time Frame
from baseline to post-treatment assessments (approx. one month after baseline assessment)
Title
number of participants with improved quality of life
Description
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.
Time Frame
from baseline to 3-month follow-up
Title
number of participants with improved quality of life
Description
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.
Time Frame
from baseline to 6-month follow-up
Title
number of participants with reduced suicidal ideation
Description
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.
Time Frame
from baseline to post-treatment assessments (approx. one month after baseline assessment)
Title
number of participants with reduced suicidal ideation
Description
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.
Time Frame
from baseline to 3-month follow-up
Title
number of participants with reduced suicidal ideation
Description
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.
Time Frame
from baseline to 6-month follow-up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsten H Dillon, PhD
Phone
(919) 286-0411
Email
Kirsten.Dillon@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Angela C Kirby, MS
Phone
(919) 286-0411
Ext
7456
Email
angela.kirby@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten H Dillon, PhD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705-3875
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten H Dillon, PhD
Phone
919-286-0411
Email
Kirsten.Dillon@va.gov
First Name & Middle Initial & Last Name & Degree
Kirsten H Dillon, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Randomized Clinical Trial of MARI

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