NCT06094933

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Nov 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Nov 2024Mar 2028

First Submitted

Initial submission to the registry

October 16, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 12, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

3 years

First QC Date

October 16, 2023

Last Update Submit

October 15, 2025

Conditions

Keywords

posttraumatic stress disorderangerhostile interpretation biasmHealth

Outcome Measures

Primary Outcomes (6)

  • 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. The investigators 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. The investigators 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. The investigators 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. The investigators 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. The investigators 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. The investigators 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 Outcomes (9)

  • number of participants with decreased psychosocial impairment scores

    from baseline to post-treatment assessments (approx. one month after baseline assessment)

  • number of participants with decreased psychosocial impairment scores

    from baseline to 3-month follow-up

  • number of participants with decreased psychosocial impairment scores

    from baseline to 6-month follow-up

  • number of participants with improved quality of life

    from baseline to post-treatment assessments (approx. one month after baseline assessment)

  • number of participants with improved quality of life

    from baseline to 3-month follow-up

  • +4 more secondary outcomes

Study Arms (2)

Mobile Anger Reduction Intervention (MARI)

EXPERIMENTAL

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)

Health Education Condition (HED)

ACTIVE COMPARATOR

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)

Interventions

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.

Mobile Anger Reduction Intervention (MARI)

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.

Health Education Condition (HED)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Kirsten H Dillon, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten H Dillon, PhD

CONTACT

Angela C Kirby, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 23, 2023

Study Start

November 12, 2024

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

October 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations