Posttraumatic Stress DisorderMARINCT06094933
Mobile Anger Reduction Intervention
A study testing Mobile Anger Reduction Intervention (MARI) and Health Education Condition (HED) in people with Posttraumatic Stress Disorder and Anger, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Posttraumatic Stress Disorder, Anger
- What is being tested?
- Mobile Anger Reduction Intervention (MARI) and Health Education Condition (HED)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2024to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Veterans diagnosed with Post-traumatic stress disorder (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
Who cannot join
- Currently in a period of active psychosis or mania
- Exhibit current prominent suicidal or homicidal ideation requiring immediate intervention
- Have used the Mobile Anger Reduction Intervention (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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Kirsten H Dillon, PhD, (919) 286-0411, Kirsten.Dillon@va.gov
Kirsten H Dillon, PhD
About this study
Official title: A Randomized Controlled Trial of the Mobile Anger Reduction Intervention for Veterans
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder, Anger
- Being tested
- Mobile Anger Reduction Intervention (MARI), Health Education Condition (HED)
- Keywords
- posttraumatic stress disorder, anger, hostile interpretation bias, mHealth
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Anger Reduction Intervention (MARI)Behavioural
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.
Health Education Condition (HED)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Health Education Condition (HED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from baseline to 6-month follow-up
Secondary outcomes (9)
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. The investigators will count the number of participants in each group who have a reduction of scores within the time frame.
Measured: 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. The investigators will count the number of participants in each group who have a reduction of scores within the time frame.
Measured: 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. The investigators will count the number of participants in each group who have a reduction of scores within the time frame.
Measured: 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. The investigators will count the number of participants in each group who have an increase in their score within the time frame.
Measured: 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. The investigators will count the number of participants in each group who have an increase in their score within the time frame.
Measured: 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. The investigators will count the number of participants in each group who have an increase in their score within the time frame.
Measured: 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. The investigators will count the number of participants in each group who have a decrease in their score within the time frame.
Measured: 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. The investigators will count the number of participants in each group who have a decrease in their score within the time frame.
Measured: 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. The investigators will count the number of participants in each group who have a decrease in their score within the time frame.
Measured: from baseline to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start12 Nov 2024
- Primary completion30 Oct 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kirsten H Dillon, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094933
- Sponsor's protocol ID
- D4561-R
- Acronym
- MARI
- Status last verified
- Sep 2026
- First submitted
- 16 Oct 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Mobile Anger Reduction Intervention for Veterans
- ClinicalTrials.gov ID
- NCT06094933
- Acronym / sponsor ID
- MARI / D4561-R
- Conditions
- Posttraumatic Stress Disorder, Anger
- Keywords
- posttraumatic stress disorder, anger, hostile interpretation bias, mHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Anger Reduction Intervention (MARI) | Experimental | Behavioral: Mobile Anger Reduction Intervention (MARI)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. |
| Health Education Condition (HED) | Active comparator | Behavioral: Health Education Condition (HED)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Veterans diagnosed with Post-traumatic stress disorder (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
Key exclusion criteria (4 listed)
- Currently in a period of active psychosis or mania
- Exhibit current prominent suicidal or homicidal ideation requiring immediate intervention
- Have used the Mobile Anger Reduction Intervention (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Anger Reduction Intervention (MARI)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. | Behavioural | Mobile Anger Reduction Intervention (MARI) |
| Health Education Condition (HED)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. | Behavioural | Health Education Condition (HED) |
Primary outcome
number of participants below the clinical cut off for problematic anger
Time frame: Post-treatment (approx. one month after baseline assessment)
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.
number of participants below the clinical cut off for problematic anger
Time frame: 6-month follow-up
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.
number of participants below the clinical cut off for problematic anger
Time frame: 3-month follow-up
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.
number of participants with decreased hostile interpretation bias scores
Time frame: from baseline to post-treatment assessments (approx. one month after baseline assessment)
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.
number of participants with decreased hostile interpretation bias scores
Time frame: from baseline to 3-month follow-up
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.
number of participants with decreased hostile interpretation bias scores
Time frame: from baseline to 6-month follow-up
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.
9 secondary outcomes
number of participants with decreased psychosocial impairment scores
Time frame: from baseline to post-treatment assessments (approx. one month after baseline assessment)
number of participants with decreased psychosocial impairment scores
Time frame: from baseline to 3-month follow-up
number of participants with decreased psychosocial impairment scores
Time frame: from baseline to 6-month follow-up
number of participants with improved quality of life
Time frame: from baseline to post-treatment assessments (approx. one month after baseline assessment)
number of participants with improved quality of life
Time frame: from baseline to 3-month follow-up
number of participants with improved quality of life
Time frame: from baseline to 6-month follow-up
number of participants with reduced suicidal ideation
Time frame: from baseline to post-treatment assessments (approx. one month after baseline assessment)
number of participants with reduced suicidal ideation
Time frame: from baseline to 3-month follow-up
number of participants with reduced suicidal ideation
Time frame: from baseline to 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Posttraumatic Stress Disorder
Recruiting
Trauma BPE Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center
Traumatic Injury, PTSD
Not yet recruitingPhase 4
Assessing Trauma-related Links Between Affective and Metabolic Systems
Posttraumatic Stress Disorder, Metabolic Syndrome
Not yet recruiting
EEG and Actigraphy Biomarkers of Written Exposure Therapy for Posttraumatic Stress Disorder
Posttraumatic Stress Disorder (PTSD)
Not yet recruiting
Mindful RAVANS Study
mTBI - Mild Traumatic Brain Injury, Posttraumatic Stress Disorder
Not yet recruitingEarly Phase 1
Predictors & Mechanisms of Adolescent PTSD
Posttraumatic Stress Disorder (PTSD), Trauma Exposure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kirsten H Dillon, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Anger Reduction Intervention (MARI) and Health Education Condition (HED) in people with Posttraumatic Stress Disorder and Anger, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirsten H Dillon, PhD ((919) 286-0411, Kirsten.Dillon@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants below the clinical cut off for problematic anger (time frame: Post-treatment (approx. one month after baseline assessment)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.