MARI for PTSD

(MARI Trial)

Overseen By Angela C Kirby, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Active psychosis, Suicidal ideation, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new phone app called the Mobile Anger Reduction Intervention (MARI) to assist Veterans with PTSD in managing anger. The goal is to determine if MARI can reduce anger and enhance daily life more effectively than a standard health education app. Participants will use either the MARI app or the health education app for four weeks. Veterans with PTSD and ongoing anger issues who have not recently changed their psychiatric medication may be suitable for this study. As an unphased trial, this study provides Veterans the chance to explore innovative solutions for managing anger and improving their quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have changed your psychiatric medications in the last 3 months and should not plan to change them in the next 6 months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Mobile Anger Reduction Intervention (MARI) app helps veterans manage anger more effectively. Some studies suggest that using this app might reduce anger and improve daily life. However, these studies lack specific information about safety or side effects.

As this is a new treatment and detailed safety information isn't available yet, safety evidence is still being gathered. Participants typically share their experiences with the app, aiding researchers in learning about its safety over time.

Without specific safety data, discussing any concerns with a healthcare provider before joining a clinical trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Anger Reduction Intervention (MARI) for PTSD because it offers a unique, app-based approach to managing symptoms. Unlike traditional treatments like therapy or medication, MARI provides a convenient, portable, and accessible way for users to engage in anger management techniques right from their smartphones. This digital intervention is designed to empower individuals by integrating therapeutic strategies into their daily lives, potentially offering more immediate support and flexibility. Additionally, the Health Education Condition (HED) app serves as an active comparator, providing valuable insights into the effectiveness of app-based education versus targeted interventions like MARI.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that the Mobile Anger Reduction Intervention (MARI), which participants in this trial may receive, can help lower anger in Veterans with PTSD. MARI uses a mobile app to help people view situations differently, aiming to reduce angry reactions. One study found that veterans using similar mobile tools experienced significant decreases in anger and PTSD symptoms. This suggests that MARI, by employing these proven methods, may effectively reduce anger and improve daily life for those dealing with PTSD-related anger issues. ^{1 2 3 5 6}

Who Is on the Research Team?

Kirsten H Dillon, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Are You a Good Fit for This Trial?

This trial is for Veterans with PTSD who struggle with anger. They must have a certain score on the PTSD Checklist and Anger Reactions Scale, stable psychiatric meds for 3 months, and be able to read at a 6th-grade level or higher. Those in active psychosis or mania, with urgent suicidal thoughts, previous MARI use, or undergoing other specific therapies are excluded.

Inclusion Criteria

You have reported a score of 12 or higher on the 5-item Dimensions of Anger Reactions Scale.

My psychiatric medication type and dose have been stable for 3 months, with no changes planned.

You are a veteran with PTSD, confirmed via medical records and scoring 33 or higher on the PCL-5.

Exclusion Criteria

Have used the MARI application before as part of another research study

Currently in a period of active psychosis or mania

Exhibit current prominent suicidal or homicidal ideation requiring immediate intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the MARI or HED mobile application for a period of 4 weeks

4 weeks

Follow-up

Participants are monitored for anger outcomes and functional improvements at post-treatment, 3-months, and 6-months post treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Health Education Condition (HED)
• Mobile Anger Reduction Intervention (MARI)

Trial Overview The study compares two mobile interventions: MARI aims to reduce anger in Veterans with PTSD versus HED which provides health education. Participants will randomly receive one of these treatments to see if MARI leads to better control of anger and improved daily functioning.

How Is the Trial Designed?

Group I: Mobile Anger Reduction Intervention (MARI) Experimental Treatment 1 Intervention

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.

Group II: Health Education Condition (HED) Active Control 1 Intervention

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.

Health Education Condition (HED) is already approved in United States for the following indications:

Approved in United States as Health Education Condition (HED) for:

• Posttraumatic Stress Disorder (PTSD) related anger management

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A four-week education program significantly improved the knowledge, skills, and attitudes (KSAs) of 18 Pacific Island participants working in mental health care, as measured by the Nurse Self Report (NSR) questionnaire.

The program utilized diverse teaching methods, including lectures, tutorials, and simulations, demonstrating that such educational interventions can effectively enhance mental health care delivery in specific communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An educational program for mental health nurses and community health workers from pacific island countries: results from a pilot study. Usher, K., Park, T., Trueman, S., et al.[2021]

The 'PTSD Coach' intervention, available as both a web-based and mobile application, is feasible and generally well-accepted among trauma-exposed individuals, with high satisfaction reported in most studies.

However, the effectiveness of the 'PTSD Coach' in significantly reducing posttraumatic stress symptoms (PTSS) remains unclear, as the pooled effect size was not statistically significant, indicating a need for further research, especially in low-middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and effectiveness of web-based and mobile PTSD Coach: a systematic review and meta-analysis. Bröcker, E., Suliman, S., Olff, M., et al.[2023]

A study involving 47 rural U.S. veterans, predominantly from ethnic/racial minority backgrounds, found that delivering Cognitive Processing Therapy for PTSD via home telemental health was feasible and well-received, with positive ratings on comfort, satisfaction, and usability.

Most veterans were open to receiving mental health services at home, and after treatment, they felt there was sufficient therapist contact, although a small percentage (7%) expressed concerns about technical issues or privacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diverse veterans' pre- and post-intervention perceptions of home telemental health for posttraumatic stress disorder delivered via tablet. Whealin, JM., King, L., Shore, P., et al.[2022]

A culturally tailored health promotion program for Cambodian survivors of torture significantly improved health status, lifestyle activities, sleep, and depression among 126 participants over five sessions from 2007 to 2011.

Participants reported increased confidence in communicating with their healthcare providers, suggesting that culturally relevant education can enhance both health and mental health behaviors in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An innovative model of culturally tailored health promotion groups for Cambodian survivors of torture. Berkson, SY., Tor, S., Mollica, R., et al.[2022]

The beta test of the Mind Guide mobile health app, involving 16 post-9/11 veterans with PTSD and alcohol use disorder, showed significant reductions in PTSD symptoms and alcohol-related issues, indicating its potential efficacy as an intervention.

The app demonstrated promising effects on related factors such as craving, perceived stress, and emotion regulation, suggesting that mindfulness-based techniques may help veterans manage their conditions effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a mobile mindfulness smartphone app for post-traumatic stress disorder and alcohol use problems for veterans: Beta test results and study protocol for a pilot randomized controlled trial. Davis, JP., Pedersen, ER., Borsari, B., et al.[2023]

A recovery education program significantly improved rehabilitation motivation and functional scores in 27 patients with schizophrenia after a 7-week intervention, compared to a control group.

The study suggests that implementing recovery education can be an effective rehabilitation strategy for enhancing motivation and function in individuals with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effects of a recovery education program on rehabilitation motivation, symptoms, and function for schizophrenic patients]. Kim, YY., Park, HS., Park, KM.[2019]

A three-week educational program for schizophrenic patients significantly increased their knowledge about schizophrenia and its treatment, indicating that patients can learn and retain important information about their condition.

The educational program also led to a significant decrease in negative symptoms of schizophrenia, suggesting that education can improve functioning in severely psychiatrically ill patients, although it did not affect positive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a patient education program in the treatment of schizophrenia. Goldman, CR., Quinn, FL.[2019]

The Mental Health First Aid (MHFA) training significantly improved participants' confidence in helping individuals with mental health issues, with notable increases in their ability to make contact, talk to, and provide help, as measured at a 6-month follow-up.

Participants also showed enhanced knowledge and recognition of mental illnesses, particularly schizophrenia, indicating that MHFA training is effective in increasing awareness and understanding of mental health in a Danish context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mental Health First Aid training in Denmark: a randomized trial in waitlist design. Jensen, KB., Morthorst, BR., Vendsborg, PB., et al.[2022]

In a pilot study involving 29 participants with elevated PTSD symptoms, the combination of the PTSD Coach mobile application and brief telephone support from paraprofessionals led to significant improvements in PTSD symptoms, depressive symptoms, and overall quality of life over a 4-month period.

More than 70% of participants continued using the PTSD Coach app throughout the 3-month intervention, suggesting that the added telephone support may enhance user engagement and effectiveness of the mobile application in managing psychiatric symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PTSD coach mobile application with brief telephone support: A pilot study. Tiet, QQ., Duong, H., Davis, L., et al.[2019]

A simple educational intervention for 114 schizophrenic patients at risk of relapse did not improve overall outcomes, despite some improvements in insight and treatment attitudes.

The intervention was associated with an increase in suicidal ideation, highlighting that enhancing patient insight may have unintended negative effects, and suggesting that overly simplified psychoeducational approaches may not effectively prevent relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled trial of a brief interventional package for schizophrenic out-patients. Cunningham Owens, DG., Carroll, A., Fattah, S., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37166919/

Development and refinement of the mobile anger reduction ... This study demonstrates the utility of a successive cohort treatment design for the development of mobile interventions.

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/28/NCT03733028/Prot_SAP_000.pdf

Mobile Intervention for Veterans With PTSD and Anger Background and Significance. Difficulty controlling anger is the most commonly reported reintegration concern among combat Veterans (Sayer et al., 2010).

3. ctv.veeva.com ctv.veeva.com/study/randomized-clinical-trial-of-mari

Mobile Anger Reduction Intervention (MARI) A mobile application that uses evidence-based interpretation bias modification techniques to reduce hostile interpretation bias and anger ...

4. grantome.com grantome.com/grant/NIH/IK2-RX002965-03

Developing a Mobile Intervention for Veterans with ... The goal of this project is to further develop this intervention for Veterans with PTSD, using mHealth technology to increase the portability of this promising ...

5. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id49343.pdf

Using a mobile application in the treatment of dysregulated ... Data Analysis. This study investigated whether veterans who received AMT +. RELAX demonstrated significantly larger reductions in anger and PTSD symptoms ...

6. app.trialscreen.org app.trialscreen.org/trials/randomized-clinical-mari-trial-nct06094933

Mobile Anger Reduction Intervention Participants in the MARI app group may experience reductions in anger and hostile interpretations, as well as improvements in psychosocial functioning and ...