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

Trial Summary

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.

What data supports the effectiveness of the treatment MARI for PTSD?

The research on educational interventions for mental health, such as the Mental Health First Aid training and educational programs for schizophrenia, suggests that education can improve knowledge, skills, and attitudes towards mental health issues. This implies that the educational components of MARI might help individuals with PTSD by enhancing their understanding and management of their condition. ^{1 2 3 4 5}

How is the MARI treatment for PTSD different from other treatments?

The MARI treatment for PTSD is unique because it combines mobile technology with anger reduction techniques, making it accessible and potentially reducing stigma associated with seeking mental health services. This approach is different from traditional in-person therapies and may offer a more flexible and private option for individuals with PTSD. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Kirsten H Dillon, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of Mental Health First Aid training in Denmark: a randomized trial in waitlist design. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized, controlled trial of a brief interventional package for schizophrenic out-patients. [2019]

3. England 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of a patient education program in the treatment of schizophrenia. [2019]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and effectiveness of web-based and mobile PTSD Coach: a systematic review and meta-analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

PTSD coach mobile application with brief telephone support: A pilot study. [2019]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Diverse veterans' pre- and post-intervention perceptions of home telemental health for posttraumatic stress disorder delivered via tablet. [2022]

10. Denmark pubmed.ncbi.nlm.nih.gov

An innovative model of culturally tailored health promotion groups for Cambodian survivors of torture. [2022]