MARI for PTSD
(MARI Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Active psychosis, Suicidal ideation, Others
No Placebo Group
Trial Summary
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.
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.
12345How 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.
678910Eligibility 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.
+1 more
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
+1 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Mobile Anger Reduction Intervention (MARI)Experimental Treatment1 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 Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Durham VA Medical Center, Durham, NCDurham, NC
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Effectiveness of Mental Health First Aid training in Denmark: a randomized trial in waitlist design. [2022]To examine the effect of the Australian educational intervention Mental Health First Aid (MHFA) in a Danish context. Primary outcome was improvement concerning confidence in help-giving behavior towards people suffering from mental illness. Secondary outcomes were increased knowledge and ability to recognize mental illness and improved positive attitudes towards people suffering from mental health problems.
A randomized, controlled trial of a brief interventional package for schizophrenic out-patients. [2019]To evaluate the impact on outcome of a simple educational intervention in schizophrenic patients at risk of relapse.
An educational program for mental health nurses and community health workers from pacific island countries: results from a pilot study. [2021]Delivery of mental health care relies upon professionals with the latest evidence upon which to base their care. This research reports on a pre-test/post-test evaluation of a four-week education program delivered to Pacific Island participants (n = 18) to enhance knowledge, skills, and attitudes (KSAs). The education program used a combination of formal lectures, tutorials, clinical visits, simulations, and laboratory sessions. The measure used was the Nurse Self Report (NSR) questionnaire. Results indicate an education intervention can be an effective tool for improving the knowledge, skills, and attitudes of Pacific Island people who care for persons experiencing mental health problems.
Effects of a patient education program in the treatment of schizophrenia. [2019]Two groups of schizophrenic patients were compared to determine the effects of educating patients about schizophrenia and its treatment. One group completed a three-week educational program while the other was involved in the usual ward activities. Comparison of the groups' pretest and posttest scores on three instruments (the Experiential World Inventory, the Scale for the Assessment of Negative Symptoms, and the Knowledge of Illness and Resources Inventory) revealed the experimental group had a significant increase in knowledge of the illness and a significant decrease in the negative symptoms of schizophrenia. No significant difference was found between the groups in change in the positive symptoms of schizophrenia. The results suggest that severely psychiatrically ill patients can learn and retain information and that educating chronic patients about their illness can help improve their functioning.
[The effects of a recovery education program on rehabilitation motivation, symptoms, and function for schizophrenic patients]. [2019]This study investigated the effects of a recovery education program on rehabilitation motivation, symptoms, and function for schizophrenic patients.
Feasibility, acceptability, and effectiveness of web-based and mobile PTSD Coach: a systematic review and meta-analysis. [2023]Background: Timely and effective interventions can alleviate or prevent the development of clinical symptomatology in trauma-exposed individuals. However, due to limited access to these interventions, and/or stigma around accessing mental health services, there is an unmet need. Internet-and mobile-based interventions may help to address this need.Aims: This review aims to (i) synthesise the evidence on feasibility, acceptability, and effectiveness of the 'PTSD Coach' intervention (both web-based and mobile applications) in trauma-exposed individuals; (ii) evaluate the quality of this research; and (iii) identify challenges and recommendations related to 'PTSD Coach' intervention delivery.Method: Systematic database searches were conducted (PubMed/MEDLINE, PsycINFO, EMBASE, PLoS, Web of Science, PTSDpubs, Scopus, and clinical trial databases). Review inclusion was based on predefined inclusion criteria, and study quality was assessed with the mixed methods appraisal and the risk-of-bias tools for randomised trials. Where feasible, meta-analytical pooling of intervention effects on posttraumatic stress symptoms (PTSS) was conducted.Results: Seventeen manuscripts reporting on 16 primary studies were included with the majority evaluating a self-managed PTSD Coach mobile application intervention. Most studies were conducted in higher-income countries and females were over-represented. For both platforms, satisfaction and perceived helpfulness were generally high but type of smart device operating system was identified as an influence. The pooled effect size in symptom severity in the intervention group compared to the comparison group was not significant (standardised mean difference =  - 0.19) (95% CI - 0.41 to - 0.03, p = .09). Heterogeneity was not significant (p = .14; I2 = 40%). No study was excluded based on quality assessment.Conclusion: Findings support the feasibility and acceptability of 'PTSD Coach' in trauma-exposed individuals. However, evidence on the effectiveness on PTSS remains limited. More research is still needed in low-middle-income countries, particularly those in which supported 'PTSD Coach' interventions are evaluated in larger and more diverse samples.
PTSD coach mobile application with brief telephone support: A pilot study. [2019]The number of health care mobile applications (MAs) has increased drastically in recent years, but research on efficacy and approaches to provide MA intervention is lacking. The PTSD Coach was designed to help individuals with posttraumatic stress disorder (PTSD) symptoms to understand and manage symptoms. Use of MA tends to drop off quickly; this pilot study tested the use of the PTSD Coach with brief telephone support by paraprofessionals. A total of 29 participants with elevated PTSD symptoms recruited from Veterans Affairs primary care clinics completed baseline and 4-month follow-up surveys including the PTSD Checklist, Patient Health Questionnaire for depressive symptoms, and Quality of Life Enjoyment and Satisfaction Questionnaire. Participants received PTSD Coach MA intervention plus paraprofessional brief telephone support reported the phone support was helpful and greater than 70% of participants maintained use of the MA throughout the 3-month intervention period. Results indicated that participants showed significant improvement on PTSD reexperiencing symptoms, depressive symptoms, and quality of life after intervention. The PTSD Coach MA plus brief telephone support is a promising approach for primary care patients managing psychiatric symptoms. (PsycINFO Database Record (c) 2019 APA, all rights reserved).
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]Post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) are highly prevalent, and co-occurring among post-9/11 veterans. Mobile health (mHealth) applications, specifically those focused on mindfulness-based techniques, may be an effective avenue to intervene with veterans who cannot or will not seek care at traditional in-person settings. Thus, to address areas of improvement in mHealth for veterans, we developed Mind Guide and prepared it for testing in a pilot randomized controlled trial (RCT) with veterans.
Diverse veterans' pre- and post-intervention perceptions of home telemental health for posttraumatic stress disorder delivered via tablet. [2022]Objectives Home telemental health services have the potential to overcome many individual and systemic barriers to care facing military veterans with posttraumatic stress disorder. However, little is known about the home telemental health-related attitudes and experiences of highly underserved rural or ethnically, racially diverse veterans. This study evaluated whether ethnically/racially diverse U.S. veterans residing in the rural Pacific Islands would find the delivery of evidence-based treatment for posttraumatic stress disorder via home telemental health tablet devices useful and helpful. Method Clinicians located in a central urban location delivered Cognitive Processing Therapy for posttraumatic stress disorder directly into patients' homes via a tablet device and secure WiFi connection. Pre- and post-treatment measures were collected from a clinical sample of 47 veterans (average age: 49.3 years). Most (74.4%) self-identified as being of ethnic/racial minority background. Attitudinal, satisfaction, and usability scales were collected from home telemental health engaging ( n = 29) and non-engaging ( n = 18) veterans. Results Ratings on measures of home telemental health comfort, satisfaction with care, and usability were uniformly positive. Veterans were equally open to receiving mental health services at home via home telemental health or in the clinic. In the case of services for a physical problem, however, veterans preferred in-clinic care. Following treatment, veterans' attitudinal scores increased on items such as "There is enough therapist contact in home telemental health interventions." However, a small portion of veterans (7%) reported having technical or privacy concerns. Conclusion The provision of evidence-based posttraumatic stress disorder treatment directly into the patients' homes proved feasible and was well received by the large majority of rural ethnically/racially diverse veterans.
An innovative model of culturally tailored health promotion groups for Cambodian survivors of torture. [2022]Cambodians living in the U.S.A. suffer from depression, posttraumatic stress disorder (PTSD), and chronic medical disease at rates far in excess of national averages. The Harvard Program in Refugee Trauma's Cambodian Health Promotion Program seeks to address this burden of disease by offering them culturally tailored health education in a group setting. A health professional and a bicultural health educator co-facilitated a five-session health promotion group for Cambodian survivors of torture from 2007 to 2011. The program covered five major topics from Western and Cambodian worldviews. They included the meaning of health promotion, nutrition, exercise, stress management and sleep hygiene, and health practitioner-patient communication. The bicultural worker administered Pre and Post semi-structured Health Promotion Questionnaires. The data presented here are the results from 126 participants. Changes between the Pre and Post health promotion groups demonstrated significant improvements in health status, lifestyle activities, sleep, and depression. Participants revealed greater confidence in communicating with their primary health care practitioner. Culturally tailored Cambodian health promotion education administered in a small group setting may improve health and mental health behaviors. Culturally tailored health promotion education in a small group setting may promote healing in survivors of torture. It is an intervention worthy of further research and development.