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Behavioral Intervention
MARI for PTSD (MARI Trial)
N/A
Recruiting
Led By Kirsten H Dillon, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 6-month follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at how a mobile anger intervention can help Veterans with PTSD manage their anger and improve their functioning.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves psychological interventions rather than medications, traditional side effects are not expected. However, participants may experience discomfort discussing personal experiences related to trauma and anger during the intervention.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My psychiatric medication type and dose have been stable for 3 months, with no changes planned.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 6-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 6-month follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
number of participants below the clinical cut off for problematic anger
number of participants with decreased hostile interpretation bias scores
Secondary study objectives
number of participants with decreased psychosocial impairment scores
number of participants with improved quality of life
number of participants with reduced suicidal ideation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,716 Total Patients Enrolled
Kirsten H Dillon, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
3 Previous Clinical Trials
96 Total Patients Enrolled