Mobile Anger Reduction Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorVA Office of Research and Development
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Mobile Anger Reduction Intervention (MARI)
BehavioralThis 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)
BehavioralThis 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Mobile Anger Reduction Intervention (MARI)Experimental treatment 1 intervention
Group B: Health Education Condition (HED)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Post-treatment (approx. one month after baseline assessment)2
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.
Time frame
6-month follow-up3
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.
Time frame
3-month follow-up4
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.
Time frame
from baseline to post-treatment assessments (approx. one month after baseline assessment)Secondary outcomes
1
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.
Time frame
from baseline to post-treatment assessments (approx. one month after baseline assessment)2
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.
Time frame
from baseline to 3-month follow-up3
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.
Time frame
from baseline to 6-month follow-up4
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.
Time frame
from baseline to post-treatment assessments (approx. one month after baseline assessment)Sponsors and contacts
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Source ClinicalTrials.gov