Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Randomiseret klinisk forsøg med MARI (MARI)

15. september 2026 opdateret af: VA Office of Research and Development

Et randomiseret kontrolleret forsøg med mobil vredesreduktionsintervention for veteraner

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Difficulty controlling anger is the most commonly reported reintegration concern among combat Veterans, especially those with a diagnosis of posttraumatic stress disorder (PTSD). In Veterans, problematic anger is associated with numerous negative psychosocial outcomes, including poor functional outcomes (both social and occupational), family discord, aggression, road rage, and suicide risk. Anger can also impede successful outcomes from PTSD treatment. Given the high prevalence of anger problems among Veterans with PTSD and the associated functional impairments, there is a clear need to develop innovative and effective anger interventions to improve functional outcomes. Use of mobile health (mHealth) technology could provide a low-cost method to increase the reach of anger management treatments to this high-need group of Veterans.

One of the mechanisms associated with problematic anger and aggression is hostile interpretation bias, i.e., a tendency to interpret ambiguous interpersonal situations as hostile. By reducing hostile interpretation bias, the investigators can reduce problematic anger and aggression and improve functional outcomes. A mobile application that uses evidence-based interpretation bias modification techniques to reduce hostile interpretation bias and anger outcomes has been developed and piloted. The goal of this project is to evaluate the efficacy of this mobile application among Veterans with PTSD.

A randomized controlled trial (RCT) will be conducted, in which 150 Veterans with PTSD and problematic anger will be randomized to either the Mobile Anger Reduction Intervention (MARI) or a health education condition (HED). The central hypothesis is that participants in the MARI condition will experience greater anger reductions and functional improvements relative to the HED condition.

The proposed research project will address the following Specific Aims: Aim 1: To evaluate the efficacy of MARI on anger outcomes (e.g., hostile interpretation bias, problematic anger) measured at post-treatment, 3-months, and 6-months post treatment; Aim 2: To evaluate the efficacy of MARI on functional improvements (i.e., psychosocial functioning, quality of life) and self-harm measured at post-treatment, 3-months, and 6-months post treatment; and Exploratory Aim: To explore whether changes in hostile interpretation bias (proposed treatment mechanism) mediate functional improvements.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27705-3875
        • Rekruttering
        • Durham VA Medical Center, Durham, NC
        • Kontakt:
        • Ledende efterforsker:
          • Kirsten H Dillon, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Mobile Anger Reduction Intervention (MARI)

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.
Adfærdsmæssigt: Mobile Anger Reduction Intervention (MARI)

This 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.
Aktiv komparator: Health Education Condition (HED)

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.
Adfærdsmæssigt: Health Education Condition (HED)

This 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
number of participants below the clinical cut off for problematic anger
Tidsramme: Post-treatment (approx. one month after baseline assessment)

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.
Post-treatment (approx. one month after baseline assessment)
number of participants below the clinical cut off for problematic anger
Tidsramme: 6-month follow-up

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.
6-month follow-up
number of participants below the clinical cut off for problematic anger
Tidsramme: 3-month follow-up

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.
3-month follow-up
number of participants with decreased hostile interpretation bias scores
Tidsramme: from baseline to post-treatment assessments (approx. one month after baseline assessment)

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.
from baseline to post-treatment assessments (approx. one month after baseline assessment)
number of participants with decreased hostile interpretation bias scores
Tidsramme: from baseline to 3-month follow-up

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.
from baseline to 3-month follow-up
number of participants with decreased hostile interpretation bias scores
Tidsramme: from baseline to 6-month follow-up

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.
from baseline to 6-month follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
number of participants with decreased psychosocial impairment scores
Tidsramme: from baseline to post-treatment assessments (approx. one month after baseline assessment)

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.
from baseline to post-treatment assessments (approx. one month after baseline assessment)
number of participants with decreased psychosocial impairment scores
Tidsramme: from baseline to 3-month follow-up

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.
from baseline to 3-month follow-up
number of participants with decreased psychosocial impairment scores
Tidsramme: from baseline to 6-month follow-up

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.
from baseline to 6-month follow-up
number of participants with improved quality of life
Tidsramme: from baseline to post-treatment assessments (approx. one month after baseline assessment)

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.
from baseline to post-treatment assessments (approx. one month after baseline assessment)
number of participants with improved quality of life
Tidsramme: from baseline to 3-month follow-up

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.
from baseline to 3-month follow-up
number of participants with improved quality of life
Tidsramme: from baseline to 6-month follow-up

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.
from baseline to 6-month follow-up
number of participants with reduced suicidal ideation
Tidsramme: from baseline to post-treatment assessments (approx. one month after baseline assessment)

Measured with the Columbia- Suicide Severity Rating Scale, suicidal ideation intensity rating. Scores range from 0-25, with higher scores indicating higher intensity of suicidal ideation. The investigators will count the number of participants in each group who have a decrease in their score within the time frame.
from baseline to post-treatment assessments (approx. one month after baseline assessment)
number of participants with reduced suicidal ideation
Tidsramme: from baseline to 3-month follow-up

Measured with the Columbia- Suicide Severity Rating Scale, suicidal ideation intensity rating. Scores range from 0-25, with higher scores indicating higher intensity of suicidal ideation. The investigators will count the number of participants in each group who have a decrease in their score within the time frame.
from baseline to 3-month follow-up
number of participants with reduced suicidal ideation
Tidsramme: from baseline to 6-month follow-up

Measured with the Columbia- Suicide Severity Rating Scale, suicidal ideation intensity rating. Scores range from 0-25, with higher scores indicating higher intensity of suicidal ideation. The investigators will count the number of participants in each group who have a decrease in their score within the time frame.
from baseline to 6-month follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

VA Office of Research and Development

Efterforskere

  • Ledende efterforsker: Kirsten H Dillon, PhD, Durham VA Medical Center, Durham, NC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. november 2024

Primær færdiggørelse (Anslået)

30. oktober 2027

Studieafslutning (Anslået)

31. marts 2028

Datoer for studieregistrering

Først indsendt

16. oktober 2023

Først indsendt, der opfyldte QC-kriterier

16. oktober 2023

Først opslået (Faktiske)

23. oktober 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D4561-R

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner