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Randomizowane badanie kliniczne MARI (MARI)

15 września 2026 zaktualizowane przez: VA Office of Research and Development

Randomizowana, kontrolowana próba mobilnej interwencji ograniczającej złość dla weteranów

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

150

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • North Carolina
      • Durham, North Carolina, Stany Zjednoczone, 27705-3875
        • Rekrutacyjny
        • Durham VA Medical Center, Durham, NC
        • Kontakt:
        • Główny śledczy:
          • Kirsten H Dillon, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Aktywny 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
number of participants below the clinical cut off for problematic anger
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
number of participants with decreased psychosocial impairment scores
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

VA Office of Research and Development

Śledczy

  • Główny śledczy: Kirsten H Dillon, PhD, Durham VA Medical Center, Durham, NC

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

12 listopada 2024

Zakończenie podstawowe (Szacowany)

30 października 2027

Ukończenie studiów (Szacowany)

31 marca 2028

Daty rejestracji na studia

Pierwszy przesłany

16 października 2023

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 października 2023

Pierwszy wysłany (Rzeczywisty)

23 października 2023

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • D4561-R

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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