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Ensaio clínico randomizado de MARI (MARI)

15 de setembro de 2026 atualizado por: VA Office of Research and Development

Um ensaio randomizado controlado da intervenção móvel para redução da raiva para veteranos

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

150

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

  • Nome: Angela C Kirby, MS
  • Número de telefone: 7456 (919) 286-0411
  • E-mail: angela.kirby@va.gov

Locais de estudo

  • Estados Unidos
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27705-3875
        • Recrutamento
        • Durham VA Medical Center, Durham, NC
        • Contato:
        • Investigador principal:
          • Kirsten H Dillon, PhD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: 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.
Comparador Ativo: 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.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
number of participants below the clinical cut off for problematic anger
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
number of participants with decreased psychosocial impairment scores
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

VA Office of Research and Development

Investigadores

  • Investigador principal: Kirsten H Dillon, PhD, Durham VA Medical Center, Durham, NC

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

12 de novembro de 2024

Conclusão Primária (Estimado)

30 de outubro de 2027

Conclusão do estudo (Estimado)

31 de março de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

16 de outubro de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de outubro de 2023

Primeira postagem (Real)

23 de outubro de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • D4561-R

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

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