MARI의 무작위 임상시험 (MARI)
재향 군인을 위한 이동식 분노 감소 중재에 대한 무작위 대조 시험
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Kirsten H Dillon, PhD
- 전화번호: (919) 286-0411
- 이메일: Kirsten.Dillon@va.gov
연구 연락처 백업
- 이름: Angela C Kirby, MS
- 전화번호: 7456 (919) 286-0411
- 이메일: angela.kirby@va.gov
연구 장소
-
-
North Carolina
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Durham, North Carolina, 미국, 27705-3875
- 모병
- Durham VA Medical Center, Durham, NC
-
연락하다:
- Kirsten H Dillon, PhD
- 전화번호: (919) 286-0411
- 이메일: Kirsten.Dillon@va.gov
-
수석 연구원:
- Kirsten H Dillon, PhD
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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. |
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. |
|
활성 비교기: 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. |
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
number of participants below the clinical cut off for problematic anger
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
number of participants with decreased psychosocial impairment scores
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Kirsten H Dillon, PhD, Durham VA Medical Center, Durham, NC
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- D4561-R
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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