此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Examining the Efficacy of the Man Therapy Platform in Reducing Problematic Anger Among Military Service Members With and Without a TBI History

2026年9月15日 更新者:University of Colorado, Denver

Examining the Efficacy of the Man Therapy Platform in Reducing Problematic Anger Among Military Service Members With and Without a TBI History: A Randomized Controlled Trial

The goal of this randomized controlled trial is to determine if an interactive digital solution, Man Therapy, reduces indices of problematic anger in male military service members who screen positive for problematic anger.

The man questions this study aims to answer are:

  • Does Man Therapy reduce indices of problematic anger?
  • Does Man Therapy reduce psychosocial correlates of anger?

Researchers will also examine if the effects of those aims differ based on a participant's history of a mild TBI, the mechanism of a primary mild TBI, and/or the number of mild TBIs.

Researchers will compare Man Therapy to a waitlist control. This will help determine if Man Therapy works better than no treatment.

Participants will:

  • Complete a baseline survey
  • Be randomized to intervention or waitlist control
  • If randomized to intervention, participants will receive the intervention and complete a survey immediately after the intervention and at 1-, and 3-months following the intervention
  • If randomized to waitlist control, participants complete surveys at 1-, and 3-months and have the opportunity to complete the intervention following the 3-month survey

研究概览

详细说明

Problematic anger is highly prevalent among military service members. Among service members, problematic anger prospectively predicts suicidal ideation, even after controlling for other psychiatric disorders. Existing approaches designed to reduce anger have not been shown to satisfactorily impact clinical outcomes across populations, and among service members receiving treatment for PTSD, anger is one of the few symptoms that persists even if a PTSD diagnosis subsides. Thus, there is a need to adapt existing problematic anger treatments for service members.

Man Therapy is an interactive digital solution that uses humor and straightforward language to circumvent traditional barriers to accessing mental health care. The aim of this study will evaluate the efficacy of the Man Therapy platform compared to waitlist control in reducing indices of problematic anger among male military service members with problematic anger. Participants will be randomized following the pre-intervention assessment. Participants randomized to receive Man Therapy will view the interactive digital solution in a single session. Assessments will occur pre-intervention, post-intervention, and at 1- and 3-month follow-ups. Waitlist controls will receive the intervention after the 3-month follow-up. The goal is to reduce indices of problematic anger and psychosocial correlates of anger.

Aim 1: To evaluate the efficacy of Man Therapy relative to waitlist controls in reducing indices of problematic anger among male military SMs who present with problematic anger (N = 226).

Hypothesis 1: Compared with waitlist controls at 1- and 3-month follow-ups, Man Therapy will result in lower levels of anger, as measured by the State-Trait Anger Expression Inventory-2 (STAXI-2) subscale of "State Anger (S-Anger)."

Objective 2: To evaluate the efficacy of Man Therapy relative to waitlist controls in reducing psychosocial correlates of anger (e.g., suicidal ideation, PTSD symptoms, poor interpersonal functioning) among male military SMs with problematic anger.

Hypothesis 2: Compared with waitlist control at 1- and 3-month follow-ups, Man Therapy will result in lower levels of (a) PTSD symptoms (PTSD Checklist for DSM-5 [PCL-5]), (b) suicidal ideation (Brief Suicide Cognitions Scale [B-SCS]), and (c) poor interpersonal functioning (UCLA Loneliness 3-Item Questionnaire [UCLA-3]).

Objective 3: To examine if the effects in Objectives 2 and 3 differ based on a participant's history of a mild TBI, the mechanism of primary mild TBI, and/or the number of mild TBIs.

Hypothesis 3: Compared with those without TBI, those with history of TBI will have higher levels of anger, as measured by the State-Trait Anger Expression Inventory-2 (STAXI-2), higher levels of PTSD symptoms (PTSD Checklist for DSM-5 [PCL-5]), more severe suicidal ideation (Brief Suicide Cognitions Scale [B-SCS]), and poorer interpersonal functioning (UCLA Loneliness 3-Item Questionnaire [UCLA-3]).

研究类型

介入性

注册 (估计的)

226

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Military service member
  • Identify as male
  • Aged 18+ years
  • Positive problematic anger screen (DAR-3 >8)
  • Ability to read, write, and speak English
  • Currently located in the U.S.

Exclusion Criteria:

  • Active psychosis or acute mania necessitating clinical intervention
  • Acute thoughts of self- or other-harm necessitating imminent clinical intervention (e.g., hospitalization)
  • Expect to be deployed outside of the continental United States in the next 3 months
  • Unable to provide informed consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Man Therapy

Behavioral: Man Therapy

Participants randomized to this arm will be offered Man Therapy, which is an interactive digital solution designed to reduce problematic anger.

Man Therapy is an interactive digital solution that uses humor and straightforward language to circumvent traditional barriers to accessing mental health care, such as stigma. A core Man Therapy module focuses on anger, helping recipients to understand its causes and associated mitigating and potentiating factors, as well as teaching recipients accessible, easy-to-implement anger mitigation strategies, such as cognitive retraining and paced breathing. Participants will be given a list of content regarding anger to view and interact with in the Man Therapy website and encourages to explore the website further. They will then review and interact with materials for at least 20 minutes and up to 45 minutes in a single session.
无干预:Waitlist Control

Waitlist Control:

Waitlist controls will be offered Man Therapy after the 3-month follow-up assessment. Using a waitlist control facilitates a comparison between the immediate effects of the Man Therapy intervention on problematic anger and co-occurring conditions and the natural progression of the conditions without intervention, as well as providing the control group with access to the intervention.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
State Anger (S-Anger) Subscale as Measured by State-Trait Anger Expression Inventory-2 (STAXI-2)
大体时间:From enrollment to the completion of a 3-month follow-up assessment.
The STAXI-2 is a 57-item self-report measure of various dimensions of problematic anger. The STAXI-2 can generate scores on the following six subscales: state anger (S-Anger), trait anger (T-Anger), anger expression-out (AX-O), anger expression-in (AX-I), anger control-out (AC-O), and anger control-in (AC-I). Respondents rate each item on a 4-point scale from "almost never" to "almost always." Scores are summed within each subscale and higher scores represent more problematic anger.
From enrollment to the completion of a 3-month follow-up assessment.

次要结果测量

结果测量
措施说明
大体时间
PTSD symptoms (PTSD Checklist for DSM-5 [PCL-5])
大体时间:From enrollment to the completion of the 3-month follow-up assessment.
The PCL-5 is a 20-item self-report measure of PTSD symptoms per DSM-5 diagnostic criteria. Participants rate how much they have been bothered by each symptom over the past month, using a 5-point scale (0 =Not at all, 1 = A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely). Responses are summed to generate a total score and symptom cluster scores corresponding to DSM-5 diagnostic criteria (i.e., intrusions, avoidance, negative alterations in cognitions and mood, hyperarousal); higher scores reflect more severe PTSD symptomatology.
From enrollment to the completion of the 3-month follow-up assessment.
Suicidal Ideation (UCLA Loneliness 3-Item Questionnaire [UCLA-3])
大体时间:From enrollment to the completion of the 3-month follow-up assessment.
The B-SCS is a 6-item measure of suicide related cognitions. Items include: "I am completely unworthy of love," "Nothing can help solve my problems," "I can't cope with my problems any longer," Participants rate each item on a 5-point scale ranging from 1 to 5 (1 = Strongly Disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, 5 = Strongly Agree). Items are summed to generate a total score ranging from 6 to 30, with higher scores indicating more suicide related cognitions. The B-SCS demonstrated strong psychometric properties including excellent internal consistency reliability and validity.
From enrollment to the completion of the 3-month follow-up assessment.
Poor Interpersonal Functioning (UCLA Loneliness 3-Item Questionnaire [UCLA-3])
大体时间:From enrollment to the completion of a 3-month follow-up assessment.
The UCLA-3 is a 3-item self-report measure of loneliness. Participants rate how often the feel a lack of companionship, left out, and isolated from others, using a 3-point scale (1 = Hardly Ever, 2 = Some of the time, 3 = Often). Responses are summed together with higher scores corresponding with more severe loneliness. The UCLA demonstrated strong internal consistencies, reliability, and validity.
From enrollment to the completion of a 3-month follow-up assessment.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ian Stanley, PhD、University of Colorado Anschutz School of Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月1日

初级完成 (估计的)

2028年11月30日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年5月13日

首先提交符合 QC 标准的

2026年5月19日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年9月16日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 25-1301
  • HT9425-25-1-0484 (其他赠款/资助编号:Department of Defense)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

This trial involves sensitive participant information, including information regarding problematic anger, PTSD, and TBI and requires careful handling to prevent any negative impact on participants or their families.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅