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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 226
- 试验地点
- 2
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Man Therapy (Behavioral)
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.
结局指标
主要结局
未指定
次要结局
- Suicidal Ideation (UCLA Loneliness 3-Item Questionnaire [UCLA-3])(From enrollment to the completion of the 3-month follow-up assessment.)
- Poor Interpersonal Functioning (UCLA Loneliness 3-Item Questionnaire [UCLA-3])(From enrollment to the completion of a 3-month follow-up assessment.)