Examining the Efficacy of the Man Therapy Platform in Reducing Problematic Anger Among Military Service Members With and Without a TBI History
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Man Therapy.
- Кому может быть актуально
- Состояния в реестре: Mild Traumatic Brain Injury (mTBI), Traumatic Brain Injury, Anger. Базовые параметры: от 18 лет · Мужчины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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
Подробное описание
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 (Depressive Symptom Index-Suicidal Ideation \[DSI-SS\]34), and (c) poor interpersonal functioning (Interpersonal Needs Questionnaire-15 \[INQ-15\]).
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 (Depressive Symptom Index-Suicidal Ideation \[DSI-SS\]), and poorer interpersonal functioning (Interpersonal Needs Questionnaire-15 \[INQ-15\]).
Вмешательства
- Поведенческое Man Therapy
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
Первичные конечные точки
- State Anger (S-Anger) Subscale as Measured by State-Trait Anger Expression Inventory-2 (STAXI-2) [Срок оценки: From enrollment to the completion of a 3-month follow-up assessment.]
Вторичные конечные точки (3)
- PTSD symptoms (PTSD Checklist for DSM-5 [PCL-5]) [Срок оценки: From enrollment to the completion of the 3-month follow-up assessment.]
- Suicidal Ideation (Depressive Symptom Index-Suicidal Ideation [DSI-SS]) [Срок оценки: From enrollment to the completion of the 3-month follow-up assessment.]
- Poor Interpersonal Functioning (Interpersonal Needs Questionnaire-15 [INQ-15]) [Срок оценки: From enrollment to the completion of a 3-month follow-up assessment.]
Критерии участия
Критерии включения
- Military service member
- Identify as male
- Aged 18+ years
- Positive problematic anger screen (DAR-3 >8)
- Ability to read, write, and speak English
Критерии исключения
- Active psychosis or acute mania necessitating clinical intervention
- Acute thoughts of self- or other-harm necessitating imminent clinical intervention (e.g., hospitalization)
- Unable to provide informed consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Fort Carson — Colorado Springs
Идентификаторы
NCT: NCT07604701 · 25-1301 · HT9425-25-1-0484