Examining the Efficacy of the Man Therapy Platform in Reducing Problematic Anger Among Military Service Members With and Without a TBI History
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Man Therapy.
- Who it may be relevant to
- Registry conditions: Mild Traumatic Brain Injury (mTBI), Traumatic Brain Injury, Anger. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Detailed description
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 \[INQ-15\]).
Interventions
- Behavioral 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
Primary outcome measures
- State Anger (S-Anger) Subscale as Measured by State-Trait Anger Expression Inventory-2 (STAXI-2) [Time frame: From enrollment to the completion of a 3-month follow-up assessment.]
Secondary outcome measures (3)
- PTSD symptoms (PTSD Checklist for DSM-5 [PCL-5]) [Time frame: From enrollment to the completion of the 3-month follow-up assessment.]
- Suicidal Ideation (Depressive Symptom Index-Suicidal Ideation [DSI-SS]) [Time frame: From enrollment to the completion of the 3-month follow-up assessment.]
- Poor Interpersonal Functioning (Interpersonal Needs Questionnaire-15 [INQ-15]) [Time frame: From enrollment to the completion of a 3-month follow-up assessment.]
Eligibility criteria
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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Fort Carson — Colorado Springs
Identifiers
NCT: NCT07604701 · 25-1301 · HT9425-25-1-0484