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

Part of paid clinical trials in Colorado Springs, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07604701
Status
Not Yet Recruiting

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Conditions

  • Anger
  • Mild Traumatic Brain Injury (mTBI)
  • Traumatic Brain Injury

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Man Therapy — BEHAVIORAL
    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.

Study Details

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

Key Dates

Start date
Sep 1, 2026
Status verified
May 2026
Primary completion
Nov 30, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
226 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • No Intervention: 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.

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fort CarsonColorado SpringsColorado80913
Julia Finn, MPH
720-848-6777

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