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

NCT07604701 | Not Yet Recruiting

• 2 other identifiers: 25-1301HT9425-25-1-0484
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Problematic Anger; Mild Traumatic Brain Injury (mTBI); Traumatic Brain Injury

Keywords

Problematic Anger; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• State Anger (S-Anger) Subscale as Measured by State-Trait Anger Expression Inventory-2 (STAXI-2)

  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.

Secondary Outcomes (3)

• PTSD symptoms (PTSD Checklist for DSM-5 [PCL-5])

  From enrollment to the completion of the 3-month follow-up assessment.

• Suicidal Ideation (Depressive Symptom Index-Suicidal Ideation [DSI-SS])

  From enrollment to the completion of the 3-month follow-up assessment.

• Poor Interpersonal Functioning (Interpersonal Needs Questionnaire-15 [INQ-15])

  From enrollment to the completion of a 3-month follow-up assessment.

Study Arms (2)

Man Therapy

EXPERIMENTAL

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

Behavioral: Man Therapy

Waitlist Control

NO INTERVENTION

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.

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.

Man Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Military service member
• Identify as male
• Aged 18+ years
• Positive problematic anger screen (DAR-3 \>8)
• Ability to read, write, and speak English

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• United States Department of Defense: collaborator

Study Sites (1)

Fort Carson

Colorado Springs, Colorado, 80913, United States

Location

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Ian Stanley, PhD

  University of Colorado Anschutz School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Ian Stanley PhD

CONTACT

720-848-6777; emed_ManTherapy@cuanschutz.edu

Julia Finn, MPH

CONTACT

720-848-6777; emed_ManTherapy@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants who meet the inclusion and exclusion criteria will be equally randomized between the Man Therapy Intervention condition and the Waitlist control condition. We will use computerized block randomization to allocate participants into either Man Therapy or Waitlist Control. Block randomization will vary by the number of participants in each block to ensure that the research staff cannot anticipate the next randomization, thereby reducing potential for bias. Biostatisticians will oversee randomization.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)