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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Colorado, Denver

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Military service member

Identify as male

Aged 18+ years

Positive problematic anger screen (DAR-3 >8)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

226 Participants
are divided into 2 treatment groups
Group A: Man TherapyExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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

The PCL-5 is a 20-item self-report measure of PTSD symptoms per DSM-5 diagnostic criteria. Participants rate how much they have been bothered by each symptom over the past month, using a 5-point scale (0 =Not at all, 1 = A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely). Responses are summed to generate a total score and symptom cluster scores corresponding to DSM-5 diagnostic criteria (i.e., intrusions, avoidance, negative alterations in cognitions and mood, hyperarousal); higher scores reflect more severe PTSD symptomatology.

Time frame
From enrollment to the completion of the 3-month follow-up assessment.
2

Suicidal Ideation (UCLA Loneliness 3-Item Questionnaire [UCLA-3])

The B-SCS is a 6-item measure of suicide related cognitions. Items include: "I am completely unworthy of love," "Nothing can help solve my problems," "I can't cope with my problems any longer," Participants rate each item on a 5-point scale ranging from 1 to 5 (1 = Strongly Disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, 5 = Strongly Agree). Items are summed to generate a total score ranging from 6 to 30, with higher scores indicating more suicide related cognitions. The B-SCS demonstrated strong psychometric properties including excellent internal consistency reliability and validity.

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

Poor Interpersonal Functioning (UCLA Loneliness 3-Item Questionnaire [UCLA-3])

The UCLA-3 is a 3-item self-report measure of loneliness. Participants rate how often the feel a lack of companionship, left out, and isolated from others, using a 3-point scale (1 = Hardly Ever, 2 = Some of the time, 3 = Often). Responses are summed together with higher scores corresponding with more severe loneliness. The UCLA demonstrated strong internal consistencies, reliability, and validity.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

United States Department of Defense

Collaborator