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

15 septembre 2026 mis à jour par: University of Colorado, Denver

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

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

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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 (Brief Suicide Cognitions Scale [B-SCS]), and (c) poor interpersonal functioning (UCLA Loneliness 3-Item Questionnaire [UCLA-3]).

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 (Brief Suicide Cognitions Scale [B-SCS]), and poorer interpersonal functioning (UCLA Loneliness 3-Item Questionnaire [UCLA-3]).

Type d'étude

Interventionnel

Inscription (Estimé)

226

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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
  • Currently located in the U.S.

Exclusion Criteria:

  • 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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 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.
Aucune 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
State Anger (S-Anger) Subscale as Measured by State-Trait Anger Expression Inventory-2 (STAXI-2)
Délai: From enrollment to the completion of a 3-month follow-up assessment.
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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
PTSD symptoms (PTSD Checklist for DSM-5 [PCL-5])
Délai: From enrollment to the completion of the 3-month follow-up assessment.
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.
From enrollment to the completion of the 3-month follow-up assessment.
Suicidal Ideation (UCLA Loneliness 3-Item Questionnaire [UCLA-3])
Délai: From enrollment to the completion of the 3-month follow-up assessment.
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.
From enrollment to the completion of the 3-month follow-up assessment.
Poor Interpersonal Functioning (UCLA Loneliness 3-Item Questionnaire [UCLA-3])
Délai: From enrollment to the completion of a 3-month follow-up assessment.
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.
From enrollment to the completion of a 3-month follow-up assessment.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Colorado, Denver

Collaborateurs

United States Department of Defense

Les enquêteurs

  • Chercheur principal: Ian Stanley, PhD, University of Colorado Anschutz School of Medicine

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 septembre 2026

Achèvement primaire (Estimé)

30 novembre 2028

Achèvement de l'étude (Estimé)

1 décembre 2028

Dates d'inscription aux études

Première soumission

13 mai 2026

Première soumission répondant aux critères de contrôle qualité

19 mai 2026

Première publication (Réel)

22 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 25-1301
  • HT9425-25-1-0484 (Autre subvention/numéro de financement: Department of Defense)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

This trial involves sensitive participant information, including information regarding problematic anger, PTSD, and TBI and requires careful handling to prevent any negative impact on participants or their families.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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