Anger, Mild Traumatic Brain Injury (mTBI), Traumatic Brain Injury
Conditions
Keywords
Traumatic Brain Injury, Anger
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
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 (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 \[UCLA-3\]).
Interventions
BEHAVIORALMan 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.
Sponsors
University of Colorado, Denver
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State Anger (S-Anger) Subscale as Measured by State-Trait Anger Expression Inventory-2 (STAXI-2) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD symptoms (PTSD Checklist for DSM-5 [PCL-5]) | 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. |
| Suicidal Ideation (UCLA Loneliness 3-Item Questionnaire [UCLA-3]) | 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. |
| Poor Interpersonal Functioning (UCLA Loneliness 3-Item Questionnaire [UCLA-3]) | 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. |
Countries
United States
Contacts
CONTACTDr. Ian Stanley PhD
CONTACTJulia Finn, MPH
PRINCIPAL_INVESTIGATORIan Stanley, PhD
University of Colorado Anschutz School of Medicine
Outcome results
None listed