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| ID | Type | Description | Link |
|---|---|---|---|
| HT9425-25-1-0484 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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:
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:
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 (Depressive Symptom Index-Suicidal Ideation [DSI-SS]34), and (c) poor interpersonal functioning (Interpersonal Needs Questionnaire-15 [INQ-15]).
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 (Depressive Symptom Index-Suicidal Ideation [DSI-SS]), and poorer interpersonal functioning (Interpersonal Needs Questionnaire-15 [INQ-15]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ian Stanley PhD | Contact | 720-848-6777 | emed_ManTherapy@cuanschutz.edu | |
| Julia Finn, MPH | Contact | 720-848-6777 | emed_ManTherapy@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ian Stanley, PhD | University of Colorado Anschutz School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fort Carson | Colorado Springs | Colorado | 80913 | United States |
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.
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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.
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| From enrollment to the completion of the 3-month follow-up assessment. |
| Suicidal Ideation (Depressive Symptom Index-Suicidal Ideation [DSI-SS]) | The DSI-SS is a 4-item self-report measure of the severity of suicidal ideation occurring over the past 2 weeks. Respondents rate each item on a 4-point scale ranging from 0 to 3 (e.g., Item 1: 0 = I do not have thoughts of killing myself; 1 = Sometimes I have thoughts of killing myself; 2 = Most of the time I have thoughts of killing myself; 3 = I always have thoughts of killing myself). Responses are summed to generate a total score ranging from 0 to 12; higher scores indicate more severe suicidal ideation. | From enrollment to the completion of the 3-month follow-up assessment. |
| Poor Interpersonal Functioning (Interpersonal Needs Questionnaire-15 [INQ-15]) | The INQ-15 is a 15-item self-report measure of poor interpersonal functioning, including thwarted belongingness and perceived burdensomeness. These constructs, collectively assessing social disconnectedness, are proposed by the interpersonal theory of suicide to lead to the development of suicidal desire. Respondents rate each item (e.g., "These days, I rarely interact with people who care about me") on a 7-point scale ranging from 1 to 7 (e.g., 1 = Not at all true for me, 4 = Somewhat true for me, 7 = Very true for me). Scores are summed (range: 15-105) and higher scores indicate worse interpersonal functioning. | From enrollment to the completion of a 3-month follow-up assessment. |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
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