Mild Traumatic Brain Injury (mTBI)NCT07604701
Examining the Efficacy of the Man Therapy Platform in Reducing Problematic Anger Among Military Service Members With and Without a TBI History
A study testing Man Therapy in people with Mild Traumatic Brain Injury (mTBI) and Traumatic Brain Injury, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Mild Traumatic Brain Injury (mTBI), Traumatic Brain Injury, Anger
- What is being tested?
- Man Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fort Carson
Colorado Springs, Colorado, 80913
Julia Finn, MPH, 720-848-6777, emed_stanleylab@cuanschutz.edu
About this study
Official title: 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:
Read more
- 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
Read the 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]).
- Being tested
- Man Therapy
- Keywords
- Traumatic Brain Injury, Anger
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Man TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the completion of a 3-month follow-up assessment.
Secondary outcomes (3)
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.
Measured: From enrollment to the completion of the 3-month follow-up assessment.
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.
Measured: From enrollment to the completion of the 3-month follow-up assessment.
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.
Measured: From enrollment to the completion of a 3-month follow-up assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Sep 2026
- Primary completion30 Nov 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain Injury (mTBI)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Ian Stanley, PhD, Principal investigator, University of Colorado Anschutz School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604701
- Sponsor's protocol ID
- 25-1301
- Other IDs
- HT9425-25-1-0484
- Status last verified
- Sep 2026
- First submitted
- 13 May 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07604701
- Acronym / sponsor ID
- 25-1301
- Keywords
- Traumatic Brain Injury, Anger
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Man Therapy | Experimental | Behavioral: Man TherapyBehavioral: Man Therapy Participants randomized to this arm will be offered Man Therapy, which is an interactive digital solution designed to reduce problematic anger. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Military service member
- Identify as male
- Aged 18+ years
- Positive problematic anger screen (DAR-3 >8)
- Ability to read, write, and speak English
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Man TherapyMan 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. | Behavioural | Man Therapy |
Primary outcome
State Anger (S-Anger) Subscale as Measured by State-Trait Anger Expression Inventory-2 (STAXI-2)
Time frame: 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.
3 secondary outcomes
PTSD symptoms (PTSD Checklist for DSM-5 [PCL-5])
Time frame: From enrollment to the completion of the 3-month follow-up assessment.
Suicidal Ideation (UCLA Loneliness 3-Item Questionnaire [UCLA-3])
Time frame: From enrollment to the completion of the 3-month follow-up assessment.
Poor Interpersonal Functioning (UCLA Loneliness 3-Item Questionnaire [UCLA-3])
Time frame: From enrollment to the completion of a 3-month follow-up assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ian Stanley, PhD principal investigator
University of Colorado Anschutz School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Man Therapy in people with Mild Traumatic Brain Injury (mTBI) and Traumatic Brain Injury, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Ian Stanley PhD (720-848-6777, ManTherapy@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anger (S-Anger) Subscale as Measured by State-Trait Anger Expression Inventory-2 (STAXI-2) (time frame: From enrollment to the completion of a 3-month follow-up assessment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.