Crisis Response Planning in Military Personnel With Mild Traumatic Brain Injury

NCT ID: NCT07327567

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-12-31

Study Completion Date

2027-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study purpose is to test the effect of Crisis Response Planning (CRP) when used as the second method of suicide prevention in military service members who are at risk for suicide due to mild traumatic brain injury (mTBI). CRP will be compared to usual treatment. The treatment will be a 30 to 60 minute session to one person at a time either in-person or using telehealth.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objective of this randomized clinical trial is to evaluate the efficacy of Crisis Response Planning as a secondary suicide prevention intervention among military service members who are at elevated risk for suicide due to their history of a mild traumatic brain injury (mTBI). CRP will be compared to a general review of available crisis resources facilitated by a therapist.

Specific Aims:

Aim 1: Determine the effectiveness of Crisis Response Planning (CRP) versus Treatment as Usual (TAU) on impulsivity and cognitive-affective states among military personnel with a diagnosis of mTBI.

Aim 2: Understand associations between impulsivity and cognitive-affective states among military personnel with a diagnosis of mTBI.

Aim 3: Determine if mTBI features (e.g., loss of consciousness duration, total number of lifetime TBIs, injury type) influence treatment outcomes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Traumatic Brain Injury Suicide Prevention Suicide Risk | Patient Suicide Risk Suicide Risk Factor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-armed randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Because participants, interventionalists, and study staff cannot be blind to the behavioral therapies being delivered, only the independent evaluators will be blind to the treatment condition.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1: Crisis Response Planning (CRP)

One 30-60-minute session delivered individually using in-person or telehealth format by a trained behavioral health provider.

Group Type EXPERIMENTAL

Crisis Response Planning

Intervention Type BEHAVIORAL

The CRP intervention consists of a single 30-60-minute session. The CRP intervention includes a narrative assessment of the participant's most recent emotional crisis experience in order to understand and facilitate the participants understanding of their suicide mode.

Arm 2: Treatment as Usual (TAU)

Participants will receive the standard of care treatment as usual (TAU) from the Intrepid Spirit Center interdisciplinary treatment team that includes nurse practitioners, social workers, neurologists, and psychologists.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Crisis Response Planning

The CRP intervention consists of a single 30-60-minute session. The CRP intervention includes a narrative assessment of the participant's most recent emotional crisis experience in order to understand and facilitate the participants understanding of their suicide mode.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CRP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult male and female active duty military service members aged 18 or older.
* Diagnosis of at least one mTBI
* Ability to read, write, and speak English
* Owns and regularly uses an Apple iPhone or Android smartphone

Exclusion Criteria

* Active psychosis as determined by clinical assessment.
* Moderate or greater cognitive impairment as indicated by evaluation by the Intrepid Spirit Center clinical team.
* Completed a Crisis Response Plan within the past year.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hannah Tyler

Chief of Psychology, Strong Star

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hannah Tyler, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Carl R. Darnall Army Medical Center

Fort Hood, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hannah Tyler, PhD

Role: CONTACT

(254) 423-8830

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hannah Tyler, PhD

Role: primary

(254) 423-8830

Scot Engel, PsyD

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

Bryan CJ. A Preliminary Validation Study of Two Ultra-Brief Measures of Suicide Risk: The Suicide and Perceived Burdensomeness Visual Analog Scales. Suicide Life Threat Behav. 2019 Apr;49(2):343-352. doi: 10.1111/sltb.12447. Epub 2018 Mar 7.

Reference Type BACKGROUND
PMID: 29512832 (View on PubMed)

Di Benedetto M, Lindner H, Hare DL, Kent S. A Cardiac Depression Visual Analogue Scale for the brief and rapid assessment of depression following acute coronary syndromes. J Psychosom Res. 2005 Oct;59(4):223-9. doi: 10.1016/j.jpsychores.2005.06.070.

Reference Type BACKGROUND
PMID: 16223625 (View on PubMed)

Huang Z, Kohler IV, Kampfen F. A Single-Item Visual Analogue Scale (VAS) Measure for Assessing Depression Among College Students. Community Ment Health J. 2020 Feb;56(2):355-367. doi: 10.1007/s10597-019-00469-7. Epub 2019 Sep 17.

Reference Type BACKGROUND
PMID: 31531784 (View on PubMed)

Kertzman S, Aladjem Z, Milo R, Ben-Nahum Z, Birger M, Grinspan H, Weizman A, Kotler M. The utility of the Visual Analogue Scale for the assessment of depressive mood in cognitively impaired patients. Int J Geriatr Psychiatry. 2004 Aug;19(8):789-96. doi: 10.1002/gps.1141.

Reference Type BACKGROUND
PMID: 15290703 (View on PubMed)

Bryan CJ, David Rudd M, Wertenberger E, Etienne N, Ray-Sannerud BN, Morrow CE, Peterson AL, Young-McCaughon S. Improving the detection and prediction of suicidal behavior among military personnel by measuring suicidal beliefs: an evaluation of the Suicide Cognitions Scale. J Affect Disord. 2014 Apr;159:15-22. doi: 10.1016/j.jad.2014.02.021. Epub 2014 Feb 19.

Reference Type BACKGROUND
PMID: 24679384 (View on PubMed)

Nock MK, Holmberg EB, Photos VI, Michel BD. Self-Injurious Thoughts and Behaviors Interview: development, reliability, and validity in an adolescent sample. Psychol Assess. 2007 Sep;19(3):309-17. doi: 10.1037/1040-3590.19.3.309.

Reference Type BACKGROUND
PMID: 17845122 (View on PubMed)

Gratch I, Fernandes SN, Bell KA, Pollak OH, Fox KR, Tezanos K, Ebo T, Cha CB. Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R): Reliability, Validity, and Inter-Informant Agreement in an Adolescent Sample. J Clin Child Adolesc Psychol. 2022 Jul-Aug;51(4):484-494. doi: 10.1080/15374416.2021.1901229. Epub 2021 Apr 13.

Reference Type BACKGROUND
PMID: 33847199 (View on PubMed)

Fox KR, Harris JA, Wang SB, Millner AJ, Deming CA, Nock MK. Self-Injurious Thoughts and Behaviors Interview-Revised: Development, reliability, and validity. Psychol Assess. 2020 Jul;32(7):677-689. doi: 10.1037/pas0000819. Epub 2020 Apr 23.

Reference Type BACKGROUND
PMID: 32324021 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HT94252410714

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00001922

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Team Based Initiative Support
NCT00771277 COMPLETED NA
Improving Time-Based Prospective Memory in TBI
NCT04065477 ACTIVE_NOT_RECRUITING NA