Menu
Not yet recruiting NCT07327567

Crisis Response Planning in Military Personnel With Mild Traumatic Brain Injury

No phase Interventional Mild Traumatic Brain Injury Suicide Prevention Suicide Risk | Patient Suicide Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Crisis Response Planning.
Who it may be relevant to
Registry conditions: Mild Traumatic Brain Injury, Suicide Prevention, Suicide Risk | Patient, Suicide Risk. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Clinical Trial Utilizing Crisis Response Planning in Military Personnel With Mild Traumatic Brain Injury

Overview

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

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • Beck Hopelessness Scale-5 (BHS-5) [Time frame: Baseline to 3 months]
  • Behavioral Inhibition/Activation System Scale (BIS/BAS Scale) [Time frame: Baseline to 3 months]
  • Depressive Symptoms Index-Suicidality Subscale (DSI-SS) [Time frame: Baseline to 3 months]
  • Entrapment Scale (ES) [Time frame: Baseline to 3 months]
  • Interpersonal Needs Questionnaire-5 (INQ-5) [Time frame: Baseline to 3 months]
  • Monetary Choice Questionnaire (MCQ) [Time frame: Baseline to 3 months]
  • Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline to 3 months]
  • Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R_Bryan) [Time frame: Baseline to 3 months]
  • Suicide Cognitions Scale-Revised (SCS-R) [Time frame: Baseline to 3 months]
  • Temporal Experience of Pleasure Scale (TEPS) [Time frame: Baseline to 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Carl R. Darnall Army Medical Center — Fort Hood

Publications

  • 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. PMID 29512832
  • 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. PMID 16223625
  • 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. PMID 31531784
  • 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. PMID 15290703
  • 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. PMID 24679384
  • 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. PMID 17845122
  • 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. PMID 33847199
  • 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. PMID 32324021

Identifiers

NCT: NCT07327567 · STUDY00001922 · HT94252410714

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗