Crisis Response Planning in Military Personnel With Mild Traumatic Brain Injury

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Carl R. Darnall Army Medical Center — Fort Hood

Публикации

• 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

Идентификаторы

NCT: NCT07327567 · STUDY00001922 · HT94252410714

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗