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临床试验/NCT07327567
NCT07327567尚未招募不适用

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

The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
Beck Hopelessness Scale-5 (BHS-5)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Beck Hopelessness Scale-5 (BHS-5)

时间窗: Baseline to 3 months

BHS is a self-report measure that assess hopelessness using a dichotomist scoring system (0 or 1).This study will use a 5-item version of the BHS developed by the Military Suicide Research Consortium. The score ranges between 0 and 5 with a higher scores indicated higher levels of hopelessness. A change in score will be reported.

Behavioral Inhibition/Activation System Scale (BIS/BAS Scale)

时间窗: Baseline to 3 months

BIS-BAS scale is a 24-item self-reporting scale for the assessment of BIS and BAS sensitivities. All items are measured on a four-point Likert scale with one indicating strong agreement and four as strong disagreements. BIS sensitivity is measured as a single factor with seven items, and the BAS sensitivity is measured as three subfactors, namely drive, reward responsiveness, and fun seeking, each measured by 4, 5, and 4 items, respectively. The scale also contains four filler items which are not scored. All the items other than two and 22 are reverse scored. A change in score will be reported.

Depressive Symptoms Index-Suicidality Subscale (DSI-SS)

时间窗: Baseline to 3 months

The DSI-SS will be used to assess current suicidal ideation. The DSI-SS is a 4-item self-report measure of suicidal ideation that focuses on ideation, plans, perceived control over ideation, and impulses for suicide. Scores on each item range from 0 to 3, with higher scores reflecting greater severity of suicidal ideation. Total scores range from 0-12. A change in score will be reported.

Entrapment Scale (ES)

时间窗: Baseline to 3 months

The ES is a 16-item measure utilizes a 5-point Likert scale (0 = not at all like me; 4 = extremely like me) to evaluates both internal and external entrapment. Possible range of scores is from 0-64 with a higher score indicating greater feeling of entrapment. A change in score will be reported.

Interpersonal Needs Questionnaire-5 (INQ-5)

时间窗: Baseline to 3 months

The INQ is a self-report measure that assesses perceived burdensomeness and thwarted belongingness. This study will use a 5-item version of the INQ developed by the Military Suicide Research Consortium that showed an excellent internal consistency. Items are scored using a rating scale of 1-7 where 1=Not at all true for me to 7=Very true form me. Possible scores range from 5-35, with a higher score indicating better interpersonal relationships. A change in score will be reported.

Monetary Choice Questionnaire (MCQ)

时间窗: Baseline to 3 months

The MCQ is a 27-item, selfadministered questionnaire. For each item, the participant chooses between a smaller, immediate monetary reward and a larger, delayed monetary reward (e.g., "Would you prefer $54 today or $80 in 30 days?"). The protocol is scored by calculating where the respondent's answers place them amid reference discounting curves, with steeper curves indicating higher levels of impulsivity. A change in score will be reported.

Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R_Bryan)

时间窗: Baseline to 3 months

The SITBI-R is a structured interview assessing the presence, frequency, and characteristics of self-injurious and suicidal thoughts and behaviors. The SITBI-R has high interrater reliability, strong test-retest reliability (Fox et al., 2020; Gratch et al., 2021). The SITBI-R was developed from the SITBI which also demonstrated strong psychometric properties (Nock et al., 2007). We will use the SITBI-R to measure the incidence of suicide attempts and non-suicidal self-injury.

Patient Health Questionnaire-9 (PHQ-9)

时间窗: Baseline to 3 months

The PHQ-9 is a 9-item self-report measure of the severity of depressive symptoms. Scores on the PHQ-9 have demonstrated high internal consistency and convergent validity. Items are scored from 0=Not at all to 3=Nearly every day. Total scores range from 0-27 with a higher score indicating less feeling of well-being. A change in score will be reported.

Suicide Cognitions Scale-Revised (SCS-R)

时间窗: Baseline to 3 months

The SCS-R is a 16-item, self-report with each item scored between 0=Strongly disagree to 4=Strongly Agree. Total range of score is between 0-64 with a higher score indicating a higher level of suicidal cognition. measure that assesses suicide-specific thoughts and belief. The scale has demonstrated good internal consistency, convergent validity, and divergent validity (Bryan et al., 2014). The SCS-R evaluates how much an individual agrees with the suicide-related cognition. A change in score will be reported.

Temporal Experience of Pleasure Scale (TEPS)

时间窗: Baseline to 3 months

The TEPS is a 18-item self-report measure designed to assess participants' experience of positive affect using a Likert Scale from 1 (Very false for me) to 6 (Very true for me). The TEPS has strong reliability, high test-retest reliability, as well as good convergency and discriminant validity. Total possible range of score is 18-72, with a higher score indicating greater level of temporal experience of pleasure.A change in score will be reported.

Hopelessness - Visual Analog Scale (H-VAS)

时间窗: Baseline to 3 months

A visual analog scale with scores ranging from 0-100 with higher scores reflecting the higher intensity of the item being assessed (hopelessness) at the moment of assessment. A change in score will be reported.

Suicide - Visual Analog Scale (S-VAS).

时间窗: Baseline to 3 months

A visual analog scales with scores range from 0-100 with higher scores reflecting the higher intensity of the item being assessed (urge to die by suicide) at the moment of assessment. A change in score will be reported.

Perceived Burdensomeness - Visual Analog Scale, PB-VAS

时间窗: Baseline to 3 months

A visual analog scale with scores ranging from 0-100 with higher scores reflecting the higher intensity of the item being assessed (perceived burdensomeness) at the moment of assessment. A change in score will be reported.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hannah Tyler

Chief of Psychology, Strong Star

The University of Texas Health Science Center at San Antonio

研究点 (1)

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