Decreasing Suicide Risk Among Service Members With Posttraumatic Stress Using Written Exposure Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Change in Self-Injurious Thoughts and Behaviors Interview Scores
研究概览
简要总结
In this study, the investigators will conduct a randomized controlled trial (RCT) to evaluate the efficacy of the WET-S + treatment as usual (TAU) compared with TAU among high-risk, suicidal service members with PTSD or posttraumatic stress (PTS) admitted to the Carl R. Darnall Army Medical Center (CRDAMC) acute inpatient psychiatry unit at Fort Hood, Texas. Suicide risk and PTS symptom severity are the primary outcomes. Secondary outcomes include subsequent hospitalizations for suicidal thoughts and behaviors and suicide attempts. Investigators will conduct a needs assessment with stakeholders during the RCT to develop a tool kit for WET implementation in other DoD inpatient psychiatry units.
详细描述
This study aims to compare a new formulation of WET referred to as WET-for suicide (WET-S) that includes crisis response planning + treatment as usual (TAU) compared with TAU among high-risk, suicidal service members with PTS admitted to the Carl R. Darnall Army Medical Center (CRDAMC) acute inpatient psychiatry unit at Fort Hood, Texas.
Aim 1: Determine if WET-S reduces the presence, frequency, and severity of suicidal ideation, suicide plans, suicide gestures, suicide attempts, non-suicidal self-injurious behaviors, and rehospitalization for suicidality.
Aim 2: Determine if WET-S + TAU reduces PTS symptom severity among service members admitted to an acute psychiatric inpatient unit for SI and/or attempt compared with TAU.
Aim 3: Determine if reductions in PTS symptoms mediate the association between treatment condition and suicide-related outcomes (suicidal ideation, plans, gestures, attempts, non-suicidal self-injurious behaviors, and rehospitalizations).
Aim 4: Develop a tool kit for WET-S implementation through a needs assessment with key stakeholders and evaluation of contextual factors among DoD inpatient facilities to determine readiness for successful implementation of WET-S.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (18 years or older) service members hospitalized at Carl R Darnall Army Medical Center for SI/suicide plan or attempt.
- •Symptoms of posttraumatic stress (PTS) of at least moderate severity (total scores > 20) confirmed by assessor using the CAPS-
- •Speak, read, and write English.
排除标准
- •Active psychosis.
- •The presence of moderate to severe cognitive impairment (as determined by the inability to comprehend the baseline screening questionnaires).
- •The presence of any factor that may impair an individual's ability to comprehend and effectively participate in the study, including the presence of extreme agitation or violent behavior.
结局指标
主要结局
Change in Self-Injurious Thoughts and Behaviors Interview Scores
时间窗: Baseline, 1-month, 4-month follow-up
The SITBI is a structured interview that assesses the presence (lifetime, past year, past month), frequency, severity, and characteristics of five types of SITB: (a) suicidal ideation, (b) suicide plans, (c) suicide gestures, (d) suicide attempts, and (e) non-suicidal self-injury. The SITBI assesses the frequency of each type of thought or behavior in the respondent's lifetime, past year, and past month, as well as the age of onset of each thought or behavior endorsed. The SITBI also assesses the severity of each thought or behavior endorsed on a scale from 0 (low/little) to 4 (very much/severe) scale, on average and at the worst point at each of those time frames.
Change in Clinician Administered PTSD Scale Scores
时间窗: baseline, 1-month, 4-month follow-up
The CAPS-5 is a structured diagnostic interview and gold standard for assessing PTSD. It provides a dichotomous PTSD diagnosis and overall symptom severity score. Scores range from 0 to 80, with greater scores signifying more severe PTSD symptoms.
Change in medical record outcomes
时间窗: Baseline, 1-month, 4-month follow-up
At baseline and each follow-up assessment, study staff will access participants' medical record to obtain information about current and past mental health treatment, current and past psychiatric diagnoses, current and past psychiatric medication, and history of suicidal thoughts and behaviors. If applicable, date of admission(s) to inpatient psychiatric unit, chief complaint at the time of admission(s), details of psychiatric stay(s), and length of stay(s) will also be obtained. Changes in any of these variables from baseline to follow-up will be recorded.
Change physical and mental health assessed by Military Suicide Research Consortium Common Data Elements
时间窗: Baseline, 1-month, 4-month follow-up
Participants will provide self-report information about their physical and mental health and behaviors at each time point.
次要结局
未报告次要终点
研究者
Brian Marx, PH.D.
Deputy Director, Behavioral Science Division, National Center for PTSD
Boston VA Research Institute, Inc.