Effects of Neuromodulation and Cognitive Training for Suicide in Veterans (ENACTS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Recruitment Feasibility
研究概览
简要总结
Impaired executive function, such as impaired decision making and impulsivity, has been identified as an important contributor to the transition from suicidal ideation to suicide attempt. To address the epidemic of Veteran suicide in the United States, this study tests the feasibility, acceptability, and preliminary effectiveness of a five day transcranial direct current stimulation (tDCS) augmented executive functioning training intervention. This intervention is delivered to high suicide risk inpatients. The ultimate goal is to reduce future suicide events (ideation, attempts, deaths) and improve quality of life (e.g. social relationships, health resource utilization).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •currently admitted into the MVAHCS Inpatient Psychiatric Unit
- •at a heightened risk for suicide (defined as a positive screen on the VA Comprehensive Suicide Risk Evaluation (CSRE) at intake and/or a suicide attempt within the previous 12 months)
- •able to complete procedures and tasks
排除标准
- •are unable to provide informed consent as determined by the Modified Dysken Tool
- •have moderate/severe cognitive impairment as determined by the Mini-Mental State Examination (score 27)
- •have contraindications for tDCS (history of seizures, metallic cranial plates/screws or implanted device, history of eczema on scalp)
- •do not have a smartphone or device running Android or Apple iOS with which to download the mPRO EMA app
- •have been involuntarily committed
研究组 & 干预措施
Active tDCS
Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes).
干预措施: Active Transcranial Direct Current Stimulation (tDCS) (Device)
Sham tDCS
Participants will receive 10 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session.
干预措施: Sham Transcranial Direct Current Stimulation (tDCS) (Device)
结局指标
主要结局
Recruitment Feasibility
时间窗: 2 years
Recruitment feasibility will be demonstrated by successful recruitment of 15 participants per year into the study.
Intervention Acceptability
时间窗: 2 months
Acceptability of the intervention will be demonstrated by a retention rate of 80% at the 2 month follow-up assessment, and by 70% of participants being able to complete ⅔ of treatment sessions.
次要结局
- NIH Quality of Life questionnaire(Change between baseline and 1 week follow-up; 1 and 2 months following intervention)
- Groton Maze Task(Change between baseline and 1 week follow-up; 1 and 2 months following intervention)
- UPPS-P Impulsive Behavior scale(Change between baseline and 1 week follow-up; 1 and 2 months following intervention)
- Change in Completion Time of the Groton Maze Task(Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions.)
- Change in NIH Quality of Life Questionnaire(Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions.)
- Change in UPPS-P Impulsive Behavior Scale(Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions.)