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临床试验/NCT03603717
NCT03603717已完成不适用

Improving Sleep as a Strategy to Reduce Suicide Risk Among At-Risk Veterans: A Real World Clinical Trial

VA Office of Research and Development6 个研究点 分布在 1 个国家目标入组 283 人开始时间: 2019年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
283
试验地点
6
主要终点
Insomnia Severity Index Change

研究概览

简要总结

There is a strong association between insomnia and suicidal thoughts and behaviors. Insomnia also frequently co-occurs with other common conditions associated with suicide such as depression and posttraumatic stress disorder. This project focuses on improving sleep as a novel suicide prevention strategy that can be delivered to a broad range of Veterans. The study will examine how Cognitive Behavioral Therapy for Insomnia, an efficacious treatment for insomnia, may reduce suicidal thoughts in Veterans who also suffer from co-occurring conditions when delivered by integrated primary care clinicians.

详细描述

Anticipated Benefit to VA Healthcare The proposed study will establish the feasibility and effectiveness of treating insomnia in the primary care environment as a suicide prevention strategy. By treating insomnia, a common problem that is both a risk factor for suicide and highly prevalent in common conditions associated with suicide such as depression and posttraumatic stress disorder (PTSD), the investigators expect to reduce the severity of suicidal ideation (SI) among Veterans experiencing SI, insomnia and a co-occurring condition.

Project Background Suicide is the tenth leading cause of death in the U.S., is a major concern of the Department of Veterans Affairs (VA) and occurs at elevated rates among Veterans. Veterans with common chronic conditions such as PTSD and depression are at increased risk for suicide. Although evidence-based treatments exist for these conditions, a significant number of Veterans do not engage in or complete such treatments leaving them at higher risk for suicide.

This application builds upon VA funded pilot work that demonstrated the feasibility of delivering a brief version of cognitive-behavioral therapy for insomnia (CBT-I) within primary care to Veterans experiencing SI. The pilot data suggest that the investigators' brief, primary-care based insomnia treatment was delivered with high fidelity, acceptable to Veterans and associated with significant reductions in insomnia and depression symptoms, and reduced SI intensity. The next stage of this program of research is to establish the feasibility of delivering the brief, primary care based, insomnia intervention utilizing primary care-mental health integration (PC-MHI) clinicians (as opposed to research staff) and to establish the effectiveness of the intervention on reducing the severity of factors that contribute to suicide risk and to improve other clinical markers in a definitive trial.

Project Objectives The ultimate goal of the broader program of research is to reduce suicide among Veterans by intervening upon sleep disturbance as a modifiable risk factor for suicide. In this application the investigators focus on insomnia, which is the most common sleep disorder among Veterans and is robustly associated with suicidal thoughts and behaviors.

The primary objective of this proposed clinical trial is to test whether (and how) using brief behavioral insomnia treatment can not only improve sleep, but reduce other risk factors for suicide including the severity of depression, PTSD and suicidal ideation among Veterans at risk for suicide. Secondary objectives are to: (1) gather initial data on barriers and facilitators to implementation to aid future implementation efforts in VA primary care and (2) determine if the intervention improves attitudes towards psychotherapy treatments that address the co-morbid conditions.

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 (Participant, Outcomes Assessor)

盲法说明

Participants will be informed that they are receiving one of two non-medication sleep interventions. Assessors are blinded to study condition. Study staff entering data will be blinded to condition. It is not possible to blind staff delivering the interventions. The PI's are providing some supervision of the interventionists, so they will be unblinded for those participants they supervise interventionists on.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English speaking
  • Veteran seeking or receiving services at the Canandaigua, Buffalo or Syracuse VA Medical Centers
  • Demonstrate understanding of informed consent
  • Endorse current death/suicidal ideation on item 9 of the Patient Health Questionnaire-9
  • An Insomnia Severity Index score > 10 with trouble sleeping 3 months and at least 1 insomnia-related daytime consequence
  • [a] a current diagnosis of Major Depressive Disorder, Depression not otherwise specified or PTSD
  • [b] a score of > 16 on the Patient Health Questionnaire for Depression (PHQ-9) or a score > 46 on the PTSD Symptom Checklist
  • If using psychotropic medications the dosage must be stable

排除标准

  • History of serious mental illness such as schizophrenia, Bipolar I or II disorder, or current psychiatric conditions such as psychosis, mania, dementia or cognitive impairment
  • A suicide attempt within the last 6 months or [report of SI with active plan or intent in the past month]
  • Currently engaged in inpatient or partial hospitalization programs
  • Recent substance dependence disorder with < 6 months abstinence
  • Narcolepsy
  • Circadian rhythm disorders
  • Restless legs syndrome
  • Untreated sleep apnea based upon chart review
  • A sleep disorders screening questionnaire and the STOP-BANG sleep apnea questionnaire
  • Sleep medications are not exclusionary, but participants using them must still meet insomnia criteria

结局指标

主要结局

Insomnia Severity Index Change

时间窗: Baseline (Week 0) and 6 Month follow-up (Week 30)

The Insomnia Severity Index (ISI) is a 7-item self-report measure of insomnia symptoms. Each item is rated on a 0-4-point scale with a total score range of 0-28 where higher scores indicate greater severity.

次要结局

  • PTSD Symptom Checklist-DSM 5 Change(Baseline (Week 0) and 6 Month follow-up (Week 30))
  • Patient Health Questionnaire-Depression Change(Baseline (Week 0) and 6 Month follow-up (Week 30))
  • Scale for Suicidal Ideation Change(Baseline (Week 0) and 6 Month follow-up (Week 30))

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (6)

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