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临床试验/NCT04341987
NCT04341987撤回不适用

Treating Nightmares Among Veterans Health Administration Domiciliary Patients

Canandaigua VA Medical Center0 个研究点开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Nightmare Frequency

研究概览

简要总结

The purpose of the study is to assess the efficacy of a 2-session intervention to reduce nightmares among Veterans admitted VA mental health residential rehabilitation treatment programs.

详细描述

Sleep disturbances and suicide are highly prevalent among Veterans and recent research also suggests high comorbid rates of sleep and suicide in Veterans discharged from VA mental health residential rehabilitation treatment programs (MHRRTP; domiciliaries). Nightmares are a frequent concern identified by MHRRTP patients and are a modifiable risk factor for suicide risk. Little is known, however, about the treatment of nightmares and subsequent impact in this setting. The primary aims of the present project are to investigate the efficacy and acceptability of delivering a 2-session intervention to reduce nightmares among Veterans admitted to a MHRRTP. This study will examine this intervention's impact on reducing nightmare distress and nightmare frequency, as well as assess treatment acceptability. Changes in suicide risk following intervention will also be explored. This research will be conducted within the Canandaigua and Bath VA domiciliary programs which currently accommodate ~150-175 Veterans. The study will be a randomized control trial with a hybrid design that uses stratification based on prescription use and randomly assigns individuals (N = 48) to either the treatment group or treatment as usual group (TAU). Veterans referred for the protocol will be screened for eligibility and then if appropriate, scheduled for a baseline evaluation, randomized to either the treatment group or TAU group, seen for two intervention sessions one week apart, and then be followed up with 4- and 8-weeks post initial treatment via telephone. This research has potential to highlight valuable targets for cross-cutting treatment in a rehabilitation setting that can be delivered in civilian and Veteran samples.

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
None

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

  • English-speaking
  • endorses nightmares at least once a week
  • score of 10 or greater on the Disturbing Dreams and Nightmares Severity Index

排除标准

  • unable to consent
  • diagnosis of serious mental illness (schizophrenia, schizoaffective disorder)
  • active suicide ideation with plan and intent

结局指标

主要结局

Nightmare Frequency

时间窗: Change in total nights with nigthmares in the past week from baseline to 8 week follow-up.

Disturbing Dreams and Nightmares Severity Index. The score for frequency ranges from 0-7.

Nightmare Severity

时间窗: Change in nigthmare severity from baseline to 8 week follow-up.

Disturbing Dreams and Nightmares Severity Index. The score for severity ranges from 0-6.

次要结局

未报告次要终点

研究者

发起方
Canandaigua VA Medical Center
申办方类型
Fed
责任方
Sponsor

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