EMERALD: Can a Virtual Eye Movement Desensitisation and Reprocessing Intervention Improve Psychological Outcome Following Covid-19 Related Critical Illness: A Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints
研究概览
简要总结
Primary objective is to evaluate the feasibility of delivering an online early Eye Movement Desensitisation Reprocessing (EMDR) Recent Traumatic Events Protocol (R-TEP) to patients who have survived Covid-19 related critical illness, within the context of a randomised controlled trial (RCT).
This will inform the design of a future RCT investigating the effectiveness of EMDR R-TEP in reducing psychological symptoms, for adult survivors of intensive care.
详细描述
A significant number of patients worldwide, have been admitted to intensive care suffering from Covid-19 related organ failure. Patients who survive a period of critical illness have a disproportionately high chance of suffering from significant and persistant poor psychological outcomes.
Eye-Movement Desensitisation and Reprocessing (EMDR) has reduced incidence of psychological morbidity in war veterans and victims of man-made and natural disasters. Small studies have also shown it to be effective in healthcare settings, within the Emergency department, following cancer diagnosis and implantation of cardioverter defibrillators. EMDR is validated by UK National Institute of Clinical Excellence guidance for use in treating adult onset PTSD.
Because of ongoing social distancing guidance our study programme aims to investigate whether it is feasible to treat patients with an early online Eye Movement Desensitisation Reprocessing (EMDR) intervention, delivered soon after hospital discharge and whether this intervention will improve psychological outcome for survivors of critical illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Patient reported outcomes at 6-months post-hospital discharge
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
- •Acute admission to Critical Care who have required mechanical ventilation for at least 24 hours
- •PCR confirmed Covid-19 positive
- •>18 years of age
- •Capacity to provide informed consent
排除标准
- •Acute brain injury
- •Cognitive impairment
- •Pre-existing psychotic diagnosis
- •Not expected to survive post-hospital discharge
- •Refusal to grant consent
研究组 & 干预措施
EMDR R-TEP intervention
Participants will receive a minimum of 2 and a maximum of 8 online EMDR R-TEP sessions, starting within 3-months of hospital discharge. Sessions will be delivered online by experienced, suitably trained and registered psychological practitioners.
干预措施: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol (Other)
Standard care
Patients will receive standard post-hospital discharge care.
结局指标
主要结局
Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints
时间窗: 12 months
Feasibility will be determined by the following measures: 1. Able to recruit \>30% of eligible patients approached 2. Complete early EMDR intervention programme in 75% or more of trial participants randomised to intervention. 3. Protocol adherence 4. Assignment of causality of serious events will be assessed by the chief investigator. Events attributable to trial procedures will be reviewed by trial management board, study sponsor and the research ethics committee, in order to determine ongoing feasibility. 5. Outcome measures completed in 75% or more of trial participants
次要结局
- Post-Traumatic stress disorder(6 months post-hospital discharge)
- Nutritional status(6 months post-hospital discharge)
- Cognitive function(6 months post-hospital discharge)
- Anxiety and depression(6 months)
- Health Related Quality of Life(6 months post-hospital discharge)
- Health and disability(6 months post-hospital discharge)
- Physical activity(6 months post-hospital discharge)