A Multi-centre, Randomised, Pilot Feasibility Study to Compare the Effectiveness of Eye-movement Desensitisation and Reprocessing Versus Usual Care in the Psychological Recovery of Intensive Care Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Number of participants with adverse events (safety and tolerability)
研究概览
简要总结
The goal of this multi-centre, randomised, pilot feasibility study is to assess the feasibility of recruiting intensive care survivors, with symptoms of traumatic stress, to a study evaluating the use of eye movement desensitisation and reprocessing (EMDR). The main purpose is to determine whether it is feasible and acceptable to patients, clinicians and researchers. In addition, this study aims to identify design criteria that may be of use in a subsequent randomised controlled trial of clinical effectiveness.
Participants will:
- be recruited at hospital discharge
- undergo a psychological assessment at 2-3 months post-hospital discharge
- Those exhibiting symptoms of post-traumatic stress disorder (PTSD), will be randomised (1:1) to receive either usual care or usual care plus EMDR
- Participants who do not exhibit PTSD symptoms at the 2-3 month assessment will enter a light-touch observation arm.
- All participants will repeat the psychological assessment 12-months after hospital discharge.
Feasibility parameters; recruitment, adherence, retention and safety data. Primary clinical outcomes; change in PTSD symptoms between 2-3 months and 12-months.
The investigators will undertake a qualitative process evaluation using clinical ethnography and reported according to the Theoretical Framework of Acceptability.
详细描述
Background:
Patients who survive a period of critical illness have a disproportionately high chance of suffering from disturbing and persistent downstream psychological morbidity. These are associated with reduced quality of life and increased healthcare utilisation.
A recent survey of United Kingdom follow-up services reported a lack of post-discharge psychological support. There have been calls for collaborative efforts, between ICU and mental health professionals, exploring whether established trauma-focussed treatment modalities, may be tested for the benefit of ICU survivors.
Eye-Movement Desensitisation and Reprocessing (EMDR) has improved mental health in combat 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 recommended by United Kingdom National Institute for Health and Care Excellence, World Health Organisation and the Institute for Traumatic Stress Studies, for treating adult onset PTSD.
The investigators hypothesise that post-intensive care psychological health will be improved by EMDR. Reports of it's application in this cohort have largely adopted a case study approach. EMDR has never been systematically evaluated for effect in intensive care survivors.
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
- Single (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
- •Survivors of an intensive care admission, who have received level 3 care for >24 hours.
- •Aged ≥18 years
- •Capacity to provide informed consent and complete trial interventions and assessments.
排除标准
- •Pre-existing cognitive impairment such as dementia
- •Pre-existing diagnosis of psychosis
- •Not expected to survive post-hospital discharge
- •Traumatic brain injury
结局指标
主要结局
Number of participants with adverse events (safety and tolerability)
时间窗: 12-months
Safety will be determined by assignment of causality of serious events. 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.
Recruitment, adherence, retention
时间窗: 12-months
To determine whether investigating the use of EMDR for traumatised survivors of critical care can reach predefined feasibility objectives: * Recruitment rate part A - we anticipate an average recruitment of 10 patients per month across the three participating sites. This is well above the median recruitment of 0.95 participants recruited per site per month, reported in a review of trials listed in the NIHR journals library (1997-2020)(31). * Consent rate - number of patients recruited, expressed as a percentage of patients approached. Based on our previous work we expect this to be greater than 30%(28). * Adherence will be determined by completion of ≥75% of planned EMDR sessions completed. * Retention will be determined by ≥75% of participants completing the study follow-up assessment.
Acceptability
时间窗: 12-months
To explore acceptability of participating in a Randomised Controlled Trail of EMDR for critical care survivors, psychology clinicians and research staff. Reported according to the Theoretical Framework of Acceptability. This qualitative methodology, using semi-structured interviews, provides a framework for assessing conceptually different constructs of acceptability in clinical trials; affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness and self-efficacy.
次要结局
- Post-traumatic stress disorder(12-months)
- Clinical Global Impression of Improvement (CGI-I)(12-months)
- Clinician assessed Post-traumatic stress disorder(12-months)
- Anxiety(12-months)
- Sensitivity analysis(12-months)
- Depression(12-months)
- Health related quality of life(12-months)