Early EMDR Following Covid-19 Critical Illness: A Feasibility Trial
NCT04455360
Anxiety Disorders, Behavior
Southampton, Hamphsire, United Kingdom
View Trial DetailsNCT Number: NCT05690438
The goal of this observational study is to assess whether a screening of patients at discharge from the intensive care unit (ICU) can predict psychological and physical problems three months later.
The main questions to answer are:
1. Can the screening method at ICU discharge predict psychological symptoms three months after ICU stay? 2. Can the screening method at ICU discharge predict new-onset physical disability three months after ICU stay? 3. Does pain, resilience (the individuals' ability to handle distress) and frailty affect the risk of developing psychological and physical problems three months after ICU stay? All adult patients with an ICU stay 12 hours or longer will be assessed for inclusion in the study. Three months after discharge from the ICU included patients will be asked to digitally answer a set of questionnaires, rating symptoms of depression, anxiety, post-traumatic stress and ability to perform activities of daily living. Patients will also be asked to state their health-related quality of life and on-going pain, how the pain affects their everyday life and the ability to endure difficult situations.
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Notify Me18 year and older
All sexes
Observational
Capio S:t Göran's Hospital, Stockholm, Sweden
Firstly, the investigators hypothesize that two novel screening instruments, developed by the research group, for identification of intensive care unit (ICU) survivors with elevated risk for psychological and physical morbidity have high external validity. Secondly, the investigators hypothesize that frailty, pain and resilience will affect the probability of developing post-intensive care syndrome (PICS) three months post-ICU.
The specific objectives with the project are:
Studies I-III are observational cohort studies including 800 adult patients admitted to the ICU for a minimum of 12 hours. Consecutively discharged ICU patients will be assessed with the PROGRESS-ICU screening instruments, generating an individual risk in percentage for a) psychological problems and b) new-onset physical disability three months post-ICU. The instruments consists of questions regarding depressive symptoms, traumatic memories from the ICU stay, social support and age and an evaluation of the patient´s physical status at ICU discharge, assessed with the first five items of the Chelsea Critical Care Physical Assessment Tool, CPAx. Patients will also be asked to state their level of pain at discharge with a numeric rating scale (NRS). Basic demographics will be collected from the patient data management system, such as sex, admission diagnosis, severity of illness, ICU length of stay and duration of mechanical ventilation. Patients or next of kin will also be asked to state the patients' level of independence in performing ten different ADLs two weeks prior to hospitalisation, assessed with the Barthel Index (BI). Frailty will be assessed with the Clinical Frailty Scale (CFS).
Three months after ICU discharge, patients will be asked to digitally, or on paper by regular mail, fill out validated questionnaires assessing level of symptoms of depression, anxiety (Hospital Anxiety and Depression Scale (HADS)) and post-traumatic stress (Post-Traumatic Stress Symptom 14-question inventory (PTSS-14)). New-onset physical disability will be assessed with the Barthel index (BI), a questionnaire assessing the level of independency in performing activities of daily living. In accordance with the cut-offs recommended in the literature, and level used for caseness in the studies developing the screening instruments, a HADS subscale score ≥11 and a PTSS-14 part B score >45 will define clinically substantial psychological symptoms 24,25. A BI score reduction of ≥10 compared to baseline will define substantial new-onset physical disability and is close to the minimum clinically important difference suggested for the BI. At the three months follow-up patients will also be assessed regarding pain with the NRS and resilience with the modified version of the validated questionnaire Psychological Inflexibility in Pain Scale (PIPS), addressing the tendency to avoid situations that could imply pain or other discomforts. Self-efficay will also be assessed, i.e. the belief in one's ability to handle distress as a measure of resilience with the General self-efficacy scale. Health-related quality of life will be assessed with the RAND-36. The investigators also plan to perform psychometric testing of the questionnaires used and validate them in Swedish for the relevant population.
In a subgroup of patients (n=15) daily wellbeing will be evaluated with a digital diary where patients will be asked to answer short questions regarding their present mood twice a day for a total of 30 days (14 days in a row, with a pause for 4 weeks and a new 14-day period of digital diary questions). The questions will be available to patients via an application in a smartphone/tablet, reminding them to answer the questions twice a day through a message/push notification. This will render multiple data points for each individual enabling analyses of the development over time as well as individual variations. Fifteen participants are deemed sufficient for a first analysis of aggregated individual data. This type of data is also an important step towards the next phase, to develop tailored interventions matching the specific needs of the individual ICU survivor.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Outcome measured three months after ICU discharge
Validation of a previously developed screening method for psychological problems three months post-ICU
Time frame: Outcome measured three months after ICU discharge
Validation of a previously developed screening method for physical problems three months post-ICU
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between frailty (assessed with the clinical frailty scale) and the development of symptoms of depression and anxiety post-ICU.
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between frailty (assessed with the clinical frailty scale) and the development of the post-traumatic stress symptoms.
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between frailty (assessed with the clinical frailty scale) and the development of the post-intensive care syndrome physical problems.
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between pain and the development of the post-intensive care syndrome physical aspects.
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between pain and the development of symptoms of post-traumatic stress post-ICU.
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between pain and the development of symptoms of depression and anxiety post-ICU.
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between resilience and the development of the post-intensive care syndrome physical problems.
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between resilience and the development of symptoms of depression and anxiety post-ICU.
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between resilience and the development of symptoms of post-traumatic stress post-ICU.
Time frame: Diary questions during 14 + 14 days after ICU discharge, questionnaire at termination of the diary.
Feasibility of a digital diary post-ICU assessed with a patient questionnaire at the end of the diary period and number of and reason for drop out.
Time frame: Digital diary questions during 14 + 14 days after ICU discharge, with follow-up questionnaires three months post-ICU
Digital diary with questions related to well-being for individual ICU survivors for a total of 30 days (14 + 14 days with a 4-week pause in between) post-ICU discharge.
Time frame: Digital diary questions during 14 + 14 days after ICU discharge, with follow-up questionnaires three months post-ICU
Daily diary questions on mood and cognitive state and associations with daily well-being questions (sleep, tiredness, stress) post-ICU discharge.
Time frame: Digital diary questions during 14 + 14 days after ICU discharge, with follow-up questionnaires three months post-ICU
Daily diary questions on mood and cognitive state and associations with symptoms of depression, anxiety and post-traumatic stress post-ICU discharge.
Time frame: Inclusion during one year, follow-up three months post-ICU discharge
Health-related quality of life assessed with the RAND-36
Time frame: Inclusion during one year, follow-up three months post-ICU discharge
HRQL assessed with the RAND-36
Time frame: Inclusion during one year, follow-up three months post-ICU discharge
HRQL assessed with the RAND-36, frailty with the clinical frailty scale.
Time frame: Inclusion during one year, follow-up three months post-ICU discharge
HRQL assessed with the RAND-36
Time frame: One year
Used questionnaires will be validated in a Swedish ICU population and psychometric testing will be performed.
Time frame: Outcome measured at discharge from the ICU
Clinical frailty and associations with ICU length-of-stay
Time frame: Outcome measured at discharge from the ICU
Clinical frailty and associations with duration of mechanical ventilation in ICU
Time frame: Outcome measured three months after discharge from the ICU
Clinical frailty and associations with symptoms of depression and anxiety three months post-ICU
Time frame: Outcome measured three months after discharge from the ICU
Clinical frailty and associations with symptoms of post-traumatic stress three months post-ICU
Time frame: Outcome measured at discharge from the ICU
Clinical frailty and associations with physical status at ICU discharge
Time frame: Outcome measured at discharge from the ICU
Clinical frailty and associations with ICU mortality
Time frame: Outcome measured three months after discharge from the ICU
Clinical frailty and associations with post-ICU physical functioning.
Time frame: Three months
Physical function at discharge from the ICU, assessed with the first five items of the Chelsea Critical Care Physical Assessment Tool (CPAx) and associations with mortality within three months post-ICU
Region Stockholm
Other Gov
Acronym: PREPICS
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