An observational study in Critical Care, sponsored by Region Stockholm. Completed at 4 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Region Stockholm · Observational
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:
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:
To assess the predictive value and hence the validity of a screening instrument assessing the risk for
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.
45 studies on the registry are indexed under postintensive care syndrome; 27 are open to participants now.
This study's enrollment of 773 is above the median of 300 across 21 observational studies indexed under postintensive care syndrome.
Browse postintensive care syndrome studies →Region Stockholm is the lead sponsor of 119 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
General adult ICU population, all admitted patients will be consecutively screened for inclusion.
Exclusion Criteria:
Predictive accuracy of a psychological screening method
Validation of a previously developed screening method for psychological problems three months post-ICU
Time frame: Outcome measured three months after ICU discharge
Predictive accuracy of a physical screening method
Validation of a previously developed screening method for physical problems three months post-ICU
Time frame: Outcome measured three months after ICU discharge
Frailty (assessed with the clinical frailty scale) and psychological outcome after ICU stay, assessed with the Hospital Anxiety and Depression Scale.
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
Frailty (assessed with the clinical frailty scale) and psychological outcome after ICU stay, assessed with the Post-Traumatic Stress 14-Question Inventory.
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
Frailty (assessed with the clinical frailty scale) and physical outcome after ICU stay, assessed with the Barthel Index.
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
Pain (assessed with the numeric rating scale, NRS) and physical outcome after ICU stay, assessed with the Barthel Index.
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
Pain (assessed with the numeric rating scale, NRS) and psychological outcome after ICU stay, assessed with the Post-Traumatic Stress 14-Question Inventory.
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
Pain (assessed with the numeric rating scale, NRS) and psychological outcome after ICU stay, assessed with the Hospital Anxiety and Depression Scale.
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
Resilience (assessed with the general self-efficacy scale, the pain catastrophizing scale and the psychological inflexibility in pain scale) and physical outcome after ICU stay (assessed with the Barthel Index).
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
Resilience (assessed with the general self-efficacy scale, the pain catastrophizing scale and the psychological inflexibility in pain scale) and psychological outcome after ICU stay, assessed with the Hospital Anxiety and Depression Scale.
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
Resilience (assessed with the general self-efficacy scale, the pain catastrophizing scale and the psychological inflexibility in pain scale) and psychological outcome after ICU stay
Assessment of associations between resilience and the development of symptoms of post-traumatic stress post-ICU.
Time frame: Outcome measured three months after ICU discharge
Feasibility of a daily digital diary in ICU survivors
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: Diary questions during 14 + 14 days after ICU discharge, questionnaire at termination of the diary.
Daily variations of well-being in ICU survivors
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
With-in person associations between cognitive-affective state and daily well-being in ICU survivors
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
Associations between high daily patterns of cognitive-affective state between individuals and psychological recovery
Daily diary questions on mood and cognitive state and associations with symptoms of depression, anxiety and post-traumatic stress post-ICU discharge.
Time frame: Digital diary questions during 14 + 14 days after ICU discharge, with follow-up questionnaires three months post-ICU
Health-related quality of life in patients with psychological and/or physical problems post-ICU
Health-related quality of life assessed with the RAND-36
Time frame: Inclusion during one year, follow-up three months post-ICU discharge
Health-related quality of life in patients with pain post-ICU
HRQL assessed with the RAND-36
Time frame: Inclusion during one year, follow-up three months post-ICU discharge
Health-related quality of life and associations with pre-ICU frailty assessed with the Clinical Frailty Scale.
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
Health-related quality of life and associations with resilience
HRQL assessed with the RAND-36
Time frame: Inclusion during one year, follow-up three months post-ICU discharge
Validation of questionnaires in a Swedish ICU population and psychometric testing
Used questionnaires will be validated in a Swedish ICU population and psychometric testing will be performed.
Time frame: One year
Clinical frailty, assessed with the Clinical Frailty Scale, and ICU length-of-stay
Clinical frailty and associations with ICU length-of-stay
Time frame: Outcome measured at discharge from the ICU
Clinical frailty, assessed with the Clinical Frailty Scale, and duration of mechanical ventilation in ICU
Clinical frailty and associations with duration of mechanical ventilation in ICU
Time frame: Outcome measured at discharge from the ICU
Clinical frailty, assessed with the Clinical Frailty Scale, and symptoms of psychological problems post-ICU assessed with the Hospital Anxiety and Depression Scale.
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, assessed with the Clinical Frailty Scale, and symptoms of post-traumatic stress post-ICU assessed with the Post-Traumatic Stress Symptom 14-Question Inventory.
Clinical frailty and associations with symptoms of post-traumatic stress three months post-ICU
Time frame: Outcome measured three months after discharge from the ICU
Clinical frailty, assessed with the Clinical Frailty Scale, and physical performance at ICU discharge assessed with the Chelsea Critical care physical assessment tool
Clinical frailty and associations with physical status at ICU discharge
Time frame: Outcome measured at discharge from the ICU
Clinical frailty, assessed with the Clinical Frailty Scale, and ICU mortality.
Clinical frailty and associations with ICU mortality
Time frame: Outcome measured at discharge from the ICU
Clinical frailty, assessed with the Clinical Frailty Scale, and three-month physical function assessed with the Barthel Index.
Clinical frailty and associations with post-ICU physical functioning.
Time frame: Outcome measured three months after discharge from the ICU
Physical function at ICU discharge and mortality
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
Time frame: Three months
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Region Stockholm