An interventional study of Cognitive stimulation and psychological support (RGS-ICU) in Critical Illness, sponsored by University of the Balearic Islands. Active, not recruiting at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by University of the Balearic Islands · Not applicable, Interventional, and Treatment
Admission to an Intensive Care Unit (ICU) is a potentially traumatic experience for a mentally vulnerable person. Beyond the stress and anxiety associated with the ICU environment and medical procedures, survivors of critical illness are at risk of developing cognitive and psychological sequelae related to Post-Intensive Care Syndrome (PICS). These disorders are associated with high economic, medical and personal costs.
This trial aims to evaluate the efficacy of an innovative neuropsychological e-health intervention for early cognitive stimulation and psychological support of people in critical care, i.e. the Rehabilitation Gaming System for Intensive Care Units (RGS-ICU) intervention, in improving comfort during ICU admission and cognition and mental health three and 12 months after ICU discharge. The RGS-ICU intervention, applied as an adjunct to standard ICU care, is based on non-immersive virtual reality techniques and has been specifically designed and developed to suit the needs of people in critical care and the characteristics of the ICU environment. To ensure the safety of the intervention, participants' physiological parameters will be automatically recorded by advanced continuous monitoring systems as part of standard ICU care.
The investigators hypothesize that the cognitive stimulation and psychological support protocols of the RGS-ICU intervention, applied as an adjunct to standard ICU care, in addition to being safe for people in critical care units, will improve comfort during ICU admission and cognitive and mental health outcomes after ICU discharge, compared to receiving standard ICU care alone.
The findings derived from this trial may contribute to establish a novel and superior paradigm of human-centered ICU care to improve the comfort of people admitted to the ICU. This achievement could also have a relevant impact on medical and economic costs during ICU admission, and on functionality and health-related quality of life after ICU discharge associated with the reduction of cognitive and psychological sequelae linked to PICS.
The RGS-ICU intervention has been designed at Corporacion Parc Taulí with the collaboration of the University of the Balearic Islands and has been developed by Eodyne Systems S.L., a company dedicated to the development of science-based technological solutions for intervention, monitoring, diagnosis, and prognosis in stroke and other brain disorders.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 93 is close to the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →University of the Balearic Islands is the lead sponsor of 39 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Cognitive stimulation and psychological support (RGS-ICU)
The RGS-ICU intervention consists of daily 20-minute sessions of early cognitive stimulation and psychological support adjuvant to standard ICU care administered by research staff and supervised by clinical staff each morning in the patient's own room during ICU admission and until ICU discharge or up to a maximum of 28 days after randomization. The sessions consist of orienting the patient to space and time, cognitive training of attention, working memory, learning/memory, executive function and processing speed, viewing of relaxing videos inspired by nature and fantasy scenarios to reduce stress and anxiety, and psychoeducation about the ICU environment and the characteristics of the cognitive, mental and physical state of critically ill patients.
Attention performance
Difference in attention performance (Z scores) between experimental and non-intervention groups assessed with the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Forward Digit Span subtest 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better attention performance.
Time frame: 12 months after discharge from the ICU
Working memory performance
Difference in working memory performance (Z scores) between experimental and non-intervention groups assessed with the WAIS-IV Backward Digit Span subtest 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better working memory performance.
Time frame: 12 months after discharge from the ICU
Learning/memory performance
Difference in learning/memory performance (Z scores) between experimental and non-intervention groups assessed with the Rey Auditory Verbal Learning Test (RAVLT) 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better learning/memory performance.
Time frame: 12 months after discharge from the ICU
Executive function performance
Difference in executive function performance (Z scores) between experimental and non-intervention groups assessed with the Trail Making Test (TMT), the Stroop Color and Word Test (SCWT), and the verbal phonemic fluency (FAS) test 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better executive function performance.
Time frame: 12 months after discharge from the ICU
Processing speed performance
Difference in processing speed performance (Z scores) between experimental and non-intervention groups assessed with the WAIS-IV Digit Symbol-Coding subtest and the Symbol Digit Modalities Test (SDMT) 12 months after ICU discharge. Z scores have a mean of 0 and a standard deviation of 1. Higher scores indicate better executive function performance.
Time frame: 12 months after discharge from the ICU
Incidence of Treatment-Emergent Adverse Events [Safety]
Number of interrupted sessions due to adverse events in the patients' physiological parameters (oxygen saturation, respiratory rate and heart rate) during admission to the ICU. The higher the number of interrupted sessions, the less safe the intervention.
Time frame: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
Dyspnea intensity
Change in dyspnea intensity before and after the intervention evaluated with a Visual Analogue Scale (VAS) with range 0-10. Higher scores indicate more intense dyspnea.
Time frame: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
Pain intensity
Change in pain intensity before and after the intervention evaluated with a Visual Analogue Scale (VAS) with range 0-10. Higher scores indicate more intense pain.
Time frame: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
Worry intensity
Change in worry intensity before and after the intervention evaluated with a Visual Analogue Scale (VAS) with range 0-10. Higher scores indicate more intense worry.
Time frame: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
Sadness intensity
Change in sadness intensity before and after the intervention evaluated with a Visual Analogue Scale (VAS) with range 0-10. Higher scores indicate more intense sadness.
Time frame: From ICU admission to ICU discharge or up to a maximum of 28 days after randomization
Comfort experienced
Difference in experienced comfort between experimental and non-intervention groups assessed with the Patient Evaluation of Emotional Comfort Experienced (PEECE) questionnaire at ICU discharge, a 12-item instrument with range 0-48. Higher scores indicate better subjective psychological well-being.
Time frame: Discharge from the ICU
Anxiety symptoms
Difference in anxiety symptoms between experimental and non-intervention groups assessed with the Generalized Anxiety Disorder (GAD-7) questionnaire 12 months after ICU discharge, a 7-item instrument with range 0-21. Higher scores indicate more severe anxiety symptoms.
Time frame: 12 months after discharge from the ICU
Symptoms of depression
Difference in symptoms of depression between experimental and non-intervention groups assessed with the Patient Health Questionnaire-9 (PHQ-9) 12 months after ICU discharge, a 9-item instrument with range 0-27. Higher scores indicate more severe symptoms of depression.
Time frame: 12 months after discharge from the ICU
Symptoms of post-traumatic stress disorder
Difference in post-traumatic stress disorder symptoms between experimental and non-intervention groups assessed with the Treatment-Outcome Post-Traumatic Stress Disorder Scale (TOP-8) 12 months after ICU discharge, a 8-item instrument with range 0-32. Higher scores indicate more severe symptoms of post-traumatic stress disorder.
Time frame: 12 months after discharge from the ICU
Objective cognition
Difference in objective cognition between experimental and non-intervention groups assessed with the Montreal Cognitive Assessment (MoCA) 12 months after ICU discharge, a screening instrument with range 0-30. Higher scores indicate better objective cognitive performance.
Time frame: 12 months after discharge from the ICU
Subjective cognition
Difference in subjective cognition between experimental and non-intervention groups assessed with the Perceived Deficits Questionaire-5 (PDQ-5) 12 months after ICU discharge, a 5-item instrument with range 0-20. Higher scores indicate greater perceived cognitive deficits.
Time frame: 12 months after discharge from the ICU
Functionality
Difference in functionality between experimental and non-intervention groups assessed with the self-reported 12-item version of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) 12 months after ICU discharge, an instrument with range 0-100. Higher scores indicate worse functionality.
Time frame: 12 months after discharge from the ICU
Health-related quality of life
Difference in health-related quality of life between experimental and non-intervention groups assessed with the 12-item Short-Form Health Survey (SF-12) 12 months after ICU discharge, an instrument with range 0-100. Higher scores indicate better health-related quality of life.
Time frame: 12 months after discharge from the ICU
Plan to share: No
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of the Balearic Islands