Cited by 124Intensive Care Unit Cognitive DisordersPosttraumatic Stress Disorder ResearchFamily and Patient Care in Intensive Care Units

Effect of a Nurse-Led Preventive Psychological Intervention on Symptoms of Posttraumatic Stress Disorder Among Critically Ill Patients: A Randomized Clinical Trial

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Wade, Dorothy M., Mouncey, Paul R., Richards-Belle, Alvin, Wulff, Jerome, Harrison, David A., Sadique, M. Zia, Grieve, Richard D., Emerson, Lydia M. +14 more·2019·JAMA

Abstract

Importance: A meta-analysis of outcomes during the 6 months after intensive care unit (ICU) discharge indicate a prevalence for clinically important posttraumatic stress disorder (PTSD) symptoms of 25%. Objective: To determine whether a nurse-led preventive, complex psychological intervention, initiated in the ICU, reduces patient-reported PTSD symptom severity at 6 months. Design, Setting, and Participants: A multicenter, parallel-group, cluster-randomized clinical trial with integrated economic and process evaluations conducted in 24 ICUs in the United Kingdom. Participants were critically ill patients who regained mental capacity following receipt of level 3 (intensive) care. A total of 2961 eligible patients were identified from September 2015 to January 2017. A total of 2048 were approached for participation in the ICU, of which 1458 provided informed consent. Follow-up was completed December 2017. Interventions: Twenty four ICUs were randomized 1:1 to the intervention or control group. Intervention ICUs (n = 12; 669 participants) delivered usual care during a baseline period followed by an intervention period. The preventive, complex psychological intervention comprised promotion of a therapeutic ICU environment plus 3 stress support sessions and a relaxation and recovery program delivered by trained ICU nurses to high-risk (acutely stressed) patients. Control ICUs (n = 12; 789 participants) delivered usual care in both baseline and intervention periods. Main Outcomes and Measures: The primary clinical outcome was PTSD symptom severity among survivors at 6 months measured using the PTSD Symptom Scale-Self-Report questionnaire (score range, 0-51, with higher scores indicating greater symptom severity; the minimal clinically important difference was considered to be 4.2 points). Results: Among 1458 enrolled patients (mean [SD] age, 58 [16] years; 599 women [41%]), 1353 (93%) completed the study and were included in the final analysis. At 6 months, the mean PTSD Symptom Scale-Self-Report questionnaire score in intervention ICUs was 11.8 (baseline period) compared with 11.5 (intervention period) (difference, -0.40 [95% CI, -2.46 to 1.67]) and in control ICUs, 10.1 (baseline period) compared with 10.2 (intervention period) (difference, 0.06 [95% CI, -1.74 to 1.85]) between periods. There was no significant difference in PTSD symptom severity at 6 months (treatment effect estimate [difference in differences] of -0.03 [95% CI, -2.58 to 2.52]; P = .98). Conclusions and Relevance: Among critically ill patients in the ICU, a nurse-led preventive, complex psychological intervention did not significantly reduce patient-reported PTSD symptom severity at 6 months. These findings do not support the use of this psychological intervention. Trial Registration: ISRCTN53448131.

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Authors
Wade, D. M., Mouncey, P. R., Richards-Belle, A., Wulff, J., Harrison, D. A., Sadique, M. Z., Grieve, R. D., Emerson, L. M., Mason, A. J., Aaronovitch, D., Als, N., Brewin, C. R., Harvey, S. E., Howell, D. C. J., Hudson, N., Mythen, M. G., Smyth, D., Weinman, J., Welch, J., Whitman, C., Rowan, K. M., & for the POPPI Trial Investigators
Affiliations
  • University College London Hospitals NHS Foundation Trust (GB)
  • Intensive Care National Audit & Research Centre (GB)
  • Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom
  • London School of Hygiene & Tropical Medicine, London, United Kingdom
  • London School of Hygiene & Tropical Medicine (GB)
  • Queen's University Belfast (GB)
  • Patient representative, United Kingdom
  • University College London (GB)
  • National Institute for Health and Care Research (GB)
  • King's College London (GB)
Venue
JAMA
Published
2019-02-19
Volume
321
Issue
7
Pages
665
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
OpenAlex
W2911285781
Cited by
124
References
39
Citations by year
2026: 17 · 2025: 11 · 2024: 8 · 2023: 12 · 2022: 21 · 2021: 23 · 2020: 19 · 2019: 12 · 2018: 1
FWCI
17.44
Type
journal article
Language
en
Open access
Locations
  • JAMA (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
  • Research Portal (Queen's University Belfast) (submittedVersion, other-oa)
  • UCL Discovery (University College London) (submittedVersion)
  • Research Portal (King's College London) (submittedVersion, other-oa)
  • Edinburgh Napier Research Repository (Edinburgh Napier University) (submittedVersion)
Funders
  • National Institute for Health and Care Research (12/64/124, SRF-2013-06-016)
  • University of Warwick
  • Royal College of Anaesthetists
  • James Cook University
  • University Hospitals Coventry and Warwickshire NHS Trust
  • Medical Research Council (MR/L004933/1, MR/L004933/2)
Topics
  • Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Intensive Care Unit Cognitive Disorders
  • Social Sciences › Psychology › Clinical Psychology › Posttraumatic Stress Disorder Research
  • Health Sciences › Health Professions › Radiological and Ultrasound Technology › Family and Patient Care in Intensive Care Units
Keywords
post-traumatic stress disorder, critical illness, intensive care unit survivors, nurse-led intervention, psychological intervention, PTSD symptom severity, intensive care unit discharge
MeSH terms
Adult, Aged, Female, Follow-Up Studies, Humans, Intensive Care Units, Male, Middle Aged, Psychotherapy, Surveys and Questionnaires, Severity of Illness Index, Stress Disorders, Post-Traumatic, Critical Illness, Treatment Failure, Nurse's Role, Self Report

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