Effects of an online information tool on post-traumatic stress disorder in relatives of intensive care unit patients: a multicenter double-blind, randomized, placebo-controlled trial (ICU-Families-Study)

Intensive Care Med. 2023 Nov;49(11):1317-1326. doi: 10.1007/s00134-023-07215-4. Epub 2023 Oct 23.

Abstract

Purpose: Intensive care unit (ICU) hospitalization is challenging for the family members of the patients. Most family members report some level of anxiety and depression, sometimes even resulting in post-traumatic stress disorder (PTSD). An association has been reported between lack of information and PTSD. This study had three aims: to quantify the psychological burden of family members of critically ill patients, to explore whether a website with specific information could reduce PTSD symptoms, and to ascertain whether a website with information about intensive care would be used.

Method: A multicenter double-blind, randomized, placebo-controlled trial was carried out in Austria and Switzerland.

Results: In total, 89 members of families of critically ill patients (mean age 47.3 ± 12.9 years, female n = 59, 66.3%) were included in the study. 46 relatives were allocated to the intervention website and 43 to the control website. Baseline Impact of Event Scale (IES) score was 27.5 ± 12.7. Overall, 50% showed clinically relevant PTSD symptoms at baseline. Mean IES score for the primary endpoint (~ 30 days after inclusion, T1) was 24 ± 15.8 (intervention 23.9 ± 17.9 vs. control 24.1 ± 13.5, p = 0.892). Hospital Anxiety and Depression Scale (HADS - Deutsch (D)) score at T1 was 12.2 ± 6.1 (min. 3, max. 31) and did not differ between groups. Use of the website differed between the groups (intervention min. 1, max. 14 vs. min. 1, max. 3; total 1386 "clicks" on the website, intervention 1021 vs. control 365). Recruitment was prematurely stopped in February 2020 due to coronavirus disease 2019 (COVID-19).

Conclusion: Family members of critically ill patients often have significant PTSD symptoms and online information on critical illness did not result in reduced PTSD symptoms.

Trial registration: ClinicalTrials.gov NCT02931851.

Keywords: Communication; Families; Family-centered care; Information; Intensive care; Online; Post-traumatic stress disorder.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Comment

MeSH terms

  • Adult
  • Anxiety / psychology
  • Critical Care / psychology
  • Critical Illness / psychology
  • Critical Illness / therapy
  • Depression / psychology
  • Double-Blind Method
  • Female
  • Humans
  • Intensive Care Units
  • Male
  • Middle Aged
  • Stress Disorders, Post-Traumatic* / prevention & control
  • Stress Disorders, Post-Traumatic* / psychology

Associated data

  • ClinicalTrials.gov/NCT02931851