Background: Posttraumatic stress disorder (PTSD) is a frequent long-term consequence of intensive care in both, patients and spouses, and there is a specific need of respective tailored intervention approaches. Aim of this trial was to investigate the efficacy, safety and applicability of internet-based cognitive-behavioral writing therapy (iCBT) for posttraumatic stress after intensive care for sepsis in patients and their spouses compared to a waitlist (WL) control group.Methods: In a

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... ed-controlled, parallel group, superiority trial we included patients after intensive care (>5 days) for sepsis and their spouses, if at least one of them had a presumptive PTSD diagnosis (PTSD Checklist [PCL-5] ≥ 33). Dyads were randomized 1:1 either to the iCBT (including two internet-based writing assignments per week over a 5-week period) or to the WL control group. Primary outcome was pre-post change in PTSD symptom severity score (measured via the PCL-5) in participants with a presumptive PTSD diagnosis from randomization to ~5 weeks later. Results: Twenty-five dyads were included representing 34 participants with presumptive PTSD diagnosis (patient and spouse: 9 dyads, patient only: 12, spouse only: 4). We did not observe evidence for a difference in the primary outcome for iCBT compared to WL in the confirmatory analysis according to the intention-to-treat principle. The mean difference in score point reductions between iCBT and WL was -0.96 (95% confidence interval, -5.88 to 3.97; p = 0.703), which was adjusted for pre-values of the PCL-5 in the generalized estimating equations model. No adverse events were reported. Participants confirmed the applicability of iCBT.Conclusions: We applied an iCBT to reduce PTSD symptoms after sepsis and intensive care, for the first time addressing both patients and their spouses. ICBT was applicable in the given population. We did not observe evidence for the efficacy of iCBT for the primary outcome of pre-post changes in PCL-5 PTSD symptom severity score. Due to the small sample size our trial should be regarded as a pilot study and findings remain preliminary. Nevertheless, our results can guide further research, which is needed to determine if modified approaches to post-intensive care PTSD may be more effective.Trial registration: German Clinical Trials Register (DRKS00010676). Registered 14 June 2016, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00010676