Internet-based Cognitive-behavioral Writing Therapy for Reducing Posttraumatic Stress After Severe Sepsis in Patients and Their Spouses (REPAIR): Results of a Randomized Controlled Trial 

Abstract

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 randomized-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

Post–Intensive Care Unit Syndrome in a Cohort of COVID-19 Survivors in New York City

“…Total scores were recorded, and scores above 8 in either domain was considered a positive screen. 31,32 The Post-Traumatic Symptom Scale-10 (PTSS-10) [33][34][35][36] was used to assess PTSD symptoms in video visits, and the PTSD Checklist for DSM-5 (PCL-5) [37][38][39] was used to assess PTSD symptoms for in-person visits. Total scores were recorded.…”

Trauma‐focused guided self‐help interventions for posttraumatic stress disorder: A meta‐analysis of randomized controlled trials

“…A flow diagram of study identification and selection is presented in Figure 1. The characteristics of included studies are described in Engel et al, 2015; Gawlytta et al, 2017; Ivarsson et al, 2014; Knaevelsrud & Maercker, 2009; Knaevelsrud et al, 2015, 2017; Lange et al, 2003; Latif et al, 2021; Lehavot et al, 2021; Lewis et al, 2017; Litz et al, 2007; Nieminen et al, 2016; Sloan et al, 2012; Spence et al, 2011; Tables 1 and 2 (Acosta, 2017; Vinke et al, 2019; Wagner et al, 2006). The review identified 17 trials comparing a TF‐GSH intervention (total N = 610) with a control group comparator (total N = 570) for individuals experiencing PTSD.…”

“…The review identified 17 trials comparing a TF‐GSH intervention (total N = 610) with a control group comparator (total N = 570) for individuals experiencing PTSD. Control conditions included treatment as usual ( k = 2), (Acosta, 2017; Engel et al, 2015) waiting list ( k = 11), (Gawlytta et al, 2017; Knaevelsrud & Maercker, 2009; Knaevelsrud et al, 2015, 2017; Lange et al, 2003; Latif et al, 2021; Lewis et al, 2017; Nieminen et al, 2016; Sloan et al, 2012; Spence et al, 2011; Wagner et al, 2006) phone monitoring ( k = 1), (Lehavot et al, 2021) nontrauma writing ( k = 1), (Vinke et al, 2019) general support ( k = 1), (Ivarsson et al, 2014) and supportive counseling ( k = 1) (Litz et al, 2007). Trials evaluating the efficacy of TF‐GSH were conducted in a range of countries and in relation to a broad range of traumas.…”

“…Several different TF-GSH protocols were tested. Therapist input entailed less than 1 h (k = 1), (Vinke et al, 2019) 3.7-4.5 h (k = 4), (Gawlytta et al, 2017;Lange et al, 2003;Latif et al, 2021;Sloan et al, 2012) Event Scale (Horowitz et al, 1979;IES Dutch version, Brom & Kleber, 1985); IES-R = Impact of Event Scale-Revised (Weiss & Marmar, 1997); MINI-PTSD = PTSD module of the Mini-International Neuropsychiatric Interview (Sheehan et al, 1998); MVA = Motor Vehicle Accident; NR = not reported; PDS = Posttraumatic Diagnostic Scale (Foa et al, 1997); PSS-I = PTSD Symptom Scale-Interview (Foa & Tolin, 2000). Abbreviation: PTSD, posttraumatic stress disorder.…”

“…Several different TF-GSH protocols were tested. Therapist input entailed less than 1 h (k = 1),(Vinke et al, 2019) 3.7-4.5 h (k = 4),(Gawlytta et al, 2017;Lange et al, 2003;Latif et al, 2021;Sloan et al, 2012) 7-5-8.3 h (k = 5),(Knaevelsrud & Maercker, 2009;Knaevelsrud et al, 2015 Lehavot SIDDAWAY ET AL.…”