title: Internet-based cognitive-behavioural writing therapy for reducing post-traumatic stress after intensive care for sepsis in patients and their spouses (REPAIR): study protocol for a randomised-controlled trial.
abstract: As a consequence of sepsis and intensive care, considerable proportions of patients but also of their spouses develop a post-traumatic stress disorder (PTSD). However, only a very small number receive psychotherapeutic treatment. Internet-based cognitive-behavioural writing therapy (IB-CBWT) has proven to be an effective treatment option for PTSD. It seems to fit the specific needs of this cohort and to overcome treatment barriers. Aim of the REPAIR trial is to examine the efficacy, safety and applicability of IB-CBWT for PTSD in patients and their spouses after intensive care for sepsis.
  
  
  
  Participants will be assigned randomly either to a treatment or a wait-list (WL) control group. The treatment group receives IB-CBWT for PTSD, actively involving the partners of the participants. IB-CBWT will be guided by a therapist and comprises two written assignments per week over a 5 week period. After completing the assignments, the participants obtain individual responses from the therapist. Participants of the WL control group will receive treatment after a waiting period of 5 weeks. The primary outcome is PTSD symptom severity in self-rated PTSD Checklist for Diagnostic and Statistical Manual Fifth Edition at the end of treatment and waiting time, respectively. Secondary outcomes are remission of PTSD, depression, anxiety, and somatisation measured by the Brief Symptom Inventory-18, marital satisfaction measured by the Relationship Assessment Scale, health-related quality of life measured by the EQ-5D-5L, and the feasibility of IB-CBWT for this cohort (ie, dropout rate). Statistical analysis will be performed according to the intent-to-treat principle.
  
  
  
  The study is conducted according to the principles of Good Clinical Practice and has been approved by the ethics committee of the Friedrich-Schiller University Jena, Germany. Results will be disseminated at scientific conferences, published in peer-reviewed journals, and provided to consumers of healthcare.
  
  
  
  Pre-results, DRKS00010676.
authors.affiliation: Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Jena, Germany.|Integrated Research and Treatment Center, Center for Sepsis Control and Care, Jena University Hospital, Jena, Germany.
authors.forename: Romina
authors.initials: R
authors.lastname: Gawlytta
authors.affiliation: Department of Clinical Psychological Intervention, Freie Universität Berlin, Berlin, Germany.
authors.forename: Helen
authors.initials: H
authors.lastname: Niemeyer
authors.affiliation: Department of Clinical Psychological Intervention, Freie Universität Berlin, Berlin, Germany.|Berlin Center for Torture Victims, Zentrum ÜBERLEBEN, Berlin, Germany.
authors.forename: Maria
authors.initials: M
authors.lastname: Böttche
authors.affiliation: Integrated Research and Treatment Center, Center for Sepsis Control and Care, Jena University Hospital, Jena, Germany.
authors.forename: André
authors.initials: A
authors.lastname: Scherag
authors.affiliation: Department of Clinical Psychological Intervention, Freie Universität Berlin, Berlin, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Knaevelsrud
authors.affiliation: Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Jena, Germany.|Integrated Research and Treatment Center, Center for Sepsis Control and Care, Jena University Hospital, Jena, Germany.
authors.forename: Jenny
authors.identifier: 0000-0001-7535-7571
authors.initials: J
authors.lastname: Rosendahl
mesh_terms: D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003422:Critical Care / Q000523:psychology*; D005260:Female; D005858:Germany; D006801:Humans; D020407:Internet / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012044:Regression Analysis; D012107:Research Design; D018805:Sepsis / Q000523:psychology*; D012720:Severity of Illness Index; D018454:Spouses / Q000523:psychology*; D013313:Stress Disorders, Post-Traumatic / Q000628:therapy*; D016896:Treatment Outcome; D014850:Waiting Lists; D014956:Writing; D055815:Young Adult
keywords: Cognitive behavior therapy; Internet; Posttraumatic stress disorder; Randomized controlled trial; Sepsis