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

IntroductionAs 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.Methods and analysisParticipants 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.Ethics and disseminationThe 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.Trial registration numberPre-results, DRKS00010676.

The Effectiveness of Internet-Based Cognitive Behavioral Therapy in Treatment of Psychiatric Disorders

“…In diabetes mellitus, one of the most common chronic medical illnesses, depression is twice as common when compared to the general population [ 35 ]. Generic programs offering ICBT were found to be efficient and acceptable in patients with diabetes and depression [ 5 ]. However, there is a need to tailor programs to those with diabetes mellitus and to further evaluate outcomes in the long-term.…”

“…The study found that IB-CBWT was effective in this particular cohort of patients. Additionally, It could be easily translated into multiple languages and spread globally [ 5 ] (Table 1 ).…”

“…ICBT is used to manage various psychiatric disorders such as mild to moderate depression and other disorders such as anxiety, obsessive compulsive disorder (OCD), and panic disorder [ 1 - 3 ]. ICBT has also been used to treat patients who have chronic illnesses such as diabetes with comorbidities such as depression and in those who received intensive care and had developed post-traumatic stress disorder (PTSD) [ 4 - 5 ]. Traditional therapies face drawbacks, including cost inefficiency and a lack of follow-up, especially among younger adults and patients belonging to a low socio-economic status, but ICBT has been shown to be more cost-effective in this context [ 6 - 7 ].…”

Effectiveness of Cognitive-Emotional Training on Post-Traumatic Stress Disorder in Women with Breast Cancer: A Clinical Trial Study

“…Gawlytta et al (25), evaluated the effectiveness of internet-based cognitive-behavioral intervention on the reduction of PTSD after severe care of sepsis among patients and their spouses. According to their results, the symptoms of PTSD changed during the intervention and led to the elimination of PTSD at the end of the intervention, which is in line with this study.…”

Long-term outcome in 324 polytrauma patients: what factors are associated with posttraumatic stress disorder and depressive disorder symptoms?

“…Internet-based strategies are able to overcome the trouble with stigmatisation and also availability of health care professionals which makes it a valuable option in patients suffering from PTSD [ 67 ]. Upcoming studies also deal with specifications such as internet-based cognitive-behavioural writing therapy [ 68 ].…”