No 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.

No abstract

Background Negative or adverse effects of psychological treatments are increasingly a focus of psychotherapy research. Yet, we still know little about the prevalence of these effects. Aims Starting from a representative national sample, the prevalence of negative effects and malpractice was determined in a subsample of individuals reporting psychotherapy currently or during the past 6 years. Method Out of an initial representative sample of 5562 individuals, 244 were determined to have had psychotherapy within the past 6 years. Besides answering questions related to treatment, its effects and the therapists, patients filled out the Negative Effects Questionnaire, items of the Inventory of Negative Effects of Psychotherapy reflecting malpractice and the Helping Alliance Questionnaire, and rated psychotherapeutic changes in different areas. Results Rates of positive changes related to therapy varied between 26.6% (relationship to parents) and 67.7% (improvement in depressed mood). Deteriorations were most commonly related to physical well-being (13.1%), ability to work (13.1%) and vitality (11.1%). Although patients generally reported a positive helping alliance, many of them reported high rates of negative effects (though not always linked to treatment). This was especially true of the experience of unpleasant memories (57.8%), unpleasant feelings (30.3%) and a lack of understanding of the treatment/therapist (19.3/18.4%). Indicators of malpractice were less common, with the exception that 16.8% felt violated by statements of their therapist. Conclusions This study helps to better estimate aspects of negative effects in psychotherapy ranging from deteriorations, specific effects and issues of malpractice that should be replicated and specified in future studies.