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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.

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Based upon the concept of supportive-expressive therapy (SET), we developed a psychodynamic group treatment manual for social phobia, with a special focus on the patients' individual core conflictual relationship themes, their universality, as well as interventions promoting group processes and therapeutic factors of group therapy. We introduce the new concept and report results of a pilot case study (N=8). Analyses revealed a pre-post-treatment effect size of g=0.64 (95% CI [0.29; 1.00]) on the primary outcome measure, the Liebowitz Social Anxiety Scale (LSAS). Furthermore we obtained positive evidence with regard to acceptance, safety and feasibility of the psychodynamic group therapy concept for social phobia. Subsequent proof-of-concept studies are required to foster treatment development and to proof the replicability of results.

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.

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