Experiences and perceptions of patients with psoriatic arthritis participating in a trial of faecal microbiota transplantation: a nested qualitative study.

OBJECTIVES: Patients' first-hand experiences of faecal microbiota transplantation (FMT) performed in a rheumatological care setting have yet to be elucidated. The objectives were to explore participants' perceptions of being part of an FMT trial thereby identifying potential trial participation effects and enlightening the patient perspective on the outlook for future FMT trials in rheumatic diseases. DESIGN: In a qualitative study nested within a double-blind, randomised, placebo-controlled trial (RCT) testing FMT as a potential new antirheumatic treatment, semistructured telephone interviews were conducted following the trial participants' final 26-week visit. Qualitative researchers, who did not take part in the main trial, performed the interviews and the primary analysis. The experiences explored related to the conduct of the RCT and changes in the participants' everyday life. The analysis was carried out using a thematic approach. SETTING: A Danish rheumatology university outpatient clinic with nationwide inclusion. PARTICIPANTS: The study included 10 patients with psoriatic arthritis (PsA) who were unaware of their treatment allocation (FMT/sham transplantation) and completed the final 26-week trial visit. RESULTS: Participation in the RCT influenced the patients' understanding of PsA and induced positive changes in their everyday life. Renewed hopes for the future in addition to a feeling of enhanced care contributed to significant trial participation effects. FMT was deemed a tolerable and safe treatment. CONCLUSIONS: Discrepancies between the clinical and the research setting should be considered when discussing the clinical relevance of the results of the RCT. Overall, patients with PsA who have participated in an RCT testing FMT find the treatment acceptable and safe encouraging more research into the field of microbiota-targeted interventions in rheumatic diseases. TRIAL REGISTRATION NUMBER: NCT03058900; Pre-results.

Body therapy versus treatment as usual among Danish veterans with PTSD: Study protocol for a randomised controlled trial combined with a qualitative study.

BACKGROUND: Many veterans suffer from Post-Traumatic Stress Disorder (PTSD) after returning from military missions. This implies complex physical and psychosocial problems for veterans and their families. Treatment options today are primarily medically and psychologically founded but treatment response is incomplete. Body therapy for PTSD is scarcely researched though subject of increased attention. In 2015, a Danish pilot study was conducted exploring body therapy for PTSD. The study showed positive results and formed basis for a randomised controlled trial. This paper outlines the protocol for this trial. METHODS: The intervention will be evaluated in a two-arm randomised controlled trial (1:1). The trial will include 42 veterans with PTSD recruited by the Danish Military Psychiatric Centre. The intervention group receives treatment as usual and weekly body therapy treatment as add-on. The control group receives treatment as usual (TAU). Participants will complete four questionnaires assessing PTSD, depression, quality of life, function level and body awareness: at baseline, and at 3 months, 6 months and 12 months post baseline. Linear regression models and mixed effects models will be used to assess intervention effects. Furthermore, an ethnographic study will examine how the participants experience the treatment and changes in their everyday life. The ethnographic study is based on in-depth interviews, participant observations and focus groups. A mixed method, convergent parallel design will be applied. DISCUSSION: This study examines the efficacy of body therapy for veterans with PTSD and how the treatment is experienced and affects daily life. The study will contribute with important knowledge on an alternative treatment for PTSD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03777800.

Implementing Mental Health Promotion Initiatives-Process Evaluation of the ABCs of Mental Health in Denmark.

Treatment and prevention alone are unlikely to make a significant difference in reducing the burden of poor mental health and mental illness. Therefore, mental health promotion (MHP) initiatives are advocated. In 2014, the ABCs of mental health (ABCs) partnership was established in Denmark; in the partnership, partner organisations, e.g., municipalities and NGOs, use a research-based framework for MHP, the ABC-framework, to develop and implement MHP initiatives. This paper has two aims: (1) to outline the overall characteristics of these MHP initiatives; and (2) to explore local coordinator and stakeholder perceptions of the implementation processes and the impact of the MHP initiatives. Questionnaire surveys, individual interviews and group interviews were conducted during 2017-2020. The MHP initiatives were grouped according to three strategies: building MHP capacity, campaign activities to promote mental health awareness and knowledge and establishing and promoting opportunities to engage in mentally healthy activities. The ABC-framework was positively received and viewed as providing relevant knowledge for working with MHP as well as fostering intersectoral and interprofessional collaborations. However, using a bottom-up approach to develop and implement MHP initiatives can be time-consuming and resource demanding, and it requires a deliberate balancing of local adaptability and concrete guidance when engaging stakeholders and implementers. Overall, using the ABC-framework to develop and implement MHP initiatives holds great promise for advancing and promoting MHP practice.