Effectiveness and cost-effectiveness of a guided internet- and mobile-based despair intervention for people with continual again ache: protocol of a multi-centre randomised managed trial.
BMJ Open. 2017 Dec 28;7(12):e015226
Authors: Lin J, Sander L, Paganini S, Schlicker S, Ebert D, Berking M, Bengel J, Nobis S, Lehr D, Mittag O, Riper H, Baumeister H
INTRODUCTION: Melancholy typically co-occurs with continual again ache (CBP). Web and mobile-based interventions (IMIs) is perhaps a promising strategy for successfully treating despair on this affected person group. Within the current research, we are going to consider the effectiveness and cost-effectiveness of a guided despair IMI for people with CBP (eSano BackCare-D) built-in into orthopaedic healthcare.
METHODS AND ANALYSIS: On this multicentre randomised managed trial of parallel design, the teams eSano BackCare-D versus therapy as standard will probably be in contrast. 210 contributors with CBP and recognized despair will probably be recruited subsequent to orthopaedic rehabilitation care. Assessments will probably be carried out previous to randomisation and 9 weeks (post-treatment) and 6 months after randomisation. The first consequence is despair severity (Hamilton Ranking Scale for Melancholy-17). Secondary outcomes are despair remission and response, health-related high quality of life, ache depth, pain-related incapacity, self-efficacy and work capability. Demographic and medical variables in addition to web affinity, intervention adherence, intervention satisfaction and detrimental results will even be assessed. Knowledge will probably be analysed on an intention-to-treat foundation with extra per-protocol analyses. Furthermore, a cost-effectiveness and cost-utility evaluation will probably be carried out from a societal perspective after 6 months.
ETHICS AND DISSEMINATION: All procedures are authorized by the ethics committee of the Albert-Ludwigs-College of Freiburg and the info safety committee of the German Pension Insurance coverage (Deutsche Rentenversicherung). The outcomes will probably be revealed in peer-reviewed journals and offered on worldwide conferences.
TRIAL REGISTRATION NUMBER: DRKS00009272; Pre-results.
PMID: 29288172 [PubMed – in process]