Effectiveness and cost-effectiveness of a guided internet- and mobile-based depression intervention for individuals with chronic back pain: Protocol of a multi-centre randomised controlled trial

Jiaxi Lin, Lasse Sander, Sarah Paganini, Sandra Schlicker, David Ebert, Matthias Berking, Jürgen Bengel, Stephanie Nobis, Dirk Lehr, Oskar Mittag, Heleen Riper, Harald Baumeister*

*Corresponding author for this work

Research output: Contribution to JournalArticleAcademicpeer-review

Abstract

Introduction Depression often co-occurs with chronic back pain (CBP). Internet and mobile-based interventions (IMIs) might be a promising approach for effectively treating depression in this patient group. In the present study, we will evaluate the effectiveness and cost-effectiveness of a guided depression IMI for individuals with CBP (eSano BackCare-D) integrated into orthopaedic healthcare. Methods and analysis In this multicentre randomised controlled trial of parallel design, the groups eSano BackCare-D versus treatment as usual will be compared. 210 participants with CBP and diagnosed depression will be recruited subsequent to orthopaedic rehabilitation care. Assessments will be conducted prior to randomisation and 9 weeks (post-treatment) and 6 months after randomisation. The primary outcome is depression severity (Hamilton Rating Scale for Depression-17). Secondary outcomes are depression remission and response, health-related quality of life, pain intensity, pain-related disability, self-efficacy and work capacity. Demographic and medical variables as well as internet affinity, intervention adherence, intervention satisfaction and negative effects will also be assessed. Data will be analysed on an intention-to-treat basis with additional per-protocol analyses. Moreover, a cost-effectiveness and cost-utility analysis will be conducted from a societal perspective after 6 months. Ethics and dissemination All procedures are approved by the ethics committee of the Albert-Ludwigs-University of Freiburg and the data security committee of the German Pension Insurance (Deutsche Rentenversicherung). The results will be published in peer-reviewed journals and presented on international conferences. Trial registration number DRKS00009272; Pre-results.

Original languageEnglish
Article numbere015226
JournalBMJ Open
Volume7
Issue number12
DOIs
Publication statusPublished - 1 Dec 2017

Funding

Funding This study is funded by the Federal Ministry of Education and Research of Germany (project: effectiveness of a guided web-based intervention for depression in back pain rehabilitation aftercare, grant number: 01GY1330A). This funding source has no influence on the design of this study and will not influence its execution, analyses, interpretation of the data or decision to submit results.

FundersFunder number
Bundesministerium für Bildung und Forschung01GY1330A

    Keywords

    • chronic back pain
    • depression
    • e-mental-health
    • health care services research
    • randomized controlled trial
    • study protocol

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