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
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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.
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Psychische Komorbidität bei muskuloskelettalen Erkrankungen
Baumeister, H., & Härter, M. C. (2010) · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz · doi:10.1007/s00103-010-1185-x · Cited by 23 · see citing works
Kein signifikanter Zusatznutzen als Add-on in der allgemeinärztlichen Routineversorgung
Baumeister, H. (2016) · InFo Neurologie + Psychiatrie · doi:10.1007/s15005-016-1601-3 · Cited by 2 · see citing works
Flagged first, then by citations
4 of the 106 references couldn’t be matched to a known paper.
Research works printed but not linked: 1
- [94]Breivik H, Collett B, Ventafridda V, et al Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain 2006; 10: 287 10.1016/j.ejpain.2005.06.009 16095934 · DOI · Paper page
Cited by
Sorted by citations
Josephine, K., Josefine, L., Philipp, D., David, E., & Harald, B. (2017) · Journal of Affective Disorders · doi:10.1016/j.jad.2017.07.021 · Cited by 341 · see citing works
The German Version of the Mobile App Rating Scale (MARS-G): Development and Validation Study
Messner, E.-M., Terhorst, Y., Barke, A., Baumeister, H., Stoyanov, S., Hides, L., Kavanagh, D., Pryss, R., Sander, L., & Probst, T. (2020) · JMIR mHealth and uHealth · doi:10.2196/14479 · Cited by 156 · see citing works
Self-citationLin, J., Faust, B., Ebert, D. D., Krämer, L., & Baumeister, H. (2018) · Journal of Medical Internet Research · doi:10.2196/jmir.9925 · Cited by 97 · see citing works
Etzelmueller, A., Radkovsky, A., Hannig, W., Berking, M., & Ebert, D. D. (2018) · Internet Interventions · doi:10.1016/j.invent.2018.01.003 · Cited by 75 · see citing works
Self-citationBaumeister, H., Paganini, S., Sander, L. B., Lin, J., Schlicker, S., Terhorst, Y., Moshagen, M., Bengel, J., Lehr, D., & Ebert, D. D. (2021) · Psychotherapy and Psychosomatics · doi:10.1159/000511881 · Cited by 55 · see citing works
Persuasive E-Health Design for Behavior Change
Baumeister, H., Kraft, R., Baumel, A., Pryss, R., & Messner, E.-M. (2019) · Studies in Neuroscience, Psychology and Behavioral Economics · doi:10.1007/978-3-030-31620-4_17 · Cited by 53 · see citing works
Self-citationSchlicker, S., Baumeister, H., Buntrock, C., Sander, L., Paganini, S., Lin, J., Berking, M., Lehr, D., & Ebert, D. D. (2020) · JMIR Mental Health · doi:10.2196/16398 · Cited by 46 · see citing works
Self-citationSander, L., Paganini, S., Lin, J., Schlicker, S., Ebert, D. D., Buntrock, C., & Baumeister, H. (2017) · BMC Psychiatry · doi:10.1186/s12888-017-1193-6 · Cited by 44 · see citing works
Internet- und mobilebasierte Ansätze
Baumeister, H., Lin, J., & Ebert, D. D. (2017) · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz · doi:10.1007/s00103-017-2518-9 · Cited by 40 · see citing works
Cong, W., Yu, P., Meng, B., Jia, X., & Jin, Z. (2021) · Annals of Palliative Medicine · doi:10.21037/apm-20-1900 · Cited by 33 · see citing works
Zhu, C., Xu, J., Lin, Y., Ju, P., Duan, D., Luo, Y., Ding, W., Huang, S., Chen, J., & Cui, D. (2018) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2018.00442 · Cited by 31 · see citing works
Moshe, I., Terhorst, Y., Paganini, S., Schlicker, S., Pulkki-Råback, L., Baumeister, H., Sander, L. B., & Ebert, D. D. (2022) · Journal of Medical Internet Research · doi:10.2196/38261 · Cited by 28 · see citing works
“Dropout was defined as completing 6 intervention modules, in accordance with the intervention developers [49,50].”
Freund, J., Titzler, I., Thielecke, J., Braun, L., Baumeister, H., Berking, M., & Ebert, D. D. (2020) · BMC Psychiatry · doi:10.1186/s12888-020-02800-z · Cited by 17 · see citing works
Optimizing the predictive power of depression screenings using machine learning
Terhorst, Y., Sander, L., Ebert, D. D., & Baumeister, H. (2023) · Digital Health · doi:10.1177/20552076231194939 · Cited by 11 · see citing works
Gardner, T., Schultz, R., Haskelberg, H., Newby, J. M., Wheatley, J., Millard, M., Faux, S. G., & Shiner, C. T. (2021) · Journal of Medical Internet Research · doi:10.2196/30880 · Cited by 11 · see citing works
Terhorst, Y., Braun, L., Titzler, I., Buntrock, C., Freund, J., Thielecke, J., Ebert, D., & Baumeister, H. (2020) · BMJ Open · doi:10.1136/bmjopen-2019-034271 · Cited by 9 · see citing works
Harrer, M., Ebert, D. D., Kuper, P. R., Paganini, S., Schlicker, S., Terhorst, Y., Reuter, B., Sander, L., & Baumeister, H. (2023) · Internet Interventions · doi:10.1016/j.invent.2023.100634 · Cited by 7 · see citing works
Gil, M., & Kim, S. (2022) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph19042142 · Cited by 7 · see citing works
Lutsch, A., Baumeister, H., Paganini, S., Sander, L., Terhorst, Y., & Domhardt, M. (2023) · Behaviour Research and Therapy · doi:10.1016/j.brat.2023.104369 · Cited by 5 · see citing works
Models of care for managing non-specific low back pain
Docking, S., Sridhar, S., Haas, R., Mao, K., Ramsay, H., Buchbinder, R., & O’Connor, D. A. (2025) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd015083.pub2 · Cited by 6 · see citing works
Paganini, S., Terhorst, Y., Sander, L., Lin, J., Schlicker, S., Ebert, D. D., Berking, M., Riper, H. M., & Baumeister, H. (2022) · Journal of Affective Disorders · doi:10.1016/j.jad.2022.04.004 · Cited by 4 · see citing works
Baumeister, H., Lin, J., & Ebert, D. D. (2017) · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz · Cited by 3 · see citing works
Meßner, E.-M., Kraft, R., Baumel, A., Pryss, R. C., & Baumeister, H. (2023) · Springer eBooks · doi:10.1007/978-3-662-65816-1_26 · Cited by 1 · see citing works
Gil, M., Kim, S., Kim, D., & Kim, S. (2023) · Family Process · doi:10.1111/famp.12924 · Cited by 1 · see citing works
Hariz, A. J., Chevreul, K., Daval, L., Husson, M., Alberti, C., & Michel, M. (2025) · Value in Health · doi:10.1016/j.jval.2025.01.023
Haller, N., Köbel, L. M., Schäffer, L., Overath, J., & Niederer, D. (2026) · Scientific Reports · doi:10.1038/s41598-026-54397-0
- 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.
- Affiliations
- University of Freiburg (DE)
- Friedrich-Alexander-Universität Erlangen-Nürnberg (DE)
- University of Vechta (DE)
- Leuphana University of Lüneburg (DE)
- Vrije Universiteit Amsterdam (NL)
- Universität Ulm (DE)
- Corresponding author
- Baumeister, Harald
- ORCID
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2017-12
- Volume
- 7
- Issue
- 12
- Pages
- e015226
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC5770830
- OpenAlex
- W2775963546
- Cited by
- 27
- References
- 106
- Citations by year
- 2026: 1 · 2025: 2 · 2023: 6 · 2022: 3 · 2021: 2 · 2020: 4 · 2019: 2 · 2018: 3 · 2017: 4
- FWCI
- 4.07
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ Open (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (acceptedVersion, other-oa)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (acceptedVersion)
- Multilingual Matters (Channel View Publications) (acceptedVersion, cc-by-nc)
- VU Research Portal (acceptedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (acceptedVersion)
- OPen Access Repositorium der Universität Ulm (OPARU) (Ulm University) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Universität Ulm, Kommunikations- und Informationszentrum (kiz)
- Funders
- Federal Ministry of Education and Research of Germany
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- depression, chronic back pain, online intervention, mobile-based interventions, guided self-help, orthopedic rehabilitation, cost-effectiveness, cost-utility analysis, depression severity, health-related quality of life, pain-related disability, self-efficacy, work capacity
- MeSH terms
- Adult, Back Pain, Cost-Benefit Analysis, Depression, Female, Germany, Humans, Male, Middle Aged, Psychiatric Status Rating Scales, Quality of Life, Research Design, Severity of Illness Index, Cognitive Behavioral Therapy, Treatment Outcome, Telemedicine, Internet, Suicidal Ideation, Chronic Pain, Text Messaging
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
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