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BMJ Open. 2017 Dec 28;7(12):e015226. doi: 10.1136/bmjopen-2016-015226.

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.

Author information

1
Department of Rehabilitation Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Freiburg, Germany.
2
Psychology Department, Health Psychology Section, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), London, United Kingdom.
3
Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Erlangen-Nürnberg, Erlangen, Germany.
4
Department of Gerontology, University of Vechta, Vechta, Germany.
5
Department of Psychology, Leuphana University Lüneburg, Lüneburg, Germany.
6
Section of Health Care Research and Rehabilitation, Center for Medical Biometry and Medical Informatics, Medical Center, University of Freiburg, Freiburg, Germany.
7
Department of Clinical, Neuro and Developmental Psychology, VU University, Amsterdam, The Netherlands.
8
Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Ulm, Ulm, Germany.

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.

KEYWORDS:

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

PMID:
29288172
PMCID:
PMC5770830
DOI:
10.1136/bmjopen-2016-015226
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

Competing interests: JL, LS, SP, SS, JB, SN, OM, HR and HB report no conflict of interest. DE, MB and DL are stakeholders of the ’Institute for Online Health Trainings', a company aiming to transfer scientific knowledge related to the present research into routine healthcare. A committee of independent scientists has been formed (Data Safety and Monitoring Board (DSMB)) to supervise study-related decisions and prevent any influence of a potential conflict of interest.

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