TY - JOUR

T1 - Effectiveness and cost-effectiveness of a guided internet- and mobile-based depression intervention for individuals with chronic back pain

T2 - protocol of a multi-centre randomised controlled trial

AU - Lin, Jiaxi

AU - Sander, Lasse

AU - Paganini, Sarah

AU - Schlicker, Sandra

AU - Ebert, David

AU - Berking, Matthias

AU - Bengel, Jürgen

AU - Nobis, Stephanie

AU - Lehr, Dirk

AU - Mittag, Oskar

AU - Riper, Heleen

AU - Baumeister, Harald

N1 - Publisher Copyright: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

PY - 2017/12/1

Y1 - 2017/12/1

N2 - 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.

AB - 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.

KW - Psychology

KW - chronic back pain

KW - depression

KW - e-mental-health

KW - health care services research

KW - randomized controlled trial

KW - study protocol

UR - http://www.scopus.com/inward/record.url?scp=85046845288&partnerID=8YFLogxK

UR - https://www.mendeley.com/catalogue/c7f38fb1-4c71-3b23-a32e-b5dae120936f/

U2 - 10.1136/bmjopen-2016-015226

DO - 10.1136/bmjopen-2016-015226

M3 - Journal articles

C2 - 29288172

VL - 7

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 12

M1 - e015226

ER -