Effectiveness and cost-effectiveness of a guided Internet- and mobile-based intervention for the indicated prevention of major depression in patients with chronic back pain—study protocol of the PROD-BP multicenter pragmatic RCT

Sander et al. BMC Psychiatry (2017) 17:36 DOI 10.1186/s12888-017-1193-6 STUDY PROTOCOL Open Access Effectiveness and cost-effectiveness of a guided Internet- and mobile-based intervention for the indicated prevention of major depression in patients with chronic back pain—study protocol of the PROD-BP multicenter pragmatic RCT L. Sander1,2*, S. Paganini1, J. Lin1, S. Schlicker3, D. D. Ebert3, C. Buntrock3 and H. Baumeister4 Abstract Background: Reducing the disease burden of major depressive disorder (MDD) is of major public health relevance. The prevention of depression is regarded as one possible approach to reach this goal. People with multiple risk factors for MDD such as chronic back pain and subthreshold depressive symptoms may benefit most from preventive measures. The Internet as intervention setting allows for scaling up preventive interventions on a public mental health level. Methods: This study is a multicenter pragmatic randomized controlled trial (RCT) of parallel design aiming to investigate the (cost-) effectiveness of an Internet- and mobile-based intervention (IMI) for the prevention of depression in chronic back pain patients (PROD-BP) with subthreshold depressive symptoms. eSano BackCare-DP is a guided, chronic back pain-specific depression prevention intervention based on cognitive behavioral therapy (CBT) principles comprising six weekly plus three optional modules and two booster sessions after completion of the intervention. Trained psychologists provide guidance by sending feedback messages after each module. A total of 406 patients with chronic back pain and without a depressive disorder at baseline will be recruited following orthopedic rehabilitation care and allocated to either intervention or treatment-as-usual (TAU). Primary patient-relevant endpoint of the trial is the time to onset of MDD measured by the telephone-administered Structured Clinical Interview for DSM (SCID) at baseline and 1-year post-randomization. Key secondary outcomes are health-related quality of life, depression severity, pain intensity, pain-related disability, ability to work, intervention satisfaction and adherence as well as side effects of the intervention. Online assessments take place at baseline and 9 weeks as well as 6 and 12 months post-randomization. Cox regression survival analysis will be conducted to estimate hazard ratio at 12-month follow-up. Moreover, an economic analysis will be conducted from a societal and public health perspective. (Continued on next page) * Correspondence: 1 Institute of Psychology, Department of Rehabilitation Psychology and Psychotherapy, University of Freiburg, Engelbergerstr. 41, D-79085 Freiburg, Germany 2 Medical Faculty, Medical Psychology and Medical Sociology, University of Freiburg, Hebelstraße 29, Freiburg 79104, Germany Full list of author information is available at the end of the article © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Sander et al. BMC Psychiatry (2017) 17:36 Page 2 of 13 (Continued from previous page) Discussion: This is the first study examining an IMI for depression prevention in a sample of chronic pain patients. If this implementation of a depression prevention IMI into orthopedic aftercare proves effective, the intervention could be integrated into routine care with minimal costs and extended for use with other chronic diseases. Results will have implications for researchers, health care providers and public health policy makers. Trial registration: The trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register (DRKS): DRKS00007960. Registered 12 August 2015. Keywords: Prevention, RCT, eHealth, Internet and mobile based, Major depression, Chronic back pain, CBT, Effectiveness, Economic evaluation Background Major depressive disorder (MDD) is related to high disease burden for both people affected and society [1]. In a recent literature review investigating global variation in the prevalence and incidence of MDD, a global point prevalence of 4.7%, a lifetime prevalence between 10 and 15% and a global incidence of 3.0% have been reported [2, 3]. It is estimated that existing psychological and pharmacological treatments have the potential to avert only 36% of the burden of MDD, and only when assuming perfectly efficient provision of existing treatments in terms of coverage, patient compliance, an d clinician competence [4, 5]. Thus, we are either in need of more powerful interventions for treating depression or we should aim at diminishing the likelihood of developing depression in the first place, highlighting prevention of depression as a promising approach. Recent research suggests that psychological preventive interventions such as cognitive behavioral therapy (CBT) or interpersonal psychotherapy have the potential to prevent a clinically significant number of new depression cases [6]. A meta-analysis of 32 randomized controlled trials (RCTs) reported a reduced incidence rate for MDD of 21% (incidence rate ratio = 0.79, 95% confidence interval: 0.69–0.91) when comparing psychotherapy-based preventive interventions with usual care or wait list conditions. While the effectiveness of preventive interventions seems sufficiently documented, it remains challenging to identify target populations that benefit most from preventive measures [7]. According to Cuijpers and colleagues [8] two factors need be taken into account: the “impact” and the “effort” of preventive measures. An adequate “impact” means that prevention must lead to a substantial reduction of total disease burden. Therefore, a substantial proportion of new cases must be prevented if assembled risk indicators are fully blocked. A reasonable level of “effort” is primarily defined as a low number needed to be treated (NNT) to prevent one new case of MDD. Additionally, persons at risk should be easily identifiable and interventions should not only be costeffective but also low priced to allow for their implementation at a population level. From this viewpoint, chronically medically ill patients appear to be a meaningful target population for the prevention of MDD, given the substantially increased prevalence for MDD in this population compared to the general population [9, 10]. In addition, comorbid MDD in medically ill patients is associated with numerous negative implications such as problems in the physicia (...truncated)