Researchers from the University of Freiburg, University of Erlangen-Nürnberg, and University of Ulm in Germany are conducting the first study examining the efficacy of Internet- and mobile device-based interventions to prevent depression in patients with chronic back pain.
“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,” wrote Lasse Sander, from the University of Freiburg, and colleagues.
The researchers will recruit 406 participants who have chronic back pain and who have undergone orthopedic rehabilitation but who do not have a depressive disorder at baseline. The participants will be randomly assigned either to intervention or to receive treatment as usual. Recruitment began in October 2015 and will continue until the target number has been reached. The trial is registered at the World Health Organization International Clinical Trials Registry Platform via the German Clinical Studies Trial Register (DRKS00007960).
The participants in the intervention group will use eSano BackCare-DP, an Internet-based, guided, chronic back pain-specific depression prevention intervention based on principles from cognitive behavioral therapy. There are 6 weekly sessions, 3 optional modules, and 2 booster sessions the participants can complete within 3 months on dates of their choice after the end of the last session.
The primary end point is the time to onset of MDD, measured by the Structured Clinical Interview for DSM via telephone at baseline and at 1-year postrandomization. Secondary outcomes include health-related quality of life, depression severity, pain intensity, pain-related disability, ability to work, and intervention satisfaction and adherence, as well as side effects of the intervention. Online assessments for these secondary outcomes will take place at baseline and at 9 weeks, as well as 6 and 12 months postrandomization.
An analysis will also be performed to examine the cost-effectiveness of the intervention from a societal and public health perspective.
Internet-based interventions can have certain limitations, including high drop-out rates, a bias toward recruiting participants already connected to the Internet, and negative side effects. The researchers are working to combat these possible limitations by providing guidance to participants with eCoaches, which have been shown to decrease drop-out rates, by integrating the intervention into routine care and asking all patients to participate (which will then also allow them to see which types of patients might be more willing to participate in online interventions and who might benefit most from them) and by mitigating possible negative side effects of the intervention by allowing a more flexible schedule and assessing possible negative side effects regularly.
“If this study — the first of its kind — shows to be effective, the intervention could be implemented into general (chronic) back pain and mental health treatment protocols as well as adapted to other chronically ill patient groups, thus helping to reduce the disease burden of depression for both affected persons and society,” the authors wrote. “Thus, the results of this study will be of major public health relevance.”
Sander L, Paganini S, Lin J, et al. 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. BMC Psychiatry. 2017;17(36). doi: 10.1186/s12888-017-1193-6