Reducing the incidence of depression for patients with back pain and subclinical depression using an internet- and mobile-based intervention– Follow-up assessment of a pragmatic randomized controlled large-scale trial

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Background: Prevention of major depression (MDD) is of major public health relevance. However, most depression prevention trials worldwide lack appropriate follow-up assessments that include clinical interviews to assess the incidence of MDD. Within the framework of the WARD-BP study, funded by the BMBF, we established a so far self-funded prevention side-study called PROD-BP (Prevention of Depression in Back Pain Patients). As the funding of WARD-BP and the possibility of self-funding ends, PROD-BP will end with a post-treatment assessment. With a 12-months follow-up, however, PROD-BP would become the first large-scale depression prevention trial in this field. Methods: PROD-BP 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 with subthreshold depressive symptoms. The investigated intervention 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 and supervised psychologists provide guidance by sending feedback messages after each module. A total of 295 patients with chronic back pain without a clinician rated depressive disorder at baseline (PHQ ≥ 5; no SCID-5 depression diagnosis) have been recruited following orthopedic rehabilitation care and allocated to either intervention or treatment-as-usual (TAU) until July 2017, making the self-funded PROD-BP-study to one of the largest depression prevention trials ever conducted. Primary outcome is depression onset (SCID-5 diagnosis) at 12 months follow-up. Key secondary outcomes are quality of life, depression severity, pain intensity and disability, ability to work, intervention satisfaction and adherence as well as side effects of the intervention and costs. PROD-BP was designed and conducted following the highest methodological standards, supported by the methodological rigor of the large-scale, multi-centre WARD-BP study. Online assessments are scheduled at baseline and 9 weeks (already conducted until October 2017), 6 months and 12 months post-randomization. In the present applied funding period the assessment of the primary outcome and the medium- and long-term secondary outcomes takes place, as well as data clearance and data analyses and dissemination of results. Discussion: The PROD-BP trial is the first examining an IMI for depression prevention in a sample of chronic pain patients. It is implemented into routine orthopedic health care, specifically tailored to the sample of chronic back pain patients and very unusually well powered. With the proposed grant PROD-BP would be uplifted to become a landmark study in its field at relatively low costs.