Effectiveness of a Guided Web-Based Self-help Intervention to Prevent Depression in Patients With Persistent Back Pain

Abstract

IMPORTANCE Depression is a frequent comorbid condition in patients with persistent back pain and is associated with substantial adverse consequences, including the risk of developing opioid use disorders. Shifting the focus from depression treatment to preventing depression might be a viable way to reduce the disease burden.OBJECTIVE To evaluate the effectiveness of a web-based self-help intervention to reduce the incidence of major depressive episode (MDE) in patients with persistent back pain. DESIGN, SETTING, AND PARTICIPANTS Prevention of Depression in Back Pain Patients (PROD-BP) was a pragmatic, observer-blinded randomized clinical trial with a parallel design conducted in Germany. Eligible adults with a diagnosis of persistent back pain and subclinical depressive symptoms, but who were depression free, were recruited either on-site or after discharge from 82 orthopedic clinics between October 1, 2015, and July 31, 2017. All analyses were conducted according to the intention-to-treat principle from October 31, 2018, to April 30, 2019. INTERVENTIONSThe intervention group received an e-coach-guided, web-based self-help intervention that was based on cognitive behavioral therapy and tailored to the needs of patients with persistent back pain. The intervention included 6 obligatory modules and 3 optional modules to be completed by participants as well as feedback from e-coaches. Both the intervention and control groups had unrestricted access to treatment as usual.MAIN OUTCOMES AND MEASURES Primary outcome was time to onset of an MDE over a 12-month period as assessed by blinded diagnostic raters using the Structured Clinical Interview for DSM-5. Secondary outcomes included depression severity, quality of life, pain intensity, pain-related disability, pain self-efficacy, work capacity, and user satisfaction assessed with a variety of instruments.RESULTS A total of 295 participants (mean [SD] age, 52.8 [7.7] years; 184 women [62.4%]) were recruited and randomized to either the intervention group (n = 149) or control group (n = 146). The intervention reduced the risk of MDE onset by 52% (hazard ratio, 0.48; 95% CI, 0.28-0.81; P < .001). Twenty-one participants (14.1%) in the intervention group and 41 participants (28.1%) in the control group experienced an MDE over the 12-month period. The number needed to treat to prevent 1 new case of MDE was 2.84 (95% CI, 1.79-9.44). CONCLUSIONS AND RELEVANCEResults of this trial showed that among patients with persistent back pain, depression can be prevented by a guided web-based self-help intervention in addition to treatment as usual. This finding suggests that using a scalable digital approach to integrate psychological treatment into routine pain management is feasible.TRIAL REGISTRATION German Clinical Trials Register Identifier: DRKS00007960

Lessons learned from an attempted randomized-controlled feasibility trial on “WIDeCAD” - An internet-based depression treatment for people living with coronary artery disease (CAD)

“…The informed consent process could have been too complicated or the described requirements for study participation might have been perceived as too demanding (7 weekly modules, 2 measurements, 1 booster module, technical demands). However, these obstacles to successful clinical trials in patients with somatic diseases and depression were also present in other trials of the present research group using similar interventions ( Nobis et al, 2015 ; Bauereiß et al, 2017 ; Baumeister et al, 2020 ; Sander et al, 2020 ). All of these trials have been successfully completed and showed mostly promising results regarding uptake and effectiveness ( Nobis et al, 2015 ; Bauereiß et al, 2017 ; Baumeister et al, 2020 ; Sander et al, 2020 ).…”

“…However, these obstacles to successful clinical trials in patients with somatic diseases and depression were also present in other trials of the present research group using similar interventions ( Nobis et al, 2015 ; Bauereiß et al, 2017 ; Baumeister et al, 2020 ; Sander et al, 2020 ). All of these trials have been successfully completed and showed mostly promising results regarding uptake and effectiveness ( Nobis et al, 2015 ; Bauereiß et al, 2017 ; Baumeister et al, 2020 ; Sander et al, 2020 ). Thus, whilst the informed consent process has likely an impact on uptake, this alone does not explain the recruitment problems seemingly specific to psychotherapy trials on patients with CAD.…”

“…The present intervention is based on professional and patient feedback, however, not specific to CAD. Thus, we still need to examine whether there is a need of depression interventions tailored to patients' conditions ( Nobis et al, 2015 ; Baumeister et al, 2020 ; Sander et al, 2020 ) or whether a more generic transdiagnostic intervention approach is sufficiently effective.…”

Clinical and Cost-Effectiveness of PSYCHOnlineTHERAPY: Study Protocol of a Multicenter Blended Outpatient Psychotherapy Cluster Randomized Controlled Trial for Patients With Depressive and Anxiety Disorders

“…From a conceptual point of view, blended therapy approaches can be subdivided into (1) sequential and (2) integrated blended therapy concepts focusing on (a) maximizing the effectiveness of psychotherapy or (b) maximizing the efficiency of psychotherapy (19). Examples for sequential blended therapy concepts are IMIs provided prior to on-site psychotherapy, e.g., during waitingtime (25), or IMIs following on-site psychotherapy, e.g., as inpatient aftercare and relapse prevention (26)(27)(28).…”

Does m-health based exercise (guidance plus education) improve efficacy in patients with chronic low-back pain？A preliminary report on the intervention’s significance

“…Additionally, medical resources are unevenly distributed in China [12] ,as a result, patients in remote areas have di culty in receiving accurate and scienti c-educational information. With the emergence of mobile health (m-health), solutions to di cult problems are provided [13][14] . A preliminary study suggested that application (app)-based patient self-management has a better effect [15] .…”