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. Interventions: The 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 Relevance: Results 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.
| Original language | English |
|---|---|
| Pages (from-to) | 1001-1011 |
| Number of pages | 11 |
| Journal | JAMA Psychiatry |
| Volume | 77 |
| Issue number | 10 |
| Early online date | 27 May 2020 |
| DOIs | |
| Publication status | Published - Oct 2020 |
Funding
Ministry of Education and Research) and DFG (German Research Foundation) during the conduct of the study and personal fees from Psychotherapy Training Institutes outside the submitted work. Dr Paganini reported receiving grants from The German Federal Ministry of Education and Research during the conduct of the study. Dr Schlicker reported receiving grants from BMBF and DFG during the conduct of the study and personal fees from Workshops on E-Mental Health outside the submitted work. Dr Ebert reported holding shares in the GET.On Institut GmbH; receiving personal fees for advice from several companies and health insurance providers and for lectures from psychotherapy and psychiatry associations; and receiving third-party funding from health insurance providers. Dr Baumeister reported receiving grants from BMBF and DFG during the conduct of the study, BARMER Health Insurance, and SVLFG Health Insurance; receiving personal fees from Psychotherapy Chamber, psychotherapy and psychiatry associations, and psychotherapy training institutes outside the submitted work; and being a speaker for E-Mental Health Special Interest Group (SIG) of German Psychological Society, Internet-Based Interventions in Chronic Medical Conditions SIG of ISRII, E-Health Task Force of German Society for Rehabilitation Sciences. No other disclosures were reported. Funding/Support: This trial was funded by grant 01GY1330 from the German Federal Ministry of Education and Research and grant BA3407/5-1 from the DFG funded the trial. The article processing charge was funded by the German Research Foundation (DFG) and the Albert Ludwigs University Freiburg in the funding programme Open Access Publishing. This trial is conducted within the framework of the project “Effectiveness of a guided web-based intervention for depression in back pain rehabilitation aftercare” funded by the German Federal Ministry of Education and Research (grant number: 01GY1330A). The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript.
| Funders | Funder number |
|---|---|
| BARMER Health Insurance | |
| German Society for Rehabilitation Sciences | |
| ISRII | |
| Deutsche Forschungsgemeinschaft | |
| Bundesministerium für Bildung und Forschung | BA3407/5-1, 01GY1330A |
| Albert-Ludwigs-Universität Freiburg |
