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Can major depression be prevented in routine health care for patients with persistent back pain?
In this randomized clinical trial of 295 adults with persistent back pain, participants who received a guided, web-based, self-help intervention as an adjunct to treatment as usual showed a significant reduction in the incidence of major depressive episodes over a 12-month period compared with participants who received treatment as usual only.
This finding suggests that a proactive, web-based self-help intervention is an appropriate, low-threshold therapy in routine health care that can reduce the incidence of major depressive episodes in patients with persistent back pain.
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.
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.
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.
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.
German Clinical Trials Register Identifier: DRKS00007960
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: March 16, 2020.
Corresponding Author: Lasse B. Sander, PhD, Institute of Psychology, Department of Rehabilitation Psychology and Psychotherapy, Albert-Ludwigs-University of Freiburg, Engelbergerstr 41, 79085 Freiburg, Germany (firstname.lastname@example.org).
Published Online: May 27, 2020. doi:10.1001/jamapsychiatry.2020.1021
Author Contributions: Drs Sander and Baumeister had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Sander, Paganini, Lin, Spanhel, Ebert, Baumeister.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Sander, Terhorst, Lin, Baumeister.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Sander, Terhorst, Buntrock.
Obtained funding: Ebert, Baumeister.
Administrative, technical, or material support: Sander, Paganini, Terhorst, Schlicker, Lin, Spanhel, Ebert, Baumeister.
Supervision: Lin, Ebert, Baumeister.
Other—adaption and development of the intervention content and provision of expertise on economic evaluation: Paganini.
Conflict of Interest Disclosures: Dr Sander reported receiving grants from BMBF (Federal 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.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: see Supplement 3.
Additional Contributions: We thank colleagues and study assistants for being part of the development of previous interventions that partly form the basis of eSano BackCare-DP. Jürgen Bengel, PhD, Kristin Kieselbach, PhD, and Anja Göritz, PhD, Albert-Ludwigs-University of Freiburg, provided their expertise in the treatment of chronic pain patients. Ellen Meierotto, Dipl.-Psych., supervised the SCID interviewers. Julian Mack, MSc Psych, Albert-Ludwigs-University of Freiburg, and Anna Fritz, BSc Psych, assisted with data analysis and final review of the manuscript. The Clinical Trial Unit Freiburg and an independent Data and Safety Monitoring Board comprising researchers not involved in the study (Martin Hautzinger, PhD, Martin Härter, PhD, and Levente Kriston, PhD) oversaw and monitored the trial; Christina Ramsenthaler, PhD, Albert-Ludwigs-University of Freiburg, proofread the manuscript. These individuals received no additional compensation, outside of their usual salary, for their contributions. Thank you to the following orthopedic rehabilitation facilities for their cooperation during the on-site participant recruitment: Schoen Klinik, Bad Staffelstein; Rehaklinik Sonnhalde, Donaueschingen; RehaKlinikum Bad Säckingen; Städt. Rehakliniken Bad Waldsee; Schwarzwaldklinik Orthopädie–Abteilung Medizinische Rehabilitation, Bad Krozingen; Rheintalklinik Bad Krozingen; REGIO-Reha Tagesklinik, Freiburg; and Universitäts-und Rehabilitationskliniken, Ulm. Thank you to the following orthopedic rehabilitation units involved in the second recruitment strategy: Ambulantes Rehabilitationszentrum Bautzen; Medical Park Am Kirschbaumhügel, Bad Wiessee; Klinik Wendelstein, Bad Aibling; Edith Stein Fachklinik, Bad Bergzabern; ZAR Zentrum für ambulante Rehabilitation im MineralBad Cannstatt, Bad Cannstatt; Caspar Heinrich Klinik, Bad Driburg; Rehazentrum Bad Eilsen; Fachklinik und Moorbad Bad Freienwalde; Orthopädie-Zentrum Bad Füssing; Paracelsus-Klinik an der Gande, Bad Gandersheim; HolsingVital, Bad Holzhausen; Deegenbergklinik, Bad Kissingen; Frankenklinik Bad Kissingen; Mittelbayerisches Rehabiliatationszentrum Klinik Luitpold Klinik Maximilian, Bad Kötzting; Kurpark Klinik, Bad Nauheim; Klinik Niedersachsen, Bad Nenndorf; Landgrafen Klinik, Bad Nenndorf; MediClin Schlüsselbad Klinik, Bad Peterstal-Griesbach; Klinik der Fürstenhof, Bad Pyrmont; Klinik Weser, Bad Pyrmont; Klinik Münsterland, Bad Rothenfelde; Klinik am Park, Bad Sassendorf; Klinik Lindenplatz, Bad Sassendorf; Klinik Dübener Heide, Bad Schmiedeberg; Asklepios Klinik Am Kurpark, Bad Schwartau; Klinik Hoher Meissner, Bad Sooden-Allendorf; Klinik Werra, Bad Sooden-Allendorf; THERAmed Zentrum für Therapie und Gesundheit, Bad Staffelstein; Reha-Zentrum Bad Steben; Klinik Birkental, Bad Wildungen; MediClin Klinik für Akutpsychosomatik und Reha-Zentrum am Hahnberg, Bad Wildungen; Rheumaklinik Bad Wildungen; Klinik Dr Franz Dengler, Baden-Baden; REHA Baunatal; Gesundheitszentrum Prenzlauer Berg, Berlin; MEDIAN Klinik Berlin Kladow, Berlin; Reha Tagesklinik im Forum Pankow, Berlin; ZAR, Berlin; Reha-Zentrum HESS, Bietigheim-Bissingen; Klinik und Rehabiliationszentrum Lippoldsberg, Bodenfelde; Vitalis, Brandenburg; Fachklinikum Brandis; Gesundheitszentrum Lang, Dinslaken; Klinik Königsfeld, Ennepetal; REHAKTIV-Oberberg, Gummersbach; Gesundheitszentrum Hannover; Ortho-Mobile Hattingen; Kurparkklinik Heilbad Heiligenstadt; Fachklinik Herzogenaurach; Therapiezentrum Schmerz weg, Hofheim; Fachklinik Enzensberg, Hopfen am See; Tagesklinik für Rehabilitation und Prävention, Hoyerswerda; Fachklinik Ichenhausen; Reha Vital, Ingelheim; Argentalklinik, Isny; ZANR Kaiserslautern; Ambulantes Zentrum für Rehabilitation und Prävention am Entenfang, Karlsruhe; Sport Reha Kiel; Therapiezentrum Brüderhaus, Koblenz; UniReha, Köln; Salvea Krefeld; MediClin Hedon Klinik, Lingen; Tagesklinik am Kurpark, Lüneburg; MEDIAN Saale Klinik, Bad Kösen; Medicos, Osnabrück; Asklepios Klinik, Schaufling; MEDIAN Klinik, Schlangenbad; Schön Klinik Berchtesgadener Land, Schönau am Königssee; MediClin Klinikum, Soltau; Ziegelfeld-Klinik, St Blasien; rehamed Stuttgart; Gesundheitszentrum Chiemgau, Traunstein; MEDIAN Rehaklinik Aukammtal, Wiesbaden; Impuls Reha- und Gesundheitszentrum, Würzburg.
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