TY - JOUR

T1 - Effectiveness of a Guided Internet- and Mobile-Based Intervention for Patients with Chronic Back Pain and Depression (WARD-BP): A Multicenter, Pragmatic Randomized Controlled Trial

AU - Baumeister, Harald

AU - Paganini, Sarah

AU - Sander, Lasse Bosse

AU - Lin, Jiaxi

AU - Schlicker, Sandra

AU - Terhorst, Yannik

AU - Moshagen, Morten

AU - Bengel, Jürgen

AU - Lehr, Dirk

AU - Ebert, David Daniel

N1 - Funding Information: L.B.S. and S.S. have received payments for workshops on e-mental-health. H.B. received consultancy fees, reimbursement of congress attendance and travel costs as well as payments for lectures from Psychotherapy and Psychiatry Associations as well as Psychotherapy Training Institutes in the context of E-Mental-Health topics. He has been the beneficiary of study support (third-party funding) from several public funding organizations. D.D.E. and D.L. possess shares in the GET.On Institut GmbH, which works to transfer research findings on internet-and mobile-phone-based health interventions into routine care. D.D.E. has received payments from several companies and health insurance providers for advice on the use of Internet-based interventions. He has received payments for lectures from Psychotherapy and Psychiatry Associations and has been the beneficiary of third-party funding from health insurance providers. J.B. is a member of the committee on E-Mental Health in the Association of Psychotherapists (Landespsychotherapeutenkammer Baden-Württemberg). Publisher Copyright: © 2020

PY - 2021

Y1 - 2021

N2 - Introduction: There is neither strong evidence on effective treatments for patients with chronic back pain (CBP) and depressive disorder nor sufficiently available mental health care offers. Objective: The aim is to assess the effectiveness of internet- A nd mobile-based interventions (IMI) as a scalable approach for treating depression in a routine care setting. Methods: This is an observer-masked, multicenter, pragmatic randomized controlled trial with a randomization ratio of 1:1.Patients with CBP and diagnosed depressive disorder (mild to moderate severity) were recruited from 82 orthopedic rehabilitation clinics across Germany. The intervention group (IG) received a guided depression IMI tailored to CBP next to treatment-as-usual (TAU; including medication), while the control group (CG) received TAU. The primary outcome was observer-masked clinician-rated Hamilton depression severity (9-week follow-up). The secondary outcomes were: Further depression outcomes, pain-related outcomes, health-related quality of life, and work capacity. Biostatistician blinded analyses using regression models were conducted by intention-to-treat and per protocol analysis. Results: Between October 2015 and July 2017, we randomly assigned 210 participants (IG, n = 105; CG, n = 105), mostly with only a mild pain intensity but substantial pain disability. No statistically significant difference in depression severity between IG and CG was observed at the 9-week follow-up (β =-0.19, 95% CI-0.43 to 0.05). Explorative secondary depression (4/9) and pain-related (4/6) outcomes were in part significant (p < 0.05). Health-related quality of life was significantly higher in the IG. No differences were found in work capacity. Conclusion: The results indicate that an IMI for patients with CBP and depression in a routine care setting has limited impact on depression. Benefits in pain and health-related outcomes suggest that an IMI might still be a useful measure to improve routine care.

AB - Introduction: There is neither strong evidence on effective treatments for patients with chronic back pain (CBP) and depressive disorder nor sufficiently available mental health care offers. Objective: The aim is to assess the effectiveness of internet- A nd mobile-based interventions (IMI) as a scalable approach for treating depression in a routine care setting. Methods: This is an observer-masked, multicenter, pragmatic randomized controlled trial with a randomization ratio of 1:1.Patients with CBP and diagnosed depressive disorder (mild to moderate severity) were recruited from 82 orthopedic rehabilitation clinics across Germany. The intervention group (IG) received a guided depression IMI tailored to CBP next to treatment-as-usual (TAU; including medication), while the control group (CG) received TAU. The primary outcome was observer-masked clinician-rated Hamilton depression severity (9-week follow-up). The secondary outcomes were: Further depression outcomes, pain-related outcomes, health-related quality of life, and work capacity. Biostatistician blinded analyses using regression models were conducted by intention-to-treat and per protocol analysis. Results: Between October 2015 and July 2017, we randomly assigned 210 participants (IG, n = 105; CG, n = 105), mostly with only a mild pain intensity but substantial pain disability. No statistically significant difference in depression severity between IG and CG was observed at the 9-week follow-up (β =-0.19, 95% CI-0.43 to 0.05). Explorative secondary depression (4/9) and pain-related (4/6) outcomes were in part significant (p < 0.05). Health-related quality of life was significantly higher in the IG. No differences were found in work capacity. Conclusion: The results indicate that an IMI for patients with CBP and depression in a routine care setting has limited impact on depression. Benefits in pain and health-related outcomes suggest that an IMI might still be a useful measure to improve routine care.

KW - Chronic back pain

KW - Comorbidity

KW - Depression

KW - eHealth

KW - Internet-delivered CBT

UR - http://www.scopus.com/inward/record.url?scp=85098158854&partnerID=8YFLogxK

U2 - 10.1159/000511881

DO - 10.1159/000511881

M3 - Journal articles

C2 - 33321501

AN - SCOPUS:85098158854

VL - 90

SP - 255

EP - 268

JO - Psychotherapy and Psychosomatics

JF - Psychotherapy and Psychosomatics

SN - 0033-3190

IS - 4

ER -