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

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 -