TY - JOUR

T1 - A web- And mobile-based intervention for comorbid, recurrent depression in patients with chronic back pain on sick leave (get.back)

T2 - Pilot randomized controlled trial on feasibility, user satisfaction, and effectiveness

AU - Schlicker, Sandra

AU - Baumeister, Harald

AU - Buntrock, Claudia

AU - Sander, Lasse

AU - Paganini, Sarah

AU - Lin, Jiaxi

AU - Berking, Matthias

AU - Lehr, Dirk

AU - Ebert, David Daniel

N1 - ©Sandra Schlicker, Harald Baumeister, Claudia Buntrock, Lasse Sander, Sarah Paganini, Jiaxi Lin, Matthias Berking, Dirk Lehr, David Daniel Ebert. Originally published in JMIR Mental Health (http://mental.jmir.org), 15.04.2020.

PY - 2020/4/15

Y1 - 2020/4/15

N2 - BACKGROUND: Chronic back pain (CBP) is linked to a higher prevalence and higher occurrence of major depressive disorder (MDD) and can lead to reduced quality of life. Unfortunately, individuals with both CBP and recurrent MDD are underidentified. Utilizing health care insurance data may provide a possibility to better identify this complex population. In addition, internet- and mobile-based interventions might enhance the availability of existing treatments and provide help to those highly burdened individuals.OBJECTIVE: This pilot randomized controlled trial investigated the feasibility of recruitment via the health records of a German health insurance company. The study also examined user satisfaction and effectiveness of a 9-week cognitive behavioral therapy and Web- and mobile-based guided self-help intervention Get.Back in CBP patients with recurrent MDD on sick leave compared with a waitlist control condition.METHODS: Health records from a German health insurance company were used to identify and recruit participants (N=76) via invitation letters. Study outcomes were measured using Web-based self-report assessments at baseline, posttreatment (9 weeks), and a 6-month follow-up. The primary outcome was depressive symptom severity (Center for Epidemiological Studies-Depression); secondary outcomes included anxiety (Hamilton Anxiety and Depression Scale), quality of life (Assessment of Quality of Life), pain-related variables (Oswestry Disability Index, Pain Self-Efficacy Questionnaire, and pain intensity), and negative effects (Inventory for the Assessment of Negative Effects of Psychotherapy).RESULTS: The total enrollment rate with the recruitment strategy used was 1.26% (76/6000). Participants completed 4.8 modules (SD 2.6, range 0-7) of Get.Back. The overall user satisfaction was favorable (mean Client Satisfaction Questionnaire score=24.5, SD 5.2). Covariance analyses showed a small but statistically significant reduction in depressive symptom severity in the intervention group (n=40) at posttreatment compared with the waitlist control group (n=36; F 1,76=3.62, P=.03; d=0.28, 95% CI -0.17 to 0.74). Similar findings were noted for the reduction of anxiety symptoms (F 1,76=10.45; P=.001; d=0.14, 95% CI -0.31 to 0.60) at posttreatment. Other secondary outcomes were nonsignificant (.06≤P≤.44). At the 6-month follow-up, the difference between the groups with regard to reduction in depressive symptom severity was no longer statistically significant (F 1,76=1.50, P=.11; d=0.10, 95% CI -0.34 to 0.46). The between-group difference in anxiety at posttreatment was maintained to follow-up (F 1,76=2.94, P=.04; d=0.38, 95% CI -0.07 to 0.83). There were no statistically significant differences across groups regarding other secondary outcomes at the 6-month follow-up (.08≤P≤.42). CONCLUSIONS: These results suggest that participants with comorbid depression and CBP on sick leave may benefit from internet- and mobile-based interventions, as exemplified with the positive user satisfaction ratings. The recruitment strategy via health insurance letter invitations appeared feasible, but more research is needed to understand how response rates in untreated individuals with CBP and comorbid depression can be increased.TRIAL REGISTRATION: German Clinical Trials Register DRKS00010820; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00010820.

AB - BACKGROUND: Chronic back pain (CBP) is linked to a higher prevalence and higher occurrence of major depressive disorder (MDD) and can lead to reduced quality of life. Unfortunately, individuals with both CBP and recurrent MDD are underidentified. Utilizing health care insurance data may provide a possibility to better identify this complex population. In addition, internet- and mobile-based interventions might enhance the availability of existing treatments and provide help to those highly burdened individuals.OBJECTIVE: This pilot randomized controlled trial investigated the feasibility of recruitment via the health records of a German health insurance company. The study also examined user satisfaction and effectiveness of a 9-week cognitive behavioral therapy and Web- and mobile-based guided self-help intervention Get.Back in CBP patients with recurrent MDD on sick leave compared with a waitlist control condition.METHODS: Health records from a German health insurance company were used to identify and recruit participants (N=76) via invitation letters. Study outcomes were measured using Web-based self-report assessments at baseline, posttreatment (9 weeks), and a 6-month follow-up. The primary outcome was depressive symptom severity (Center for Epidemiological Studies-Depression); secondary outcomes included anxiety (Hamilton Anxiety and Depression Scale), quality of life (Assessment of Quality of Life), pain-related variables (Oswestry Disability Index, Pain Self-Efficacy Questionnaire, and pain intensity), and negative effects (Inventory for the Assessment of Negative Effects of Psychotherapy).RESULTS: The total enrollment rate with the recruitment strategy used was 1.26% (76/6000). Participants completed 4.8 modules (SD 2.6, range 0-7) of Get.Back. The overall user satisfaction was favorable (mean Client Satisfaction Questionnaire score=24.5, SD 5.2). Covariance analyses showed a small but statistically significant reduction in depressive symptom severity in the intervention group (n=40) at posttreatment compared with the waitlist control group (n=36; F 1,76=3.62, P=.03; d=0.28, 95% CI -0.17 to 0.74). Similar findings were noted for the reduction of anxiety symptoms (F 1,76=10.45; P=.001; d=0.14, 95% CI -0.31 to 0.60) at posttreatment. Other secondary outcomes were nonsignificant (.06≤P≤.44). At the 6-month follow-up, the difference between the groups with regard to reduction in depressive symptom severity was no longer statistically significant (F 1,76=1.50, P=.11; d=0.10, 95% CI -0.34 to 0.46). The between-group difference in anxiety at posttreatment was maintained to follow-up (F 1,76=2.94, P=.04; d=0.38, 95% CI -0.07 to 0.83). There were no statistically significant differences across groups regarding other secondary outcomes at the 6-month follow-up (.08≤P≤.42). CONCLUSIONS: These results suggest that participants with comorbid depression and CBP on sick leave may benefit from internet- and mobile-based interventions, as exemplified with the positive user satisfaction ratings. The recruitment strategy via health insurance letter invitations appeared feasible, but more research is needed to understand how response rates in untreated individuals with CBP and comorbid depression can be increased.TRIAL REGISTRATION: German Clinical Trials Register DRKS00010820; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00010820.

KW - Depressive disorder

KW - Low back pain

KW - Mental health

KW - Pilot project

KW - Sick leave

KW - Health sciences

UR - http://www.scopus.com/inward/record.url?scp=85097854791&partnerID=8YFLogxK

UR - https://www.mendeley.com/catalogue/2b758c3c-dc88-3e58-ba8b-41fbeb17479b/

U2 - 10.2196/16398

DO - 10.2196/16398

M3 - Journal articles

C2 - 32293577

AN - SCOPUS:85097854791

VL - 7

JO - JMIR Mental Health

JF - JMIR Mental Health

SN - 2368-7959

IS - 4

M1 - e16398

ER -