A web- and mobile-based intervention for comorbid, recurrent depression in patients with chronic back pain on sick leave (Get.Back): pilot randomized controlled trial on feasibility, user satisfaction, and effectiveness
Open accessAbstract
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; F1,76=3.62, P=.03; d=0.28, 95% CI −0.17 to 0.74). Similar findings were noted for the reduction of anxiety symptoms (F1,76=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 (F1,76=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 (F1,76=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.
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The findings are consistent with previous large randomized controlled trials and meta-analyses demonstrating the effectiveness of digital interventions for improving symptoms of depression, anxiety, and pain-related impairment in people with chronic pain.
“Our findings are consistent with previous large randomized controlled trials and meta-analyses that have demonstrated the effectiveness of digital interventions for improving symptoms of depression, anxiety, and even pain-related impairment in people with chronic pain who have been recruited from pain management clinics, primary care clinics, and community/internet referral sources [20,21,45-47].”
From Digital Mental Health Intervention Plus Usual Care Compared With Usual Care Only and Usual Care Plus In-Person Psychological Counseling for Orthopedic Patients With Symptoms of Depression or Anxiety: Cohort Study (2022) · cites this paper as [20]
The Principal Findings and Short-Term Effects sections report reduced depressive symptoms and anxiety in this pilot trial of patients with chronic back pain. But the Principal Findings say effectiveness was not supported for pain measures; the Methods describe a 76-person trial recruited through health-insurance records, not a large trial or meta-analysis with the recruitment sources listed in the citing sentence. Page numbers are unavailable in our copy. (LLM, conf=0.90)
Experimental — accuracy not yet measuredIn Schlicker et al. (2020), there was no significant between-group difference from baseline to post-treatment on pain intensity (F(1,76) = 3.76, P = .06, d = .23, 95% CI -.22, .68).
“No significant between-group difference from baseline to post-treatment on - pain intensity (F 1,76 = 3.76, P = .06, d = .23, 95% CI -.22, .68)”
From The Effectiveness of Interventions for Improving Chronic Pain Symptoms Among People With Mental Illness: A Systematic Review (2024) · cites this paper as Schlicker et al, (2020)
The Results > Short-Term Effects table (Table 5; page not provided) supports the finding of no significant between-group difference in average pain intensity at posttreatment. It reports F(1,76)=0.03, P=.42, d=0.21, and 95% CI −0.24 to 0.66—not the statistics quoted in the claim. (LLM, conf=0.90)
Experimental — accuracy not yet measuredAnother 4 large trials included an intervention with multiple components.
“Another 4 large trials included an intervention with multiple components. 37-40”
From The Effectiveness of Interventions for Improving Chronic Pain Symptoms Among People With Mental Illness: A Systematic Review (2024) · cites this paper as [38]
The Methods > Interventions section describes Get.Back as a randomized intervention with multiple components, including behavioral activation, problem solving, cognitive restructuring, and return-to-work content. But Methods > Study Design says this was a pilot trial that enrolled 76 participants, short of its planned 250; it does not support describing this trial as large. This source accounts for one trial, not the stated total of four. (LLM, conf=0.90)
Experimental — accuracy not yet measuredNo significant differences between CBT and TAU in pain self-efficacy at follow-up in one study.
“and at follow-up in one study (Schlicker et al., 2020) exploring pain self-efficacy.”
From A systematic review of cognitive behavioral therapy-based interventions for comorbid chronic pain and clinically relevant psychological distress (2023) · cites this paper as Schlicker et al., 2020
No significant differences between CBT and TAU in work capacity at post-treatment and follow-up in two studies.
“Two studies explored work capacity at post-treatment and follow-up (Schlicker et al., 2020; Baumeister et al., 2021), but neither found significant differences (0%).”
From A systematic review of cognitive behavioral therapy-based interventions for comorbid chronic pain and clinically relevant psychological distress (2023) · cites this paper as Schlicker et al., 2020
In Schlicker et al. (2020), the Get.Back group demonstrated greater reduction in anxiety than the waitlist group at post-treatment (F(1,76) = 10.45, P = .001, d = .14, 95% CI -.31, .60).
“but Get.Back group demonstrated greater reduction in anxiety than the waitlist group (F 1,76 = 10.45, P = .001, d = .14, 95% CI -.31, .60)”
From The Effectiveness of Interventions for Improving Chronic Pain Symptoms Among People With Mental Illness: A Systematic Review (2024) · cites this paper as Schlicker et al, (2020)
In Schlicker et al. (2020), there were significant reductions on the CES-D from baseline to 6-month follow-up in both the Get.Back group (t(40) = 5.99, P < .001, d = .98, 95% CI .51, 1.46) and the waitlist group (t(36) = 4.99, P < .001, d = .94, 95% CI .43, 1.45).
“Significant reductions on the CES-D from baseline 6-month follow-up in both Get.Back (t 40 = 5.99, P < .001, d = .98, 95% CI .51, 1.46) and waitlist group (t 36 = 4.99, P < .001, d = .94, 95% CI .43, 1.45)”
From The Effectiveness of Interventions for Improving Chronic Pain Symptoms Among People With Mental Illness: A Systematic Review (2024) · cites this paper as Schlicker et al, (2020)
In Schlicker et al. (2020), there was no significant between-group difference from baseline to 6-month follow-up on pain intensity (F(1,76) = .03, P = .42, d = .21, 95% CI -.24, .66).
“No significant between-group difference from baseline to 6-month follow-up on - pain intensity (F 1,76 = .03, P = .42, d = .21, 95% CI -.24, .66)”
From The Effectiveness of Interventions for Improving Chronic Pain Symptoms Among People With Mental Illness: A Systematic Review (2024) · cites this paper as Schlicker et al, (2020)
In Schlicker et al. (2020), there was no significant between-group difference from baseline to post-treatment on pain-related disability (F(1,76) = .15, P = .35, d = .02, 95% CI -.42, .47).
“- pain-related disability (F 1,76 = .15, P = .35, d = .02, 95% CI -.42, .47)”
From The Effectiveness of Interventions for Improving Chronic Pain Symptoms Among People With Mental Illness: A Systematic Review (2024) · cites this paper as Schlicker et al, (2020)
In Schlicker et al. (2020), there was a significant between-group difference and a small between-group effect size favouring the Get.Back group on CES-D at post-treatment (F(1,76) = 3.62, P = .03, d = .28, 95% CI -.17, .74).
“with significant between-group difference and a small between-group effect size favouring the Get.Back group (F 1,76 = 3.62, P = .03, d = .28, 95 -.17, .74)”
From The Effectiveness of Interventions for Improving Chronic Pain Symptoms Among People With Mental Illness: A Systematic Review (2024) · cites this paper as Schlicker et al, (2020)
In Schlicker et al. (2020), there was no significant between-group difference from baseline to 6-month follow-up on pain-related disability (F(1,76) = .11, P = .36, d = .14, 95% CI -.30, .59).
“- pain-related disability (F 1,76 = .11, P = .36, d = .14, 95% CI -.30, .59)”
From The Effectiveness of Interventions for Improving Chronic Pain Symptoms Among People With Mental Illness: A Systematic Review (2024) · cites this paper as Schlicker et al, (2020)
In Schlicker et al. (2020), the within-group effect size was d = .81 in the Get.Back group (95% CI .36, 1.28, t(40) = 5.40, P < .001) versus d = .18 in the waitlist group (95% CI -.27, .65, t(36) = 1.26, P = .21).
“A within-group effect size d = .81 the Get.Back group (95% CI .36, 1.28, t 40 = 5.40, P < .001) vs d = .18 in the waitlist group (95% CI -.27, .65, t 36 = 1.26, P = .21)”
From The Effectiveness of Interventions for Improving Chronic Pain Symptoms Among People With Mental Illness: A Systematic Review (2024) · cites this paper as Schlicker et al, (2020)
In Schlicker et al. (2020), at post-treatment there was no significant between-group difference on QIDS-SR16 (F(1,76) = 1.24, P = .13, d = .16, 95% CI -.28, .62).
“At post-treatment no significant between-group difference on QIDS-SR16 (F 1,76 = 1.24, P = .13, d = .16, 95% CI -.28, .62)”
From The Effectiveness of Interventions for Improving Chronic Pain Symptoms Among People With Mental Illness: A Systematic Review (2024) · cites this paper as Schlicker et al, (2020)
In Schlicker et al. (2020), there was a significant between-group difference on anxiety at 6-month follow-up (F(1,76) = 2.94, P = .047, d = .38, 95% CI -.07, .83).
“Significant between-group difference on anxiety 6-month follow-up (F 1,76 = 2.94, P = .047, d = .38, 95% CI -.07, .83)”
From The Effectiveness of Interventions for Improving Chronic Pain Symptoms Among People With Mental Illness: A Systematic Review (2024) · cites this paper as Schlicker et al, (2020)
In Schlicker et al. (2020), there was no significant between-group difference from baseline to 6-month follow-up on pain-related self-efficacy (F(1,76) = .57, P = .22, d = .23, 95% CI -.21, .68).
“- pain-related self-efficacy (F 1,76 = .57, P = .22, d = .23, 95% CI -.21, .68)”
From The Effectiveness of Interventions for Improving Chronic Pain Symptoms Among People With Mental Illness: A Systematic Review (2024) · cites this paper as Schlicker et al, (2020)
In Schlicker et al. (2020), there was no significant between-group difference on the CES-D at 6-month follow-up (F(1,76) = 1.50, P = .11, d = .10, 95% CI -.34, ...).
“but no significant between- group difference on - the CES-D (F 1,76 = 1.50, P = .11, d = .10, 95% CI -.34,”
From The Effectiveness of Interventions for Improving Chronic Pain Symptoms Among People With Mental Illness: A Systematic Review (2024) · cites this paper as Schlicker et al, (2020)
In Schlicker et al. (2020), there was no significant between-group difference from baseline to post-treatment on pain-related self-efficacy (F(1,76) = .02, P = .43, d = .11, 95% CI -.33, .56).
“- pain-related self-efficacy (F 1,76 = .02, P = .43, d = .11, 95% CI -.33, .56)”
From The Effectiveness of Interventions for Improving Chronic Pain Symptoms Among People With Mental Illness: A Systematic Review (2024) · cites this paper as Schlicker et al, (2020)
In Schlicker et al. (2020), there was no significant between-group difference on the QIDS-SR16 at 6-month follow-up (F(1,76) = 1.93, P = .08, d = .23, 95% CI -.21, .69).
“- the QIDS-SR16 (F 1,76 = 1.93, P = .08, d = .23, 95% CI -.21, .69)”
From The Effectiveness of Interventions for Improving Chronic Pain Symptoms Among People With Mental Illness: A Systematic Review (2024) · cites this paper as Schlicker et al, (2020)
In Schlicker et al. (2020), there were significant reductions on the CES-D from baseline to post-treatment in both the Get.Back group (t(40) = 5.82, P < .001, d = .84, 95% CI .39, 1.30) and the waitlist group (t(36) = 3.86, P < .001, d = .64, 95% CI .17, 1.12).
“Significant reductions on the CES-D from baseline post-treatment in both the Get.Back (t 40 = 5.82, P < .001, d = .84, 95% CI .39, 1.30) and the waitlist group (t 36 = 3.86, P < .001, D = .64, 95% CI .17, 1.12)”
From The Effectiveness of Interventions for Improving Chronic Pain Symptoms Among People With Mental Illness: A Systematic Review (2024) · cites this paper as Schlicker et al, (2020)
No differences between CBT and TAU in social functioning at post-treatment in three studies.
“No differences were found between these groups at post-treatment in the three studies (Ólason et al., 2018; Schlicker et al., 2020; Gasslander et al., 2022) exploring this outcome.”
From A systematic review of cognitive behavioral therapy-based interventions for comorbid chronic pain and clinically relevant psychological distress (2023) · cites this paper as Schlicker et al., 2020
The Methods > Outcomes section describes quality-of-life measures but does not identify a social-functioning outcome. The Results > Short-Term Effects table reports no significant posttreatment difference on those quality-of-life measures, but that does not establish the claimed result for social functioning. The study also compares an intervention group with a waitlist control, both with access to treatment as usual, rather than CBT against TAU alone. (LLM, conf=0.75)
Experimental — accuracy not yet measured
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Internet-Based Interventions in Chronic Somatic Disease
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Self-citationThe Inventory of Depressive Symptomatology: German translation and psychometric validation
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Lin, J., Sander, L., Paganini, S., Schlicker, S., Ebert, D., Berking, M., Bengel, J., Nobis, S., Lehr, D., Mittag, O., et al. (2017) · BMJ Open · doi:10.1136/bmjopen-2016-015226 · Cited by 27 · see citing works
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Darcy, A., Daniels, J., Salinger, D., Wicks, P., & Robinson, A. (2021) · JMIR Formative Research · doi:10.2196/27868 · Cited by 260 · see citing works
Gandy, M., Pang, S. T. Y., Scott, A. J., Heriseanu, A. I., Bisby, M. A., Dudeney, J., Karin, E., Titov, N., & Dear, B. F. (2022) · PAIN · doi:10.1097/j.pain.0000000000002606 · Cited by 102 · see citing works
Sanabria-Mazo, J. P., Colomer-Carbonell, A., Fernández-Vázquez, Ó., Noboa-Rocamora, G., Cardona-Ros, G., McCracken, L. M., Montes-Pérez, A., Castaño-Asins, J. R., Edo, S., Borràs, X., et al. (2023) · Frontiers in Psychology · doi:10.3389/fpsyg.2023.1200685 · Cited by 56 · see citing works
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RetractedLewkowicz, D., Slosarek, T., Wernicke, S., Winne, A., Wohlbrandt, A. M., & Böttinger, E. P. (2021) · JMIR Rehabilitation and Assistive Technologies · doi:10.2196/26612 · Cited by 44 · see citing works
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A meta-analysis of persuasive design, engagement, and efficacy in 92 RCTs of mental health apps
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“There is now a large body of evidence supporting the efficacy of digital interventions for the prevention and treatment of depression [16-20], with recent studies providing promising evidence for the treatment of depression in patients with comorbid physical conditions [21-25].”
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Wilhelm, S., Bernstein, E. E., Bentley, K. H., Snorrason, Í., Hoeppner, S. S., Klare, D. L., Greenberg, J. L., Weingarden, H. M., McCoy, T. H., & Harrison, O. (2024) · JMIR Mental Health · doi:10.2196/53998 · Cited by 17 · see citing works
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Hennemann, S., Böhme, K., Kleinstäuber, M., Ruckes, C., Baumeister, H., Daniel Ebert, D., Küchler, A.-M., & Witthöft, M. (2022) · Behavior Therapy · doi:10.1016/j.beth.2022.06.006 · Cited by 11 · see citing works
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The role of online communities in supporting mental health during the COVID-19 pandemic
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- Authors
- Schlicker, S., Baumeister, H., Buntrock, C., Sander, L., Paganini, S., Lin, J., Berking, M., Lehr, D., & Ebert, D. D.
- Affiliations
- Philipps University of Marburg (DE)
- Universität Ulm (DE)
- Friedrich-Alexander-Universität Erlangen-Nürnberg (DE)
- University of Freiburg (DE)
- Leuphana University of Lüneburg (DE)
- Corresponding author
- Schlicker, Sandra
- ORCID
- Venue
- JMIR Mental Health
- Publisher
- JMIR Publications Inc.
- Published
- 2020-04-15
- Volume
- 7
- Issue
- 4
- Pages
- e16398
- ISSN
- 2368-7959 (ISSN-L)
- PMC
- PMC7191351
- OpenAlex
- W3016213546
- Cited by
- 46
- References
- 72
- Citations by year
- 2026: 6 · 2025: 7 · 2024: 6 · 2023: 11 · 2022: 12 · 2021: 4
- FWCI
- 6.10
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- JMIR Mental Health (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Multilingual Matters (Channel View Publications) (publishedVersion, cc-by)
- VU Research Portal (publishedVersion, other-oa)
- OPUS Repository (Kooperativer Bibliotheksverbund Berlin-Brandenburg) (submittedVersion, cc-by)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Funders
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Deutsche Forschungsgemeinschaft
- Bundesministerium für Bildung und Forschung (01GY1330B, 01GY1330A)
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- chronic back pain, recurrent depression, major depressive disorder, sick leave, guided self-help, cognitive behavioral therapy, user satisfaction, depression severity, anxiety, quality of life, pain outcomes, feasibility, health care utilization, health care costs
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