Mediators of digital depression prevention in patients with chronic back pain: Findings from a multicenter randomized clinical trial.

OBJECTIVE: The mechanisms of change in digital interventions for the prevention of depression are largely unknown. Here, we explored whether five theoretically derived intervening variables (i.e., pain intensity, pain-related disability, pain self-efficacy, quality of life [QoL], and work capacity) were mediating the effectiveness of a digital intervention specifically designed to prevent depression in patients with chronic back pain (CBP). METHOD: This study is a secondary analysis of a pragmatic, observer-masked randomized clinical trial conducted at 82 orthopedic clinics in Germany. A total of 295 adults with a diagnosis of CBP and subclinical depressive symptoms were randomized to either the intervention group (n = 149) or treatment-as-usual (n = 146). Longitudinal mediation analyses were conducted with structural equation modeling and depression symptom severity as primary outcome (Patient Health Questionnaire-9 [PHQ-9]; 6 months after randomization) on an intention-to-treat basis. RESULTS: Beside the effectiveness of the digital intervention in preventing depression, we found a significant causal mediation effect for QoL as measured with the complete scale of Assessment of Quality of Life (AQoL-6D; axb: -0.234), as well as for the QoL subscales mental health (axb: -0.282) and coping (axb: -0.249). All other potential intervening variables were not significant. CONCLUSION: Our findings suggest a relevant role of QoL, including active coping, as change mechanism in the prevention of depression. Yet, more research is needed to extend and specify our knowledge on empirically supported processes in digital depression prevention. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Culturally adapting internet- and mobile-based health promotion interventions might not be worth the effort: a systematic review and meta-analysis.

Health promotion interventions offer great potential in advocating a healthy lifestyle and the prevention of diseases. Some barriers to communicating health promotion to people of certain cultural groups might be overcome via the internet- and mobile-based interventions (IMI). This systematic review and meta-analysis aims to explore the effectiveness of culturally adapted IMI for health promotion interventions among culturally diverse populations. We systematically searched on Cochrane Central Register of Controlled Trials (CENTRAL), EbscoHost/MEDLINE, Ovid/Embase, EbscoHost/PsychINFO, and Web of Science databases in October 2020. Out of 9438 records, 13 randomized controlled trials (RCT) investigating culturally adapted health promotion IMI addressing healthy eating, physical activity, alcohol consumption, sexual health behavior, and smoking cessation included. From the included studies 10,747 participants were eligible. Culturally adapted IMI proved to be non-superior over active control conditions in short- (g = 0.10, [95% CI -0.19 to 0.40]) and long-term (g = 0.20, [95% CI -0.11 to 0.51]) in promoting health behavior. However, culturally adapted IMI for physical activity (k = 3, N = 296) compared to active controls yielded a beneficial effect in long-term (g = 0.48, [95%CI 0.25 to 0.71]). Adapting health promotion IMI to the cultural context of different cultural populations seems not yet to be recommendable given the substantial adaption efforts necessary and the mostly non-significant findings. However, these findings need to be seen as preliminary given the limited number of included trials with varying methodological rigor and the partly substantial between-trial heterogeneity pointing in the direction of potentially useful culturally adapted IMI which now need to be disentangled from the less promising approaches.PROSPERO registration number: 42020152939.

Protocol for a systematic review and meta-analysis of culturally adapted internet- and mobile-based health promotion interventions.

INTRODUCTION: High rates of immigration pose challenges for the healthcare systems of many countries to offer high-quality care to diverse populations. Advancing health interventions with incorporating the cultural background of diverse populations can be helpful to overcome this challenge. First studies suggest that culturally diverse populations might benefit from culturally adapted internet-based and mobile-based interventions (IMI) to promote health behaviours. However, the effectiveness of culturally adapted IMIs for health promotion interventions has not been evaluated systematically. Therefore, the aim of this review is to assess the effectiveness of culturally adapted IMIs regarding health promotion. Additionally, the cultural adaptation features of these interventions will be outlined. METHODS AND ANALYSIS: Randomised controlled trials (RCTs) investigating the effectiveness of culturally adapted IMIs to promote health behaviours in the field of healthy eating, smoking cessation, alcohol consumption, physical activity and sexual health behaviour will be identified via a systematic search of the databases MEDLINE, Embase, PsycINFO, CENTRAL. The preliminary search has been conducted on the 26 August 2019 and will be updated in the process. Data will be pooled meta-analytically in case of at least three included studies reporting on the same outcome. Moreover, a narrative synthesis of the included studies will be conducted. The risk of bias will be assessed using the Cochrane Collaboration's tool for the Quality Assessment of RCTs V. 2.0. Publication bias will be assessed using funnel plots. ETHICS AND DISSEMINATION: Ethical approval is not required for this study. The results of this study will be published in a peer-reviewed international journal. PROSPERO REGISTRATION NUMBER: PROSPERO; CRD42020152939.

Effectiveness of a Guided Web-Based Self-help Intervention to Prevent Depression in Patients With Persistent Back Pain: The PROD-BP Randomized Clinical Trial.

Importance: 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. Objective: 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. Interventions: 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. Results: 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. Trial Registration: German Clinical Trials Register Identifier: DRKS00007960.