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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- and 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Interventions designed to increase the level of physical activity are crucial in the treatment of patients with musculoskeletal conditions. The psychological group-based intervention MoVo-LISA based on the Motivation-Volition (MoVo) Process Model has been shown to effectively promote physical activity. The aim of this study is to evaluate whether a MoVo-based app (MoVo-App) subsequent to MoVo-LISA during orthopedic inpatient care can support people to increase and maintain their amount of physical activity.Methods/design: In this parallel-group randomized controlled trial, patients with musculoskeletal disorders will be randomized to either (a) a combination of the group-based intervention program MoVo-LISA to promote physical activity plus the MoVo-App or (b) the group-based intervention program alone without the app. The intervention group will receive the MoVo-App after discharge from inpatient rehabilitation. They receive help to increase and maintain their level of physical activity (initiated by the group program) by tracking their health goals, activity plans, major barriers, and barrier management that were developed during the group-based program. We will recruit 224 initially minimally active participants during orthopedic rehabilitation care. Outcomes are assessed at clinic admission; discharge; 6 weeks; and 3 (post-treatment), 6, and 12 months after discharge (follow-up). The primary outcome is sport activity (active/inactive and minutes of activity) at 6-month follow-up. Secondary outcomes are movement activity, cognitive mediators of behavioral change (e.g., self-efficacy, action planning), and health-related variables (e.g., pain intensity, depression). To evaluate intervention effects, linear mixed effects models (both on intention-to-treat basis with an additional per-protocol analysis) will be conducted with each outcome variable and with time as the within-subjects factor and group as the between-subjects factor, along with all two-way interactions and accounting for covariates as fixed effects.Discussion: This is the first evaluation of the effectiveness of an app in combination with a face-to-face group intervention to promote physical activity. The approach of using an app in addition to an effective face-to-face intervention program, both based on the MoVo model, might sustain positive intervention effects introduced in routine health care.Trial Registration: The trial "A group- and smartphone-based psychological intervention to increase physical activity in patients with musculoskeletal conditions: A randomized controlled trial" is registered at the World Health Organization International Clinical Trials Registry Platform via the German Clinical Studies Trial Register (DRKS), DRKS00014814. Registered on 18 October 2018; URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014814. [ABSTRACT FROM AUTHOR]

We examined the long-term effectiveness of a group-based psychological intervention ("MoVo-LISA") to promote physical activity in patients with coronary heart disease. In this randomized controlled trial, N = 202 inactive patients with coronary heart disease were assigned to the control group (n = 102; treatment as usual) or the intervention group (n = 100; treatment as usual plus MoVo-LISA). Physical activity was assessed at baseline, 6 weeks (post-treatment), 6 months, and 12 months after discharge. ANCOVA for repeated measures revealed a significant interaction effect [p <.001; ηp2=.214] indicating a large effect [d = 1.03] of the intervention on behavior change post-treatment. At 12-month follow-up, the level of physical activity in the intervention group was still 94 min per week higher than in the control group (p <.001; d = 0.57). Results of this RCT indicate that the MoVo-LISA intervention substantially improves the level of physical activity among initially inactive patients with coronary heart disease up to 1 year after the intervention. [ABSTRACT FROM AUTHOR]

Background: Acceptance and commitment therapy (ACT) can be effective in treating chronic pain. Despite evidence supporting the effectiveness of ACT, uncertainties remain regarding which subgroups in the chronic pain population are likely to benefit most and least. This protocol describes the application for two meta-analytic approaches, one at the level of individual participant data and the other at the level of aggregated data, from randomized controlled trials of ACT for chronic pain (ACT-CP-MA). Methods: We will systematically conduct literature searches in CENTRAL, MEDLINE, EMBASE, PsycINFO, and trial registers. Two reviewers will independently select studies for inclusion and data extraction. ACT-CP-MA will include randomized controlled trials with ACT for chronic pain compared to control conditions for adults (≥ 18 years) with chronic pain (> 3 months). We will invite the authors of all eligible trials to share individual participant data. Outcomes will include standardized measures of pain interference, pain intensity, depression, anxiety, health-related quality of life, participants' rating of overall improvement, and ACT-related process variables. Using the Cochrane Collaboration's tool and GRADE, reviewers will independently check for risk of bias, quality of evidence, and strength of recommendations. In the individual participant data meta-analysis, we will use a one-step approach where participants are clustered with studies and data from all studies are modeled simultaneously. For analyses, we will use mixed-effects models. Additionally, we will employ a meta-analysis with aggregate data and compare the results of both meta-analyses. Discussion: This collaborative meta-analysis of individual participant data from randomized controlled trials of ACT for chronic pain versus control conditions will demonstrate how the known benefits of ACT for chronic pain vary across different subtypes of the chronic pain population. The results of the meta-analyses will be based on a comprehensive search of multiple databases and will help to inform future clinical trials and decision-making on the use of ACT in chronic pain and improve the quality, design, and reporting of future trials in this field. Systematic review registration: PROSPERO CRD42019120901. [ABSTRACT FROM AUTHOR]

[This corrects the article DOI: 10.2196/jmir.9925.]. [ABSTRACT FROM AUTHOR]

Background: Internet- and mobile-based interventions are effective for the treatment of chronic pain. However, little is known about patients' willingness to engage with these types of interventions and how the uptake of such interventions can be improved.Objective: The aim of this study was to identify people's acceptance, uptake, and adherence (primary outcomes) with regard to an internet- and mobile-based intervention for chronic pain and the influence of an information video as an acceptance-facilitating intervention (AFI).Methods: In this randomized controlled trial with a parallel design, we invited 489 individuals with chronic pain to participate in a Web-based survey assessing the acceptance of internet- and mobile-based interventions with the offer to receive an unguided internet- and mobile-based intervention for chronic pain after completion. Two versions of the Web-based survey (with and without AFI) were randomly sent to two groups: one with AFI (n=245) and one without AFI (n=244). Participants who completed the Web-based survey with or without AFI entered the intervention group or the control group, respectively. In the survey, the individuals' acceptance of pain interventions, measured with a 4-item scale (sum score ranging from 4 to 20), predictors of acceptance, sociodemographic and pain-related variables, and physical and emotional functioning were assessed. Uptake rates (log in to the intervention) and adherence (number of completed modules) to the intervention was assessed 4 months after intervention access. To examine which factors influence acceptance, uptake rate, and adherence in the internet- and mobile-based interventions, we conducted additional exploratory subgroup analyses.Results: In total, 57 (intervention group) and 58 (control group) participants in each group completed the survey and were included in the analyses. The groups did not differ with regard to acceptance, uptake rate, or adherence (P=.64, P=.56, P=.75, respectively). Most participants reported moderate (68/115, 59.1%) to high (36/115, 31.3%) acceptance, with 9.6% (11/115) showing low acceptance (intervention group: mean 13.91, SD 3.47; control group: mean 13.61, SD 3.50). Further, 67% (38/57, intervention group) and 62% (36/58, control group) had logged into the intervention. In both groups, an average of 1.04 (SD 1.51) and 1.14 (SD 1.90) modules were completed, respectively.Conclusions: The informational video was not effective with regard to acceptance, uptake rate, or adherence. Despite the high acceptance, the uptake rate was only moderate and adherence was remarkably low. This study shows that acceptance can be much higher in a sample participating in an internet- and mobile-based intervention efficacy trial than in the target population in routine health care settings. Thus, future research should focus not only on acceptance and uptake facilitating interventions but also on ways to influence adherence. Further research should be conducted within routine health care settings with more representative samples of the target population.Trial Registration: German Clinical Trial Registration DRKS00006183; http://www.drks.de/drks_web/navigate.do ?navigationId=trial.HTML&TRIAL_ID=DRKS00006183 (Archived by WebCite at http://www.webcitation.org/70ebHDhne). [ABSTRACT FROM AUTHOR]

Background: Depression and comorbid chronic back pain (CBP) lead to high personal and economic burden. Internet- and mobile-based interventions (IMI) might be a cost-effective adjunct to established interventions.Methods: A health economic evaluation was embedded into an observer-blinded, multicenter RCT (societal and health care perspective). We randomly assigned participants (≥18 years) with CBP and diagnosed depression from 82 orthopedic clinics across Germany to intervention (IG + treatment as usual [TAU]) or TAU control group (CG). The IG received a guided IMI. Primary outcomes were depression response and quality-adjusted life years (QALYs) at 6-months follow-up. Multiple imputation was used to address missing data. Incremental cost-effectiveness/cost-utility ratios (ICER/ICUR) and the probability of being cost-effective at different willingness-to-pay thresholds were calculated. Statistical uncertainty was estimated using bootstrapping techniques (N = 10,000).Results: Between October 2015 and July 2017 210 participants were randomly assigned to IG (n = 105) and CG (n = 105). Depression response did not differ significantly between groups. QALYs were significantly higher in the IG compared to the CG. Taking the societal perspective and assuming a commonly used willingness-to-pay of €34,000/QALY, the intervention's likelihood of being cost-effective was 64%.Limitations: The main limitation is that the study was powered to detect clinical but not health economic differences between groups.Conclusion: The IMI is considered cost-effective (vs. CG) for individuals with depression and CBP (societal perspective). These results are promising when considering the high individual and economic burden of this patient group. Further research is needed to adequately inform political decision makers before implementation into routine care. [ABSTRACT FROM AUTHOR]