Predicting heterogeneous treatment effects of an Internet-based depression intervention for patients with chronic back pain: Secondary analysis of two randomized controlled trials.

Background: Depression is highly prevalent among individuals with chronic back pain. Internet-based interventions can be effective in treating and preventing depression in this patient group, but it is unclear who benefits most from this intervention format. Method: In an analysis of two randomized trials (N = 504), we explored ways to predict heterogeneous treatment effects of an Internet-based depression intervention for patients with chronic back pain. Univariate treatment-moderator interactions were explored in a first step. Multilevel model-based recursive partitioning was then applied to develop a decision tree model predicting individualized treatment benefits. Results: The average effect on depressive symptoms was d = -0.43 (95 % CI: -0.68 to -0.17; 9 weeks; PHQ-9). Using univariate models, only back pain medication intake was detected as an effect moderator, predicting higher effects. More complex interactions were found using recursive partitioning, resulting in a final decision tree with six terminal nodes. The model explained a large amount of variation (bootstrap-bias-corrected R2 = 45 %), with predicted subgroup-conditional effects ranging from di = 0.24 to -1.31. External validation in a pilot trial among patients on sick leave (N = 76; R2 = 33 %) pointed to the transportability of the model. Conclusions: The studied intervention is effective in reducing depressive symptoms, but not among all chronic back pain patients. Predictions of the multivariate tree learning model suggest a pattern in which patients with moderate depression and relatively low pain self-efficacy benefit most, while no benefits arise when patients' self-efficacy is already high. If corroborated in further studies, the developed tree algorithm could serve as a practical decision-making tool.

Stress Management Apps: Systematic Search and Multidimensional Assessment of Quality and Characteristics.

BACKGROUND: Chronic stress poses risks for physical and mental well-being. Stress management interventions have been shown to be effective, and stress management apps (SMAs) might help to transfer strategies into everyday life. OBJECTIVE: This review aims to provide a comprehensive overview of the quality and characteristics of SMAs to give potential users or health professionals a guideline when searching for SMAs in common app stores. METHODS: SMAs were identified with a systematic search in the European Google Play Store and Apple App Store. SMAs were screened and checked according to the inclusion criteria. General characteristics and quality were assessed by 2 independent raters using the German Mobile Application Rating Scale (MARS-G). The MARS-G assesses quality (range 1 to 5) on the following four dimensions: (1) engagement, (2) functionality, (3) esthetics, and (4) information. In addition, the theory-based stress management strategies, evidence base, long-term availability, and common characteristics of the 5 top-rated SMAs were assessed and derived. RESULTS: Of 2044 identified apps, 121 SMAs were included. Frequently implemented strategies (also in the 5 top-rated SMAs) were psychoeducation, breathing, and mindfulness, as well as the use of monitoring and reminder functions. Of the 121 SMAs, 111 (91.7%) provided a privacy policy, but only 44 (36.4%) required an active confirmation of informed consent. Data sharing with third parties was disclosed in only 14.0% (17/121) of the SMAs. The average quality of the included apps was above the cutoff score of 3.5 (mean 3.59, SD 0.50). The MARS-G dimensions yielded values above this cutoff score (functionality: mean 4.14, SD 0.47; esthetics: mean 3.76, SD 0.73) and below this score (information: mean 3.42, SD 0.46; engagement: mean 3.05, SD 0.78). Most theory-based stress management strategies were regenerative stress management strategies. The evidence base for 9.1% (11/121) of the SMAs could be identified, indicating significant group differences in several variables (eg, stress or depressive symptoms) in favor of SMAs. Moreover, 38.0% (46/121) of the SMAs were no longer available after a 2-year period. CONCLUSIONS: The moderate information quality, scarce evidence base, constraints in data privacy and security features, and high volatility of SMAs pose challenges for users, health professionals, and researchers. However, owing to the scalability of SMAs and the few but promising results regarding their effectiveness, they have a high potential to reach and help a broad audience. For a holistic stress management approach, SMAs could benefit from a broader repertoire of strategies, such as more instrumental and mental stress management strategies. The common characteristics of SMAs with top-rated quality can be used as guidance for potential users and health professionals, but owing to the high volatility of SMAs, enhanced evaluation frameworks are needed.

Mechanisms of change in digital cognitive behavioral therapy for depression in patients with chronic back pain: A mediation analysis of a multicenter randomized clinical trial.

BACKGROUND: While there is evolving knowledge on change processes of digital cognitive behavioral therapy (CBT) in the treatment of depression, little is known about how these interventions produce therapeutic change in the comorbid constellation of chronic back pain (CBP). Here, we examined whether the effects of a digital intervention to treat depression in patients with CBP are mediated by three pain-related variables (i.e., pain self-efficacy, pain-related disability, pain intensity). METHODS: This study is a secondary analysis of a randomized clinical trial conducted in routine care at 82 orthopedic clinics across Germany. In total, 209 adults with CBP and diagnosed depression (SCID interview) were randomly assigned to the intervention (n = 104) or treatment-as-usual (n = 105). Cross-lagged mediation models were estimated to investigate longitudinal mediation effects of putative mediators with depression symptom severity (PHQ-9) as primary outcome at post-treatment. RESULTS: Longitudinal mediation effects were observed for pain self-efficacy (ß = -0.094, 95%-CI [-0.174, -0.014], p = 0.021) and pain-related disability (ß = -0.068, 95%-CI [-0.130, -0.001], p = 0.047). Furthermore, the hypothesized direction of the mediation effects was supported, reversed causation did not occur. Pain intensity did not reveal a mediation effect. CONCLUSIONS: The results suggest a relevant role of pain self-efficacy and pain-related disability as change processes in the treatment of depression for patients with CBP in routine care. However, further research is needed to disclose potential reciprocal relationships of mediators, and to extend and specify our knowledge of the mechanisms of change in digital CBT for depression.

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).

Adoption and maintenance of physical activity: Mediation analysis of a psychological intervention.

OBJECTIVE: To analyze the cognitive mediation processes of an effective psychological group-based intervention promoting physical activity (based on motivational and volitional theories; MoVo-LISA) and to test for different underlying intervention mechanisms in the adoption and maintenance phase of physical activity behavior change. METHOD: In an RCT, N = 202 patients with coronary heart disease were randomly allocated to the group-based MoVo-LISA intervention or a control group (treatment-as-usual). Primary outcome was physical activity (in minutes per week, significant group differences: posttreatment: d = 1.03; 12-months follow-up: d = .57). Potential mediator variables were self-efficacy, outcome expectations, intention strength, self-concordance, action planning and barrier management. A mediation analysis of longitudinal data in SPSS AMOS v.24 was conducted. RESULTS: The intervention was successful in modifying most of the examined cognitive variables in the adoption and/or the maintenance phase, with exception of self-concordance. Intention strength and self-concordance were significant predictors of behavior change in both phases. Findings suggest that the observed intervention effects on physical activity behavior were only partially mediated through the motivational variables self-efficacy and outcome expectation. CONCLUSIONS: The results contribute to opening "the black box" of processes behind an intervention and show that intervention effects of MoVo-LISA are partially mediated through the specified cognitive variables. The relevance of motivational variables (intention strength and self-concordance) in the adoption and maintenance phases is highlighted in this study and leads to relevant intervention design implications. Nevertheless, the differentiation of the two phases might help to improve intervention programs through a stronger focus on those cognitive parameters that are critical at a certain point in the behavior change process. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Predictors of Dropout in a Digital Intervention for the Prevention and Treatment of Depression in Patients With Chronic Back Pain: Secondary Analysis of Two Randomized Controlled Trials.

BACKGROUND: Depression is a common comorbid condition in individuals with chronic back pain (CBP), leading to poorer treatment outcomes and increased medical complications. Digital interventions have demonstrated efficacy in the prevention and treatment of depression; however, high dropout rates are a major challenge, particularly in clinical settings. OBJECTIVE: This study aims to identify the predictors of dropout in a digital intervention for the treatment and prevention of depression in patients with comorbid CBP. We assessed which participant characteristics may be associated with dropout and whether intervention usage data could help improve the identification of individuals at risk of dropout early on in treatment. METHODS: Data were collected from 2 large-scale randomized controlled trials in which 253 patients with a diagnosis of CBP and major depressive disorder or subclinical depressive symptoms received a digital intervention for depression. In the first analysis, participants' baseline characteristics were examined as potential predictors of dropout. In the second analysis, we assessed the extent to which dropout could be predicted from a combination of participants' baseline characteristics and intervention usage variables following the completion of the first module. Dropout was defined as completing <6 modules. Analyses were conducted using logistic regression. RESULTS: From participants' baseline characteristics, lower level of education (odds ratio [OR] 3.33, 95% CI 1.51-7.32) and both lower and higher age (a quadratic effect; age: OR 0.62, 95% CI 0.47-0.82, and age2: OR 1.55, 95% CI 1.18-2.04) were significantly associated with a higher risk of dropout. In the analysis that aimed to predict dropout following completion of the first module, lower and higher age (age: OR 0.60, 95% CI 0.42-0.85; age2: OR 1.59, 95% CI 1.13-2.23), medium versus high social support (OR 3.03, 95% CI 1.25-7.33), and a higher number of days to module completion (OR 1.05, 95% CI 1.02-1.08) predicted a higher risk of dropout, whereas a self-reported negative event in the previous week was associated with a lower risk of dropout (OR 0.24, 95% CI 0.08-0.69). A model that combined baseline characteristics and intervention usage data generated the most accurate predictions (area under the receiver operating curve [AUC]=0.72) and was significantly more accurate than models based on baseline characteristics only (AUC=0.70) or intervention usage data only (AUC=0.61). We found no significant influence of pain, disability, or depression severity on dropout. CONCLUSIONS: Dropout can be predicted by participant baseline variables, and the inclusion of intervention usage variables may improve the prediction of dropout early on in treatment. Being able to identify individuals at high risk of dropout from digital health interventions could provide intervention developers and supporting clinicians with the ability to intervene early and prevent dropout from occurring.

Blended Care Interventions to Promote Physical Activity: A Systematic Review of Randomized Controlled Trials.

BACKGROUND: Blended care interventions combine therapeutic guidance with digital care. Current research results show the promising role of the blended care approach in clinical care. This new way of delivering health care could have the potential to effectively promote physical activity in different public health settings. OBJECTIVE: The aim of the systematic review is to investigate the varieties of intervention characteristics of blended care interventions to promote physical activity in terms of structure, behavior change goals, behavior change techniques, and effectiveness of blended care interventions compared to a control group. METHODS: We searched for randomized controlled trials published from 2000 to March 2021 in MEDLINE, CINAHL, Cochrane Central Register of Controlled Trials, SPORTDiscus, PsycINFO, and Web of Science according to the PRISMA guidelines. Risk of bias was assessed using the Cochrane Collaboration tool. Study characteristics, intervention characteristics, and outcome data were extracted. Furthermore, the effect size on the outcome of physical activity was examined or calculated. RESULTS: In total, the number of reports identified from the database searches was 4828. Of these, 25 studies were included in the review, with a total of 5923 study participants. Results indicated that the characteristics of blended care interventions showed a high heterogeneity. The combinations of therapist-guided interventions and digital interventions allowed the identification of specific subgroups, but they varied in length (range 8-52 weeks, SD 16.6), intensity, and the combination of the components. The most used combination of blended care interventions to promote physical activity was the combination of one-on-one meetings via telephone and Web-based interventions. Motivational models of behavior change were used most frequently as underlying theoretical foundations. Certain behavior change techniques were used consistently across the individual components, e.g., "problem solving" in the therapist-guided component and "feedback on behavior" in the digital component. Considering the effect size of blended care interventions compared with control groups, most studies showed a small effect. CONCLUSIONS: It can be concluded that blended care interventions have potential to promote physical activity. In the future, further high-quality studies should investigate which type of blended care intervention is effective for which target group. Additionally, insights are required on which intervention characteristics are most effective, taking into account new evidence on behavior change. Registration This systematic literature review was registered in PROSPERO ( CRD42020188556 ).

Internet- and mobile-based intervention for depression in adults with chronic back pain: A health economic evaluation.

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.

Quality of Physical Activity Apps: Systematic Search in App Stores and Content Analysis.

BACKGROUND: Physical inactivity is a major contributor to the development and persistence of chronic diseases. Mobile health apps that foster physical activity have the potential to assist in behavior change. However, the quality of the mobile health apps available in app stores is hard to assess for making informed decisions by end users and health care providers. OBJECTIVE: This study aimed at systematically reviewing and analyzing the content and quality of physical activity apps available in the 2 major app stores (Google Play and App Store) by using the German version of the Mobile App Rating Scale (MARS-G). Moreover, the privacy and security measures were assessed. METHODS: A web crawler was used to systematically search for apps promoting physical activity in the Google Play store and App Store. Two independent raters used the MARS-G to assess app quality. Further, app characteristics, content and functions, and privacy and security measures were assessed. The correlation between user star ratings and MARS was calculated. Exploratory regression analysis was conducted to determine relevant predictors for the overall quality of physical activity apps. RESULTS: Of the 2231 identified apps, 312 met the inclusion criteria. The results indicated that the overall quality was moderate (mean 3.60 [SD 0.59], range 1-4.75). The scores of the subscales, that is, information (mean 3.24 [SD 0.56], range 1.17-4.4), engagement (mean 3.19 [SD 0.82], range 1.2-5), aesthetics (mean 3.65 [SD 0.79], range 1-5), and functionality (mean 4.35 [SD 0.58], range 1.88-5) were obtained. An efficacy study could not be identified for any of the included apps. The features of data security and privacy were mainly not applied. Average user ratings showed significant small correlations with the MARS ratings (r=0.22, 95% CI 0.08-0.35; P<.001). The amount of content and number of functions were predictive of the overall quality of these physical activity apps, whereas app store and price were not. CONCLUSIONS: Apps for physical activity showed a broad range of quality ratings, with moderate overall quality ratings. Given the present privacy, security, and evidence concerns inherent to most rated apps, their medical use is questionable. There is a need for open-source databases of expert quality ratings to foster informed health care decisions by users and health care providers.

Systematic evaluation of content and quality of English and German pain apps in European app stores.

BACKGROUND AND OBJECTIVE: Pain spans a broad spectrum of diseases and types that are highly prevalent and cause substantial disease burden for individuals and society. Up to 40% of people affected by pain receive no or inadequate treatment. Providing a scalable, time-, and location-independent way for pain diagnostic, management, prevention and treatment mobile health applications (MHA) might be a promising approach to improve health care for pain. However, the commercial app market is rapidly growing and unregulated, resulting in an opaque market. Studies investigating the content, privacy and security features, quality and scientific evidence of the available apps are highly needed, to guide patients and clinicians to high quality MHA.Contributing to this challenge, the present study investigates the content, quality, and privacy features of pain apps available in the European app stores. METHODS: An automated search engine was used to identify pain apps in the European Google Play and Apple App store. Pain apps were screened and checked for systematic criteria (pain-relatedness, functionality, availability, independent usability, English or German). Content, quality and privacy features were assessed by two independent reviewers using the German Mobile Application Rating Scale (MARS-G). The MARS-G assesses quality on four objectives (engagement, functionality, aesthetics, information quality) and two subjective scales (perceived impact, subjective quality). RESULTS: Out of 1034 identified pain apps 218 were included. Pain apps covered eight different pain types. Content included basic information, advice, assessment and tracking, and stand-alone interventions. The overall quality of the pain apps was average M = 3.13 (SD = 0.56, min = 1, max = 4.69). The effectiveness of less than 1% of the included pain apps was evaluated in a randomized controlled trial. Major problems with data privacy were present: 59% provided no imprint, 70% had no visible privacy policy. CONCLUSION: A multitude of pain apps is available. Most MHA lack scientific evaluation and have serious privacy issues, posing a potential threat to users. Further research on evidence and improvements privacy and security are needed. Overall, the potential of pain apps is not exploited.

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.

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 (ß = -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.

Validation of the Mobile Application Rating Scale (MARS).

BACKGROUND: Mobile health apps (MHA) have the potential to improve health care. The commercial MHA market is rapidly growing, but the content and quality of available MHA are unknown. Instruments for the assessment of the quality and content of MHA are highly needed. The Mobile Application Rating Scale (MARS) is one of the most widely used tools to evaluate the quality of MHA. Only few validation studies investigated its metric quality. No study has evaluated the construct validity and concurrent validity. OBJECTIVE: This study evaluates the construct validity, concurrent validity, reliability, and objectivity, of the MARS. METHODS: Data was pooled from 15 international app quality reviews to evaluate the metric properties of the MARS. The MARS measures app quality across four dimensions: engagement, functionality, aesthetics and information quality. Construct validity was evaluated by assessing related competing confirmatory models by confirmatory factor analysis (CFA). Non-centrality (RMSEA), incremental (CFI, TLI) and residual (SRMR) fit indices were used to evaluate the goodness of fit. As a measure of concurrent validity, the correlations to another quality assessment tool (ENLIGHT) were investigated. Reliability was determined using Omega. Objectivity was assessed by intra-class correlation. RESULTS: In total, MARS ratings from 1,299 MHA covering 15 different health domains were included. Confirmatory factor analysis confirmed a bifactor model with a general factor and a factor for each dimension (RMSEA = 0.074, TLI = 0.922, CFI = 0.940, SRMR = 0.059). Reliability was good to excellent (Omega 0.79 to 0.93). Objectivity was high (ICC = 0.82). MARS correlated with ENLIGHT (ps<.05). CONCLUSION: The metric evaluation of the MARS demonstrated its suitability for the quality assessment. As such, the MARS could be used to make the quality of MHA transparent to health care stakeholders and patients. Future studies could extend the present findings by investigating the re-test reliability and predictive validity of the MARS.

A group- and smartphone-based psychological intervention to increase and maintain physical activity in patients with musculoskeletal conditions: study protocol for a randomized controlled trial ("MoVo-App").

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.

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.

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.

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.

A guided and unguided internet- and mobile-based intervention for chronic pain: health economic evaluation alongside a randomised controlled trial.

OBJECTIVE: This study aims at evaluating the cost-effectiveness and cost-utility of a guided and unguided internet-based intervention for chronic pain patients (ACTonPainguided and ACTonPainunguided) compared with a waitlist control group (CG) as well as the comparative cost-effectiveness of the guided and the unguided version. DESIGN: This is a health economic evaluation alongside a three-arm randomised controlled trial from a societal perspective. Assessments were conducted at baseline, 9 weeks and 6 months after randomisation. SETTING: Participants were recruited through online and offline strategies and in collaboration with a health insurance company. PARTICIPANTS: 302 adults (≥18 years, pain for at least 6 months) were randomly allocated to one of the three groups (ACTonPainguided, ACTonPainunguided, CG). INTERVENTIONS: ACTonPain consists of seven modules and is based on Acceptance and Commitment Therapy. ACTonPainguided and ACTonPainunguided only differ in provision of human support. PRIMARY AND SECONDARY OUTCOME MEASURES: Main outcomes of the cost-effectiveness and the cost-utility analyses were meaningful change in pain interference (treatment response) and quality-adjusted life years (QALYs), respectively. Economic evaluation estimates were the incremental cost-effectiveness and cost-utility ratio (ICER/ICUR). RESULTS: At 6-month follow-up, treatment response and QALYs were highest in ACTonPainguided (44% and 0.280; mean costs = €6,945), followed by ACTonPainunguided (28% and 0.266; mean costs = €6,560) and the CG (16% and 0.244; mean costs = €6,908). ACTonPainguided vs CG revealed an ICER of €45 and an ICUR of €604.ACTonPainunguided dominated CG. At a willingness-to-pay of €0 the probability of being cost-effective was 50% for ACTonPainguided (vs CG, for both treatment response and QALY gained) and 67% for ACTonPainunguided (vs CG, for both treatment response and QALY gained). These probabilities rose to 95% when society's willingness-to-pay is €91,000 (ACTonPainguided) and €127,000 (ACTonPainunguided) per QALY gained. ACTonPainguided vs ACTonPainunguided revealed an ICER of €2,374 and an ICUR of €45,993. CONCLUSIONS: Depending on society's willingness-to-pay, ACTonPain is a potentially cost-effective adjunct to established pain treatment. ACTonPainunguided (vs CG) revealed lower costs at better health outcomes. However, uncertainty has to be considered. Direct comparison of the two interventions does not indicate a preference for ACTonPainguided. TRIAL REGISTRATION NUMBER: DRKS00006183.

Processing of Emotional Faces in Patients with Chronic Pain Disorder: An Eye-Tracking Study.

OBJECTIVE: Problems in emotion processing potentially contribute to the development and maintenance of chronic pain. Theories focusing on attentional processing have suggested that dysfunctional attention deployment toward emotional information, i.e., attentional biases for negative emotions, might entail one potential developmental and/or maintenance factor of chronic pain. METHODS: We assessed self-reported alexithymia, attentional orienting to and maintenance on emotional stimuli using eye tracking in 17 patients with chronic pain disorder (CP) and two age- and sex-matched control groups, 17 healthy individuals (HC) and 17 individuals who were matched to CP according to depressive symptoms (DC). In a choice viewing paradigm, a dot indicated the position of the emotional picture in the next trial to allow for strategic attention deployment. Picture pairs consisted of a happy or sad facial expression and a neutral facial expression of the same individual. Participants were asked to explore picture pairs freely. RESULTS: CP and DC groups reported higher alexithymia than the HC group. HC showed a previously reported emotionality bias by preferentially orienting to the emotional face and preferentially maintaining on the happy face. CP and DC participants showed no facilitated early attention to sad facial expressions, and DC participants showed no facilitated early attention to happy facial expressions, while CP and DC participants did. We found no group differences in attentional maintenance. CONCLUSION: Our findings are in line with the clinical large overlap between pain and depression. The blunted initial reaction to sadness could be interpreted as a failure of the attentional system to attend to evolutionary salient emotional stimuli or as an attempt to suppress negative emotions. These difficulties in emotion processing might contribute to etiology or maintenance of chronic pain and depression.

Economic evaluations of internet- and mobile-based interventions for the treatment and prevention of depression: A systematic review.

BACKGROUND: Internet- and mobile-based interventions (IMIs) targeting depression have been shown to be clinically effective and are considered a cost-effective complement to established interventions. The aim of this review was to provide an overview of the evidence for the cost-effectiveness of IMIs for the treatment and prevention of depression. METHODS: A systematic database search was conducted (Medline, PsychInfo, CENTRAL, PSYNDEX, OHE HEED). Relevant articles were selected according to defined eligibility criteria. IMIs were classified as cost-effective if they were below a willingness-to-pay threshold (WTP) of €22,845 (£20,000) - €34,267 (£30,000) per additional quality-adjusted life year (QALY) according to the National Institute for Health and Clinical Excellence (NICE) standard. Study quality was assessed using the Consolidated Health Economic Evaluation Reporting Standard guidelines and the Cochrane Risk of Bias Tool. RESULTS: Of 1538 studies, seven economic evaluations of IMIs for the treatment of major depression, four for the treatment of subthreshold/minor depression and one for the prevention of depression. In six studies, IMIs were classified as likely to be cost-effective with an incremental cost-utility ratio between €3088 and €22,609. All of these IMIs were guided. Overall quality of most economic evaluations was evaluated as good. All studies showed some risk of bias. LIMITATIONS: The studies used different methodologies and showed some risk of bias. These aspects as well as the classification of cost-effectiveness according to the WTP proposed by NICE should be considered when interpreting the results. CONCLUSIONS: Results indicate that guided IMIs for the treatment of (subthreshold) depression have the potential to be a cost-effective complement to established interventions, but more methodologically sound studies are needed.

Effectiveness and cost-effectiveness of a guided internet- and mobile-based depression intervention for individuals with chronic back pain: protocol of a multi-centre randomised controlled trial.

INTRODUCTION: Depression often co-occurs with chronic back pain (CBP). Internet and mobile-based interventions (IMIs) might be a promising approach for effectively treating depression in this patient group. In the present study, we will evaluate the effectiveness and cost-effectiveness of a guided depression IMI for individuals with CBP (eSano BackCare-D) integrated into orthopaedic healthcare. METHODS AND ANALYSIS: In this multicentre randomised controlled trial of parallel design, the groups eSano BackCare-D versus treatment as usual will be compared. 210 participants with CBP and diagnosed depression will be recruited subsequent to orthopaedic rehabilitation care. Assessments will be conducted prior to randomisation and 9 weeks (post-treatment) and 6 months after randomisation. The primary outcome is depression severity (Hamilton Rating Scale for Depression-17). Secondary outcomes are depression remission and response, health-related quality of life, pain intensity, pain-related disability, self-efficacy and work capacity. Demographic and medical variables as well as internet affinity, intervention adherence, intervention satisfaction and negative effects will also be assessed. Data will be analysed on an intention-to-treat basis with additional per-protocol analyses. Moreover, a cost-effectiveness and cost-utility analysis will be conducted from a societal perspective after 6 months. ETHICS AND DISSEMINATION: All procedures are approved by the ethics committee of the Albert-Ludwigs-University of Freiburg and the data security committee of the German Pension Insurance (Deutsche Rentenversicherung). The results will be published in peer-reviewed journals and presented on international conferences. TRIAL REGISTRATION NUMBER: DRKS00009272; Pre-results.

An Internet-Based Intervention for Chronic Pain.

BACKGROUND: Persons with chronic pain can be treated effectively with acceptance and commitment therapy (ACT). In this trial, we examined the effectiveness of guided and unguided ACT-based online treatment (ACTonPain) for chronic pain patients. METHODS: 302 individuals were randomly assigned to ACTonPain with or without guidance (n = 100/101) or to a waiting-list control group (n=101). The primary outcome was pain interference as measured by the Multidimensional Pain Inventory. The secondary outcomes were physical and emotional functioning, pain intensity, ACT process variables, quality of life, satisfaction with the intervention, adherence, and participants' rating of overall improvement. The online measurements were carried out before randomization (T0) and 9 weeks and 6 months after randomization (T1 and T2, respectively). Intention-to-treat (ITT) data analysis was supplemented with additional per-protocol analyses. RESULTS: The guided ACTonPain group showed significantly less pain interference than the control group in the ITT analysis (p = 0.01), with a moderate effect size at T1 and T2 (d = 0.58 respectively), corresponding to a number needed to treat (NNT) of 3.14 for both time points. Participants in the guided ACTonPain group also indicated higher pain acceptance (T1: d = 0.59; T2: d = 0.76). The unguided ACTonPain group showed to be significantly less depressed in comparison to the control group at at time T2 (d = 0.50). No significant differences with respect to effectiveness were found between the two ACTonPain groups (p>0.05). CONCLUSION: The online intervention ACTonPain is effective for persons with chronic pain when the program is guided. Further research in a variety of settings of health care is needed in order to determine whether and how ACTonPain can be implemented.