Development of a digital biomarker and intervention for subclinical depression: study protocol for a longitudinal waitlist control study

Background Depression remains a global health problem, with its prevalence rising worldwide. Digital biomarkers are increasingly investigated to initiate and tailor scalable interventions targeting depression. Due to the steady influx of new cases, focusing on treatment alone will not suffice; academics and practitioners need to focus on the prevention of depression (i.e., addressing subclinical depression). Aim With our study, we aim to (i) develop digital biomarkers for subclinical symptoms of depression, (ii) develop digital biomarkers for severity of subclinical depression, and (iii) investigate the efficacy of a digital intervention in reducing symptoms and severity of subclinical depression. Method Participants will interact with the digital intervention BEDDA consisting of a scripted conversational agent, the slow-paced breathing training Breeze, and actionable advice for different symptoms. The intervention comprises 30 daily interactions to be completed in less than 45 days. We will collect self-reports regarding mood, agitation, anhedonia (proximal outcomes; first objective), self-reports regarding depression severity (primary distal outcome; second and third objective), anxiety severity (secondary distal outcome; second and third objective), stress (secondary distal outcome; second and third objective), voice, and breathing. A subsample of 25% of the participants will use smartwatches to record physiological data (e.g., heart-rate, heart-rate variability), which will be used in the analyses for all three objectives. Discussion Digital voice- and breathing-based biomarkers may improve diagnosis, prevention, and care by enabling an unobtrusive and either complementary or alternative assessment to self-reports. Furthermore, our results may advance our understanding of underlying psychophysiological changes in subclinical depression. Our study also provides further evidence regarding the efficacy of standalone digital health interventions to prevent depression. Trial registration Ethics approval was provided by the Ethics Commission of ETH Zurich (EK-2022-N-31) and the study was registered in the ISRCTN registry (Reference number: ISRCTN38841716, Submission date: 20/08/2022)

Just-in-Time Adaptive Mechanisms of Popular Mobile Apps for Individuals With Depression: Systematic App Search and Literature Review

BACKGROUND The number of smartphone apps that focus on the prevention, diagnosis, and treatment of depression is increasing. A promising approach to increase the effectiveness of the apps while reducing the individual's burden is the use of just-in-time adaptive intervention (JITAI) mechanisms. JITAIs are designed to improve the effectiveness of the intervention and reduce the burden on the person using the intervention by providing the right type of support at the right time. The right type of support and the right time are determined by measuring the state of vulnerability and the state of receptivity, respectively. OBJECTIVE The aim of this study is to systematically assess the use of JITAI mechanisms in popular apps for individuals with depression. METHODS We systematically searched for apps addressing depression in the Apple App Store and Google Play Store, as well as in curated lists from the Anxiety and Depression Association of America, the United Kingdom National Health Service, and the American Psychological Association in August 2020. The relevant apps were ranked according to the number of reviews (Apple App Store) or downloads (Google Play Store). For each app, 2 authors separately reviewed all publications concerning the app found within scientific databases (PubMed, Cochrane Register of Controlled Trials, PsycINFO, Google Scholar, IEEE Xplore, Web of Science, ACM Portal, and Science Direct), publications cited on the app's website, information on the app's website, and the app itself. All types of measurements (eg, open questions, closed questions, and device analytics) found in the apps were recorded and reviewed. RESULTS None of the 28 reviewed apps used JITAI mechanisms to tailor content to situations, states, or individuals. Of the 28 apps, 3 (11%) did not use any measurements, 20 (71%) exclusively used self-reports that were insufficient to leverage the full potential of the JITAIs, and the 5 (18%) apps using self-reports and passive measurements used them as progress or task indicators only. Although 34% (23/68) of the reviewed publications investigated the effectiveness of the apps and 21% (14/68) investigated their efficacy, no publication mentioned or evaluated JITAI mechanisms. CONCLUSIONS Promising JITAI mechanisms have not yet been translated into mainstream depression apps. Although the wide range of passive measurements available from smartphones were rarely used, self-reported outcomes were used by 71% (20/28) of the apps. However, in both cases, the measured outcomes were not used to tailor content and timing along a state of vulnerability or receptivity. Owing to this lack of tailoring to individual, state, or situation, we argue that the apps cannot be considered JITAIs. The lack of publications investigating whether JITAI mechanisms lead to an increase in the effectiveness or efficacy of the apps highlights the need for further research, especially in real-world apps

Less stick more carrot? Increasing the uptake of deposit contract financial incentives for physical activity:A randomized controlled trial

BACKGROUND: Financial incentives are a promising tool to help people increase their physical activity, but they are expensive to provide. Deposit contracts are a type of financial incentive in which participants pledge their own money. However, low uptake is a crucial obstacle to the large-scale implementation of deposit contracts. Therefore, we investigated whether (1) matching the deposit 1:1 (doubling what is deposited) and (2) allowing for customizable deposit amounts increased the uptake and short term effectiveness of a deposit contract for physical activity.METHODS: In this randomized controlled trial, 137 healthy students (age M = 21.6 years) downloaded a smartphone app that provided them with a tailored step goal and then randomized them to one of four experimental conditions. The deposit contract required either a €10 fixed deposit or a customizable deposit with any amount between €1 and €20 upfront. Furthermore, the deposit was either not matched or 1:1 matched (doubled) with a reward provided by the experiment. During 20 intervention days, daily feedback on goal progress and incentive earnings was provided by the app. We investigated effects on the uptake (measured as agreeing to participate and paying the deposit) and effectiveness of behavioral adoption (measured as participant days goal achieved).FINDINGS: Overall, the uptake of deposit contracts was 83.2%, and participants (n = 113) achieved 14.9 out of 20 daily step goals. A binary logistic regression showed that uptake odds were 4.08 times higher when a deposit was matched (p = .010) compared to when it was not matched. Furthermore, uptake odds were 3.53 times higher when a deposit was customizable (p = .022) compared to when it was fixed. Two-way ANCOVA showed that matching (p = .752) and customization (p = .143) did not impact intervention effectiveness. However, we did find a marginally significant interaction effect of deposit matching X deposit customization (p = .063, ηp2 = 0.032). Customization decreased effectiveness when deposits were not matched (p = .033, ηp2 = 0.089), but had no effect when deposits were matched (p = .776, ηp2 = 0.001).CONCLUSIONS: We provide the first experimental evidence that both matching and customization increase the uptake of a deposit contract for physical activity. We recommend considering both matching and customization to overcome lack of uptake, with a preference for customization since matching a deposit imposes significant additional costs. However, since we found indications that customizable deposits might reduce effectiveness (when the deposits are not matched), we urge for more research on the effectiveness of customizable deposit contracts. Finally, future research should investigate which participant characteristics are predictive of deposit contract uptake and effectiveness.PRE-REGISTRATION: OSF Registries, https://osf.io/cgq48.</p

Investigating Rewards and Deposit Contract Financial Incentives for Physical Activity Behavior Change Using a Smartphone App: Randomized Controlled Trial

Background Financial incentive interventions for improving physical activity have proven to be effective but costly. Deposit contracts (in which participants pledge their own money) could be an affordable alternative. In addition, deposit contracts may have superior effects by exploiting the power of loss aversion. Previous research has often operationalized deposit contracts through loss framing a financial reward (without requiring a deposit) to mimic the feelings of loss involved in a deposit contract. Objective This study aimed to disentangle the effects of incurring actual losses (through self-funding a deposit contract) and loss framing. We investigated whether incentive conditions are more effective than a no-incentive control condition, whether deposit contracts have a lower uptake than financial rewards, whether deposit contracts are more effective than financial rewards, and whether loss frames are more effective than gain frames. Methods Healthy participants (N=126) with an average age of 22.7 (SD 2.84) years participated in a 20-day physical activity intervention. They downloaded a smartphone app that provided them with a personalized physical activity goal and either required a €10 (at the time of writing: €1=US $0.98) deposit up front (which could be lost) or provided €10 as a reward, contingent on performance. Daily feedback on incentive earnings was provided and framed as either a loss or gain. We used a 2 (incentive type: deposit or reward) × 2 (feedback frame: gain or loss) between-subjects factorial design with a no-incentive control condition. Our primary outcome was the number of days participants achieved their goals. The uptake of the intervention was a secondary outcome. Results Overall, financial incentive conditions (mean 13.10, SD 6.33 days goal achieved) had higher effectiveness than the control condition (mean 8.00, SD 5.65 days goal achieved; P=.002; ηp2=0.147). Deposit contracts had lower uptake (29/47, 62%) than rewards (50/50, 100%; P<.001; Cramer V=0.492). Furthermore, 2-way analysis of covariance showed that deposit contracts (mean 14.88, SD 6.40 days goal achieved) were not significantly more effective than rewards (mean 12.13, SD 6.17 days goal achieved; P=.17). Unexpectedly, loss frames (mean 10.50, SD 6.22 days goal achieved) were significantly less effective than gain frames (mean 14.67, SD 5.95 days goal achieved; P=.007; ηp2=0.155). Conclusions Financial incentives help increase physical activity, but deposit contracts were not more effective than rewards. Although self-funded deposit contracts can be offered at low cost, low uptake is an important obstacle to large-scale implementation. Unexpectedly, loss framing was less effective than gain framing. Therefore, we urge further research on their boundary conditions before using loss-framed incentives in practice. Because of limited statistical power regarding some research questions, the results of this study should be interpreted with caution, and future work should be done to confirm these findings. Trial Registration Open Science Framework Registries osf.io/34ygt; https://osf.io/34yg

Effectiveness of the Austrian disease-management-programme for type 2 diabetes: study protocol of a cluster-randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Due to its rising prevalence type 2 diabetes plays an important role concerning population health in Austria and other western countries. In various studies deficiencies in the care of diabetic patients have been revealed. These deficiencies may be overcome by disease-management-programmes (DMPs), but international experience shows that the effectiveness of DMPs is inconsistent. In particular large programmes designed by state-affiliated public health insurances have not been evaluated in randomized controlled trials (RCTs). We are therefore conducting a large scale RCT of the Austrian DMP for type 2 diabetic patients in the province of Salzburg to evaluate the programme regarding its effects on metabolic control, guideline adherent care and the quality of life of diabetic patients.</p> <p>Methods/Design</p> <p>The study is open for participation to all GPs and internists in the province of Salzburg. Physicians are randomized before recruitment of patients with the districts of Salzburg as clusters of randomisation. A total of over 1200 patients with type 2 diabetes will then be recruited. In the intervention group the DMP is applied for one year. Controls receive usual care. Endpoints are a decrease in HbA1c in the intervention group > 0,5% compared to controls, a higher percentage of patients with required diagnostic measures according to guidelines, improved cardiovascular risk profile and higher quality of life scores within one year.</p> <p>Current status of the study</p> <p>98 Physicians agreed to participate in the study. 96 of them recruited 1494 patients, 654 in the intervention and 840 in the control group.</p> <p>Trail Registration</p> <p>This trial has been registered with Current Controlled Trials Ltd. (ISRCTN27414162).</p

Asuhan Kebidanan Berkelanjutan Pada Ny U.R Puskesmas Sagu Periode 22 April sampai 29 Juni 2019

Latar Belakang : Penyusunan Laporan Tugas Akhir adalah kegiatan belajar mengajar yang memberikan kesempatan kepada mahasiswa untuk mendapatkan pengalaman nyata dalam melaksanakan asuhan kebidanan yang komprehensif dalam lingkup kesehatan reproduksi.Data Puskesmas Sagu diperoleh tidak ada kematian bayi dan kematian ibu dalam 1 tahun terakhir. Sasaran ibu hamil di Puskesmas Sagu sebanyak 178 orang, jumlah persalinan sebanyak 194 orang, jumlah kunjungan nifas sebanyak 193 orang. Tujuan Penelitian : Diharapkan mahasiswa mampu menerapkan asuhan kebidanan berkelanjutan pada Ny.U.R Usia Kehamilan 37 Minggu 2 Hari Janin Hidup Tunggal Letak Kepala Intra Uterine Keadaan Jalan Lahir Normal Keadaan Ibu dan Janin Baik di Puskesmas Sagu Periode 22 April sampai 29 Juni 2019. Metode Penelitian : Jenis penelitian yang digunakan adalah studi penelaahan kasus. Studi kasus dilakukan pada Ny.U.R Usia Kehamilan 37 Minggu 2 Hari Janin Tunggal Hidup Intra Uterine Letak Kepala Keadaan Ibu dan Janin Baik di PuskesmaS Sagu Periode 22 April sampai 29 Juni 2019. Hasil : Setelah dilakukan asuhan kebidanan berkelanjutan pada Ny. U.R Usia Kehamilan 37 minggu 2 Hari Janin Tunggal Hidup Intra Uterine Letak Kepala Keadaan Ibu dan Janin Baik di Puskesmas Sagu Periode 22 April sampai 29 Juni 2019, ibu sudah melewati masa kehamilan, persalinan dan nifas dengan baik tanpa ada penyulit, bayi baru lahir dalam keadaan sehat, ibu belum menggunakan KB karena masih menunggu persetujuan suami. Kesimpulan : Asuhan kebidanan yang dilakukan pada Ny U.R mulai dari hamil, bersalin, BBL dan nifas, serta KB tidak ditemukan adanya kelainan dan penyulit yang menyertai

The effectiveness of the Austrian disease management programme for type 2 diabetes: a cluster-randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Disease management programmes (DMPs) are costly and impose additional work load on general practitioners (GPs). Data on their effectiveness are inconclusive. We therefore conducted a cluster-randomised controlled trial to evaluate the effectiveness of the Austrian DMP for diabetes mellitus type 2 on HbA1c and quality of care for adult patients in primary care.</p> <p>Methods</p> <p>All GPs of Salzburg-province were invited to participate. After cluster-randomisation by district, all patients with diabetes type 2 were recruited consecutively from 7-11/2007. The DMP, consisting mainly of physician and patient education, standardised documentation and agreement on therapeutic goals, was implemented in the intervention group while the control group received usual care. We aimed to show superiority of the intervention regarding metabolic control and process quality. The primary outcome measure was a change in HbA1c after one year. Secondary outcomes were days in the hospital, blood pressure, lipids, body mass index (BMI), enrolment in patient education and regular guideline-adherent examination. Blinding was not possible.</p> <p>Results</p> <p>92 physicians recruited 1489 patients (649 intervention, 840 control). After 401 ± 47 days, 590 intervention-patients and 754 controls had complete data. In the intention to treat analysis (ITT) of all 1489 patients, HbA1c decreased 0.41% in the intervention group and 0.28% in controls. The difference of -0.13% (95% CI -0.24; -0.02) was significant at p = 0.026. Significance was lost in mixed models adjusted for baseline value and cluster-effects (adjusted mean difference -0.03 (95% CI -0.15; 0.09, p = 0.607). Of the secondary outcome measures, BMI and cholesterol were significantly reduced in the intervention group compared to controls in ITT after adjustments (-0.53 kg/m²; 95% CI -1.03;-0.02; p = 0.014 and -0.10 mmol/l; 95% CI -0.21; -0.003; p = 0.043). Additionally, more patients received patient education (49.5% vs. 20.1%, p < 0.0001), eye- (71.0% vs. 51.2%, p < 0.0001), foot examinations (73.8% vs. 45.1%, p < 0.0001), and regular HbA1c checks (44.1% vs. 36.0%, p < 0.01) in the intervention group.</p> <p>Conclusion</p> <p>The Austrian DMP implemented by statutory health insurance improves process quality and enhances weight reduction, but does not significantly improve metabolic control for patients with type 2 diabetes mellitus. Whether the small benefit seen in secondary outcome measures leads to better patient outcomes, remains unclear.</p> <p>Trial Registration</p> <p>Current Controlled trials Ltd., ISRCTN27414162.</p

Elena+ Care for COVID-19, A Pandemic Lifestyle Care Intervention: Intervention Design and Study Protocol

Background: The current COVID-19 coronavirus pandemic is an emergency on a global scale, with huge swathes of the population required to remain indoors for prolonged periods to tackle the virus. In this new context, individuals’ health-promoting routines are under greater strain, contributing to poorer mental and physical health. Additionally, individuals are required to keep up to date with latest health guidelines about the virus, which may be confusing in an age of social-media disinformation and shifting guidelines. To tackle these factors, we developed Elena+, a smartphone-based and conversational agent (CA) delivered pandemic lifestyle care intervention.Methods: Elena+ utilizes varied intervention components to deliver a psychoeducation-focused coaching program on the topics of: COVID-19 information, physical activity, mental health (anxiety, loneliness, mental resources), sleep and diet and nutrition. Over 43 subtopics, a CA guides individuals through content and tracks progress over time, such as changes in health outcome assessments per topic, alongside user-set behavioral intentions and user-reported actual behaviors. Ratings of the usage experience, social demographics and the user profile are also captured. Elena+ is available for public download on iOS and Android devices in English, European Spanish and Latin American Spanish with future languages and launch countries planned, and no limits on planned recruitment. Panel data methods will be used to track user progress over time in subsequent analyses. The Elena+ intervention is open-source under the Apache 2 license (MobileCoach software) and the Creative Commons 4.0 license CC BY-NC-SA (intervention logic and content), allowing future collaborations; such as cultural adaptions, integration of new sensor-related features or the development of new topics.Discussion: Digital health applications offer a low-cost and scalable route to meet challenges to public health. As Elena+ was developed by an international and interdisciplinary team in a short time frame to meet the COVID-19 pandemic, empirical data are required to discern how effective such solutions can be in meeting real world, emergent health crises. Additionally, clustering Elena+ users based on characteristics and usage behaviors could help public health practitioners understand how population-level digital health interventions can reach at-risk and sub-populations