784 registered reports
Physical inactivity is a leading preventable cause of chronic disease and premature death globally, yet over half of the adult Australian population is inactive. To address this, web-based physical activity interventions, which have the potential to reach large numbers of users at low costs, have received considerable attention. To fully realise the potential of such interventions, there is a need to further increase their appeal to boost engagement and retention, and sustain intervention effects over longer periods of time. This randomised controlled trial aims to evaluate the efficacy of a gamified physical activity intervention that connects users to each other via Facebook and is delivered via a mobile app.
Gestational diabetes (GDM) is a known risk factor for type 2 diabetes mellitus (T2DM), and women with a history of GDM have a 7-fold increased risk of developing the disease. Achieving a healthy weight post-delivery is key in reducing the risk of future diabetes in these women. The aim of this trial is to investigate the use of an interactive smartphone application (APP) to restore women to optimal weight following delivery.
Heart failure (HF) is a highly prevalent chronic disease, for which there is no cure available. Therefore, improving disease management is crucial, with mobile health (mHealth) being a promising technology. The aim of the HeartMan study is to evaluate the effect of a personal mHealth system on top of standard care on disease management and health-related quality of life (HRQoL) in HF.
To address the lack of social interaction and meaningful activities for persons with dementia (PWD) in nursing homes an artistic Photo-Activity was designed. The present study aims to develop a digital version of the Photo-Activity and to investigate its implementation and impact on nursing home residents with advanced dementia, and their (in)formal carers.
People living with HIV (PLWH) suffer from high rates of mental illness; but targeted effective interventions are limited, especially in developing countries. High penetration of smartphone usage and widespread acceptance of social media applications provide an unprecedented opportunity for mobile-based health interventions (mHealth interventions) in resource-limited settings like China. The current report describes the design and sample characteristics of the Run4Love randomized controlled trial (RCT) aimed at improving mental health in PLWH in China.
Background Violence against adolescents is a universal reality, with severe individual and societal costs. There is a critical need for scalable and effective violence prevention strategies such as parenting programmes, particularly in low‑ and middle‑income countries where rates of maltreatment are highest. Digital interventions may be a scalable and cost‑effective alternative to in‑person delivery, yet maximising caregiver engagement is a substantial challenge. This trial employs a cluster randomised factorial experiment and a novel mixed‑methods analytic approach to assess the effectiveness, cost‑effectiveness, and feasibility of intervention components designed to optimise engagement in an open‑source parenting app, ParentApp for Teens. The app is based on the evidence‑based Parenting for Lifelong Health for Teens programme, developed collaboratively by academic institutions in the Global South and North, the WHO, and UNICEF. Methods/design Sixteen neighbourhoods, i.e., clusters, will be randomised to one of eight experimental conditions which consist of any combination of three components (Support: self‑guided/moderated WhatsApp groups; App Design: sequential workshops/non‑sequential modules; Digital Literacy Training: on/off ). The study will be conducted in low‑income communities in Tanzania, targeting socioeconomically vulnerable caregivers of adolescents aged 10 to 17 years (16 clusters, 8 conditions, 640 caregivers, 80 per condition). The primary objective of this trial is to estimate the main effects of the three components on engagement. Secondary objectives are to explore the interactions between components, the effects of the components on caregiver behavioural outcomes, moderators and media‑tors of programme engagement and impact, and the cost‑effectiveness of components. The study will also assess enablers and barriers to engagement qualitatively via interviews with a subset of low, medium, and high engaging participants. We will combine quantitative and qualitative data to develop an optimised ParentApp for Teens delivery package.
Background: Students in the United States spend a meaningful portion of their developmental lives in school. In recent years, researchers and educators have begun to focus explicitly on social and emotional learning (SEL) in the school setting. Initial evidence from meta-analyses suggests that curricula designed to promote SEL likely produce benefits in terms of social-emotional competence (SEC) and numerous related behavioral and affective outcomes. At the same time, there are often barriers to implementing such curricula as intended, and some researchers have questioned the strength of the evaluation data from SEL programs. As part of the effort to improve programming in SEL, this paper describes the protocol for a cluster randomized trial of the ACT OUT! Social Issue Theater program, a brief psychodramatic intervention to build SEC and reduce bullying behavior in students. Objective: The objective of this trial is to examine if a short dose of interactive psychodrama can affect SEC metrics and bullying experiences in schoolchildren in either the short (2-week) or medium (6-month) term. Methods: The ACT OUT! trial is a cluster randomized superiority trial with 2 parallel groups. The unit of measurement is the student, and the unit of randomization is the classroom. For each grade (fourth, seventh, and 10th), an even number of classrooms will be selected from each school—half will be assigned to the intervention arm and half will be assigned to the control arm. The intervention will consist of 3 moderated psychodramatic performances by trained actors, and the control condition will be the usual school day. Outcome data will be collected at baseline (preintervention), 2-week postintervention (short term), and 6-month postintervention (medium term). Outcomes will include social-emotional competency; self-reported bullying and experiences of being bullied; receptivity to the program; and school-level data on truancy, absenteeism, and referrals to school displinary action for bullying. A power analysis adjusted for clustering effect, design effect, and potential attrition yielded a need for approximately 1594 students, consisting of an estimated 80 classrooms split evenly into intervention and control arms. Results: This study was funded in June 2019; approved by the Indiana University Institutional review board on September 17, 2019; began subject recruitment on November 5, 2019; and prospectively registered with ClinicalTrials.gov. Conclusions: Many states have issued recommendations for the integration of SEL into schools. The proposed study uses a rigorous methodology to determine if the ACT OUT! psychodramatic intervention is a cost-effective means of bolstering SEC and reducing bullying incidence in schools. Trial Registration: ClinicalTrials.gov NCT04097496; https://clinicaltrials.gov/ct2/show/NCT04097496
Background: Participatory health approaches are increasingly drawing attention among the scientific community, and could be used for health promotion programmes on diabetes through social media. The main aim of this project is to research how to best use social media to promote healthy lifestyles with and within the Norwegian population. Methods: The design of the health promotion intervention (HPI) will be participatory, and will involve both a panel of healthcare experts and social media users following the Norwegian Diabetes Association. The panel of experts will agree on the contents by following the Delphi method, and social media users will participate in the definition of the HPI by expressing their opinions through an adhoc online questionnaire. The agreed contents between both parties to be used in the HPI will be posted on three social media channels (Facebook, Twitter and Instagram) along 24 months. The 3 months before starting the HPI, and the 3 months after the HPI will be used as control data. The effect of the HPI will be assessed by comparing formats, frequency, and reactions to the published HPI messages, as well as comparing potential changes in five support-intended communication behaviours expressed on social media, and variations in sentiment analysis before vs during and after the HPI. The HPI’s effect on social media users’ health-related lifestyles, online health behaviours, and satisfaction with the intervention will be assessed every 6 months through online questionnaires. A separate questionnaire will be used to assess the panel of experts’ satisfaction and perceptions of the benefits for health professionals of a HPI as this one. Discussion: The time constraints of today’s medical practice combined with the piling demand of chronic conditions such as diabetes make any additional request of extra time used by health care professionals a challenge. Social media channels provide efficient, ubiquitous and user-friendly platforms that can encourage participation, engagement and action necessary from both those who receive and provide care to make health promotion interventions successful.
This research explores the relationship between different subtypes of disgust, different moral concerns, and attitudes toward policies that restrict bathroom choice for transgender people to the sex on one's birth certificate.
Background: Psychophysiological stress and decreased well-being are relevant issues during prolonged social isolation periods. Relaxation practices may represent helpful exercises to cope with anxiety and stressful sensations. Objective: The aim of this research protocol is to test whether remote relaxation practices such as natural sounds, deep respiration, and body scan meditation promote relaxation and improved emotional state and reduce psychomotor activation and the preoccupation related to the coronavirus disease (COVID-19) pandemic. Methods: The study population will consist of 3 experimental groups that will randomly receive one of 3 internet-based audio clips containing a single session of guided breathing exercise, guided body scan exercise, or natural sounds. The participants will listen to the fully automated audio clip for 7 minutes and complete pre-post self-assessment scales on their perceived relaxation, psychomotor activation, level of worry associated with COVID-19, and emotional state. At the end of the session, the participants will also be asked to provide qualitative reports on their subjective experiences. Results: Analyses will be performed to test the differences in the efficacy of the different audio clips in an internet-based intervention on 252 participants (84 per group), investigating whether natural sounds or remote guided practices such as deep respiration and body scan meditation positively enhance the participants’ perceived psychological state. Conclusions: The study will provide information on if and to what extent guided practices can help in reducing psychological side effects related to social isolation during the COVID-19 pandemic.
Background: Smoking is considered the main cause of preventable illness and early deaths worldwide. The treatment usually prescribed to people who wish to quit smoking is a multidisciplinary intervention, combining both psychological advice and pharmacological therapy, since the application of both strategies significantly increases the chance of success in a quit attempt. Objective: We present a study protocol of a 12-month randomized open-label parallel-group trial whose primary objective is to analyze the efficacy and efficiency of usual psychopharmacological therapy plus the Social-Local-Mobile app (intervention group) applied to the smoking cessation process compared with usual psychopharmacological therapy alone (control group). Methods: The target population consists of adult smokers (both male and female) attending the Smoking Cessation Unit at Virgen del Rocío University Hospital, Seville, Spain. Social-Local-Mobile is an innovative intervention based on mobile technologies and their capacity to trigger behavioral changes. The app is a complement to pharmacological therapies to quit smoking by providing personalized motivational messages, physical activity monitoring, lifestyle advice, and distractions (minigames) to help overcome cravings. Usual pharmacological therapy consists of bupropion (Zyntabac 150 mg) or varenicline (Champix 0.5 mg or 1 mg). The main outcomes will be (1) the smoking abstinence rate at 1 year measured by means of exhaled carbon monoxide and urinary cotinine tests, and (2) the result of the cost-effectiveness analysis, which will be expressed in terms of an incremental cost-effectiveness ratio. Secondary outcome measures will be (1) analysis of the safety of pharmacological therapy, (2) analysis of the health-related quality of life of patients, and (3) monitoring of healthy lifestyle and physical exercise habits. Results: Of 548 patients identified using the hospital’s electronic records system, we excluded 308 patients: 188 declined to participate and 120 did not meet the inclusion criteria. A total of 240 patients were enrolled: the control group (n=120) will receive usual psychopharmacological therapy, while the intervention group (n=120) will receive usual psychopharmacological therapy plus the So-Lo-Mo app. The project was approved for funding in June 2015. Enrollment started in October 2016 and was completed in October 2017. Data gathering was completed in November 2018, and data analysis is under way. The first results are expected to be submitted for publication in early 2019. Conclusions: Social networks and mobile technologies influence our daily lives and, therefore, may influence our smoking habits as well. As part of the SmokeFreeBrain H2020 European Commission project, this study aims at elucidating the potential role of these technologies when used as an extra aid to quit smoking. Trial Registration: ClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/record/NCT03553173 (Archived by WebCite at http://www.webcitation.org/74DuHypOW). International Registered Report Identifier (IRRID): PRR1-10.2196/12464
Information search is key to making decision from experience: exploration permits people to learn about the statistical properties of choice options and thus to become aware of rare but potentially momentous decision consequences. This registered report investigates whether and how people differ when making decisions from experience in isolation versus under competitive pressure, which may have important implications for choice performance in different types of choice environments: in “kind” environments without any rare and extreme events, frugal search is sufficient to identify advantageous options. Conversely, in “wicked” environments with skewed outcome distributions, rare but important events will tend to be missed in frugal search. One theoretical view is that competitive pressure encourages efficiency and may thereby boost adaptive search in different environments. An alternative and more pessimistic view is that competitive pressure triggers agency-related concerns, leading to minimal search irrespective of the choice environment, and hence to inferior choice performance. Using a sampling game, the present study (𝑁 = 277) found that solitary search was not adaptive to different choice environments (𝑀 = 14 samples), leading to a high choice performance in a kind and in a moderately wicked environment, but somewhat lower performance in an extremely wicked environment. Competitive pressure substantially reduced search irrespective of the choice environment (𝑀 = 4 samples), thus negatively affecting overall choice performance. Yet, from the perspective of a cost-benefit framework, frugal search may be efficient under competitive pressure. In sum, this report extends research on decisions from experience by adopting an ecological perspective (i.e., systematically varying different choice environments) and by introducing a cost-benefit framework to evaluate solitary and competitive search — with the latter constituting a challenging problem for people in an increasingly connected world.
Background: Cardiovascular disease (CVD) poses a substantial global health burden, necessitating effective and scalable interventions for primary prevention. Despite the increasing recognition of peer-based interventions in managing chronic diseases, their application in CVD prevention still needs to be explored. Aims: We describe the protocol of a quasi-experiment to evaluate the effectiveness of a peer-led digital health lifestyle intervention, MYCardio-PEER, for a low-income community at risk for CVD. This study aims to assess the effectiveness of MYCardio-PEER in improving the participants’ knowledge, lifestyle behaviours and biomarkers related to CVD. Secondarily, we aim to assess the adherence and satisfaction of participants towards MYCardio-PEER. Methods: A minimum total sample of 68 low-income community members at risk for CVD will be recruited and allocated either to the control group or the intervention group. Participants in the control group will receive standard lifestyle advice and printed materials for CVD prevention, while the intervention group will participate in the 8-week MYCardio-PEER intervention program. The participants will be assessed at Week 0 (baseline), Week 8 (post-intervention) and Week 20 (post-follow-up). Discussion: We anticipate a net improvement in CVD risk score, besides investigating the effectiveness of the intervention program on CVD-related knowledge, biomarkers, and diet and lifestyle behaviours. The successful outcome of this study is essential for various healthcare professionals and stakeholders to implement population-based, cost-effective, and accessible interventions in reducing CVD prevalence in the country.
Establishing generalisable humour style profiles promises to have significant value for educational, clinical, and occupational application. However, previous research investigating such profiles has thus far presented inconsistent results. To determine the generalisability and value of humour style profiles, a large and geographically diverse examination of humour styles was conducted through a cross-sectional questionnaire methodology involving 863 participants from across three world regions. Findings identify inconsistencies in the humour style profiles across countries tested and the extant literature, possibly indicative of cultural differences in the behavioural expression of trait humour. Furthermore, when directly compared, humour types, rather than humour styles, consistently provide the greatest predictive value for friendship and well-being outcomes. As such, with respect to both consistency and value, capturing humour style profiles appears to represent a relatively reductionist approach to appreciating the nuances in the use and consequences of humour.
We examined the effect of social value orientation on the perception of self-protective value and public protective value of protective measures as well as the effect of both perceptions of protective value on behavior. We find that self-protective value is most important for behavior. A preprint sumarising the results can be found in the osf project.
Each year, over 15,000 preschoolers die from unintentional injuries in China. Many interventions proven to work in other nations have not been implemented nationwide in China. The rapid popularity of smartphones offers an opportunity to overcome this limitation and disseminate evidence-based interventions to the large population of China. This study aims to assess the effectiveness of an app-based intervention for caregivers of preschoolers to prevent unintentional injury among young Chinese children.
PsychArchives is a disciplinary repository for psychological science and neighboring disciplines.
Kubin & Brandt's project examining ideological differences and similarities using the AIID data.
Background: Efforts to elucidate subtypes within depression have yet to establish a consensus. This study aims to rigorously compare different subtyping approaches in the same subject space, to quantitatively test agreement across subtyping approaches and determine if the different approaches are sensitive to different sources of heterogeneity in depression. Methods: We will implement six different data-driven subtyping methods developed in prior work using the same UK Biobank participants (N=3,724 depressed cases and N=2,631 healthy controls). The six approaches include two symptom-based, two structural neuroimaging-based and two functional neuroimaging-based techniques. The resulting subtypes will be compared based on subject assignment, stability, and sensitivity to subgroup differences in categories of demographics, general health, clinical characteristics, neuroimaging, trauma, cognitive, genetics, inflammation markers. Proposed Analyses: We will assess the subject agreement of the subtype solutions using Adjusted Rand Index, the stability of the subtype solutions using bootstrapping, and evaluate domain (clinical, biological, neuroimaging) sensitivity differences between subtype approaches by performing general linear models on phenotypes unseen by previous analysis comparing subtypes within each approach and determining statistical difference in variance explained across subtype approaches (using permutation testing).
This pre-registered report outlines a comprehensive plan for a paper aimed at examining the positive relationship between stock liquidity and corporate cash holdings within the context of Japan. This study aims to offer a novel explanation. Our explanation is rooted in the “dark side” of stock liquidity, suggesting that liquidity could exacerbate corporate financial constraints by increasing the stock price crash risk. If managers expect liquidity to cause the surge of the cost of external capital, they will have a precautionary motive to retain cash. We plan to examine whether stock liquidity positively affects corporate cash holdings in Japan. Furthermore, we plan to isolate our hypothesis from other possible explanations by assessing whether the positive liquidity-cash relationship is more pronounced in firms experiencing overvaluation.
A body of research suggests cross-neurotype interpersonal interactions may be more challenging, and non-autistic individuals show less interest in interactions with their autistic peers. However, it is not clear whether such cross-neurotype differences extend to prosocial decision-making behaviour – something that is vital for forming and maintaining social bonds. In this Registered Report Protocol (given Stage 1 in principle acceptance from Research in Autism Spectrum Disorder) and using a well-established physical-effort-based decision-making paradigm, in combination with computational modelling, we examine autistic and non-autistic prosocial willingness to exert physical effort for oneself and others, as a function of whether they know the beneficiary of those actions to be of the same or cross-neurotype. We collect data from 60 individuals; 30 with and 30 without a clinical diagnosis of autism and compare decisions to exert effort as well as subsequent effort put into those actions when participants are making decisions for the self, other same-neurotype and other different-neurotype. Finally, we explore whether prosocial effort differences can be explained by biases (explicitly or implicitly) held about autism. This work has implications for understanding how interactor neurotypes and autism-specific biases may feed into prosocial decision-making contexts such as employment, health and education settings, where autistic individuals face the everyday consideration whether to disclose their diagnostic status.
The purpose of this study is to develop adaptive (AI) and micro-incentive (MI) interventions and test them against static (SI) and delayed-incentive (DI) interventions in a 4-arm randomized factorial trial to increase MVPA adoption and maintenance among inactive adults. Using neighborhood walkability and socioeconomic status, participants will be recruited from four neighborhood types: "high walkable/high SES," "high walkable/low SES," "low walkable/high SES," and "low walkable/low SES." We will evaluate synergistic or antagonistic effects of interventions and neighborhood factors on MVPA adoption by 12 months and maintenance by 24 months.
Background: Knee osteoarthritis (OA) is a leading contributor to global disability, with exercise proven to be an effective treatment. Tai Chi is a recommended type of exercise, but it is primarily done in person which imposes an accessibility issue. This study aims to evaluate the effects of an online unsupervised program, when provided with online educational information and exercise adherence support, on changes in knee pain and physical function, when compared to online education control for people with knee OA.
Background: Skin picking disorder is an under-recognized and understudied mental disorder associated with severe psychological and medical consequences. Affected individuals barely receive adequate treatment, given the scarcity of expertise in healthcare professionals and the lack of evidence-based interventions.
This pre-registered study seeks to investigate the effects of bank ties on corporate repurchase decisions and stock price reactions to buyback announcements. We make causal inferences to provide more insights into bank ties for stock repurchase decisions during extreme financial distress. We focus on the COVID-19 pandemic as an exogenous shock and identify whether the COVID-19 shock affected the bank-ties effect of the motives of stock repurchase decisions in a bank-based financial system. Our study sheds light on the motives behind stock repurchase decisions and the role of banks in corporate cash distribution to shareholders. Furthermore, our study contributes to understanding how extreme financial distress, such as COVID-19, affects the motive for stock repurchase in a bank-based financial system.
Introduction Expectant mothers in low-income and middle-income countries often lack access to vital information about pregnancy, preparation for birth and best practices when caring for their newborn. Innovative solutions are needed to bridge this knowledge gap and dramatically improve maternal and neonatal health in these settings. This study aims to evaluate the impact of an innovative text messaging intervention on maternal and neonatal health outcomes. Methods and analysis This study offers expectant mothers in rural China a package of free short messages via cell phone regarding pregnancy and childbirth. These messages are tailored to each mother's gestational week. It is hypothesised that delivering these short advice messages to pregnant women can improve maternal and newborn health. The study uses factorial quasi-randomisation to compare psychological, behavioural and health outcomes between 4 groups: 2 groups receiving different sets of short message interventions (ie, good household prenatal practices and healthcare seeking), a group receiving both interventions and a control group. Treatment assignment occurs at the individual level. The primary outcome is newborn health, measured by appropriateness of weight for gestational age. Secondary outcomes include severe neonatal and maternal morbidity as well as psychological and behavioural measures. This study has enrolled pregnant women who attend county maternal and child health centres for their prenatal visits. Discussion This pilot is the first large-scale effort to build a comprehensive evidence base on the impact of prenatal text messages via cell phone on maternal and newborn health outcomes in China. The study has broad implications for public health policy in China and the implementation of mobile health interventions in low-resource settings around the world. Ethics This study was approved by the Ethics Committee of the School of Medicine at Xi'an Jiaotong University on 18 January 2013. Trial registration number NCT02037087; Pre-results.
Background: Informal caregivers (CGs) of patients with Alzheimer’s disease are at risk of suffering from psychological and physical weakening. Several psychoeducational interventions have been designed to prevent stress and burden of caregivers. In France, despite health authorities’ recommendations, to our knowledge there is no rigorously assessed Web-based psychoeducational program to date. Objective: The objective of our study was to assess the efficacy of a French Web-based psychoeducational program (called Diapason) with an unblinded randomized clinical trial. Methods: In this protocol, 80 informal caregivers of patients followed at Broca Hospital are recruited offline and randomized in the experimental condition (EC) or the control condition (CC). The volunteers in EC have to visit a closed online user group at least once a week and validate one new session of this fully automated Web program, during 12 weeks. Each week a new thematic is added to the website. The participants in the CC receive usual care, and have access to the Diapason program after their participation (6 months). Face-to-face evaluations for both groups are planned every 3 months (M0–M3 and M6). The main objective of this program is to provide CGs with information on the disease process, how to prevent psychological strain (using anticipation and relaxation techniques), and offering a virtual space (forum) to discuss with other caregivers. The primary outcome of this study is the self-perceived stress, while self-efficacy, burden, depression, and self-perceived health status are defined as secondary outcomes. Other variables that might have an impact on the program efficacy are collected. Results: This protocol was accepted for funding. The enrollment began in October 2011, and participants currently recruited will finish their evaluations in January 2014. The results are expected for June 2014. Conclusions: Findings might provide empirical evidence on: (1) the feasibility of an Internet-based program in the French context, (2) the effectiveness of a Web-based program for informal caregivers, and (3) the identification of caregivers who will benefit from this type of intervention.
Background: With a growing focus on patient interaction with health management, mobile apps are increasingly used to deliver behavioral health interventions. The large variation in these mobile health apps—their target patient group, health behavior, and behavioral change strategies—has resulted in a large but incohesive body of literature. Objective: This systematic review aimed to assess the effectiveness of mobile apps in improving health behaviors and outcomes and to examine the inclusion and effectiveness of behavior change techniques (BCTs) in mobile health apps. Methods: PubMed, EMBASE, CINAHL, and Web of Science were systematically searched for articles published between 2014 and 2019 that evaluated mobile apps for health behavior change. Two authors independently screened and selected studies according to the eligibility criteria. Data were extracted and the risk of bias was assessed by one reviewer and validated by a second reviewer. Results: A total of 52 randomized controlled trials met the inclusion criteria and were included in the analysis—37 studies focused on physical activity, diet, or a combination of both, 11 on drug and alcohol use, and 4 on mental health. Participant perceptions were generally positive—only one app was rated as less helpful and satisfactory than the control—and the studies that measured engagement and usability found relatively high study completion rates (mean 83%; n=18, N=39) and ease-of-use ratings (3 significantly better than control, 9/15 rated >70%). However, there was little evidence of changed behavior or health outcomes. Conclusions: There was no strong evidence in support of the effectiveness of mobile apps in improving health behaviors or outcomes because few studies found significant differences between the app and control groups. Further research is needed to identify the BCTs that are most effective at promoting behavior change. Improved reporting is necessary to accurately evaluate the mobile health app effectiveness and risk of bias.