• The mPED randomized controlled clinical trial: applying mobile persuasive technologies to increase physical activity in sedentary women protocol

    stage 1

    Despite the significant health benefits of regular physical activity, approximately half of American adults, particularly women and minorities, do not meet the current physical activity recommendations. Mobile phone technologies are readily available, easily accessible and may provide a potentially powerful tool for delivering physical activity interventions. However, we need to understand how to effectively apply these mobile technologies to increase and maintain physical activity in physically inactive women. The purpose of this paper is to describe the study design and protocol of the mPED (mobile phone based physical activity education) randomized controlled clinical trial that examines the efficacy of a 3-month mobile phone and pedometer based physical activity intervention and compares two different 6-month maintenance interventions.

    Yoshimi Fukuoka, Judith Komatsu, Larry Suarez, Eric Vittinghoff, William Haskell, Tina Noorishad, Kristin Pham·2011·BMC Public Health
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  • The IRYSS-COPD appropriateness study: objectives, methodology, and description of the prospective cohort

    stage 1

    Patients with chronic obstructive pulmonary disease (COPD) often experience exacerbations of the disease that require hospitalization. Current guidelines offer little guidance for identifying patients whose clinical situation is appropriate for admission to the hospital, and properly developed and validated severity scores for COPD exacerbations are lacking. To address these important gaps in clinical care, we created the IRYSS-COPD Appropriateness Study.

    José M. Quintana, Cristóbal Esteban, Irantzu Barrio, Susana Garcia-Gutierrez, Nerea Gonzalez, Inmaculada Arostegui, Iratxe Lafuente, Marisa Bare, Juan Antonio Blasco, Silvia Vidal, the IRYSS-COPD group·2011·BMC Health Services Research
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  • Development of an e-supported illness management and recovery programme for consumers with severe mental illness using intervention mapping, and design of an early cluster randomized controlled trial

    stage 1

    E-mental health is a promising medium to keep mental health affordable and accessible. For consumers with severe mental illness the evidence of the effectiveness of e-health is limited. A number of difficulties and barriers have to be addressed concerning e-health for consumers with severe mental illness. One possible solution might be to blend e-health with face-to-face delivery of a recovery-oriented treatment, like the Illness Management & Recovery (IMR) programme. This paper describes the development of an e-health application for the IMR programme and the design of an early clustered randomized controlled trial.

    Titus A. A. Beentjes, Betsie G. I. van Gaal, Peter J. J. Goossens, Lisette Schoonhoven·2016·BMC Health Services Research
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  • A study to prolong breastfeeding duration: design and rationale of the Parent Infant Feeding Initiative (PIFI) randomised controlled trial

    stage 1

    Very few Australian infants are exclusively breastfed to 6 months as recommended by the World Health Organization. There is strong empirical evidence that fathers have a major impact on their partner’s decision to breastfeed and continuation of breastfeeding. Fathers want to participate in the breastfeeding decision making process and to know how they can support their partner to achieve their breastfeeding goals. The aim of the Parent Infant Feeding Initiative (PIFI) is to evaluate the effect on duration of any and exclusive breastfeeding of three breastfeeding promotion interventions of differing intensity and duration, targeted at couples but channelled through the male partner. The study will also undertake a cost-effectiveness evaluation of the interventions.

    Bruce R. Maycock, Jane A. Scott, Yvonne L. Hauck, Sharyn K. Burns, Suzanne Robinson, Roslyn Giglia, Anita Jorgensen, Becky White, Annegrete Harries, Satvinder Dhaliwal, Peter A. Howat, Colin W. Binns·2015·BMC Pregnancy and Childbirth
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  • The Binge Eating Genetics Initiative (BEGIN): study protocol

    stage 1

    The Binge Eating Genetics Initiative (BEGIN) is a multipronged investigation examining the interplay of genomic, gut microbiota, and behavioral factors in bulimia nervosa and binge-eating disorder.

    Cynthia M. Bulik, Jonathan E. Butner, Jenna Tregarthen, Laura M. Thornton, Rachael E. Flatt, Tosha Smith, Ian M. Carroll, Brian R.W. Baucom, Pascal R. Deboeck·2020·BMC Psychiatry
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  • The iTreAD project: a study protocol for a randomised controlled clinical trial of online treatment and social networking for binge drinking and depression in young people

    stage 1

    Depression and binge drinking behaviours are common clinical problems, which cause substantial functional, economic and health impacts. These conditions peak in young adulthood, and commonly co-occur. Comorbid depression and binge drinking are undertreated in young people, who are reluctant to seek help via traditional pathways to care. The iTreAD project (internet Treatment for Alcohol and Depression) aims to provide and evaluate internet-delivered monitoring and treatment programs for young people with depression and binge drinking concerns.

    F. J. Kay-Lambkin, A. L. Baker, J. Geddes, S. A. Hunt, K. L. Woodcock, M. Teesson, C. Oldmeadow, T. J. Lewin, B. M. Bewick, K. Brady, B. Spring, M. Deady, E. Barrett, L. Thornton·2015·BMC Public Health
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  • The GET READY relapse prevention programme for anxiety and depression: a mixed-methods study protocol

    stage 1

    Since anxiety and depressive disorders often recur, self-management competencies are crucial for improving the long-term course of anxiety and depressive disorders. However, few relapse prevention programmes are available that focus on improving self-management. E-health combined with personal contact with a mental health professional in general practice might be a promising approach for relapse prevention. In this protocol, the GET READY (Guided E-healTh for RElapse prevention in Anxiety and Depression) study will be described in which a relapse prevention programme is developed, implemented and evaluated. The aim of the study is to determine patients’ usage of the programme and the associated course of their symptoms, to examine barriers and facilitators of implementation, and to assess patients’ satisfaction with the programme.

    Esther Krijnen-de Bruin, Anna D. T. Muntingh, Adriaan W. Hoogendoorn, Annemieke van Straten, Neeltje M. Batelaan, Otto R. Maarsingh, Anton J. L. M. van Balkom, Berno van Meijel·2019·BMC Psychiatry
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  • The Smart City Active Mobile Phone Intervention (SCAMPI) study to promote physical activity through active transportation in healthy adults: a study protocol for a randomised controlled trial

    stage 1

    The global pandemic of physical inactivity represents a considerable public health challenge. Active transportation (i.e., walking or cycling for transport) can contribute to greater total physical activity levels. Mobile phone-based programs can promote behaviour change, but no study has evaluated whether such a program can promote active transportation in adults. This study protocol presents the design and methodology of The Smart City Active Mobile Phone Intervention (SCAMPI), a randomised controlled trial to promote active transportation via a smartphone application (app) with the aim to increase physical activity.

    Anna Ek, Christina Alexandrou, Christine Delisle Nyström, Artur Direito, Ulf Eriksson, Ulf Hammar, Pontus Henriksson, Ralph Maddison, Ylva Trolle Lagerros, Marie Löf·2018·BMC Public Health
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  • Blockchain Implementation in Health Care: Protocol for a Systematic Review

    stage 1

    Background: A blockchain is a digitized, decentralized, distributed public ledger that acts as a shared and synchronized database that records cryptocurrency transactions. Despite the shift toward digital platforms enabled by electronic medical records, demonstrating a will to reform the health care sector, health systems face issues including security, interoperability, data fragmentation, timely access to patient data, and silos. The application of health care blockchains could enable data interoperability, enhancement of precision medicine, and reduction in prescription frauds through implementing novel methods in access and patient consent. Objective: To summarize the evidence on the strategies and frameworks utilized to implement blockchains for patient data in health care to ensure privacy and improve interoperability and scalability. It is anticipated this review will assist in the development of recommendations that will assist key stakeholders in health care blockchain implementation, and we predict that the evidence generated will challenge the health care status quo, moving away from more traditional approaches and facilitating decision making of patients, health care providers, and researchers. Methods: A systematic search of MEDLINE/PubMed, Embase, Scopus, ProQuest Technology Collection and Engineering Index will be conducted. Two experienced independent reviewers will conduct titles and abstract screening followed by full-text reading to determine study eligibility. Data will then be extracted onto data extraction forms before using the Cochrane Collaboration Risk of Bias Tool to appraise the quality of included randomized studies and the Risk of Bias in nonrandomized studies of Interventions to assess the quality of nonrandomized studies. Data will then be analyzed and synthesized. Results: Database searches will be initiated in September 2018. We expect to complete the review in January 2019. Conclusions: This review will summarize the strategies and frameworks used to implement blockchains in health care to increase data privacy, interoperability, and scalability. This review will also help clarify if the strategies and frameworks required for the operationalization of blockchains in health care ensure the privacy of patient data while enabling efficiency, interoperability, and scalability.

    Edward Meinert, Abrar Alturkistani, Kimberley A. Foley, Tasnime Osama, Josip Car, Azeem Majeed, Michelle Van Velthoven, Glenn Wells, David Brindley·2019·JMIR Research Protocols
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  • A patient-centered, coordinated care approach delivered by community and pediatric primary care providers to promote responsive parenting: pragmatic randomized clinical trial rationale and protocol

    stage 1

    Economically disadvantaged families receive care in both clinical and community settings, but this care is rarely coordinated and can result in conflicting educational messaging. WEE Baby Care is a pragmatic randomized clinical trial evaluating a patient-centered responsive parenting (RP) intervention that uses health information technology (HIT) strategies to coordinate care between pediatric primary care providers (PCPs) and the Special Supplemental Nutrition Program for Women, Infant and Children (WIC) community nutritionists to prevent rapid weight gain from birth to 6 months. It is hypothesized that data integration and coordination will improve consistency in RP messaging and parent self-efficacy, promoting shared decision making and infant self-regulation, to reduce infant rapid weight gain from birth to 6 months.

    Jennifer S. Savage, Samantha M. R. Kling, Adam Cook, Lindsey Hess, Shawnee Lutcher, Michele Marini, Jacob Mowery, Shannon Hayward, Sandra Hassink, Jennifer Franceschelli Hosterman, Ian M. Paul, Chris Seiler, Lisa Bailey-Davis·2018·BMC Pediatrics
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  • “Active Team” a social and gamified app-based physical activity intervention: randomised controlled trial study protocol

    stage 1

    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.

    Sarah Edney, Ronald Plotnikoff, Corneel Vandelanotte, Tim Olds, Ilse De Bourdeaudhuij, Jillian Ryan, Carol Maher·2017·BMC Public Health
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  • Smart Phone APP to Restore Optimal Weight (SPAROW): protocol for a randomised controlled trial for women with recent gestational diabetes

    stage 1

    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.

    Karen Lim, Claudia Chi, Shiao-Yng Chan, Su Lin Lim, Siew Min Ang, Joanne S. Yoong, Cammy Tsai, Su Ren Wong, Tong Wei Yew, E. Shyong Tai, Eu-Leong Yong·2019·BMC Public Health
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  • A Personal Decision Support System for Heart Failure Management (HeartMan): study protocol of the HeartMan randomized controlled trial

    stage 1

    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.

    Anneleen Baert, Els Clays, Larissa Bolliger, Delphine De Smedt, Mitja Lustrek, Aljoša Vodopija, Marko Bohanec, Paolo Emilio Puddu, Maria Costanza Ciancarelli, Michele Schiariti, Jan Derboven, Gennaro Tartarisco, Sofie Pardaens, on behalf of the HeartMan consortium·2018·BMC Cardiovascular Disorders
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  • Known in the nursing home: development and evaluation of a digital person-centered artistic photo-activity intervention to promote social interaction between residents with dementia, and their formal and informal carers

    stage 1

    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.

    Josephine Rose Orejana Tan, Petra Boersma, Teake P. Ettema, Laurence Aëgerter, Robbert Gobbens, Max L. Stek, Rose-Marie Dröes·2022·BMC Geriatrics
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  • Run4Love, a mHealth (WeChat-based) intervention to improve mental health of people living with HIV: a randomized controlled trial protocol

    stage 1

    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.

    Yan Guo, Y. Alicia Hong, Jiaying Qiao, Zhimeng Xu, Hanxi Zhang, Chengbo Zeng, Weiping Cai, Linghua Li, Cong Liu, Yiran Li, Mengting Zhu, Nathan Asher Harris, Cui Yang·2018·BMC Public Health
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  • The use of the mHealth program Smarter Pregnancy in preconception care: rationale, study design and data collection of a randomized controlled trial

    stage 1
    Matthijs R. Van Dijk, Elsje C. Oostingh, Maria P. H. Koster, Sten P. Willemsen, Joop S. E. Laven, Régine P. M. Steegers-Theunissen·2017·BMC Pregnancy and Childbirth
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  • Study protocol for a controlled trial of an eHealth system utilising patient reported outcome measures for personalised treatment and care: PROMPT-Care 2.0

    stage 1
    on behalf of the PROMPT-Care Program Group, Afaf Girgis, Ivana Durcinoska, Martha Gerges, Nasreen Kaadan, Anthony Arnold, Joseph Descallar, Geoff P. Delaney·2018·BMC Cancer
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  • Optimising engagement in a digital parenting intervention to prevent violence against adolescents in Tanzania: protocol for a cluster randomised factorial trial

    stage 1

    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.

    Roselinde Janowski, Ohad Green, Yulia Shenderovich, David Stern, Lily Clements, Joyce Wamoyi, Mwita Wambura, Jamie M. Lachman, G. J. Melendez-Torres, Frances Gardner, Lauren Baerecke, Esmee Te Winkel, Anna Booij, Orli Setton, Sibongile Tsoanyane, Sussie Mjwara, Laetitia Christine, Abigail Ornellas, Nicole Chetty, Jonathan Klapwijk, Isang Awah, Nyasha Manjengenja, Kudely Sokoine, Sabrina Majikata, Lucie D. Cluver·2023·BMC Public Health
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  • Effects of the ACT OUT! Social Issue Theater Program on Social-Emotional Competence and Bullying in Youth and Adolescents: Protocol for a Cluster Randomized Controlled Trial

    stage 1

    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

    Jon Agley, Wasantha Jayawardene, Mikyoung Jun, Daniel L. Agley, Ruth Gassman, Steve Sussman, Yunyu Xiao, Stephanie L. Dickinson·2020·JMIR Research Protocols
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  • Design, implementation and evaluation of a web-based computer-tailored intervention to prevent binge drinking in adolescents: study protocol

    stage 1
    Marta Lima-Serrano, José Manuel Martínez-Montilla, Joaquín S. Lima-Rodríguez, Liesbeth Mercken, Hein De Vries·2018·BMC Public Health
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  • Internet-delivered treatment: its potential as a low-intensity community intervention for adults with symptoms of depression: protocol for a randomized controlled trial

    stage 1
    Derek Richards, Ladislav Timulak, Gavin Doherty, John Sharry, Amy Colla, Ciara Joyce, Claire Hayes·2014·BMC Psychiatry
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  • Social media for health promotion in diabetes: study protocol for a participatory public health intervention design

    stage 1

    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.

    E. Gabarron, M. Bradway, L. Fernandez-Luque, T. Chomutare, A. H. Hansen, R. Wynn, E. Årsand·2018·BMC Health Services Research
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  • Beliefs about What Disadvantaged Groups Would Do with Power Shape Advantaged Groups’ (Un)Willingness to Relinquish it

    stage 1
    Frank Kachanoff, Jennifer Sheehy-Skeffington, Arnold Ho, Jennifer Richeson, Nour Kteily·2025·Journal of Personality and Social Psychology
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  • Open Science Training in APA-accredited Clinical Psychology Programs

    stage 1
    Kaela Van Til, Nathaniel Phillips, Josh Miller, Donald Lynam, Leigha Rose, Tianwei Du·2023
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  • 2022_09_14_Registered Report Protocol Preregistration.pdf

    stage 1
    Trude Nergård-Nilssen, Bjarte Furnes, Ømur Caglar-Ryeng, Oddgeir Friborg, Monica Melby-Lervåg·2022
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  • Effect of apolipoprotein E polymorphism on cognition and brain in the Cambridge Centre for Ageing and Neuroscience cohort

    Richard N. Henson, Sana Suri, Ethan Knights, James B. Rowe, Rogier A. Kievit, Donald M. Lyall, Dennis Chan, Else Eising, Simon E. Fisher·2020·Brain and Neuroscience Advances
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  • Disgust, Moral Concerns, and Attitudes Toward Bathroom Choice for Transgender People

    stage 1

    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.

    Matthew Vanaman, Hanah Chapman·2019
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  • An Internet-Based Intervention to Alleviate Stress During Social Isolation With Guided Relaxation and Meditation: Protocol for a Randomized Controlled Trial

    stage 1

    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.

    Silvia Maria Francesca Pizzoli, Chiara Marzorati, Davide Mazzoni, Gabriella Pravettoni·2020·JMIR Research Protocols
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  • Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial

    stage 1

    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

    Francisco Jódar-Sánchez, Laura Carrasco Hernández, Francisco J. Núñez-Benjumea, Marco Antonio Mesa González, Jesús Moreno Conde, Carlos Luis Parra Calderón, Luis Fernandez-Luque, Santiago Hors-Fraile, Anton Civit, Panagiotis Bamidis, Francisco Ortega-Ruiz·2018·JMIR Research Protocols
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  • Life History Strategies

    stage 1
    Paula Sheppard·2020
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  • Decisions from experience: Competitive search and choice in kind and wicked environments

    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.

    Renato Frey·2020·Judgment and Decision Making
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  • Peer-led digital health lifestyle intervention for a low-income community at risk for cardiovascular diseases (MYCardio-PEER): a quasi-experimental study protocol

    stage 1

    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.

    Geok Pei Lim, Jamuna Rani Appalasamy, Badariah Ahmad, Kia Fatt Quek, Shazwani Shaharuddin, Amutha Ramadas·2025·Primary Health Care Research & Development
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  • Earning Money Goal: Conceptual Replication and Extension of Aarts et al. (2004)

    stage 1
    Hilmar Brohmer, Andreas Hoefler, Katja Corcoran, Lisa Eckerstorfer, Robert Spörk, Silvia Macher·2017
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  • Exploring the Consistency and Value of Humour Style Profiles

    stage 1

    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.

    Thomas Evans, Niklas Johannes, Joanna Winska, Aldona Glińska-Neweś, Aart van Stekelenburg, Gustav Nilsonne, Laura Dean, Dean Fido, Graeme Galloway, Sian Jones·2018
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  • A Smart and Multifaceted Mobile Health System for Delivering Evidence-Based Secondary Prevention of Stroke in Rural China: Design, Development, and Feasibility Study

    Na Wu, Enying Gong, Bo Wang, Wanbing Gu, Nan Ding, Zhuoran Zhang, Mengyao Chen, Lijing L Yan, Brian Oldenburg, Li-Qun Xu·2019·JMIR mHealth and uHealth
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  • Yikes! Are we disgusted by politicians?

    Bert Bakker, Gijs Schumacher, Maaike Homan·2019
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  • Main Study

    stage 1
    Jan Voelkel, Mark Brandt, Matteo Colombo·2017
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  • COVID19, SVO, and Protection Behavior

    stage 1

    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.

    Johannes Leder, Astrid Schütz, Alexander Pastukhov·2020
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  • Effectiveness of an app-based intervention for unintentional injury among caregivers of preschoolers: protocol for a cluster randomized controlled trial

    stage 1

    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.

    Peishan Ning, Bo Chen, Peixia Cheng, Yang Yang, David C. Schwebel, Renhe Yu, Jing Deng, Shukun Li, Guoqing Hu·2018·BMC Public Health
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  • How leaders’ multiple identity prototypicality is related to their perceived effectiveness

    stage 1
    Niklas Steffens, Kim Peters, S. Haslam, Michael Platow·2017
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  • The value of money: On how childhood economic resources influence value assessments later in life.

    stage 1
    Gró Einarsdóttir, André Hansla, Lars-Olof Johansson·2017
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  • Status, Power, and Moral Licensing

    stage 1
    Alexander Danvers·2020
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  • Differences in Prosocial Behavior Regarding Decisions About how to Allocate Money and Time are due to Decision-Makers’ Characteristics

    stage 1

    PsychArchives is a disciplinary repository for psychological science and neighboring disciplines.

    Johannes Leder, Alexander Pastukhov, Astrid Schütz·2019
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  • Ideological Differences (AIID)

    stage 1

    Kubin & Brandt's project examining ideological differences and similarities using the AIID data.

    Emily Kubin, Mark Brandt·2019
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  • Effectiveness of an mHealth Intervention Combining a Smartphone App and Smart Band on Body Composition in an Overweight and Obese Population: Randomized Controlled Trial (EVIDENT 3 Study)

    Cristina Lugones-Sanchez, Maria Antonia Sanchez-Calvaera, Irene Repiso-Gento, Esther G Adalia, J Ignacio Ramirez-Manent, Cristina Agudo-Conde, Emiliano Rodriguez-Sanchez, Manuel Angel Gomez-Marcos, Jose I Recio-Rodriguez, Luis Garcia-Ortiz·2020·JMIR mHealth and uHealth
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  • Unethical Behaviour in the Workplace:A Direct and Conceptual Replication of Jon7es & Kavanagh (1996)

    stage 1
    Thomas Evans, James Bartlett·2022
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  • Comparing data-driven subtypes of depression informed by clinical and neuroimaging data: A Registered Report

    stage 1

    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).

    Kayla Hannon, Luca Balogh, Fyzeen Ahmad, Petra Lenzini, Aristeidis Sotiras, Janine Bijsterbosch·2023
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  • Does Ego Depletion Reduce Judgment Adjustment for Both Internally and Externally Generated Anchors?

    stage 1
    Lukas Röseler, Astrid Schütz, Ulrike Starker, Roy Baumeister·2019
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  • How does stock liquidity affect corporate cash holdings in Japan?: A pre-registered report

    stage 1

    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.

    Ryosuke Fujitani, Kiyonori Iwata, Yukihiro Yasuda·2024·Pacific-Basin Finance Journal
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  • Autistic and non-autistic prosocial decision-making: The impact of recipient neurotype

    stage 1

    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.

    Sophie Sowden-Carvalho, Selma Lugtmeijer, Connor Keating, Peter Rush·2025
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