Pilot and Feasibility Studies最新文献

{"title":"A pilot sequential multiple assignment randomized trial for developing a biobehavioral adaptive intervention to improve insulin sensitivity in patients with stage 1 obesity.","authors":"Aseel El Zein, Katie M Ellison, Julianne G Clina, Chelsi Reynolds, Caroline W Cohen, James O Hill, Gareth R Dutton, Tapan S Mehta, R Drew Sayer","doi":"10.1186/s40814-025-01618-4","DOIUrl":"10.1186/s40814-025-01618-4","url":null,"abstract":"<p><strong>Background: </strong>Intervention packages targeting obesity-related conditions often include multiple behavioral and pharmacological components, yet the independent and synergistic effects of these strategies on disease progression remain largely unexplored. Adaptive interventions offer a structured approach to tailoring treatments based on individual responses, but feasibility data in primary care settings are limited. The objective of this pilot Sequential Multiple Assignment Randomized Trial (SMART) was to investigate the feasibility of a 25-week adaptive biobehavioral intervention designed to improve insulin sensitivity among patients with stage 1 obesity.</p><p><strong>Methods: </strong>Forty participants were initially randomized to either nutrition counseling (NC) or exercise counseling (EC), both employing a weight-neutral approach. At week 8, insulin sensitivity was reassessed using the Quantitative Insulin Sensitivity Check Index (QUICKI). Participants with a > 5% improvement were classified as responders, while non-responders were re-randomized to either augment their first-stage intervention with metformin or switch to weight loss counseling (WLC). Feasibility outcomes included recruitment and retention, adherence to intervention components, and preliminary treatment effect estimates.</p><p><strong>Results: </strong>Findings support the overall feasibility of the SMART design, with high adherence to virtual counseling sessions and favorable participant retention. The study effectively differentiated responders from non-responders at week 8, with responders showing greater improvements in insulin sensitivity. Among non-responders, WLC and metformin provided a potential rescue effect, but overall insulin sensitivity remained lower than at of responders. While NC and WLC were preferred over EC and metformin, adherence to counseling sessions remained high across all interventions, regardless of preference. Metformin adherence posed challenges due to frequent gastrointestinal side effects and difficulties tracking usage.</p><p><strong>Conclusions: </strong>This pilot study supports the feasibility of an adaptive biobehavioral intervention for improving insulin sensitivity among adults with obesity in a primary care setting. However, further refinement is needed to enhance clinical integration, optimize intervention messaging, and improve medication tracking. Findings from this study will inform a second pilot SMART, laying the foundation for a full-scale primary-care embedded intervention delivering personalized, adaptive strategies for improving cardiometabolic health.</p><p><strong>Trial registration: </strong>NCT04392283 on April 19th, 2020.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"40"},"PeriodicalIF":1.5,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11971893/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143788768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tailoring registered dietitian and occupational therapy services for home-delivered meal recipients: feasibility study protocol for a randomized controlled trial.","authors":"Lisa A Juckett, Shivam Joshi, J Madison Hyer, Govind Hariharan, Kali S Thomas, Tejeswini Siva Sathya, Mequeil L Howard, Leah E Bunck, Melinda L Rowe, Andrea Devier, Kelly Parrett","doi":"10.1186/s40814-025-01623-7","DOIUrl":"10.1186/s40814-025-01623-7","url":null,"abstract":"<p><strong>Background: </strong>Home-delivered meal recipients often present with complex nutritional and functional needs that place them at elevated risk for health decline and potential institutionalization. To address these complex needs, clinical services-namely registered dietitian and occupational therapy services-may be warranted to reduce the risk of health decline and maximize outcomes of this vulnerable older adult population. Accordingly, this study will explore the feasibility of testing four different clinical service models with home-delivered meal recipients. In particular, this study will determine the feasibility of recruiting and retaining participants from one home-delivered meal provider, determine challenges and opportunities to improve data collection procedures, assess resources needed to conduct study activities, and identify if service models can be implemented as intended.</p><p><strong>Methods: </strong>This is a feasibility RCT with 1:1:1:1 allocation to four service arms: (a) meals only, (b) meals + registered dietitian services, (c) meals + occupational therapy services, or (d) meals + registered dietitian services + occupational therapy services. Study activities will be conducted in collaboration with one, large community-based agency in the Midwest United States. We will recruit 60 participants who meet the following inclusion criteria: is eligible to receive home-delivered meals funded through Title 3 of the Older Americans Act, has a self-reported diagnosis of diabetes and/or heart disease, is at risk for falling, and can store and reheat up to 14 frozen meals per week. Data collection will occur at baseline and at 3 months after informed consent to assess malnutrition risk, self-management of health conditions, and fall risk.</p><p><strong>Discussion: </strong>While tailored dietitian and occupational therapy services may be warranted to address the nutritional and functional needs of home-delivered meal recipients, the effect of these services on recipient outcomes has yet to be rigorously examined. This feasibility study will identify the degree to which our service models can be tested with one community-based agency and identify opportunities to improve study procedures prior to conducting a definitive, stage III randomized controlled trial.</p><p><strong>Trial registration: </strong>NCT06059404.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"41"},"PeriodicalIF":1.5,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11971902/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143788775","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The feasibility and acceptability of delivering and evaluating a physical activity intervention (ACCEPTANCE) for cervical cancer survivors.","authors":"Nessa Millet, Hilary J McDermott, Fehmidah Munir, Charlotte L Edwardson, Tatiana Plekhanova, Esther L Moss","doi":"10.1186/s40814-025-01622-8","DOIUrl":"10.1186/s40814-025-01622-8","url":null,"abstract":"<p><strong>Background: </strong>Cervical cancer treatment can be associated with long-term physical, psychological and emotional issues leading to compromised quality of life (QOL). Physical activity (PA) may improve QOL in cervical cancer survivors.</p><p><strong>Methods: </strong>A one-arm pre/post-feasibility study with parallel process evaluation was conducted to test the feasibility and acceptability of a 12-week PA intervention (ACCEPTANCE). Feasibility was determined by using pre-established criteria relating to inclusion criteria, recruitment and retention, compliance with intervention components and compliance with evaluation measures. The 12-week intervention consisted of (1) an online education session on the benefits of PA and a barrier identification and problem-solving session; (2) a Fitbit monitor; (3) daily and weekly diary entries; (4) brief fortnightly online health coaching sessions; and (5) organising and participating in group walks; (6) online social interaction via a messaging group. Measures included accelerometer assessed PA and sleep, quality-of-life and PA behaviour change questionnaires distributed at 4-time points (baseline, week 6, week 12, and week 24). Process evaluation measures were questionnaires on the acceptance of intervention components and semi-structured interviews with participants after completion.</p><p><strong>Results: </strong>Thirty participants were recruited with a retention rate of 77% at week 24. The education session, health coaching and Fitbit PA monitor were deemed to be feasible based on compliance rates whilst the online messaging group, diary and group walking compliance suggested that modifications would be needed for these components. Accelerometer and questionnaires were deemed to be feasible evaluation measures based on compliance rates. Process evaluation results suggest that the Fitbit and health coaching sessions were perceived to be the most beneficial aspects of the programme as they enabled self-monitoring of behaviour and goal setting. Unexpected mechanisms of behaviour change were the integration of a small change approach and formation of habits to facilitate PA, whilst barriers to behaviour change included the online, virtual nature of the programme, poor mental health, and environmental challenges. PA levels were higher after the intervention, whilst global QOL was seen to worsen throughout the study, and depression and anxiety symptoms improved.</p><p><strong>Conclusions: </strong>The ACCEPTANCE study is deemed to be feasible based on criteria established a priori, and only minor modifications would needed to implement in a definitive randomised control trial. The intervention showed potential to increase PA, through hypothesised mechanisms of self-monitoring behaviour and problem solving and unexpected mechanisms such as habit formation.</p><p><strong>Trial registration: </strong>ISRCTN16349793, Registered 30 September 2020.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"42"},"PeriodicalIF":1.5,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11971866/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143788776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Support for young people who are distressed by hearing voices: protocol for an uncontrolled feasibility evaluation of a psychological intervention package delivered within secondary schools (the ECHOES study).","authors":"Mark Hayward, Mary John, Sarah Parry, Anna-Marie Bibby-Jones, Faith Orchard, Fiona Malpass, Clare Dixon, Akira Naito","doi":"10.1186/s40814-025-01611-x","DOIUrl":"10.1186/s40814-025-01611-x","url":null,"abstract":"<p><strong>Background: </strong>Hearing voices is a common experience for young people and can cause significant distress. There are no evidence-based psychological interventions for distressing voices in young people, although a focus on coping strategies has been suggested as a useful approach. We have developed and evaluated a brief 1:1 coping intervention for young people who hear distressing voices. This intervention has been successfully piloted within Child and Adolescent Mental Health Services (CAMHS), together with a psychoeducational workshop for parents. The 1:1 intervention and the workshop will be combined into an intervention package and offered within schools to maximise accessibility.</p><p><strong>Methods: </strong>This study will be an uncontrolled feasibility evaluation addressing the following questions: is the intervention package acceptable to young people, those who support them, and staff and practitioners within secondary schools? What is the optimum content, structure, and duration for the intervention package? Is delivery of the intervention package feasible for the practitioners and what are their requirements for training and supervision? What tools can be used to evaluate the impact of the intervention package? The study will be guided by the MRC Framework for the development of complex interventions and consist of an iterative process over four phases: phase 1-adaptation of the intervention package with young people, parents, and school staff; phase 2-delivery of the intervention package through Mental Health Support Teams to students, supporters who have been nominated by the students and school staff; phase 3-analysis of quantitative and qualitative data collected from participants and practitioners; phase 4-further adaptation of the intervention package with young people, parents and school staff.</p><p><strong>Discussion: </strong>If the findings from the study suggest that a future trial is warranted, a feasibility Randomised Controlled Trial will be designed to establish the parameters for a definitive trial.</p><p><strong>Trial registration: </strong>Current Controlled Trials ISRCTN registration number: 16395888. Registered on 11 January 2024. 10.1186/ISRCTN16395888.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"39"},"PeriodicalIF":1.5,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11971772/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143788773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Findings from a cluster randomised feasibility study of a school-based physical activity role model intervention (CHARMING) for 9-10-year-old girls.","authors":"Kelly Morgan, Jordan Van Godwin, Rebecca Cannings-John, Rhiannon Tudor Edwards, Rachel Granger, Britt Hallingberg, Graham Moore, Bethan Pell, Esther van Sluijs, Holly Whiteley, Jemma Hawkins","doi":"10.1186/s40814-025-01615-7","DOIUrl":"10.1186/s40814-025-01615-7","url":null,"abstract":"<p><strong>Background: </strong>Girls' physical activity levels decline to a greater extent than boys as they enter adolescence. Role model interventions offer a potential solution to combat this public health issue. This study reports findings of a feasibility study of the CHARMING (CHoosing Active Role Models to INspire Girls) programme, a 6-week after-school primary school-based, community linked, role-model intervention.</p><p><strong>Methods: </strong>Between January 2021 and August 2022, a feasibility cluster randomised controlled trial (cRCT), with process and health economic evaluations was conducted in South Wales. Secondary schools were recruited, along with their adjoining primary schools to recruit Year 5 girls (aged 9-10 years). Role models were recruited from the surrounding school community (community role models) and from each secondary school (peer role models). A survey of self-reported outcome measures and accelerometers were administered at baseline and at 12 months. Following baseline, six primary schools were randomly allocated to intervention or control (usual practice) on a 2:1 basis. Post-intervention delivery, observations (n = 30), focus groups (n = 13) and interviews (n = 22) were conducted to explore study and intervention acceptability, feasibility and fidelity. Five pre-specified progression criteria included: implementation, attendance rates, and acceptability of the intervention, as well as completion of the primary outcome, including levels of completeness.</p><p><strong>Results: </strong>One hundred and fifty-six girls from six primary schools (four intervention and two control) were eligible to take part. Of these, 96 (62%) and 97 (62%) Year 5 girls took part in the survey and accelerometer measures respectively, with 78 (81%) and 77 (79%) participating in the 12-month follow-up. Findings indicate that it is feasible to collect health-related quality of life information from 9- to 10-year-olds using a digital self-report survey completed in schools. Despite the impacts of the COVID-19 pandemic, three of the five criteria (implementation, acceptability and completion of primary outcome) for progressing to a full-scale evaluation were met. Process evaluation data provide understandings of why two criteria (attendance and completeness of the primary outcome) were not met. Overall, data suggest that acceptability and feasibility of the intervention were high, and that the intervention was broadly delivered as intended. Alterations to the study measures and the intervention were suggested to increase intervention acceptability and feasibility, including recruitment and retention and extending the length of delivery in line with original intentions (12 weeks).</p><p><strong>Conclusions: </strong>Findings suggest the CHARMING intervention and cRCT design are likely to be acceptable and feasible, subject to further intervention and evaluation design optimisation.</p><p><strong>Trial registration: </strong>ClinicalTrial","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"38"},"PeriodicalIF":1.5,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969858/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143788771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Four-week Nordic hamstring exercise intervention for individuals with ACL reconstruction via hamstrings tendon autograft: feasibility of a pilot randomized controlled trial.","authors":"Grant E Norte, Neal R Glaviano, David A Sherman, Justin L Rush, Amanda M Murray","doi":"10.1186/s40814-025-01624-6","DOIUrl":"10.1186/s40814-025-01624-6","url":null,"abstract":"<p><strong>Background: </strong>The Nordic hamstring exercise (NHE) has been widely used among uninjured, athletic populations to mitigate the risk of hamstring injury, yet little is known about its utility as an intervention for individuals who undergo ACL reconstruction with hamstring tendon autograft (ACLR-HT). Understanding the feasibility of NHE as a means of enhancing hamstring function may aid in the development of evidence-based recommendations to guide hamstring recovery. Our aim was to determine the feasibility of conducting a pilot NHE trial among individuals with ACLR-HT.</p><p><strong>Methods: </strong>We used a single-blind randomized controlled trial with parallel arms to investigate individuals 18-35 years with primary, unilateral ACLR-HT. Twenty-three participants were randomized to a standardized, 4-week (10 session) progressive NHE intervention (n = 17) or usual care control (n = 6) group at a 3:1 ratio. Those randomized to the control group were eligible to open-enroll in the intervention group at the completion of the original study period. Primary feasibility outcomes included recruitment uptake, protocol adherence, dose goal attainment, and retention. Exercise perceptions and safety were also assessed. Summary statistics were used to descriptively report all findings.</p><p><strong>Results: </strong>Two control participants were open-enrolled in the intervention group after completing their original study period (n = 19). All participants (88.5% recruitment uptake) adhered to the exercise protocol (100%) and 18 participants (94.7%) attained the total exercise dosage goal. A 100% retention rate was observed, as all participants (intervention 17 randomized, 2 open-enrolled; control 6) returned for their follow-up assessment.</p><p><strong>Conclusions: </strong>A standardized, 4-week progressive NHE protocol is feasible for individuals with ACLR-HT. Positive perceptions of exercise, minimal exercise-related discomfort, and no reported adverse events further support the acceptability of this protocol and the likelihood of successful implementation in future efficacy trials.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT05738200. Registered 2 November 2022-retrospectively registered, https://clinicaltrials.gov/study/NCT05738200 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"37"},"PeriodicalIF":1.5,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969947/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143780811","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility of an exercise program in endocrine-treated metastatic breast cancer patients with overweight: protocol for the FEMA study.","authors":"May Wissing, Pernille Skovlund, Susanne Drysdale, Ali Amidi, Robert Zachariae, Tinne Laurberg, Signe Borgquist","doi":"10.1186/s40814-025-01621-9","DOIUrl":"10.1186/s40814-025-01621-9","url":null,"abstract":"<p><strong>Background: </strong>Many patients with metastatic breast cancer can live relatively long lives but are challenged by treatment- and cancer-related side effects such as weight gain, physical deconditioning, and reduced quality of life, possibly affecting survival. In particular, endocrine treatments are associated with an increased risk of weight gain and adverse metabolic effects. There is a need for interventions to prevent side effects among patients with disseminated breast cancer. Exercise is found to be effective in improving quality of life, metabolic health, and body composition in the curative setting, yet evidence in the metastatic setting is sparse. The aim of this study is to assess feasibility of a 12-week exercise intervention for metastatic breast cancer patients with overweight receiving endocrine therapy and to explore potential effects on metabolic health, body composition, physical performance, obesity-related biomarkers, and patient-reported outcomes.</p><p><strong>Methods: </strong>The FEMA study is a randomized controlled feasibility trial in which 21 endocrine-treated patients with metastatic breast cancer and overweight will be randomly assigned in a 2:1 ratio to either a 12-week training program with three weekly training sessions (intervention), or usual care (control), which includes standard clinical follow-up and supportive care without structured exercise. Feasibility will be assessed based on recruitment rate, adherence, retention, and acceptability, employing both quantitative and qualitative approaches for data collection. Participants' experiences will be explored by interviews and analyzed based on content analysis. Data are collected from blood samples, bioelectrical impedance analysis, physical performance tests, blood pressure measurements, and validated questionnaires on health-related quality of life, self-efficacy for coping with cancer, and sleep quality for explorative analyses.</p><p><strong>Discussion: </strong>The planned study will allow us to determine whether this 12-week exercise intervention is feasible in endocrine-treated metastatic breast cancer patients with overweight and explore potential effects on metabolic health, body composition, physical performance, obesity-related biomarkers, and patient-reported outcomes. Information from feasibility outcomes will inform the design of a future definitive randomized controlled trial.</p><p><strong>Trial registration: </strong>Retrospectively registered on March 6, 2024, at ClinicalTrials.gov (NCT06343987).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"36"},"PeriodicalIF":1.5,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11963278/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143772873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A pilot randomized controlled double-blind trial of intermittent theta burst stimulation (iTBS) repetitive transcranial magnetic stimulation (rTMS) to improve memory in mild cognitive impairment (MCI): a study protocol.","authors":"Maria I Lapid, Sandeep R Pagali, Michael R Basso, Paul E Croarkin, Jennifer R Geske, John Huston, Karimul Islam, Boney Joseph, Walter W Kennebeck, Daehun Kang, Simon Kung, Allison M LeMahieu, Brian N Lundstrom, Ronald C Petersen, Mikaela M Sarran, Yunhong Shu, Ilya M Swanson, Erik K St Louis, Melissa K Wang, Yogatheesan Varatharajah, Neeraj Wagh, Kirk M Welker, Gregory A Worrell, Bradley F Boeve","doi":"10.1186/s40814-025-01625-5","DOIUrl":"10.1186/s40814-025-01625-5","url":null,"abstract":"<p><strong>Background: </strong>Mild cognitive impairment (MCI), prevalent among older adults, often precedes Alzheimer's disease (AD) or Alzheimer's disease-related dementias (ADRD), emphasizing the need for effective interventions. Early intervention in MCI is crucial, not only to alleviate symptoms but to potentially delay the progression of cognitive decline. The lack of definitive treatments for MCI has prompted the exploration into alternative non-pharmacological therapeutic approaches. Specifically, noninvasive brain stimulation using repetitive transcranial magnetic stimulation (rTMS) has demonstrated promise in improving cognition in MCI and AD.</p><p><strong>Objectives: </strong>Our study will test the feasibility of using intermittent theta burst stimulation (iTBS) technique of rTMS in MCI, pilot test the study design, and collect pilot data on the effect of iTBS over three different brain regions on working memory, new learning, and executive function in MCI. Exploratory objectives are to assess the feasibility and usefulness of functional magnetic resonance imaging (fMRI), high-density electroencephalography (HD-EEG), and sleep architecture as potential biomarkers in response to iTBS.</p><p><strong>Methods: </strong>A pilot randomized double-blind controlled cross-over trial of iTBS on 20 MCI participants randomized to 10 days of active iTBS (left dorsolateral prefrontal cortex or left lateral parietal cortex) or control (vertex). After 4-6-week washout period, they cross over to the alternative treatment arm for another 10 days. Each participant will undergo a total of 20 iTBS sessions. Pre- and post-iTBS assessments include neuropsychological tests, fMRI, HD-EEG, and sleep architecture.</p><p><strong>Discussion: </strong>This innovative study aims to test the feasibility of iTBS as a cognitive enhancement strategy in MCI. If our study is feasible, it could lead to a future larger trial to further test whether iTBS can modulate underlying neurobiology and offer a therapeutic avenue to remediate cognitive decline in MCI or ultimately delay progression to dementia.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT05327257. Registered 04 April 2022.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"35"},"PeriodicalIF":1.5,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11963328/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143764332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Feasibility and acceptability of implementing the Global Scales for Early Development (GSED) package for children 0-3 years across three countries.","authors":"Ambreen Nizar Merchant, Raghbir Kaur, Gareth McCray, Vanessa Cavallera, Ann Weber, Melissa Gladstone, Magdalena Janus, Imran Nisar, Patricia Kariger, Sunil Sazawal, Arup Dutta, Salahuddin Ahmed, Yunting Zhang, Mariana Pacifico Mercadante, Arsene Zongo, Yvonne Schönbeck, Tarun Dua, Iris Eekhout, Fahmida Tofail, Maureen Black, Abdullah H Baqui, Dana McCoy, Farzana Begum, Romuald Kouadio E Anago, Alexandra Brentani, Fan Jiang, Symone Detmar, Michelle Perez Maillard, Marcus Waldman, Stef van Buuren, Abbie Raikes, Katelyn Hepworth, Marta Rubio Codina, Shirina Akhtar, Fyezah Jehan, Rasheda Khanam, Hassan Naqvi, Abrarul Haque Asif, Junaid Mehmood, Sidra Afzal, Gillian Lancaster","doi":"10.1186/s40814-025-01620-w","DOIUrl":"10.1186/s40814-025-01620-w","url":null,"abstract":"","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"34"},"PeriodicalIF":1.5,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11951581/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143743448","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mobile telephone contingency management to encourage adherence to supervised medication among individuals most at risk of non-adherence to opioid agonist treatment: a study protocol for a feasibility study (TIES2).","authors":"Nicola Metrebian, Carol-Ann Getty, Ewan Carr, Timothy Weaver, Stephen Pilling, Mike Kelleher, Jenny Scott, John Strang","doi":"10.1186/s40814-025-01614-8","DOIUrl":"10.1186/s40814-025-01614-8","url":null,"abstract":"<p><strong>Background: </strong>Supervision of opioid agonist treatment (OAT) ensures that individuals take their correct daily dose to minimise withdrawal and craving, safeguard against diversion and overdose, and receive optimal benefit from OAT. There is an urgent need to develop effective interventions to increase medication adherence and technological solutions to streamline communication between pharmacies and prescribers. The authors have developed technology to deliver contingency management (CM) remotely by mobile telephone (mCM) and alert prescribers of missed doses. In a previous feasibility study, the authors found mCM was feasible to deliver and acceptable to patients, prescribers, and pharmacists but encountered difficulty recruiting patients starting methadone treatment. Since COVID-19, supervision guidelines have changed to focus on patients at risk of/not adhering to their medication. This study aims to assess the feasibility of conducting a future confirmatory trial to assess the clinical and cost-effectiveness of mCM to encourage adherence with supervised methadone or buprenorphine. It will use broader eligibility criteria, including patients receiving buprenorphine, and target a revised group of serial re-starters.</p><p><strong>Methods: </strong>Using a cluster randomised design, three drug services will be randomised 1:1:1 and 20 patients, attending seven pharmacies linked to each service, will be recruited (i.e. a total of N = 60). Each drug service providing supervised medication will be randomly allocated to deliver: (i) telephone-delivered text-message reinforcement with modest financial incentives; (ii) telephone-delivered text-message reminders; or (iii) no telephone text-messages. Prescribers will receive reports of patient attendance. Feasibility will be determined based on four progression criteria: the number of patients enrolled, the percentage of screened patients who are eligible, adherence to the telephone system, based on matches between sign-in at the pharmacy and pharmacy dispensing records and follow-up rates. We will also undertake qualitative assessments of clinicians' perspectives on the revised eligibility criteria undertaken.</p><p><strong>Discussion: </strong>This study will assess the feasibility of using mCM to target a clinically important group of patients non-adhering to their supervised medication. In the future, and if effective, mCM will encourage medication adherence among patients, enabling them to achieve an optimum dose and full benefit from OAT.</p><p><strong>Trial registration: </strong>ISRCTN33965312 (26/06/2023). This manuscript was submitted on February 27th, 2024. While recruitment was due to end on February 29th, we recruited our last patient on February 12th. The last patient/last visit took place on May 2nd, 2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"33"},"PeriodicalIF":1.5,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11931786/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143701216","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}