Pilot and Feasibility Studies最新文献

{"title":"A school-based intervention to improve mental health outcomes for children with cerebral visual impairment (CVI): feasibility cluster randomised trial.","authors":"Cathy Williams, Anna Pease, Trudy Goodenough, Katie Breheny, Beverly Shirkey, Rose Watanabe, Parisa Sinai, Manmita Rai, Innes C Cuthill, Mark Mumme, Andrew W Boyd, Cassandra Wye, Chris Metcalfe, Daisy Gaunt, Kate Barnes, Siobhan Rattigan, Stephanie West, John Ferris, Jay Self","doi":"10.1186/s40814-025-01603-x","DOIUrl":"10.1186/s40814-025-01603-x","url":null,"abstract":"<p><strong>Background: </strong>Cerebral visual impairment (CVI) refers to brain-related vision difficulties, which are often undiagnosed and may lead to poor mental health outcomes. We have developed an intervention to improve mental health outcomes for affected children, and it requires evaluation. The aim of this study was to assess the feasibility of methods proposed for a future definitive cluster randomised trial.</p><p><strong>Methods: </strong>This 18-month study took place in South West England, UK, between 2019 and 2021 including a 6-month pause due to the COVID pandemic. Participants were children aged 7-10 years in mainstream primary schools and their teachers and parents. We recruited head teachers on behalf of their school. The intervention was a resource pack for teachers explaining about CVI, providing universal and targeted strategies to help children with CVI and the offer of CVI assessments at the local eye clinic. The control schools continued with usual practice. Our objectives were to evaluate the feasibility of recruitment and data collection, attrition, acceptability of the study methods and implementation of the intervention. We conducted a process evaluation including interviews and questionnaires.</p><p><strong>Results: </strong>We sent invitation letters to 297 schools, received responses to 6% and recruited 40% of these (7 schools, 1015 children). Parents of 36/1015 (3.5%) children opted out. Baseline data were collected from teachers for 94% children, and 91% children completed self-report questionnaires; parent-report questionnaires were returned for 19% of children. During the exceptional circumstance of the COVID pandemic, two schools left the study, and many children were not attending school, meaning follow-up data were received from 32% of children, 16% of teachers and 14% of parents. Interview data indicated that the intervention was acceptable, and teachers would have preferred on-site eye tests to the offer of a clinic appointment and a clear timetable for study events. Teachers in intervention schools reported expected changes in the children's and their own behaviour. There was some contamination between study arms.</p><p><strong>Conclusions: </strong>A full-scale trial would be feasible, enhanced by insights from this feasibility trial, in non-pandemic times. Sharing these data with teachers, education policymakers and parents is planned to refine the design.</p><p><strong>Trial registration: </strong>ISRCTN13762177.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"24"},"PeriodicalIF":1.5,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11874832/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143542989","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":"Optimizing Attention and Sleep Intervention Study (OASIS): a protocol for a pilot randomized controlled trial to compare parent behavioral interventions with and without sleep strategies delivered in pediatric primary care for preschool-aged children at risk of childhood ADHD.","authors":"Heather M Joseph, Jessica C Levenson, Rachel P K Conlon, Katherine Mannion, Heidi L Kipp, Angelina Gradian, Meredith L Wallace, Ariel A Williamson","doi":"10.1186/s40814-025-01600-0","DOIUrl":"10.1186/s40814-025-01600-0","url":null,"abstract":"<p><strong>Background: </strong>Attention-deficit/hyperactivity disorder (ADHD) is a prevalent neurodevelopmental disorder that presents as early as preschool. Inattention and hyperactivity in childhood interfere with developing social and preacademic skills, leading to lifelong impairment. Evidence-based treatments for children with ADHD exist, including parent behavioral interventions (PBIs). However, current treatments have failed to substantially change the long-term trajectory of symptoms and impairment for individuals with ADHD, suggesting the need to enhance treatment approaches and intervene earlier. Given that sleep is a modifiable factor linked to ADHD symptom persistence and exacerbation, it may be a useful target in addressing ADHD among preschool children (ages 3-5 years). The most common sleep problems among preschoolers are behavioral and amenable to PBIs. However, sleep strategies have not been included within PBIs to address ADHD symptoms in young children. Thus, this pilot trial aims to assess the feasibility, acceptability, and appropriateness of a novel sleep-focused PBI (SF-PBI). Moreover, given the barriers to accessing care for sleep-related issues, this pilot trial aims to increase access to evidence-based care by partnering with behavioral health therapists embedded in pediatric primary care to deliver intervention.</p><p><strong>Methods: </strong>A pilot randomized clinical trial is being conducted in 5 pediatric primary care offices by embedded behavioral health therapists with 50 families of 3- to 5-year-old children with elevated ADHD symptoms and behavioral sleep problems. Families are randomized (1:1) to six sessions of either standard PBI or SF-PBI, informed by focus groups with caregivers, therapists embedded in pediatric primary care, and pediatric providers. Primary outcomes at post-intervention will be therapist and caregiver report on the intervention's acceptability, appropriateness, and feasibility.</p><p><strong>Discussion: </strong>Primary outcomes will inform the decision to transition to a definitive trial testing SF-BPI targeting sleep among preschool-aged children at elevated risk for ADHD via accessible, primary care-based intervention that harnesses parenting strategies. Ultimately, the SF-PBI has the potential to improve outcomes for children at risk for ADHD by increasing access to early intervention for behavioral sleep issues to reduce the prevalence, symptoms, and associated impairments of ADHD among children and families.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05683756 (prospectively registered, date registered 4 January 2023): https://clinicaltrials.gov/study/NCT05683756.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"22"},"PeriodicalIF":1.6,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11852881/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143503353","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":"Sessions of acupuncture and nutritional therapy evaluation for atrial fibrillation (Santé-AF): a randomised feasibility study.","authors":"Karen Charlesworth, David J Torgerson, Judith M Watson","doi":"10.1186/s40814-025-01604-w","DOIUrl":"10.1186/s40814-025-01604-w","url":null,"abstract":"<p><strong>Background: </strong>Atrial fibrillation is a common cardiac arrhythmia, associated with debilitating symptoms and a decrease in health-related quality of life. Current treatments for atrial fibrillation may not provide symptomatic relief and are associated with risks and adverse responses. Large-scale trials are justified to investigate whether complementary therapies may improve symptoms and/or health-related quality of life in atrial fibrillation. To reduce the uncertainty of a future trial, a feasibility study was carried out.</p><p><strong>Design and methods: </strong>A three-arm, parallel-group, pragmatic randomised controlled feasibility study recruited 30 participants with paroxysmal AF aged 45-70 from NHS primary care, randomising to Group A (acupuncture + usual care), Group B (nutritional therapy + usual care) or Group C (usual care alone) using a 2:2:1 allocation ratio in favour of the interventions. Interventions were delivered by private practitioners. Seven feasibility objectives were investigated, including participants' willingness to take part, appropriateness of eligibility criteria, participant retention and acceptability of interventions and study assessments. Additional exploratory feasibility objectives were investigated, including the effect of the COVID-19 pandemic and the safety of interventions. Data was analysed using descriptive statistics and reflexive thematic analysis, and the study used a sequential convergent mixed methods design to understand whether, and why, objectives were feasible and to make recommendations for a future trial.</p><p><strong>Results: </strong>Five feasibility objectives' progression criteria were met, one did not meet its progression threshold and one was abandoned as infeasible to analyse but did not affect feasibility. Recommendations for a future trial include changes in eligibility criteria to reflect real-world populations and changes to assessment methods to reduce participant burden. Uncertainty remains around the effect on the feasibility of reversion to pre-COVID therapy and study assessment delivery, including a recommended longer follow-up.</p><p><strong>Conclusion: </strong>A future large-scale trial was found to be feasible with adjustments, but some uncertainty remains.</p><p><strong>Trial registration: </strong>ISRCTN13671984. Registered on June 04, 2020.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"21"},"PeriodicalIF":1.5,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11854018/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143503356","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":"Enhanced psychosocial assessment and rapid follow-up care for people presenting to emergency departments with self-harm and/or suicidal ideation: the Assured feasibility study and internal pilot trial.","authors":"Sally O'Keeffe, Mimi Suzuki, Mary Ryan, Stefan Priebe, Richard Byng, Alan Simpson, Vera Araújo-Soares, Rikke Albert, Renata Fialho, Neil Walker, Alexandra Elissavet Bakou, Rose McCabe","doi":"10.1186/s40814-025-01602-y","DOIUrl":"10.1186/s40814-025-01602-y","url":null,"abstract":"<p><strong>Background: </strong>Patients presenting to emergency departments (EDs) following an episode of self-harm are at risk of future suicide. There are few evidence-based interventions for self-harm in the ED context in England. This study sought to assess the feasibility of a trial of a newly developed brief psychological intervention, the Assured approach. This approach consisted of an enhanced psychosocial assessment, collaborative safety planning and three rapid solution-focussed follow-up sessions. Phase 1 was a feasibility study, and phase 2 was an internal pilot trial of a cluster randomised controlled trial to assess whether progression to a full-scale trial was warranted.</p><p><strong>Methods: </strong>In phase 1, patients were recruited and allocated to a study arm, the Assured arm or treatment as usual, depending on the allocation of their assessing practitioner, in four EDs in England. They were invited to research assessments after consent and at 6 months. Phase 2 was the internal pilot of a cluster randomised controlled trial conducted in six EDs in England. Practitioners were randomised to deliver the Assured approach or treatment as usual. Patients were recruited and allocated to a study arm depending on the allocation of their assessing practitioner. They were invited to complete research assessments after consent and at 3, 9 and 18 months.</p><p><strong>Results: </strong>Sixty-one patients were recruited into the Assured (n = 46) and treatment as usual (n = 15) arms in phase 1. Findings showed we could recruit and follow up patients over a 6-month period. The research procedures were acceptable to patients and practitioners, and the intervention was delivered with acceptable fidelity to the intervention manual. Forty-seven patients were recruited into the phase 2 internal pilot trial, falling substantially short of our target of 491 in the stop-go criteria, indicating that the trial was not feasible in its current design.</p><p><strong>Conclusion: </strong>The feasibility study indicated that both the intervention and research processes were acceptable. However, the internal pilot trial revealed substantial challenges in recruiting patients and delivering the intervention in the ED context. Adaptations to the trial design and intervention are proposed to enable the Assured approach to be tested in a future trial, to improve care for this underserved population.</p><p><strong>Trial registration: </strong>ISRCTN16003313, 04/02/2020; ISRCTN13472559, 18/11/2021.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"20"},"PeriodicalIF":1.5,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11841326/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143468428","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 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/s40814-024-01583-4","DOIUrl":"10.1186/s40814-024-01583-4","url":null,"abstract":"<p><strong>Background: </strong>To assess the neurodevelopment of children under three years, a multinational team of subject matter experts (SMEs) led by the World Health Organization (WHO) developed the Global Scales for Early Development (GSED). The measures include (1) a caregiver-reported short form (SF), (2) a directly administered long form (LF), and (3) a caregiver-reported psychosocial form (PF). The feasibility objectives of this study in Bangladesh, Pakistan, and the United Republic of Tanzania were to assess (1) the study implementation processes, including translation, training, reliability testing, and scheduling of visits and (2) the comprehensibility, cultural relevance, and acceptability of the GSED measures and the related GSED tablet-based application (app) for data collection for caregivers, children, and assessors.</p><p><strong>Methods: </strong>In preparation for a large-scale validation study, we implemented several procedures to ensure that study processes were feasible during the main data collection and that the GSED was culturally appropriate, including translation and back translation of the GSED measures and country-specific training packages on study measures and procedures. Data were collected from at least 32 child-caregiver dyads, stratified by age and sex, in each country. Two methods of collecting inter-rater reliability data were tested: live in-person versus video-based assessment. Each country planned two participant visits: the first to gain consent, assess eligibility, and begin administration of the caregiver-reported GSED SF, PF, and other study measures and the second to administer the GSED LF directly to the child. Feedback on the implementation processes was evaluated by in-country assessors through focus group discussions (FGDs). Feedback on the comprehensibility, relevance, and acceptability of the GSED measures from caregivers was obtained through exit interviews in addition to the FGD of assessors. Additional cognitive interviews were conducted during administration to ensure comprehension and cultural relevance for several GSED PF items.</p><p><strong>Results: </strong>The translation-back translation process identified items with words and phrases that were either mistranslated or did not have a literal matching translation in the local languages, requiring rewording or rephrasing. Implementation challenges reiterated the need to develop a more comprehensive training module covering GSED administration and other topics, including the consent process, rapport building, techniques for maintaining privacy and preventing distraction, and using didactic and interactive learning modes. Additionally, it suggested some modifications in the order of administration of measures. Assessor/supervisor concurrent scoring of assessments proved to be the most cost-effective and straightforward method for evaluating inter-rater reliability. Administration of measures using the app was considered culturally accept","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"18"},"PeriodicalIF":1.5,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11827458/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425643","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":"SENSE-Cog Residential Care: hearing and vision support for residents with dementia in long-term care in Ireland-protocol for a pilot cluster-randomised controlled trial.","authors":"J P Connelly, Erin Boland, Brenda Buckley, Niall Curley, Amr El Refaie, Miriam Galvin, Matthew Gibb, Liz Graham, Brendan Lennon, Alejandro Lopez Valdes, Ann-Michelle Mullally, Nicole Müller, Janice Nolan-Palmer, Gerald O' Nolan, Cíara O'Reilly, Valeria Raaft Rezk, Helen Rochford-Brennan, Katy Tobin, Helen Tormey, Dominic Trépel, Iracema Leroi","doi":"10.1186/s40814-024-01582-5","DOIUrl":"10.1186/s40814-024-01582-5","url":null,"abstract":"<p><strong>Background: </strong>Hearing and vision loss is highly prevalent in residents with dementia (RwD) living in long-term care (LTC) facilities. Sensory loss often has a negative impact on quality of life and other dementia-related outcomes. Optimising sensory function may improve dementia-related outcomes in LTC facilities. The SENSE-Cog Residential Care pilot trial will evaluate whether a multi-faceted hearing and vision intervention for RwD and concurrent sensory loss is suitable for definitive testing in a large-scale cluster-randomised control trial (RCT) in Ireland and how this can best be achieved.</p><p><strong>Methods: </strong>This is a 6-month feasibility-pilot, multicentre, cluster RCT. Between eight and 15 LTC facilities (with an average of 5 RwD recruited per home) will be randomly assigned to receive either 'care as usual' (CAU) or a multi-component sensory intervention comprising (1) personalised resident hearing and vision support, (2) staff training in sensory health, (3) fostering a 'sensory friendly' environment, and (4) mapping sensory care provision with community-based audiologists and opticians. The intervention's feasibility, acceptability, and tolerability for residents and staff will be examined. In addition, a battery of exploratory outcome measures will be evaluated for suitability for the definitive trial and to inform the choice of primary and secondary outcome measures.</p><p><strong>Discussion: </strong>If the SENSE-Cog Residential Care pilot trial demonstrates that the sensory support intervention for residential care is feasible and tolerated in LTC facilities in Ireland, a larger definitive trial to evaluate its effectiveness in improving dementia-related outcomes will be conducted. Training materials, resources, and information will be made available to health and social care providers to enable the implementation of sensory support for RwD in routine LTC, potentially improving the quality of such care in Ireland.</p><p><strong>Trial registration: </strong>ISRCTN, ISRCTN14462472. Registered 24 February 2022, https://doi.org/10.1186/ISRCTN14462472.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"17"},"PeriodicalIF":1.5,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11818014/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143409934","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":"Protocol for a single-arm feasibility trial of virtual family-centered rounds: increasing opportunities for family engagement among caregivers with language preference other than English.","authors":"Adrienne E Hoyt-Austin, Erika N Zerda, Daniel J Tancredi, James P Marcin, Audriana Ketchersid, Elva T Horath, Trevor R Bushong, Daniel S Merriott, Patrick S Romano, Kristin R Hoffman, Jennifer L Rosenthal","doi":"10.1186/s40814-025-01599-4","DOIUrl":"10.1186/s40814-025-01599-4","url":null,"abstract":"<p><strong>Background: </strong>Telehealth use during family-centered rounds in the neonatal intensive care unit has been shown to shorten length of hospitalization and improve breastfeeding outcomes. For families who speak languages other than English, access to and use of telehealth technologies can be impeded by lack of interpreter services. We aim to evaluate the feasibility of telehealth use during family-centered rounds in the neonatal intensive care unit for families who speak languages other than English.</p><p><strong>Methods: </strong>In this study proposal, we will conduct an intervention evaluation using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to assess the feasibility of telehealth use during family-centered rounds among families who speak languages other than English in a single-arm feasibility trial. We will provide language-appropriate materials to assist parents with accessing the telehealth technology and bring interpreters into the telehealth encounter directly with neonatal providers. All eligible infants whose families speak languages other than English in a single-site level 4 neonatal intensive care unit during the study period will be included. These families can participate in hospital rounds via telehealth, in-person, or not participate in hospital rounds. We will examine feasibility objectives that assess parental uptake of telehealth for rounds, parental participation in rounds, presence of a certified medical interpreter, telehealth technical issues, and parental survey response rates. We will conduct a mixed methods implementation evaluation using the RE-AIM framework. Exploratory outcomes include parent attendance, length of hospitalization of the infant, human milk feeding, frequency of medical error, parent-reported experience, parental comfort with their child's care, and parental quality of life will be collected.</p><p><strong>Discussion: </strong>This study will aid in understanding gaps to telehealth care in languages other than English. We believe this approach will improve health outcomes for hospitalized premature infants, understanding of medical conditions, improve parental quality of life, and reduce inequities in access to healthcare via telehealth technologies.</p><p><strong>Trial registration: </strong>NCT05917899 Limited English Proficiency Virtual Family-Centered Rounds, first posted June 26, 2023, last update posted November 11, 2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"16"},"PeriodicalIF":1.5,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11816777/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143409917","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 self-management intervention for newly diagnosed with inflammatory arthritis: a randomized controlled feasibility and fidelity study.","authors":"Luise Holberg Lindgren, Tanja Thomsen, Merete Lund Hetland, Mette Aadahl, Sara Danshøj Kristensen, Annette de Thurah, Bente Appel Esbensen","doi":"10.1186/s40814-025-01601-z","DOIUrl":"10.1186/s40814-025-01601-z","url":null,"abstract":"<p><strong>Background: </strong>Inflammatory arthritis affects approximately 2-3% of adults worldwide. For patients newly diagnosed with arthritis, effective self-management is crucial, as they often face several physiological, emotional, and social challenges. A self-management intervention called NISMA was thus developed to cater to this group. This study aimed to evaluate the feasibility and fidelity of this intervention before conducting a full-scale randomized controlled trial.</p><p><strong>Methods: </strong>This feasibility study was conducted as a single-center randomized controlled trial. Twenty participants were expected to be sufficient for assessing the feasibility outcomes. The control group received only the usual care, while the intervention group received the NISMA intervention in addition, which involved individual and group sessions in a multidisciplinary setting. Feasibility was evaluated based on the recruitment, data collection, retention, and randomization processes. The patient-reported outcome measures and clinical measures were collected to review their potential for inclusion in a future randomized controlled trial. Fidelity was assessed by using documentation sheets filled in by the health professionals and audio recordings of the sessions to examine whether the intervention's principles and components were adequately addressed.</p><p><strong>Results: </strong>Among 47 eligible patients, we recruited 23 participants during a period of 4 months. The recruitment rate was 47% and the retention rate 91%. Randomization, although accepted, led to some disappointment in the control group. Data collection was effective, with only minimal missing data (< 1%). The fidelity was considered as high, as results indicated that nurses effectively engaged in collaborative partnerships with patients, utilizing planned questioning techniques and self-management strategies for problem-solving and resource utilization. However, action planning was inconsistently applied.</p><p><strong>Conclusion: </strong>The study demonstrated the feasibility and the overall high fidelity of delivering the NISMA intervention to patients newly diagnosed with inflammatory arthritis. The insights from the study are useful for identifying the areas that require modifications before initiating a randomized controlled trial.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov ID: NCT06063252. Registered 02 October 2023 - retrospectively registered.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"15"},"PeriodicalIF":1.5,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11817759/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143399667","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":"Shortening duration of untreated illness in young people with first episode eating disorders: protocol of a randomised controlled feasibility trial of a smartphone friendly multi-modal decision-making tool (FREED-M) to improve help-seeking.","authors":"Luiza Grycuk, Dina Monssen, Molly R Davies, Helen Sharpe, Karina L Allen, Vibhore Prasad, Rachel Potterton, Priya Popat, Victoria A Mountford, Sheryllin McNeil, Vanessa Lawrence, Nina Grant, Kimberley A Goldsmith, Danielle Glennon, Sarah Byford, Amy Brown, Ulrike Schmidt","doi":"10.1186/s40814-024-01585-2","DOIUrl":"10.1186/s40814-024-01585-2","url":null,"abstract":"<p><strong>Background: </strong>Early intervention gives young people the best chance to recover from eating disorders (EDs). An important focus of early intervention is shortening the time between a person first developing symptoms and starting treatment (duration of untreated eating disorder; DUED). Patient-related factors (e.g. poor mental health literacy and help-seeking difficulties) are strongly associated with DUED. The aims of our study are to co-design and test the feasibility of FREED-Mobile (FREED-M), an online intervention tool for young people with early-stage EDs. This tool aims to improve knowledge about EDs, increase motivation to seek treatment and teach early steps towards change or recovery, thus reducing DUED.</p><p><strong>Methods: </strong>We will carry out a randomised controlled feasibility trial comparing the FREED-M tool with a control intervention where individuals are sign-posted to an ED charity website. The objectives of the proposed trial are to establish/estimate: (a) attrition rates at follow-up (primary feasibility outcome); (b) participant recruitment; (c) intervention uptake, completion rates and acceptability; (d) intervention effect sizes and standard deviations for outcomes to inform the sample size calculation for a large-scale randomised controlled trial (RCT); (e) stakeholder views on the intervention. We aim to recruit 116 participants (young people, aged 16-25, with first episode ED) from primary care, schools and universities, ED services and social media. Online assessments will be carried out at baseline, end of intervention and follow-up (weeks 0, 4 and 12 post-randomisation, respectively). Outcomes will include motivation and readiness to change, attitudes and intentions towards help-seeking, ED symptoms, mood and social functioning, and health-related quality of life. Additionally, we will carry out a qualitative evaluation of participants' views of the intervention and study design.</p><p><strong>Discussion: </strong>The results of this feasibility trial will inform adaptations to the intervention as needed, as well as the study design (e.g. sample size, primary outcomes) of a future large-scale RCT to assess the effectiveness of the FREED-M intervention. If effective, this novel, online intervention has the potential for wide dissemination and for substantially reducing DUED to improve long-term patient outcomes.</p><p><strong>Trial registration: </strong>ISRCTN, ISRCTN15662055. Registered 27 July 2022, https://www.isrctn.com/ISRCTN15662055 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"14"},"PeriodicalIF":1.5,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11804029/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143370933","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":"Evaluation of a transdiagnostic mental health intervention in German primary care: study protocol for a parallel-group, two-arm, cluster randomised controlled pilot study.","authors":"Christopher Ebert, Marie Vogel, Jochen Gensichen, Hanna Reif, Lena Grögor, Lukas Junker, Thomas Ehring, Alkomiet Hasan, Stefan Leucht, Kirsten Lochbühler","doi":"10.1186/s40814-025-01597-6","DOIUrl":"10.1186/s40814-025-01597-6","url":null,"abstract":"<p><strong>Background: </strong>General practitioners play an important role in the first-line care of individuals with mental health conditions. However, factors such as time constraints, limited experience in managing mental health conditions and high rates of comorbidity may hinder adequate treatment. To improve psychological care, adopting a transdiagnostic approach shows potential. Research on transdiagnostic interventions delivered by general practitioners is scarce. Thus, a transdiagnostic intervention adapted from the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders was developed specifically for primary care. In a parallel-group, two-arm, cluster randomised controlled pilot study, the transdiagnostic intervention will be evaluated for feasibility, acceptability and potential effectiveness in German primary care.</p><p><strong>Methods: </strong>A total of 100 adult patients with a mental health condition will be recruited by general practitioners. In the intervention group, general practitioners will administer the transdiagnostic intervention, introducing patients to psychological concepts based on transdiagnostic factors (i.e., understanding emotions, cognitive flexibility, countering emotion-based avoidance). In the control group, general practitioners will provide improved treatment as usual oriented on official German treatment guidelines for depression, anxiety and somatoform disorders. In both study groups, treatment will be carried out in four 20-min sessions over 12-weeks. Self-report questionnaires will be completed before treatment initiation (only patients) and after treatment completion (patients and general practitioners) to assess feasibility and acceptability (i.e., treatment recruitment, delivery, response, effectiveness, unintended consequences and maintenance) as well as potential effectiveness (i.e., change in transdiagnostic factors).</p><p><strong>Discussion: </strong>The pilot study will address the research gap concerning general practitioner-led psychological interventions in primary care and will give insights into whether the adoption of a transdiagnostic approach is of benefit to general practitioners and patients. Findings may inform the design of a main trial by identifying barriers to the transdiagnostic intervention's feasibility and acceptability, whilst advancing treatment delivery protocols to support effectiveness.</p><p><strong>Trial registration: </strong>The protocol for this study has been registered with the German Clinical Trials Register: DRKS00033386, Date of registration: 18^th of March 2024, https://drks.de/search/en/trial/DRKS00033386 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"13"},"PeriodicalIF":1.5,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11784113/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143075074","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}