Pilot and Feasibility Studies最新文献

{"title":"Individual supported work placements (ReISE) for improving sustained return to work in unemployed people with persistent pain: an internal pilot study of a cohort randomised controlled approach.","authors":"Pål André Amundsen, Martin Underwood, Kim Burton, Margreth Grotle, Martin Stav Engedahl, Ira Malmberg-Heimonen, Pernille Marie Stähr Irgens, Magnus Højen, Adnan Kisa, Milada Hagen, Thor Einar Holmgard, Amy Martinsen, Jakob Lothe, Sølvi Spilde Monsen, Robert Froud","doi":"10.1186/s40814-024-01538-9","DOIUrl":"10.1186/s40814-024-01538-9","url":null,"abstract":"<p><strong>Background: </strong>Persistent pain is a frequent cause of sick leave and work disability in Norway. A return-to-work intervention featuring supported work placements, developed in the UK, demonstrated feasibility, and a return-to-work rate of 20% within 6 months was observed in the sample. We sought to adapt the intervention for delivery in Norway and to confirm feasibility prior to a full-scale trial.</p><p><strong>Methods: </strong>In this internal pilot, we used a pragmatic cohort randomised controlled approach with national recruitment in Norway. We recruited people who were unemployed (for at least 1 month), having persistent pain (for at least 3 months), aged between 18 and 64, and wanting to return to work. We initially recruited people to an observational cohort study of the impact of being unemployed with persistent pain. After baseline measurement, we randomly sub-sampled participants to whom we offered the intervention, which featured individual case management and support, work-familiarisation sessions, and the offer of a 6-week part-time unpaid work placement. We assessed recruitment rates (aiming to recruit 66, and sub-sample 17 within 6 months); optimal recruitment pathways; intervention acceptance rates; the feasibility of data collection; using video links for work-familiarisation sessions and remote case manager support.</p><p><strong>Results: </strong>The pilot ran from June to November 2022. Of 168 people expressing interest, 94 consented. Recruitment posts on Facebook yielded the most 'expressions of interest' (66%, n = 111). After screening for eligibility, we included 55 participants. Of these, 19 were randomised to be offered the intervention. Of these, less than half (n = 8) consented to intervention participation. Remote case manager and work-familiarisation sessions appeared feasible. Following a delay in identifying placements, three participants received offers of work placements, with one starting and completing during the pilot period. Data collection methods were feasible, and no adverse events were reported.</p><p><strong>Conclusions: </strong>Recruitment and logistical processes, such as remote management by video link, are feasible. However, delivery of the intervention is challenging. In particular, sourcing placements and the time required for identifying appropriate placements was more challenging than anticipated. A full-scale trial is feasible but will require improvements to the placement identification processes.</p><p><strong>Trial registration: </strong>ISRCTN85437524 (Referring to the ReISE trial, of which this internal pilot was a part), Registered 31 of May 2022 https://doi.org/10.1186/ISRCTN85437524 TRIAL FUNDING: Norwegian Research Council.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"110"},"PeriodicalIF":1.5,"publicationDate":"2024-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11321075/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141976362","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":"Co-production of the 'EPIC' multidimensional tool-kit to support neurodivergent children and young people at home and school: a feasibility and pilot study.","authors":"Sinead M Rhodes, Emily McDougal, Christina Efthymiou, Tracy M Stewart, Josie N Booth","doi":"10.1186/s40814-024-01530-3","DOIUrl":"10.1186/s40814-024-01530-3","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Interventions focused on cognitive function in neurodivergent children typically focus on single functions, e.g. working memory training. They are often focused on 'deficit' models and lack an emphasis on understanding areas of individual strengths and difficulties as a prerequisite to appropriate support. The multidimensional nature and phenotypic variability of cognitive profiles in these children indicate a need for a multicomponent-tailored intervention programme focused on understanding and supporting an individual child's cognitive functioning.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Aims: &lt;/strong&gt;The 'EPIC' intervention (Edinburgh Psychoeducation Intervention for Children and Young People) is focused on improving cognition, learning and behaviour in neurodivergent children such as those with attention deficit hyperactivity disorder (ADHD) or who are autistic. Building on our previous co-production work, this study aimed to use a participatory methods approach to develop EPIC practices and materials in relation to our key principles which include psychoeducation, multicomponent, individualised approach, strengths and difficulties profiling and pairing of a child's individual strengths and difficulties with internal and external strategies. We also set out to assess the feasibility and acceptability of EPIC, and pilot this novel tool-kit intervention with neurodivergent children and their parents and teachers.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The intervention practices, materials and strategies of EPIC were co-produced with neurodivergent children, their parents, teachers and clinicians taking a strengths and difficulties approach. Identification of psychoeducation activities and strategy practices (e.g. mind-maps, chunking), testing of feasibility and collection of pilot data were conducted over a bi-weekly 8-week programme. Eleven neurodivergent children aged 7 to 12 completed the 16-session individualised programme. Acceptability and feasibility were ascertained via qualitative reports elicited within child and teacher interviews and child ratings of enjoyment. Pilot evaluation data was collected pre- and post-intervention participation, and across cognitive assessments (CANTAB, BRIEF), educational attainment (WIAT) and parent and teacher questionnaires measuring clinical symptoms and behaviour (Conners, AQ, SDQ, self-perception). Data was compared with a matched neurodivergent treatment-as-usual control group (N = 9).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The co-produced EPIC intervention was both feasible to deliver and acceptable to children, parents and their teachers. Pilot data identified that the 8-week intervention improved cognition (short-term and working memory) and literacy (receptive vocabulary, oral word fluency, listening comprehension). Improvements in the intervention group were also found for parent-reported child behavioural difficulties and aggression, and teacher-reported scholastic competence. Effect sizes generated ","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"108"},"PeriodicalIF":1.5,"publicationDate":"2024-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11316409/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141913689","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":"Development and implementation of a self-directed violence prevention training program for correctional behavioral health providers: a clinical trial study protocol.","authors":"Lewis J Peiper, Robert J Cramer, Sam C Cacace, Ava Peters, Adria R Corral, Abigail F Post, Skyler D Prowten, Jessamyn Moxie","doi":"10.1186/s40814-024-01533-0","DOIUrl":"10.1186/s40814-024-01533-0","url":null,"abstract":"<p><strong>Background: </strong>Self-directed violence (SDV) comprises both suicide and self-injury and represents a pressing problem among incarcerated persons. Negative impacts of SDV in correctional settings also extend to behavioral health clinicians (BHCs) (e.g., job turnover). Correctional SDV risk assessment and management standards include staff training as part of the comprehensive approach. The Core Competency Model for Corrections (CCM-C) is a novel, evidence-informed training program for BHCs covering both clinician self-management and clinical care skills.</p><p><strong>Methods: </strong>This pilot trial is a type 3 hybrid implementation-effectiveness approach. It will employ a wait-list control sequential cross-over design. Participants (N = 50-100) will be BHCs employed by the North Carolina Department of Adult Corrections. Following stratification for years of clinical experience, BHCs will be randomly assigned to (1) a training group that receives CCM-C immediately and (2) a wait-list control receiving CCM-C approximately 6 weeks later. Electronically administrated survey evaluation will occur across baseline and two follow-up (i.e., 2 weeks after each training session) time points.</p><p><strong>Discussion: </strong>The primary outcome is feasibility assessed through collaboration with a Corrections Advisory Panel and feedback from BHCs. Secondary effectiveness outcomes that will be evaluated over time include SDV-related knowledge, attitudes, stigma, and intent to use training content. We will examine a tertiary outcome, namely compassion fatigue. Clinical trial limitations and impacts are discussed.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov, NCT06359574. This study was registered on 04/05/2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"107"},"PeriodicalIF":1.5,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11308153/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141907412","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 implementation of EMI-Heart, a family-tailored early motor intervention in infants with complex congenital heart disease, in practice: a feasibility RCT.","authors":"Elena Mitteregger, Tineke Dirks, Manuela Theiler, Oliver Kretschmar, Beatrice Latal","doi":"10.1186/s40814-024-01532-1","DOIUrl":"10.1186/s40814-024-01532-1","url":null,"abstract":"<p><strong>Background: </strong>Children with congenital heart disease (CHD) who undergo open-heart surgery are at risk of developmental impairment, including motor delay, which contributes to parental concerns. Additionally, parents experience prolonged stress associated with their child's disease. There is a lack of early motor interventions in infants with CHD accounting for parental burdens. We developed a family-tailored early motor intervention (EMI-Heart), aiming to promote motor development in infants with CHD and family well-being. The primary aim was to evaluate the feasibility of the study design and the intervention. The secondary aim was to evaluate differences between the intervention and the control group in motor outcomes and family well-being at baseline (3-5 months), post-treatment (6-8 months), and at follow-up (12 months).</p><p><strong>Method: </strong>In this single-centre feasibility randomized control trial (RCT), infants with CHD after open-heart surgery without genetic or major neurological comorbidities were randomly allocated to EMI-Heart or the control group (standard of care). EMI-Heart's key elements promote postural functional activities and encourage parental sensitivity to infants' motor and behaviour cues. Infants assigned to EMI-Heart received nine sessions of early motor intervention at home, in the hospital, and online for a duration of 3 months by a paediatric physiotherapist. We performed descriptive statistics for feasibility and secondary outcomes.</p><p><strong>Results: </strong>The recruitment rate was 59% (10/17), all participating families completed the study (10/10), and the intervention duration was 3.9 months (± 0.54), including nine intervention sessions per family. Median acceptability to parents was 3.9 (1 = not agree-4 = totally agree, Likert scale). The paediatric physiotherapist considered the intervention as feasible. The comparison of motor outcomes did not show differences between groups. However, we detected improved reliable change scores in family well-being outcomes for families of the intervention group compared to the controls.</p><p><strong>Conclusions: </strong>Our research indicates that EMI-Heart is a feasible intervention for infants with CHD after open-heart surgery. The intervention was highly acceptable both to parents and to the paediatric physiotherapist. Online treatment sessions offer a valuable alternative to home and hospital visits. This feasibility RCT provides a foundation for a future full trial.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCTT04666857. Registered 23.11.2020.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"105"},"PeriodicalIF":1.5,"publicationDate":"2024-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11295334/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141879181","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 prospective non-randomized feasibility study of an online membership-based fitness program for promoting physical activity in people with mobility impairments.","authors":"Laurie A Malone, Tapan Mehta, Christen J Mendonca, Sangeetha Mohanraj, Mohanraj Thirumalai","doi":"10.1186/s40814-024-01528-x","DOIUrl":"10.1186/s40814-024-01528-x","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;People with mobility limitations have a disproportionately higher rate of acquiring secondary conditions such as obesity, cardiovascular comorbidity, pain, fatigue, depression, deconditioning, and type 2 diabetes. These conditions often result from poor access to home and community-based health promotion/wellness programs. The aim of this project was to determine the feasibility of delivering an online community membership-based fitness program for individuals with mobility impairments.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;For this prospective single-arm study, participants were recruited from members of a community fitness facility that serves people with physical disabilities and chronic health conditions. While all members had access to the online platform, individuals had to opt-in to participate in the research component. Activity options included 16 pre-recorded videos and 9 live exercise classes. During the 8-week program, participants had an opportunity to earn three exercise incentives for reaching certain activity milestones. Enrollment percentage, attendance, and attrition were tracked to assess program feasibility and acceptability. Changes in participant-reported outcomes including self-reported physical activity, psychosocial outcomes, and health-related quality of life (HRQOL) were examined using non-parametric analyses.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 146 eligible individuals were screened of which 33 enrolled (22.6%). Two participants withdrew from the study, so a total of 31 were used for analyses. Participants included 29 women and 12 Black people with an average age of 60 (± 15.9) years. Health conditions included stroke, post-polio, arthritis, neuropathy, cerebral palsy, and obesity. Ten participants used an assistive device to get around inside the home. Twenty-six participants (78.8%) completed the online program, and 5 participants earned all 3 participation incentives. The mean number of live Zoom exercise classes attended by the participants was 12.8 (range = 0-43) over 8 weeks; 3 of 31 participants did not attend any classes. On average, participants watched 128 min (range = 0-704 min) of pre-recorded videos; 6 of 31 participants did not view any pre-recorded videos. Self-reported physical activity showed the largest improvement (11.15 units; 95% CI, 3.08, 19.56) with an effect size of 0.51 (Cohen's d).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This pilot study of an online membership-based fitness program for people with mobility impairments demonstrated preliminary effectiveness in increasing physical activity and was found to be feasible and acceptable. Feasibility endpoints do indicate potential to improve retention. These results suggest that online delivery of exercise programs can broaden the reach of specialized community fitness programs and is a promising direction for future work and fully powered trials are warranted to assess intervention efficacy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registr","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"104"},"PeriodicalIF":1.5,"publicationDate":"2024-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11295342/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141879240","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":"Study protocol for a single-site feasibility study evaluating the adoption and fidelity of Prep-4-RT: prehabilitation for head and neck cancer patients undergoing radiotherapy.","authors":"H Ray, E Sexton, J Frowen, K Gough, S Turnbull, S Abo, M Ftanou, J Loeliger","doi":"10.1186/s40814-024-01531-2","DOIUrl":"10.1186/s40814-024-01531-2","url":null,"abstract":"<p><strong>Introduction: </strong>Prep-4-RT is a co-designed stepped-care multimodal prehabilitation program for people scheduled to receive radiotherapy for head and neck cancer (HNC). Prehabilitation, which occurs between diagnosis and treatment commencement, aims to improve a patient's health to reduce the incidence and severity of current and future impairments. HNC treatment can be distressing and has detrimental impacts on function and quality of life. HNC patients have increased social vulnerabilities including higher rates of socio-economic disadvantage and engagement in lifestyle habits which increase cancer risk. High levels of physical and psychological impacts of HNC treatment and increased social vulnerabilities of this population warrant investigation of optimal pathways of care, such as prehabilitation. This paper describes a research protocol to evaluate the feasibility of Prep-4-RT, which was designed to prepare HNC patients for the physical and psychological impacts of radiotherapy.</p><p><strong>Methods and analysis: </strong>At least sixty adult HNC patients, scheduled to receive radiotherapy (with or without chemotherapy), will be recruited over a five-month period. All participants will receive access to Prep-4-RT self-management resources. Participants identified through screening as high-risk will also be offered individualised interventions with relevant allied health professionals prior to the commencement of radiotherapy (psychologists, dietitians, speech pathologists and physiotherapists). Participants will complete evaluation surveys assessing their experiences with Prep-4-RT resources and interventions. Clinicians will also complete program evaluation surveys. Primary feasibility outcomes include adoption (uptake and intention to try) and fidelity (adherence to the specialist prehabilitation pathway). Secondary feasibility outcomes include acceptability (patient and clinician) of and satisfaction (patient) with Prep-4-RT as well as operational costs. Feasibility outcome data will be analysed using exact binomial and one-sample t tests, as appropriate.</p><p><strong>Ethics and dissemination: </strong>Ethics approval has been obtained at the Peter MacCallum Cancer Centre in Melbourne, Australia. Results will be presented at national conferences and published in peer-reviewed journal(s) so that it can be accessed by clinicians involved in the care of HNC patients receiving radiotherapy. If the model of care is found to be feasible and acceptable, the transferability and scalability to other cancer centres, or for other cancer types, may be investigated.</p><p><strong>Registration details: </strong>ANZCTA (Australian New Zealand Clinical Trials Registry) ACTRN12623000770662.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"106"},"PeriodicalIF":1.5,"publicationDate":"2024-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11295311/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141879180","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 feasibility registry-based randomised controlled trial investigating a tailored follow-up service for stroke (A-LISTS).","authors":"Dominique A Cadilhac, Andrew G Ross, Kathleen L Bagot, Jannette M Blennerhassett, Monique F Kilkenny, Joosup Kim, Tara Purvis, Karen M Barclay, Fiona Ellery, Julie Morrison, Jennifer Cranefield, Timothy J Kleinig, Rohan Grimley, Katherine Jaques, Dana Wong, Lisa Murphy, Grant Russell, Mark R Nelson, Vincent Thijs, Colin Scott, Sandy Middleton","doi":"10.1186/s40814-024-01527-y","DOIUrl":"10.1186/s40814-024-01527-y","url":null,"abstract":"<p><strong>Background: </strong>Stroke affects long-term physical and cognitive function; many survivors report unmet health needs, such as pain or depression. A hospital-led follow-up service designed to address ongoing health problems may avoid unplanned readmissions and improve quality of life.</p><p><strong>Methods: </strong>This paper outlines the protocol for a registry-based, randomised controlled trial with allocation concealment of participants and outcome assessors. Based on an intention-to-treat analysis, we will evaluate the feasibility, acceptability, potential effectiveness and cost implications of a new tailored, codesigned, hospital-led follow-up service for people within 6-12 months of stroke. Participants (n = 100) from the Australian Stroke Clinical Registry who report extreme health problems on the EuroQol EQ-5D-3L survey between 90 and 180 days after stroke will be randomly assigned (1:1) to intervention (follow-up service) or control (usual care) groups. All participants will be independently assessed at baseline and 12-14-week post-randomisation. Primary outcomes for feasibility are the proportion of participants completing the trial and for intervention participants the proportion that received follow-up services. Acceptability is satisfaction of clinicians and participants involved in the intervention. Secondary outcomes include effectiveness: change in extreme health problems (EQ-5D-3L), unmet needs (Longer-term Unmet Needs questionnaire), unplanned presentations and hospital readmission, functional independence (modified Rankin Scale) and cost implications estimated from self-reported health service utilisation and productivity (e.g. workforce participation). To inform future research or implementation, the design contains a process evaluation including clinical protocol fidelity and an economic evaluation.</p><p><strong>Discussion: </strong>The results of this study will provide improved knowledge of service design and implementation barriers and facilitators and associated costs and resource implications to inform a future fully powered effectiveness trial of the intervention.</p><p><strong>Trial registration: </strong>ACTRN12622001015730pr.</p><p><strong>Trial sponsor: </strong>Florey Institute of Neuroscience and Mental Health, 245 Burgundy Street, Heidelberg, VIC, 3084, PH: +61 3 9035 7032.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"103"},"PeriodicalIF":1.5,"publicationDate":"2024-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11290067/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141856212","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 an online multicomponent very low-carbohydrate intervention in young adult women with obesity: a pilot study.","authors":"Laura R Saslow, Alison O'Brien, Kaitlyn Raymond, Hovig Bayandorian, Deanna Marriott, Judith T Moskowitz, Jennifer Daubenmier, Dave Bridges, Cody M Cousineau, Dina H Griauzde","doi":"10.1186/s40814-024-01525-0","DOIUrl":"10.1186/s40814-024-01525-0","url":null,"abstract":"<p><strong>Background: </strong>Approximately one-third of US young adults (18-25 years) have obesity, and there are calls to help young adults lose weight to prevent weight-related chronic conditions. This pilot trial tested the feasibility and acceptability of a very low-carbohydrate (VLC) eating pattern, with supportive positive affect and mindful eating skills, for weight management among young females with obesity.</p><p><strong>Methods: </strong>In a single-arm trial, women (N = 17), aged 19-23, with obesity participated in a 4-month diet and lifestyle intervention. Participants were taught how to follow a VLC eating pattern with the help of a coach and 16 weekly web-based sessions. We assessed feasibility and acceptability through session participation, outcome collection, intervention satisfaction, and adverse events.</p><p><strong>Results: </strong>Seventeen participants enrolled and 14 (82%) reported body weight at 4 months. Fifteen participants (94% of those beginning the intervention) viewed at least one session, and 8/15 (53%) of these participants were active in the intervention, viewing at least half of the sessions. Among the nine participants who provided 4-month self-report information, intervention satisfaction was high (mean 5.89/7, 95% CI 4.59 to 7.19). Among participants with a 4-month body weight, 7/14 (50%) lost ≥ 5% of their body weight, and of those who were also active in the intervention, 6/7 (86%) lost ≥ 5% of their body weight. There were no serious adverse events.</p><p><strong>Conclusions: </strong>The results of this pilot study suggest that a VLC eating pattern may be a feasible and acceptable approach for weight loss in some young women with obesity.</p><p><strong>Trial registration: </strong>This trial was registered with ClinicalTrials.gov on August 18, 2021. The trial number is NCT05010083.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"102"},"PeriodicalIF":1.5,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11285338/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141793025","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 Relational Approach to Treating Self-Harm (RELATE): study protocol for a feasibility randomised controlled trial study of cognitive analytic therapy for adults who self-harm versus treatment at usual.","authors":"Peter James Taylor, Isabel Adeyemi, Katie Marlow, Sarah Cottam, Zerena Airnes, Samantha Hartley, Victoria Howells, Barnaby D Dunn, Rachel A Elliott, Mark Hann, Cameron Latham, Catherine Robinson, Clive Turpin, Stephen Kellett","doi":"10.1186/s40814-024-01526-z","DOIUrl":"10.1186/s40814-024-01526-z","url":null,"abstract":"<p><strong>Background: </strong>Self-harm is a prevalent behaviour that has a major detrimental impact on a person's life. Psychological therapies have the potential to help, but evidence of effective interventions remains limited. Access and acceptability of interventions can also be a significant challenge, with individuals either being unable to access help or having to endure long waiting lists. Cognitive analytic therapy (CAT) is a time-limited and relationally-focused psychotherapy that may provide a valuable treatment option for people who self-harm. This protocol outlines the methodology for the first feasibility randomised controlled trial (RCT) of CAT for adults that self-harm. The trial will aim to determine the feasibility, acceptability and safety of undertaking larger-scale evaluations of CAT for self-harm within an RCT context.</p><p><strong>Method: </strong>An RCT design with 1:1 allocation to CAT plus treatment as usual (TAU) or TAU alone. Participants will be adult outpatients with three or more instances of self-harm in the past year (target sample of n = 60). CAT will be 8 one-to-one weekly 60-min sessions plus a follow-up session up to 8 weeks after the last session. Assessments will occur at baseline, 12 weeks and 18 weeks after randomisation. Qualitative interviews with participants will gain insights into the feasibility and acceptability of CAT. Feasibility outcomes will be judged against progression criteria.</p><p><strong>Discussion: </strong>CAT may be an effective and accessible treatment option for people who self-harm, providing a more relationally orientated alternative to more behavioural therapies. The proposed feasibility RCT is an important first step in evaluating CAT as a treatment for self-harm.</p><p><strong>Trial registration: </strong>The trial was pre-registered (21/10/22) on ISR CTN (ISRCTN code: ISRCTN75661422).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"101"},"PeriodicalIF":1.5,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11256374/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141724148","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 multidisciplinary group-based survivorship intervention for those living with multiple myeloma: a feasibility study.","authors":"Nora Eilert, Norma-Jean Murphy, Hannah Cummins, Emma Houlihan, Janusz Krawczyk","doi":"10.1186/s40814-024-01524-1","DOIUrl":"10.1186/s40814-024-01524-1","url":null,"abstract":"<p><strong>Background: </strong>While multiple myeloma continues to be an incurable cancer, advances in its understanding and management have led to significantly improved survival rates. Survivorship interventions for those living with multiple myeloma remain scarce, despite mounting evidence for multiple unmet support needs among multiple myeloma survivors. The current study aimed to evaluate the feasibility and preliminary effectiveness of a novel multidisciplinary group-based multiple myeloma survivorship intervention.</p><p><strong>Methods: </strong>A mixed-method, repeated measures feasibility study was conducted within a routine cancer support service. Seven participants, aged over 18, who had a multiple myeloma diagnosis and were clinically assessed as suitable for the intervention by their haemato-oncologist, attended online for six weekly group sessions of physical exercise and self-management input, completing qualitative, physical and self-report measures at baseline, post-intervention and follow-up.</p><p><strong>Results: </strong>The intervention was deemed overall feasible, with relatively high uptake, participants describing it as largely acceptable and appropriate and providing recommendations for feasibility-enhancing intervention refinements. Findings regarding the preliminary effectiveness of the intervention were mixed. While qualitative analyses stressed the benefits of the intervention (e.g. peer support, connectedness, improved well-being) and large effect sizes were observed for most physical outcomes, no improvements in self-reported outcomes (i.e. quality of life, fatigue) were reported.</p><p><strong>Conclusions: </strong>This study represents the first investigation of a promising novel survivorship intervention for those living with multiple myeloma, highlighting the importance of peer support in particular, on which future clinical trials, aiming to establish the intervention's effectiveness for routine care, will be able to build.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"100"},"PeriodicalIF":1.5,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11247835/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141620668","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}