Pilot and Feasibility Studies最新文献

{"title":"A coadapted community-based participatory group programme for parents/carers of children with complex neurodisability (Encompass-2): a pilot and feasibility study protocol.","authors":"Kirsten Prest, Angela Harden, Kirsten Barnicot, Michelle Heys","doi":"10.1186/s40814-025-01619-3","DOIUrl":"https://doi.org/10.1186/s40814-025-01619-3","url":null,"abstract":"<p><strong>Background: </strong>Parents/carers of children with complex neurodisability continue to lack appropriate family-centred care. \"Encompass\" is a community-based group programme that was co-adapted from \"Baby Ubuntu\" in Uganda. It is an example of a \"decolonised healthcare innovation\" as it is a low-cost solution from a low-income country for use in a resource-constrained UK National Health Service (NHS).</p><p><strong>Methods and analysis: </strong>We will conduct a mixed-methods pilot feasibility study to determine the feasibility and acceptability of delivering and evaluating \"Encompass\" with parents/carers of children under 5 years with complex neurodisability in the UK. We aim to recruit 20 parents/carers of children from two NHS trusts in England serving urban areas where there is high social deprivation and ethnic diversity. Recruited parents/carers will attend the 10-modular, participatory group programme over a 6-month period. Groups will be facilitated by a trained allied health professional and an \"expert parent\" with lived experience. The primary outcomes of interest are the feasibility of delivering and evaluating the programme (recruitment, retention rates, acceptability as perceived by the parents/carers, facilitators and wider key NHS partners), intervention fidelity and participant adherence. Results will be collectively assessed against traffic light criteria. Pre-, post- and follow-up data collection questionnaires will include the Family Empowerment Scale (FES), the Power Ladder Question, the Parent Patient Activation Measure (P-PAM), Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), EuroQoL-5D-5-level (EQ-5D-5L) and parent/carer greatest needs and goals questionnaire. Post-intervention semi-structured interviews will be conducted with parents/carers, facilitators and key NHS partners.</p><p><strong>Discussion: </strong>A community-based participatory group programme is a potentially affordable and sustainable way for the NHS to provide family-centred support. The programme aims to improve outcomes for parents/carers of children with complex neurodisability. Example outcomes include knowledge, skills, confidence, wellbeing and quality of life. The programme also provides opportunities for peer support and aims to empower parents/carers in navigating community health systems.</p><p><strong>Registration: </strong>The protocol is registered on clinical trials.gov (ID: NCT06310681).</p><p><strong>Ethical approval: </strong>Health Research Authority ref. 23/EM/0213.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"59"},"PeriodicalIF":1.5,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048988/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144028719","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":"iSupport for rare dementias: a mixed-methods non-randomised feasibility study of an online self-help programme for carers.","authors":"Bethan Naunton Morgan, Gill Windle, Carolien Lamers","doi":"10.1186/s40814-025-01639-z","DOIUrl":"https://doi.org/10.1186/s40814-025-01639-z","url":null,"abstract":"<p><strong>Background: </strong>iSupport for dementia carers is an online education and self-care programme developed by the World Health Organisation for carers of people with the most common forms of dementia (Alzheimer's disease and vascular dementia). iSupport for rare dementias (RDC) is the first adaptation designed specifically to address the challenges faced by carers of individuals with rare dementias (frontotemporal dementia, posterior cortical atrophy, primary progressive aphasia or Lewy body dementia).</p><p><strong>Methods: </strong>A 12-week mixed-methods non-randomised feasibility study assessed the feasibility of recruitment and participant retention, the feasibility of outcome measures and the acceptability of iSupport RDC. Participants were recruited through the Rare Dementia Support Network (target N = 30). Data were collected through online interviews and self-report, including pre and post-intervention measures of depression, anxiety, burden and resilience. A modified version of the NoMAD questionnaire evaluated acceptability of implementation. Scores range from 0 to 4 with > / = 2.5 indicating acceptability. Usability was assessed through self-report and data from Blackboard.</p><p><strong>Results: </strong>Thirty-four (13 males and 21 females) carers of people with frontotemporal dementia, posterior cortical atrophy, primary progressive aphasia or Lewy body dementia consented to the study and given access to iSupport RDC, hosted online by Blackboard Learn. Their ethnicity was reported as white and their mean age was 64.2 (range 35-86). N = 24 completed pre and post outcome measures, N = 10 completed pre-intervention and then withdrew, n = 4 reporting technical difficulties (70.6% completion rate). There were no missing responses. N = 20 completed 3 of the 5 iSupport RDC modules; n = 13 completed five. N = 4 could not access due to technical difficulties. Technical difficulties meant the data from Blackboard Learn were not obtained. The NoMAD total score (3.5) indicated iSupport RDC was acceptable. Qualitative analysis from n = 19 participants revealed themes of 'technical difficulties' (n = 10), 'useful and informative' (n = 7), and 'provide at point of diagnosis' (n = 5).</p><p><strong>Conclusions: </strong>Recruitment targets were met but there were limitations in sample diversity. The extent of attrition warrants strategies to ensure retention to future studies, including testing online interventions on different internet browsers and operating systems. The favourable response to iSupport RDC from the participants indicates its potential as a valuable resource for supporting carers dealing with rare dementias.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"58"},"PeriodicalIF":1.5,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12042611/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144037137","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 usability of remote transcranial direct current stimulation (tDCS) for self-regulation in children with autism: protocol for a randomized controlled pilot study.","authors":"Norna Abbo, Trina Mitchell, Seyed Hassan Tonekaboni, Evdokia Anagnostou, Brendan F Andrade, Kevin Thorpe, Deryk S Beal","doi":"10.1186/s40814-025-01650-4","DOIUrl":"https://doi.org/10.1186/s40814-025-01650-4","url":null,"abstract":"<p><strong>Background: </strong>Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by social communication and self-regulation impairments. Impaired response inhibition and self-regulation in ASD have been shown to be related to abnormal functional network connectivity in the dorsolateral prefrontal cortices (DLPFC). Transcranial direct current stimulation (tDCS) of DLPFC is a safe, tolerable, and precise intervention that has shown promise for the improvement of self-regulatory behavior in ASD. However, clinical translation has been prevented by a lack of effective systematic design, experimental control, and a high participation burden. The proposed protocol aims to evaluate the feasibility and usability of home-based tDCS to promote self-regulation in children with ASD.</p><p><strong>Methods: </strong>Participants will be randomized into an active or sham tDCS group and will receive 20 min of stimulation 5 days per week for 3 weeks. Participants in the sham group receive a negligible amount of stimulation. Sessions will be virtually supported by the study team. Assessments are taken at baseline, 1-week post-treatment, and 18 weeks post-treatment. These assessments include clinical measures of self-regulation and social communication (participant-, parent-, and clinician-reported), a response inhibition task, and magnetic resonance imaging. Recruitment, retention, and adherence rates will be used to assess the feasibility of the protocol. The usability of the remote tDCS device will be assessed via a usability survey, user interviews, and video analysis of device use.</p><p><strong>Discussion: </strong>Home-based tDCS may benefit children by providing an efficient, passive, and tolerable treatment that positively impacts function, activities, and participation. This study will identify potential challenges for the clinical translation of this therapy so that home-based tDCS can be positioned for success in healthcare delivery implementation.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT06129058. Registered on November 8, 2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"57"},"PeriodicalIF":1.5,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12039062/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144037945","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":"Investigating the feasibility of an 8-week mindful breathing programme on breathlessness and self-efficacy in chronic obstructive pulmonary disease: an open-label study.","authors":"Shirley Harris, Jennifer Jordan, Amanda Wilkinson, Philippa Seaton","doi":"10.1186/s40814-025-01649-x","DOIUrl":"https://doi.org/10.1186/s40814-025-01649-x","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;High prevalences of anxiety and depression have been found in those with COPD which can exacerbate physically related impacts of increased levels of disability, and reduced enjoyment of life. Of particular concern is the anxiety-breathlessness cycle and reduced self-efficacy, which both adversely affect self-management of symptoms. Recognition of the need to address these issues has led to use of adjunctive psychologically based therapies including mindfulness. Standard mindfulness programmes have been found to be helpful in promoting a less distressing view of breathlessness and increasing self-efficacy in self-management; however, they can be difficult to access due to significant time commitments and need to travel for groups. This study examines a novel, portable, flexible mindfulness intervention for breathlessness that can be self-delivered in the person's home, enabling access to a potentially effective intervention to improve self-efficacy in COPD self-management. The primary aim of this study is to establish the feasibility of delivery of this intervention in terms of uptake and retention in the study, adherence to, and acceptability of the MBI. The secondary aim is to obtain preliminary estimates regarding change in self-efficacy in managing COPD.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This mixed method pre-post-study with 3-month follow-up will assess feasibility of recruitment, acceptability, and report preliminary descriptive data regarding this novel mindful breathing intervention (MBI) in up to 30 adults with COPD. A secondary outcome measure is change in the COPD self-efficacy scale. Other self-report measures include the St. Georges Chronic Respiratory Disease Questionnaire, Five Facet Mindfulness Questionnaire, Hospital Anxiety and Depression Scale, the EQ-5D-5L, and a daily diary recording breathlessness and mindfulness practice. Descriptive statistics and pre-post-change scores will be reported for quantitative data. A qualitative interview exploring participant experiences of the MBI will be undertaken at the 3-month follow-up point with 10 participants. Qualitative data will be analysed using thematic analysis. Data collection is ongoing at the time of submitting this manuscript.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;This study is the first to assess feasibility of a self-delivered MBI for those with COPD in New Zealand. This study will also establish preliminary estimates of change on self-efficacy and other measures of health outcomes. If feasible, with preliminary evidence of positive impact on functioning, this will support the development of a larger clinical trial. Provision of self-delivered in-home mindfulness-based interventions for people with COPD may not only contribute to improved health, but potentially a reduction in resources, costs, and the time required for travel to group treatments), reducing barriers to treatment for people with COPD.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;Austr","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"56"},"PeriodicalIF":1.5,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12039139/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144006367","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 tolerability of physiologic monitoring among pregnant nurses and nursing teams.","authors":"Isha Agarwal, Madeleine Puissant, Irit Altman, Alexandra Hinton, Tania D Strout, Erika L Sabbath","doi":"10.1186/s40814-025-01647-z","DOIUrl":"https://doi.org/10.1186/s40814-025-01647-z","url":null,"abstract":"<p><strong>Background: </strong>Most studies of stress during pregnancy have relied on self-reported and recalled measures, leaving a knowledge gap about the impact of acute, or momentary, stressors. Heart rate, blood pressure, and cortisol are physiologic measures known to increase acutely in response to acute stress. The feasibility of collecting these measures has not been widely reported among pregnant workers outside of a controlled laboratory setting.</p><p><strong>Methods: </strong>This pilot study assessed the feasibility and tolerability of measuring ambulatory heart rate, blood pressure, and diurnal urine cortisol during periods of work and rest among pregnant nurses, nursing assistants, and clinical technicians.</p><p><strong>Results: </strong>Over a 9-month enrollment period, we received 31 inquiries from potential candidates, of whom 18 met our eligibility criteria and 12 accepted enrollment (67% acceptance rate). Over the study period, 4 enrollees withdrew their participation, and 8 were retained until the end of the study (67% completion rate). Our feasibility threshold was the acquisition of ≥ 80% of expected measurements for heart rate, blood pressure, and urine cortisol among retained participants. We achieved our feasibility target for blood pressure recordings (acquiring 84% of expected measures) but not for heart rate recordings (acquiring 60% of expected measures). Urine cortisol levels were successfully obtained 97% of the time. Through qualitative analysis of comments provided by study participants, we identified three major themes surrounding barriers to completing physiological monitoring: (1) personal discomfort and technical issues with study equipment, (2) work or activity interference, and (3) concerns about study design.</p><p><strong>Conclusions: </strong>While physiologic monitoring of pregnant workers is important for learning about how work might impact pregnancy outcomes, equipment challenges pose a significant barrier to study participation. Future studies should allow for a significant withdrawal rate or explore alternative equipment options.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"55"},"PeriodicalIF":1.5,"publicationDate":"2025-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12034121/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144033711","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":"Proactive clinical review of patients taking opioid medicines long term for persistent pain led by clinical pharmacists in primary care teams (PROMPPT): a non-randomised mixed methods feasibility study.","authors":"Julie Ashworth, Nicola Cornwall, Sarah A Harrisson, Charlotte Woodcock, Elaine Nicholls, Gillian Lancaster, Simon Wathall, Libby Laing, Toby Helliwell, Sue Jowett, Jesse Kigozi, Christian D Mallen, Anthony Avery, Roger Knaggs, Tamar Pincus, Simon White, Clare Jinks","doi":"10.1186/s40814-025-01636-2","DOIUrl":"https://doi.org/10.1186/s40814-025-01636-2","url":null,"abstract":"<p><strong>Background: </strong>Given the poor long-term effectiveness of opioids for persistent non-cancer pain, and their potential for harm, evidence-based interventions to address opioid overprescribing for persistent pain are needed. This study aimed to explore the acceptability and feasibility of a primary care practice pharmacist-led intervention (PROMPPT review) for patients prescribed opioids for persistent pain and the feasibility of evaluating PROMPPT in a definitive trial.</p><p><strong>Methods: </strong>A single-arm study, with mixed methods process evaluation, was conducted in four English primary care practices. Adults prescribed opioids for ≥ 6 months were invited to participate in the Management of Opioids and Persistent Pain (MOPP) study by completing baseline and 3-month follow-up questionnaires. Practices invited a representative sample of MOPP participants to schedule a PROMPPT review, eight of which were audio-recorded. Following the review, pharmacists completed intervention delivery templates, and participants were sent an Acceptability Questionnaire and invited to consent to an interview.</p><p><strong>Results: </strong>Between November 2020 and May 2021, 148 participants were recruited to the MOPP study. Of these, 123 (83%) completed 3-month follow-up. Of 88 MOPP participants invited for a PROMPPT review, 80 (91%) attended. The review was rated completely acceptable or acceptable in 90% (45/50) of acceptability questionnaires returned. Overall, participants interviewed (n = 15) perceived the review as a good idea and recommended it to others; they preferred face-to-face consultations. Prior to the review, they reported mixed feelings, including feeling 'pleased' to be invited and 'grateful' someone was taking an interest, alongside concerns about what would happen during the review, including opioids being stopped and changes being detrimental. Following the review, those with a clear plan for follow-up/access to the pharmacist felt reassured about making changes to their pain medicines, whilst those advised to arrange follow-up as needed were less satisfied and more likely to report confusion about the plan.</p><p><strong>Conclusions: </strong>PROMPPT reviews appeared acceptable to patients, review uptake was high, and the study demonstrated the feasibility of a large definitive trial to evaluate PROMPPT. The review invitation, patient information, and pharmacist training were refined based on the findings ahead of a large cluster randomised controlled trial.</p><p><strong>Trial registration: </strong>ISRCTN, ISRCTN87628403 , registered 31 July 2020.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"53"},"PeriodicalIF":1.5,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12023653/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144033712","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":"Evaluating the Management of chronic Pelvic girdle Pain following pregnancy (EMaPP): a randomised controlled feasibility trial.","authors":"Bradley Halliday, Sarah Chatfield, Lee Cameron, Joanne Hosking, Jade Chynoweth, Lauren Stockley, Matthew Bailey, Jill Shawe, Annie Hawton, Chris Hayward, Kirsty Carter, Jennifer Freeman","doi":"10.1186/s40814-025-01638-0","DOIUrl":"https://doi.org/10.1186/s40814-025-01638-0","url":null,"abstract":"<p><strong>Background: </strong>Postpartum pelvic girdle pain (PGP), experienced by approximately 10% of women, is typically refractory to conservative management. Customised dynamic elastomeric fabric orthoses (DEFOs) are one novel option to address this. We assessed the feasibility and acceptability of a randomised controlled trial comparing a DEFO plus standardised advice/exercises (intervention) versus standardised advice/exercise alone (control).</p><p><strong>Methods: </strong>A multicentre randomised controlled feasibility trial with embedded qualitative study and economic evaluation. Participants were randomised to either intervention or control group. All received two remote physiotherapy sessions via videoconferencing separated by 14 days. Primary feasibility outcomes were related to the feasibility and acceptability of methods and interventions, recruitment, intervention fidelity, outcome measure performance and completion. The proposed primary outcome measure for the definitive trial was the Numerical Pain Rating Scale (NPRS) which assessed pain intensity fortnightly over 24 weeks. Secondary outcome measures assessed kinesiophobia, continence, function, health-related quality of life, depression and health/care resource use at baseline, 12 and 24 weeks. Adverse events were recorded. Pre-defined progression criteria were set to decide whether, and how, to proceed with a future definitive trial: (1) Target sample size (60 from 3 centres over a 7-month recruitment period), (2) outcome measure completion (> 60% at 24 weeks), (3) orthosis wear-time compliance (> 70% for 6 h/day) as measured by the Orthotimer, and (4) evidence suggesting efficacy.</p><p><strong>Results: </strong>Of 180 participants sent information sheets, 40 were screened and 24 randomised. At 24 weeks, 95% completed NPRS and 89-95% the secondary outcome measures. Wear-time adherence appeared below the set target of 42 h per week. Outcomes were broadly comparable between groups. Recruitment was insufficient to estimate a signal of efficacy with confidence. Two intervention participants experienced Candida infections, considered possibly due to the DEFO.</p><p><strong>Conclusions: </strong>Trial procedures and interventions were acceptable to participants. Technical Orthotimer issues are resolvable through modification of recording parameters. Recruitment of participants was a major challenge. Work to understand how best to engage women in this research is needed before moving to a definitive trial.</p><p><strong>Trial registration: </strong>ISCRTN, ISRCTN67232113. Registered 08/05/2021, https://www.isrctn.com/ISRCTN67232113 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"54"},"PeriodicalIF":1.5,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12023510/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144006578","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 a pilot randomized trial of a single session of imagery rescripting targeting the primary consequences of negative experiences with eating and appearance.","authors":"Nichole R Kelly, Kelly Jean Doty, Bonnie H C Schrag, Shaylah Bryant, Sammy Plezia, Nicholas J Parr, Elizabeth L Budd","doi":"10.1186/s40814-025-01630-8","DOIUrl":"https://doi.org/10.1186/s40814-025-01630-8","url":null,"abstract":"<p><strong>Background: </strong>Negative experiences related to eating and appearance (NEREAs), such as critical commentary from parents about food, are common and associated with depression and disordered eating. Imagery rescripting (IR) is a therapeutic process during which individuals are guided through recalling and bringing support into distressing memories, like NEREAs. Single sessions of IR demonstrate promise in shifting the primary negative consequences of NEREAs in clinical samples of women. The primary objectives of this pilot trial were to evaluate the feasibility and acceptability of a remote-delivered, single session of IR and a nutrition education control group in a community sample of adults with NEREAs.</p><p><strong>Methods: </strong>In this parallel two-arm pilot trial, participants completed an in-person baseline visit, one remote-delivered, single-session intervention (IR or attention-matched nutrition education control), and in-person 1- and 3-month follow-up visits between February 2023 and April 2024 in Oregon, USA. Markers of feasibility included recruitment, visit and survey completion rates, and intervention fidelity; acceptability was evaluated using participant feedback and instances of adverse events.</p><p><strong>Results: </strong>One hundred one adults completed a phone screen; 96% reported at least one NEREA. Most of these adults were ineligible because they met psychiatric disorder criteria and/or were taking medication known to influence mood and/or appetite. Thirty-two participants completed a baseline study visit; 89% of these participants (N = 27; mean age [SD] = 32.52 [15.78], range = 18-73; 56% cisgender women; 74.1% non-Hispanic White, 14.8% Asian, 11.1% Hispanic/Latine, 7.4% Black, and 3.7% multiracial) were randomly assigned (using a random number generator) to and completed an intervention condition (13 IR, 14 control). Curriculum adherence, on average, was 94% for IR and 97% for control. One-month retention was 82%, and 3-month retention was 59%. Post-intervention ratings indicated good acceptability for both arms. No adverse events occurred.</p><p><strong>Conclusions: </strong>The delivered interventions are feasible and acceptable to a community sample of men and women; as such, a future definitive trial is recommended. Additional strategies for increasing retention are needed. Single-session interventions, like IR, have the potential for high impact and reach. They are inherently flexible and cost-effective interventions that can be delivered across systems of care, while remote delivery mitigates concerns with stigma and access.</p><p><strong>Trial registration: </strong>ClinicalTrial.gov, NCT06610318 . Registered on 23 September 2024-retrospectively registered.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"51"},"PeriodicalIF":1.5,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12016433/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144021088","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 cash transfer plus gender transformative economic empowerment intervention seeking to improve the wellbeing of caregivers of children and adolescents living with HIV in South Africa: a feasibility study protocol for a pilot cluster randomized trial.","authors":"Darshini Govindasamy, Nwabisa Shai, Nelly Mwandacha, Stanley Carries, Nokwanda Sithole, Kalysha Closson, Arvin Bhana, Lovemore Sigwadhi, Laura Washington, Andrew Gibbs, Angela Kaida","doi":"10.1186/s40814-025-01643-3","DOIUrl":"https://doi.org/10.1186/s40814-025-01643-3","url":null,"abstract":"<p><strong>Background: </strong>In sub-Saharan Africa, HIV care is dependent on informal caregiving, typically by female family members. Informal caregiving has been associated with numerous negative effects on caregivers (i.e., depression, intimate partner violence (IPV), financial insecurity). These factors impact caregivers' ability to provide care and their own wellbeing. South Africa is home to approximately 17% of the world's children and adolescents living with HIV (CALHIV), making the development of initiatives that mitigate the negative effects of caregiving critical. This protocol details the design of a cluster randomized trial seeking to assess the feasibility, preliminary effectiveness, cost-effectiveness, and acceptability of a cash transfer plus gender transformative economic empowerment intervention for improving psychological wellbeing, depressive symptoms, gender equality, and economic outcomes of caregivers of CALHIV.</p><p><strong>Methods: </strong>Caregivers of CALHIV will be recruited from public sector HIV clinics within the eThekwini Municipality, KwaZulu-Natal, South Africa. Clusters will be randomly assigned to intervention or control groups. Participants in the intervention arm (n = 120) will receive cash transfers (ZAR350, USD $18.79) and enroll in a program (10 workshop sessions) over a 6-month period. Participants in the control arm (n = 120) will receive a monthly cash transfer (ZAR350, USD $18.79) for a 6-month period and a once-off standard mobile message, encouraging linkage to healthcare services. Participants will be interviewed at baseline and endline, at the 7-month mark, to collect socio-demographic, health and wellbeing status, IPV, costs and earnings, and food security data. The primary outcomes include consent rate, overall retention rate, workshops retention rate, cash transfer protocol adherence, staff perceptions on implementation, psychological wellbeing, depressive symptoms, and IPV. A qualitative study and economic evaluation will be conducted alongside the main trial to probe participant perceptions of the intervention and assess cost and cost-effectiveness.</p><p><strong>Discussion: </strong>This trial has the potential to inform a larger confirmatory trial which will be valuable for informing post-pandemic recovery efforts for caregivers of CALHIV and others disproportionally burdened by compounding health and social crises.</p><p><strong>Trial registration: </strong>PACTR202311618532061. Registry name: Pan African Clinical Trial Registry (PACTR), retrospectively registered on November 21, 2023; The first participant was enrolled on August 24, 2023.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"52"},"PeriodicalIF":1.5,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12020082/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144025136","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":"Recruitment rates, retention rates, and follow-up completion in a Brief Intervention and Contact trial for suicidal behavior: a feasibility study.","authors":"Divya Soni, Balpreet Panesar, Alexander Dufort, Lucy Guan, Jennifer Lee, Dana Waldern, Stephanie Hathaway, Nitika Sanger, Sid Stacey, Luciano Minuzzi, Lehana Thabane, Zainab Samaan","doi":"10.1186/s40814-025-01635-3","DOIUrl":"https://doi.org/10.1186/s40814-025-01635-3","url":null,"abstract":"<p><strong>Background: </strong>Suicide is a serious public health concern for which there are limited evidence-based interventions being employed. This feasibility study administered a Brief Intervention and Contact (BIC) trial adopted from the WHO Multisite Intervention Study on Suicidal Behaviors (SUPRE-MISS) and followed participants after they had been discharged from the inpatient hospital setting.</p><p><strong>Aims: </strong>To assess the recruitment and retention rates, follow-up visit completion, barriers to recruitment and retention, resources needed of employing this study, and data completion.</p><p><strong>Methods: </strong>Eligible participants were recruited from psychiatric inpatient settings, in Hamilton, Ontario. Adults with suicidal behavior were randomly allocated to BIC (intervention) plus treatment as usual (TAU) or treatment as usual (control) and were followed for 6 months. The intervention arm completed 9 follow-up points during the 6-month follow-up period post-discharge. Calculation of recruitment and retention rates and associated statistical analyses were completed using SPSS version 25.</p><p><strong>Results: </strong>A total of 154 participants were approached during the 8-month recruitment period, 60 participants were enrolled resulting in a recruitment rate of 7.625 participants per month. A total of 61 participants were recruited, with 1 duplicate. The retention rate was 47.5% for the recruited participants at the end of the study.</p><p><strong>Conclusions: </strong>Few suicide-based follow up interventions assess the feasibility of conducting the study. Retention was low for this study; however, participants outlined reasons for withdrawal that are consistent with other research areas related to mental health. Findings from this study will help inform suicide research on the barriers and challenges to participant recruitment and retention.</p><p><strong>Trial registration: </strong>NCT03825354, Registered January 30 th, 2019, ClinicalTrial.gov; https://clinicaltrials.gov/study/NCT03825354?cond=suicide&term=brief%20intervention%20and%20contact&rank=6.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"50"},"PeriodicalIF":1.5,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12004632/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143975008","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}