Pilot and Feasibility Studies最新文献

{"title":"Development of a digitalised complex intervention to promote activity of older people in rural areas: study protocol of a feasibility study.","authors":"Katrin Beutner, Juliane Lamprecht, Sigrid Roggendorf, Paula Aßmann, Gundula Hübner, Anke Steckelberg, Heike Schmidt","doi":"10.1186/s40814-026-01872-0","DOIUrl":"10.1186/s40814-026-01872-0","url":null,"abstract":"<p><strong>Background: </strong>Age-related mobility limitations are associated with reduced activity and loss of participation, which can result in loneliness and depression. Physical activity programmes can help maintain the functional status and quality of life of older individuals, but they are rarely available and often difficult to reach, especially in rural areas. Digital-assisted programmes have the potential, independent of place and time, to activate and promote physical function and social participation in older people. Therefore, this study aims (1) to develop a complex intervention comprising digital elements to promote physical activity, quality of life and participation in older people with impending or existing functional limitations and (2) to test the feasibility, acceptability, and potential benefits of the developed intervention.</p><p><strong>Methods: </strong>The development and piloting of the intervention follow the UK Medical Research Council framework for complex interventions. The intervention will be developed through participatory co-production, integrating the perspectives of all potentially relevant user groups, including older people, physiotherapists, general practitioners, and day care facilities in the participating regions. Co-production is guided by the principles of early stakeholder involvement, iterative refinement, usability-oriented development, and shared decision-making regarding intervention content and delivery. The developed intervention will be examined using a consecutive control intervention group design with 60 older people (aged ≥ 65 years) in rural areas of Saxony-Anhalt who have existing or imminent mobility restrictions and have a medical prescription for physiotherapy. The primary feasibility outcomes will be recruitment rate, completion rate, acceptability, and compliance with the study procedures and the intervention assessed by protocols, utilisation data, questionnaires, and interviews at 20-weeks follow-up. Quantitative and qualitative findings will be integrated during interpretation using a convergent mixed-methods approach. Secondary patient-related outcomes will be physical function, physical activity, self-care, quality of life, and participation measured at baseline and after 12 weeks.</p><p><strong>Discussion: </strong>The study aims to evaluate the feasibility of a new intervention designed to promote physical activity and participation among older people living in rural areas. The findings will inform intervention refinement and the design of a future definitive randomised controlled trial.</p><p><strong>Trial registration: </strong>DRKS, DRKS00031574. Registered on 5 May 2023, https://drks.de/search/de/trial/DRKS00031574 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"12 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13277191/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148271808","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":"GAIN: a multicenter pilot protocol for early initiation of enteral feeds in neonates with simple gastroschisis.","authors":"Nicole T Cacho, Anjali J Cera, Daniel J Tancredi, Minna M Wieck, Jamie E Anderson, Alexandra J Leegwater, Cherry C Uy, Yigit S Guner, Daniel A DeUgarte, Jennifer L Rosenthal, Kara L Calkins, Geoanna M Bautista","doi":"10.1186/s40814-026-01860-4","DOIUrl":"10.1186/s40814-026-01860-4","url":null,"abstract":"<p><strong>Background: </strong>Gastroschisis is a congenital abdominal wall defect characterized by severe gut dysmotility. These neonates often face lengthy hospital stays, prolonged parenteral nutrition dependence, and complications such as growth faltering, sepsis, and intestinal failure. Feeding practices for neonates with gastroschisis vary and emphasize extended bowel rest and delayed feeding initiation. Usual practices in determining timing to start feeds include awaiting return of bowel function which typically consists of low Replogle output volume, color changing from bilious to clear and/or passing stool. However, emerging studies suggest that early initiation of feeds through standardized protocols may improve outcomes. The Gastroschisis And Early Infant Nutrition (GAIN) Study aims to test the feasibility of an early feeding approach in neonates with simple gastroschisis.</p><p><strong>Methods: </strong>This two-site single-arm feasibility trial aims to enroll neonates with presumed simple gastroschisis over 30 months. The intervention has two main components: Replogle suction tube removal within 24 h of abdominal closure and starting small-volume human milk feeds within 48 h of abdominal closure. Feeding volume will be advanced as tolerated, following the University of California Fetal Consortium pathway, which is standard care. Feasibility outcomes include enrollment rate, protocol adherence, fidelity, and withdrawal rate. Exploratory outcomes include hospitalization length, time to full feeds, duration of parenteral nutrition, use of human milk, breastfeeding rates, and anthropometric measurements. Safety measures involve monitoring for feeding-related complications, infections, and unexpected surgical interventions.</p><p><strong>Discussion: </strong>This feasibility trial of early feeding initiation in neonates with gastroschisis is a critical step towards addressing the need for a standardized feeding approach. Findings will inform future clinical trials and challenge the need for prolonged bowel rest. Standardizing early feeding practices could reduce practice variation, improve gut motility, and the overall health of neonates with gastroschisis.</p><p><strong>Systematic review registration: </strong>NCT06878950.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13495323/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148259234","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":"Peer-delivered systems-integrated suicide prevention for women in Pakistan: a protocol for hybrid type II pilot cluster randomized controlled trial.","authors":"Javeria Tanveer, Erum Hamid, Gul Saeed, Sidra Mumtaz, Muhammad Ahmad, Sundus Rahman, Noor-Ul-Huda, Shumaila Saleem Malik, Nikita Rao, Atif Rahman, Abid Malik, Siham Sikander, Ashley Hagaman","doi":"10.1186/s40814-026-01841-7","DOIUrl":"10.1186/s40814-026-01841-7","url":null,"abstract":"<p><strong>Background: </strong>South Asia has the highest rates of suicide fatalities among women globally. Existing suicide prevention interventions are largely based on Western-informed risk reduction programs and theories. This pilot trial aims to test the acceptability and feasibility of a co-designed suicide prevention program for peri-rural Pakistani women called the Khushal Pur-Umeed Zindagi (KPZ, خوشحال پُرامید زندگی پروگرام), compared to enhanced usual care (EUC). The study seeks to innovate suicide prevention by grounding interventions in decolonized frameworks, leveraging peer mothers, and developing robust health system integration strategies.</p><p><strong>Methods: </strong>We will conduct a two-arm, mixed-methods, hybrid type 2, stratified pilot cluster randomized controlled trial in peri-rural areas of the Islamabad Capital Territory (ICT). KPZ is a decolonized, culturally salient brief intervention combining narrative-based safety planning and contact follow-up, delivered by peer mothers over 6 months. EUC entails the WHO Mental Health Gap Action Programme (mhGAP) suicide prevention module, along with referral support delivered through Primary Health Care (PHC) by Medical Officers (n = 2) and Lady Health Worker teams (n = 11). KPZ is integrated into the PHC system and is implemented through close collaboration between peer mothers (delivery agents) and the government-employed LHWs. A cohort of peer mothers (n = 11), identified from the same communities as participants, will be trained and supervised for the study duration. We will enroll 50 women aged 18-45 with a child under 3 years who report suicidal ideation and will conduct follow-ups at 3- and 6-months post-recruitment. Qualitative interviews with trial participants and periodic reflections from peer mothers will be conducted iteratively over 6 months. A mixed-methods approach will be used to assess both clinical and implementation outcomes. Primary clinical outcomes include suicidal ideation severity and suicidal behaviors. Implementation outcomes include feasibility, acceptability, fidelity, appropriateness, and peer mothers' competence. Secondary outcomes assess additional clinical domains (depression, anxiety) and culturally relevant constructs (moral injury, cultural suicide cognitions).</p><p><strong>Discussion: </strong>This pilot trial will provide evidence on the feasibility and acceptability of integrating a decolonized, peer-delivered suicide prevention program for women into the existing Pakistani health system. The findings have the potential for large-scale public health impact by improving the availability, accessibility, and quality of culturally appropriate suicide prevention interventions in resource-constrained and complex environments. Results will inform a larger definitive trial of a community-initiated suicide prevention program in Pakistan.</p><p><strong>Trial registration: </strong>NCT06208293.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13488200/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148239965","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 digital yoga-based 'Pause Grow Reflect' intervention for postgraduate researchers: a feasibility randomised controlled trial and embedded qualitative acceptability study.","authors":"Natalie Bisal, Riya Patel, Nikki Holliday, Deborah Lycett, Andy Turner, Maxine Whelan","doi":"10.1186/s40814-026-01807-9","DOIUrl":"10.1186/s40814-026-01807-9","url":null,"abstract":"<p><strong>Background: </strong>The prevalence of mental health and well-being problems among postgraduate researchers (PGRs) is concerning. Self-care is a protective factor; however, engagement can be low. Interventions to date are not theory-driven nor co-developed. This study assessed the feasibility and acceptability of a co-created, theory-driven digital yoga-based self-care intervention (Pause Grow Reflect).</p><p><strong>Methods: </strong>A 2:1 randomised feasibility trial of the 7-week Pause Grow Reflect intervention and embedded qualitative study was conducted in UK PGRs. Primary outcomes included rates of recruitment, retention, follow-up, adherence, and engagement. Secondary outcomes assessed fidelity, acceptability, adverse events, and preliminary signals of efficacy. Criteria determined progression to a definitive trial. An embedded qualitative study comprising 1:1 semi-structured interviews was guided by the Theoretical Framework of Acceptability (TFA) and data analysed using deductive thematic analysis.</p><p><strong>Results: </strong>PGRs were allocated to the intervention (n = 24) or control (n = 13) group. Progression criteria were met for recruitment, T1 assessments, and acceptability, whilst rates of retention, engagement, and T2 follow-up assessments were not. Marginal mean differences for stress were observed. The qualitative data (n = 10 interviews) showed that all seven TFA domains were important, with issues mostly reported for the constructs of 'burden' and 'opportunity costs'.</p><p><strong>Conclusion: </strong>Pause Grow Reflect was largely feasible to deliver and acceptable within a UK context, and may be a promising offer to promote self-care during doctoral programmes. Further intervention refinement would promote better rates of retention, adherence, and engagement. Preliminary observations were positive, though a larger RCT is needed to determine efficacy.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13495291/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148240019","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":"Phenobarbital as an Adjuvant to benzodiazepines when compared to Single-agent benzodiazepine Treatment (usual care) for Alcohol withdrawal syndrome in the intensive care unit (PASTA): a study protocol.","authors":"Haustine Patt Panganiban, Samuel G Ricciardone, Tess Evans, Melissa J Ankravs, Timothy N Fazio, Nicolas Clark, Aneil Avasthi, Christopher M MacIsaac, Jeffrey J Presneill, Emily J See, Matthew W Semler, Theodore J Iwashyna, Adam M Deane","doi":"10.1186/s40814-026-01867-x","DOIUrl":"10.1186/s40814-026-01867-x","url":null,"abstract":"<p><strong>Background: </strong>Abrupt cessation of alcohol consumption following hospital admission can induce alcohol withdrawal syndrome. This syndrome is challenging to manage and is associated with considerable morbidity and mortality. Current management of alcohol withdrawal syndrome in Australia is generally titrated benzodiazepine administration. In some regions, phenobarbital is preferred but evidence to support its superiority is weak.</p><p><strong>Methods: </strong>We will conduct a single-center, three-arm, open-label, parallel-group, randomized clinical trial. Our primary objective is to determine the feasibility of embedding a randomized clinical trial within an electronic medical record to compare phenobarbital to single-agent benzodiazepine for patients with alcohol withdrawal. We will screen and randomize 45 patients using the Epic electronic medical record system. Patients will receive either low- or standard-dose intravenous phenobarbital (4 or 8 mg per kilogram), or usual care (benzodiazepine regimen). The primary outcomes to assess feasibility are usability, screening rates, enrollment rates, and compliance. Secondary outcomes are exploratory and include alcohol withdrawal scale scores, dose of benzodiazepine administered, health utilization, adjuvant drug treatments, and patient outcomes.</p><p><strong>Discussion: </strong>There are limited high quality data evaluating the use of phenobarbital administration for alcohol withdrawal syndrome. Additionally, there is limited data evaluating the embedding of screening, randomization, and administration of a sedative drug within the electronic medical record. Our feasibility trial will establish whether this is possible within our health care system. In this protocol paper we detail how we will embed this trial within the electronic medical record Epic.</p><p><strong>Trial registration: </strong>The study (RMH2024.320 v2 06/01/2025) is registered with Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12625000320459 . Registered on 17 April 2025. Trial Sponsor: The Royal Melbourne Hospital.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13483696/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148227397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility of evaluating the effectiveness of an interprofessional rehabilitation program for people with chronic low back pain in Ethiopia: a pilot randomized control trial protocol.","authors":"Sintayehu Daba Wami, Catherine Donnelly, Kassahun Alemu, Esayas Adefris, Jordan Miller","doi":"10.1186/s40814-026-01866-y","DOIUrl":"10.1186/s40814-026-01866-y","url":null,"abstract":"<p><strong>Background: </strong>Chronic low back pain (CLBP) is a significant public health problem and the leading cause of years lived with disability globally. Evidence suggests that interprofessional rehabilitation programs are effective for people with CLBP in improving health-related quality of life, reducing pain, and improving function and work abilities for people with CLBP. So far, however, little attention has been given to interprofessional rehabilitation programs for people with CLBP in low- and middle-income countries. Hence, this pilot randomized control trial (RCT) aims to evaluate the feasibility of conducting a future fully powered RCT to assess the effectiveness of an interprofessional rehabilitation program compared to the usual care for people with CLBP in Ethiopia.</p><p><strong>Methods: </strong>A two-arm parallel pilot RCT, with embedded mixed methods process evaluation, will be employed. A total of 40 patients with CLBP will be randomly assigned to the intervention and control groups at a 1:1 ratio. Participants of the intervention group will receive interprofessional rehabilitation that contains progressive physical activity and exercise, pain education, psychological interventions, and task-oriented and ergonomic interventions components. The comparison group participants will receive usual care for the same 4-week period. The primary outcome will be the feasibility of trial procedures (recruitment rate, retention rate, adherence rate, and acceptability of intervention). Secondary outcomes include the outcomes planned for the full trial, including physical functioning, pain intensity, pain self-efficacy, and health-related quality of life. Results will be analyzed and reported using descriptive statistics. The process evaluation will include a fidelity checklist, adherence measures, and qualitative interviews with 10 patients and all care providers involved to understand their experiences, barriers, and facilitators to implementing the intervention and trial methods with the goal of refining the intervention and trial methods in preparation for the fully powered trial.</p><p><strong>Discussion: </strong>This pilot RCT will be critical to informing the methods, minimizing uncertainties, and increasing the likelihood of successfully conducting a definitive RCT in the future. In addition, it provides a source of evidence for other initiatives aimed at developing and implementing interprofessional rehabilitation programs in a similar context particularly in low- and middle-income countries.</p><p><strong>Trial registration: </strong>This trial is registered at clinicaltrials.gov (registration number, NCT05866146, date of registration, 19th July 2023).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13479865/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148227387","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 the Southeast Asian Healthy Habits, Healthy Kids (SEAHK) study, a culturally tailored family-based pilot randomized controlled trial to improve dietary quality.","authors":"Akilah Dulin, Alison Tovar, Shira Dunsiger, Kate B Carey, Kim M Gans","doi":"10.1186/s40814-026-01863-1","DOIUrl":"10.1186/s40814-026-01863-1","url":null,"abstract":"<p><strong>Background: </strong>Southeast Asian (SEA) children are burdened by high rates of diet-related chronic conditions and diseases. These burdens partly result from socioeconomic disadvantages and refugee migration trajectories. Yet, to our knowledge, no dietary interventions exist for this population. This protocol paper describes the rationale, study design, intervention and study evaluation for the SEA Healthy Habits, Healthy Kids Study.</p><p><strong>Methods: </strong>The study enrollment goal was 75 parent-child dyads recruited in Providence, Rhode Island, in the United States. A SEA parent/guardian and one of their 6-to-11-year-old children were randomized to (1) a monthly financial incentive only group; (2) an enhanced financial incentive group that receives additional interventions including family-based group nutrition education, three motivational interviewing (MI) phone calls, and weekly text messages on healthy eating norms and other nutrition topics; or (3) a structurally equivalent attention-matched control group. The primary study goals were to assess feasibility and acceptability, conduct process evaluation to determine implementation fidelity and intervention dose, and determine preliminary efficacy. Feasibility was assessed based on attendance (primary) and secondary measures, recruitment, enrollment, intervention dose, and retention at 6 months. Acceptability was measured using satisfaction questionnaires on study favorability. Preliminary efficacy (i.e., comparing changes in children's diet quality (Healthy Eating Index and dermal carotenoids)) will be determined via longitudinal mixed effects models. Regression models will investigate the relationship between dose, implementation measures and study outcomes.</p><p><strong>Results: </strong>This intervention received Institutional Review Board approval on February 16, 2023. We conducted intervention development from July 2022 to August 2022 with 62 SEA parents and children. For the intervention, we began participant recruitment in April 2023, which concluded January 2025.</p><p><strong>Discussion: </strong>This study will demonstrate whether a culturally tailored healthy eating intervention for SEA families is feasible and acceptable and whether it leads to changes on key efficacy indicators. The intervention is informed by theories and frameworks relevant for the population and utilizes a family-centered approach. If this innovative pilot intervention achieves the study objectives, then we will refine it and pursue a larger randomized control trial.</p><p><strong>Trial registration: </strong>This study is registered at ClinicalTrials.gov under registration number NCT05817838. The trial was registered on April 17, 2023. The trial registry record is available at https://clinicaltrials.gov/study/NCT05817838 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13479714/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148226828","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":"Enhancing the Health of NHS Staff: eTHOS-a randomised controlled pilot trial of an employee health screening clinic for NHS staff compared with usual care to reduce absenteeism and presenteeism.","authors":"Rachel Adams, Rachel E Jordan, Alisha Maher, Peymané Adab, Tim Barrett, Sheriden Bevan, Lucy Cooper, Ingrid DuRand, Florence Edwards, Pollyanna Hardy, Ciara Harris, Nicola Heneghan, Natalie Ives, Kate Jolly, Sue Jowett, Tom Marshall, Margaret O'Hara, Christopher Poyner, Kiran K Rai, Hugh Rickards, Steven Sadhra, Sarah Tearne, Gareth Walters, Elizabeth Sapey","doi":"10.1186/s40814-026-01794-x","DOIUrl":"10.1186/s40814-026-01794-x","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Staff sickness absence incurs high costs to the NHS and is associated with adverse patient outcomes. Mental and musculoskeletal ill-health are the main causes, with cardiovascular risk factors also common. We tested the feasibility of undertaking a definitive randomised controlled trial to assess the effectiveness and cost-effectiveness of a staff health screening clinic (SHSC) in reducing sickness absenteeism and presenteeism.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Individually randomised controlled pilot trial of a SHSC compared with usual care recruiting employees from four English NHS hospitals. Those in the intervention arm were assessed by a nurse using electronic database-driven screening for musculoskeletal, mental and cardiovascular health. Screen positives were given advice and/or referral to services according to UK guidelines. Three co-primary outcomes formed the stop-go criteria: recruitment, referrals, and attendance at referred services. Secondary outcomes included: generalisability, screening results, individual referrals required/attended, health behaviours, acceptability/feasibility of processes, indication of contamination, costs, health-related quality of life, self-reported and employee records of absenteeism. Process evaluation included interviews with participants, intervention delivery staff and service providers. Quantitative analyses used descriptive statistics with framework analysis for qualitative data. Due to the COVID-19 pandemic, follow-up was restricted to 6 months and acceptance of referral during the screening assessment used as proxy for attendance.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Despite recruitment rates during the truncated timeframe indicating potential to reach target, the final proportion recruited of 314 consented/3788 invited (8.3%) was lower than anticipated, and those recruited were not fully representative of the hospital staff population. 236/314 were randomised. Of 118 allocated to the intervention arm, screening identified 57 (48.3%) eligible for referral, with 18 (31.6%) accepting the referral. Process evaluation demonstrated that the electronic database-driven screening intervention and data collection system was efficient, promoting good fidelity. The intervention could benefit from more personalisation, better understanding of local context, longer training, and better integration with referral services.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;We have identified a clinical need and perceived benefit for a SHSC. Delivery was feasible and electronic data capture successful. The three stop-go criteria were red (recruitment), green (referral), and amber (attendance); therefore, the Trial Oversight Committee recommended that a full-scale trial should proceed, but with modifications to adapt to local context and adopt processes to engage better with underserved communities.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;ISRCTN, ISRCTN10237475, registered 09/12/2019, https://www.isrc","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13491788/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148205674","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":"Continuity Therapy for couples living with acquired brain injury: a non-randomised uncontrolled feasibility study.","authors":"Gerard A Riley, Urszula Gajewska, Barbara Hagger, Asweeni Jansdin Raj, Natasha Yasmin, Giles Yeates","doi":"10.1186/s40814-026-01854-2","DOIUrl":"10.1186/s40814-026-01854-2","url":null,"abstract":"<p><strong>Background: </strong>Brain injuries can have a significant negative impact on marriages/partnerships. Available interventions either require specialists trained in relationship therapy (which most rehabilitation services have no access to) or offer more structured manualised approaches that are restricted in scope and have generally led to only small improvements. Continuity Therapy was developed to provide a manualised approach that can be delivered by brain injury clinicians without specialist training in relationship therapy, and that addresses a broader range of relationship issues. Study aims were to complete a preliminary evaluation of the benefits of the therapy to determine whether progression to a randomised controlled trial is justified; to obtain feedback that will be used to refine the therapy; and to evaluate selection criteria and patient-reported outcome measures.</p><p><strong>Methods: </strong>Fifteen couples living with brain injury received the therapy. They completed questionnaires about their relationship and psychological wellbeing before and after the therapy, and at 3-month follow-up, and rated how helpful they found the therapy. They and the therapists were also interviewed (or provided written feedback) about their experience of the therapy. Criteria about progression to an RCT were established in terms of numbers showing statistically reliable improvement on relationship questionnaires, ratings of helpfulness, and non-completion rates.</p><p><strong>Results: </strong>Progression criteria were met. Although not everyone benefitted, participants showed a mean large effect improvement on post-therapy questionnaires about their relationship, and this was sustained at 3 months. They showed a mean moderate effect improvement in their psychological wellbeing, again sustained at 3 months. Couples and therapists made suggestions about improvements to the therapy, the circumstances of couples that may impact the effectiveness of the therapy (relevant to selection criteria), and the suitability of outcome measures.</p><p><strong>Conclusions: </strong>Effect sizes should be treated with caution because of the limitations of the study. Nevertheless, the therapy showed sufficient promise to support progression to an RCT. A broader range of outcome measures is required to capture the benefits of the therapy for the relationship. Refinement of the selection criteria is also needed.</p><p><strong>Trial registration: </strong>The study was registered with ISRCTN: The UK's Clinical Study Registry (registration number-93611293) on 6.6.2023.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13471640/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148205676","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":"Combining self-regulation and poverty reduction to prevent depression and anxiety among adolescents experiencing multi-dimensional poverty in Colombia, Nepal and South Africa: study protocol of a pilot 4-arm cluster randomised controlled trial.","authors":"Mark J D Jordans, Crick Lund, Emily C Garman, Manuel Seifert Bonifaz, Mauricio Avendano, Annette Bauer, María Cecilia Dedios Sanguineti, Georgia Eleftheriou, Sara Evans-Lacko, Sandra García Jaramillo, Juan Felipe García, Kamal Gautam, Martin Gevonden, Roxanne Jacobs, Brandon A Kohrt, Lydia Krabbendam, Nagendra P Luitel, Nicci van der Merwe, Juan Jose Castellanos Piedrahita, Rakesh Singh, Mohammadamin Sinichi, Daniela Trujillo, Katherine Sorsdahl, Sanchari Roy, Wietse A Tol, Daniela Rojas, Paula Yarrow","doi":"10.1186/s40814-026-01858-y","DOIUrl":"10.1186/s40814-026-01858-y","url":null,"abstract":"<p><strong>Background: </strong>Poverty is associated with depression and anxiety among adolescents, but evidence of interventions that prevent adolescent depression and anxiety among adolescents living in poverty is weak. Interventions either focus on reducing poverty or addressing depression and anxiety, but an approach that combines both may offer larger benefit. This multi-site parallel pilot cluster randomised controlled trial (cRCT) evaluates the feasibility and acceptability of a selective preventive intervention for depression and anxiety that simultaneously intervenes on both poverty and self-regulation among adolescents living in urban poverty.</p><p><strong>Methods: </strong>The study takes place in Bogotá (Colombia), Kathmandu (Nepal) and Cape Town (South Africa). The pilot cRCT has four arms: (i) self-regulation intervention, (ii) economic intervention, (iii) combined (self-regulation + economic) intervention, and (iv) control group (care as usual). Interventions consist of 20 weekly group sessions with adolescents, and 6 monthly group sessions with their caregivers. The self-regulation intervention for adolescents includes psychological activities (mindfulness breathing, problem solving, biofeedback and goal setting) and a physical activity. The economic intervention includes three dimensions (financial training, negotiation training, education information) and a monthly cash transfer. In each site, the aim was to recruit 240 adolescents and their caregivers across eight schools (clusters), with two schools randomised to each arm. Adolescents residing in areas at risk of multidimensional poverty and who had symptoms of depression or anxiety, but who did not meet thresholds indicating depression and anxiety disorders, were considered for enrolment. Recruitment into the study is complete: a total of 628 adolescents and 536 caregivers were enrolled. Participants will be assessed four times: at enrolment, post-intervention and at 12 and 18 months post-enrolment. Primary outcomes include feasibility and acceptability criteria for study and intervention delivery procedures (i.e. randomisation, masking, recruitment, retention, missingness, fidelity, attendance, adverse events) defined as traffic light criteria to assess progression to an adequately powered trial. Secondary outcomes include self-report instruments, physiological measures and neuropsychological tasks.</p><p><strong>Discussion: </strong>The effectiveness of combining self-regulation and anti-poverty interventions remains untested. This study will establish the feasibility and acceptability of delivering such an intervention, as well as test the trial procedures to inform a future adequately powered trial.</p><p><strong>Trial registration: </strong>ISRCTN 14601588. Retrospectively registered. Date: 19 May 2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13465900/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148199715","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}