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Background: Women experiencing pregnancy after stillbirth experience high levels of anxiety, fear and depression. Standard antenatal care may be emotionally unsuitable for many women at this time, and there is a lack of evidence on what interventions or approaches to care might benefit these women. Therapeutic massage may assist women after stillbirth by decreasing anxiety, worry and stress. Objective: This paper outlines the objectives, methodology, outcome and assessment measures for the Helping suppOrt individuals Pregnant after Experiencing a Stillbirth (HOPES) feasibility trial which evaluates massage as an adjunct approach to care for pregnant women who have experienced a prior stillbirth. It also outlines data collection timing and considerations for analysing the data. Methods: HOPES will use a convergent parallel mixed-methods, single-arm repeated measures trial design in trained massage therapists' private clinics across Australia. HOPES aims to recruit 75 individuals pregnant after a previous stillbirth. The intervention is massage therapy treatments, and participants will receive up to five massages within a 4-month period at intervals of their choosing. Primary quantitative outcomes are the feasibility and acceptability of the massage intervention. Secondary outcomes include determining the optimal timing of massage therapy delivery and the collection of measures for anxiety, worry, stress and self-management. A thematic analysis of women's experiences undertaking the intervention will also be conducted. A narrative and joint display approach to integrate mixed-methods data is planned. Discussion: The HOPES study will determine the feasibility and preliminary evidence for massage therapy as an intervention to support women who are pregnant after a stillbirth. Trial registration. ClinicalTrials.gov NCT05636553. Registered on December 3, 2022, and the trial is ongoing. [ABSTRACT FROM AUTHOR]

Background: Although internet-based stress management programs are proven effective in improving mental health among workers, micro- and small-sized enterprises (MSEs), lacking in occupational healthcare services, face challenges implementing them. To address this gap, this study will develop the program with stakeholders at MSEs to aim for real-world implementation. Objectives: This paper describes a study protocol for a pre-post feasibility study of an effectiveness-implementation hybrid type 2 trial of text-based internet-based programs ("WellBe-LINE") in MSEs with less than 50 employees. This feasibility study primarily aims to evaluate trial methods for future effectiveness-implementation hybrid type 2 trials. Methods: For this study protocol, an internet- and text-based self-care intervention program using the LINE app (a popular message tool in Japan) will be prepared according to evidence-based psychoeducational topics. Based on our online survey findings, personalized algorithms will be implemented according to employees' gender, age, and psychological distress levels. A personalized program using a popular pre-existing text app is expected to reduce employees' burdens and be attractive to them, resulting in successful implementation outcomes and mental health benefits. A pre-post design feasibility study will be conducted on ten companies to evaluate trial methods (e.g., recruitment and procedures). The primary outcome will involve individual-level penetration, defined as the proportion of the number of employees who register for the program divided by the total number of invited employees at the company. The progression criterion to go next trial specifies that more than 50% of the recruited companies obtain 60% individual penetration, which is set based on the findings of the prior survey of employees at MSEs and of interviews of stakeholders involved in this study, and will be measured by LINE system. Finally, acceptability, appropriateness, and feasibility will be measured using internet-based questionnaires and interviews. Discussion: This pre-post feasibility study for future effectiveness-implementation hybrid type 2 trials will provide in-depth knowledge about the successful implementation of text-based, semi-personalized, self-care mental health interventions in real-world settings using both quantitative and qualitative data. Conclusions: This feasibility study will help validate the effectiveness of text-based interventions using a widely used social networking service (SNS) tool for employees in MSEs. Trial registration: UMIN clinical trial registration, UMIN000046960. Registered on February 21, 2022. https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000053570 [ABSTRACT FROM AUTHOR]

Background: Pregnancy weight management interventions can improve maternal diet, physical activity, gestational weight gain, and postnatal weight retention. UK guidelines were published in 2010 but health professionals report multiple complex barriers to practice. GLOWING used social cognitive theory to address evidence-based barriers to midwives' implementation of weight management guidelines into routine practice. This paper reports the pilot trial outcomes relating to feasibility and acceptability of intervention delivery and trial procedures. Methods: GLOWING was a multi-centre parallel-group pilot cluster RCT comparing the delivery of a behaviour change intervention for midwives (delivered as training workshops) with usual practice. The clusters were four NHS Trusts in Northeast England, randomised to intervention or control arms. Blinding of allocation was not possible due to the nature of the intervention. We aimed to deliver the intervention to all eligible midwives in the intervention arm, in groups of 6 midwives per workshop, and to pilot questionnaire data collection for a future definitive trial. Intervention arm midwives' acceptability of GLOWING content and delivery was assessed using a mixed methods questionnaire, and pregnant women's acceptability of trial procedures by interviews. Quantitative data were analysed descriptively and qualitative data thematically. Results: In intervention arm Trusts, 100% of eligible midwives (n = 67) were recruited to, and received, the intervention; however, not all workshops had the planned number of attendees (range 3–8). The consent rate amongst midwives randomised (n = 100) to complete questionnaires was 74% (n = 74) (95% CI 65%, 83%), and overall completion rate 89% (n = 66) (95% CI 82%, 96%). Follow-up response rate was 66% (n = 49) (95% CI 55%, 77%), with a marked difference between intervention (39%, n = 15) and control (94%, n = 34) groups potentially due to the volume of research activities. Overall, 64% (n = 47) (95% CI 53%, 75%) completed both baseline and follow-up questionnaires. Midwives viewed the intervention as acceptable and directly relevant to routine practice. The least popular components related to scripted role-plays. Pregnant women viewed the recruitment and trial processes to be acceptable. Conclusions: This rigorously conducted pilot study demonstrated feasibility intervention delivery and a high level of acceptability amongst participants. It has provided information required to refine the intervention and trial protocol, enhancing confidence that a definitive trial could be carried out. Trial registration: ISRCTN46869894; retrospectively registered 25th May 2016, www.isrctn.com/ISRCTN46869894. [ABSTRACT FROM AUTHOR]

Background: Various service provision models for youth at risk of homelessness have been researched and implemented, including access to housing and physical and mental health resources. However, even with these interventions, we remain unaware of how best to manage symptoms of depression and anxiety and the rate of drug use in these populations primarily because of a lack of feasibility data. Methods: This paper presents the results of a mixed-methods study in London, Canada, that examined the feasibility of implementing a biopsychosocial intervention, SKY Schools, in at-risk youth aged between 16 and 25 (n = 49). The study also recorded qualitative responses about the program's usefulness from the perspective of the service users. The SKY Schools intervention consisted of social-emotional learning combined with Sudarshan Kriya Yoga, a standardized yoga-based breathing exercise routine. The intervention program was divided into two phases: an active learning phase and a reinforcement phase. The following feasibility outcome measures were collected: (1) the number of potential participants approached per month, (2) number (proportion) who were successfully screened, (3) the proportion of screened participants who enrolled, (4) the rate of retention in the study, (5) rate of adherence to study protocol, (6) proportion of planned ratings that were completed, (7) intervention cost per case, (8) completeness of final data for analysis, (9) length of time to collect all data, (10) quality of all collected data, (11) determining if partnering community organizations were willing to conduct the study as per study protocol, (12) determining if there were any capacity issues with partners providing intervention and investigators being able to perform the tasks that they were committed to doing, (13) determining if there were any problems of entering the data into a computer, (14) preliminary data about the safety of the intervention, and (15) preliminary estimate of treatment effects. Results: All feasibility outcome measures were collectible. In the city of London, Canada it was feasible to conduct a pilot study in this population of youth at risk of homelessness. Foremost among the findings was a high retention rate (61.2%) and overall positive qualitative feedback with a number of potential suggestions to improve the delivery and quality of the intervention. However, we had a significantly low recruitment rate (0.27 participants per week) suggesting that multiple sites will be needed to achieve an adequate sample size for a subsequent definitive trial. Conclusions: Future researchers may consider the findings of this feasibility study when designing a randomized control trial to further assess the efficacy and tolerability of SKY Schools. Trial registration: Trial registration: Clinicaltrials.gov, identifier NCT02749240. Registered April 22, 2016, https://clinicaltrials.gov/ct2/show/NCT02749240. [ABSTRACT FROM AUTHOR]

Background: Evaluating the effectiveness of early years parenting interventions provides evidence to improve the development and wellbeing of children. This protocol paper describes a study to explore the feasibility of evaluating the Incredible Years Toddler early life intervention programme, which is offered to parents of 1–3-year-olds via the Better Start Bradford programme. The study aims to use a Trial within a Cohort Study (TwiCS) design that randomly selects individuals participating in a cohort to be offered an intervention. The TwiCS information and consent process is person-centred and aims to replicate real-world practice whereby only those who are offered the intervention are given information about the intervention. The cohort is the Born in Bradford's Better Start (BiBBS) cohort, an interventional birth cohort recruiting expectant parents in three areas of Bradford, UK. The study will assess the feasibility of TwiCS procedures, staged consent, and intervention take-up. Methods: We will conduct a feasibility TwiCS to test study procedures. We aim to establish the following: (1) whether TwiCS methodology can be implemented to create control and intervention arms, whilst documenting any incidences of contamination within the cohort; (2) whether satisfactory rates of intervention uptake are achieved among participants allocated to the intervention; and (3) whether satisfactory rates of retention of participants in the intervention can be achieved. A Red Amber Green (RAG) rating system has been applied to support the feasibility assessment of each objective: to be rated red (not achieved), amber (partly achieved), and green (achieved). Eligible participants in the BiBBS cohort will be individually randomised 1:1 to the intervention or control arms, with stratification by child age (1 or 2 years old at the time of randomisation) and ethnicity (White British, South Asian, or other). BiBBS researchers will seek consent from participants randomised to the intervention to pass their contact details onto Incredible Years' delivery agents. Discussion: This feasibility study will inform the utility of the TwiCs approach within an experimental birth cohort to evaluate interventions for infants, toddlers, and their families. Trial registration: The study was prospectively registered on ISRCTN (ISRCTN16150114). [ABSTRACT FROM AUTHOR]

Background: The rising prevalence of adolescent mild depression in the UK and the paucity of evidence-based interventions in non-specialist sectors where most cases present, creates an urgent need for early psychological interventions. Randomised controlled trials (RCTs) are considered the gold standard for obtaining unbiased estimates of intervention effectiveness. However, the complexity of mental health settings poses great challenges for effectiveness evaluations. This paper reports learning from an embedded process evaluation of the ICALM RCT which tested the feasibility of delivering Interpersonal Counselling for Adolescents (IPC-A) plus Treatment as Usual (TAU) versus TAU only for adolescent (age 12–18) mild depression by non-qualified mental health professionals in non-specialist sectors. Methods: A qualitative mixed methods process evaluation, drawing on Bronfenbrenner's socioecological model to investigate key influences on trial delivery across macro-(e.g. policy), meso-(e.g. service characteristics) and micro-(e.g. on-site trial processes) contextual levels. Data collection methods included 9 site questionnaires, 4 observations of team meetings, policy documents, and 18 interviews with stakeholders including therapists, heads of service and managers. Thematic analysis focused on understanding how contextual features shaped trial implementation. Results: The ICALM trial concluded in 2022 having only randomised 14 out of the target 60 young people. At a macro-level, trial delivery was impacted by the COVID-19 pandemic, with services reporting a sharp increase in cases of (social) anxiety over low mood, and backlogs at central referral points which prolonged waiting times for mild cases (e.g. low mood). An interaction between high demand and lack of capacity at a meso-service level led to low prioritisation of trial activities at a micro-level. Unfamiliarity with research processes (e.g. randomisation) and variation in TAU support also accentuated the complexities of conducting an RCT in this setting. Conclusions: Conducting a RCT of IPC-A in non-specialist services is not feasible in the current context. Failure to conduct effectiveness trials in this setting has clinical implications, potentially resulting in escalation of mild mental health problems. Research done in this setting should adopt pragmatic and innovative recruitment and engagement approaches (e.g. creating new referral pathways) and consider alternative trial designs, e.g. cluster, stepped-wedge or non-controlled studies using complex systems approaches to embrace contextual complexity. Trial registration: ISRCTN registry, ISRCTN82180413. Registered on 31 December 2019. [ABSTRACT FROM AUTHOR]

Introduction: Nutrition-related factors linked to pain chronicity and disability include weight status and dietary behaviours. Dietary patterns associated with concurrent pain episodes, however, remain poorly characterised. This paper outlines the protocol for a feasibility study that aims to characterise pain-related dietary and lifestyle behaviours in people experiencing chronic musculoskeletal pain. Methods: The study will recruit participants who experience musculoskeletal pain on 5 or more days of the week for at least 3 months. Participants will attend two in-person clinic visits where physical measurements and a series of pain and lifestyle questionnaires will be completed. Visits will be conducted pre and post a 2-week self-monitoring period where participants will self-report concurrent diet, sleep, mood, and pain on four days and will wear a wrist-worn activity monitor (GENEActiv). Key feasibility metrics will evaluate participant recruitment, enrolment and retention rates, and compliance with the study data collection protocol. Discussion: There remains a lack of evidence behind dietary advice as an adjunct pain management tool. Upon completion of the protocol, feasibility outcomes will identify challenges to guide the design and delivery of a dietary intervention for chronic musculoskeletal pain. [ABSTRACT FROM AUTHOR]

Background: Pediatric brain tumor survivors (PBTS) are at risk of physical, cognitive, and psychosocial challenges related to their diagnosis and treatment. Routine follow-up care as adults is therefore essential to their long-term health and quality of life. In order to successfully navigate to adult healthcare, it is recommended that youth develop transition readiness skills. Existing transition readiness interventions often focus on disease management. However, PBTS are also at risk of social competence and cognitive functioning challenges. In this paper, we describe the protocol of this pilot study and the methodology that will be used for the evaluation of the feasibility, acceptability, and preliminary efficacy testing of the first targeted transition intervention workshops specifically designed to meet the needs of PBTS and their caregivers. Methods: This study will use a mixed method to evaluate three 1 ½-h workshops targeted for dyads (N = 40) of PBTS (14 years or older) and their parents. Dyads will be recruited via a community pediatric cancer organization and the long-term follow-up clinic of a large pediatric hospital. Participants will complete an online survey which includes the Transition Readiness Assessment Questionnaire (TRAQ) before and after the workshops. Each workshop will cover a specific topic related to PBTS transition readiness: disease management, social competence, and cognitive functioning. Workshops will follow the same structure: topic presentation, discussion by a post-transfer survivor or parent, teaching two strategies, and workshop evaluation. Workshops will be co-led by healthcare specialists and patient partners. Feasibility and acceptability will be assessed via recruitment, attendance, retention, and Likert scales, and they will be analyzed by describing and comparing rates. Satisfaction will be measured using satisfaction surveys and audio-recorded focus groups. Qualitative data will be described through thematic content analysis. In order to test the preliminary efficacy of this study, we will compare transition readiness skills pre- and post-workshops using paired samples T test and ANCOVA to examine the impact of workshop on TRAQ skills. Discussion: Results of the study will inform refinement and future broader implementation of targeted transition readiness workshops for the specific needs of pediatric brain tumor survivors. [ABSTRACT FROM AUTHOR]