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Background: Law enforcement frequently responds to substance abuse and mental health crises. Crisis stabilization units (CSUs) operate as a public-receiving facility to provide short-term stabilization services for individuals experiencing these crises and offer law enforcement an important alternative to arrest. However, there is limited understanding about how and when law enforcement decides to use CSUs. There is also the challenge of retaining individuals in treatment after CSU stabilization to prevent future crises and persistent engagement with police. This study will respond to these gaps by exploring CSU procedures and examining the feasibility and acceptability of a technology-assisted mobile aftercare intervention designed for individuals brought to a CSU by law enforcement. Methods: This study will consist of three aims. Aim 1 will include qualitative interviews with law enforcement and CSU-affiliated mental health staff (n=80) regarding CSU utilization and collaboration logistics between the groups. Findings from Aim 1 will be synthesized for the development of an implementation guide of our intervention, mobile, and technology-assisted aftercare, designed for individuals brought to a CSU by law enforcement, during Aim 2. During Aim 2, intervention services will be pilot-tested for 6 months through a small sample (n=24), randomized control trial (RCT). Control participants will receive standard services available for individuals discharging from a CSU. Treatment participants will receive the mobile aftercare intervention. Qualitative and quantitative data will be collected at 2 weeks, 3 months, and 6 months post-recruitment for all study participants. Aims 1 and 2 will inform the design of a multi-site RCT to compare CSUs with and without mobile and technology-assisted aftercare (Aim 3). Discussion: The study will offer decision making and procedural insight into law enforcement use of CSUs as an alternative to jail and provide opportunities to inform that process. This research will provide outcome trends for those who go through standard CSU services compared to those who receive mobile and technology-assisted aftercare services. The current study will inform a larger RCT efficacy study of CSUs with and without technology-assisted aftercare services. Trial registration: This study was registered on ClinicalTrials.gov (reference #NCT04899934) on May 25, 2021. [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]

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]

In 2016, we published a conceptual framework outlining the conclusions of our work in defining pilot and feasibility studies. Since then, the CONSORT extension to randomised pilot and feasibility trials has been published and there have been further developments in the pilot study landscape. In this paper, we revisit and extend our framework to incorporate the various feasibility pathways open to researchers, which include internal pilot studies. We consider, with examples, when different approaches to feasibility and pilot studies are more effective and efficient, taking into account the pragmatic decisions that may need to be made. The ethical issues involved in pilot studies are discussed. We end with a consideration of the funders' perspective in making difficult resource decisions to include feasibility work and the policy implications of these; throughout, we provide examples of the uncertainties and compromises that researchers have to navigate to make progress in the most efficient way. [ABSTRACT FROM AUTHOR]

Background: Research consistently reports elevated rates of exposure to traumatic events and post-traumatic stress disorder (PTSD) in people with severe mental illness (SMI). PTSD may be adequately managed with psychotherapy; however, there is a gap when it comes to management in culturally diverse settings like Botswana. This paper describes a study protocol whose aim is to culturally adapt the BREATHE intervention, a brief psychological intervention for people living with comorbid PTSD and SMI that was developed and tested in the USA; assess the feasibility and acceptability of the adapted BREATHE intervention and explore its efficacy. Methods: The study will be conducted in three phases using a mixed methods approach. The first phase will identify and describe the most common traumatic experiences and responses to traumatic experiences, amongst patients with SMI, and patients' and mental health care providers' perceptions about suitable PTSD interventions for Botswana. The second phase will entail cultural adaption of the intervention using findings from phase 1, and the third phase will be a pilot trial to assess the feasibility and acceptability of the culturally adapted intervention and explore its efficacy. Quantitative and qualitative data will be analysed using basic descriptive statistics and thematic analysis, respectively. Discussion: Literature highlights cultural variations in the expression and management of mental illness suggesting the need for culturally adapted interventions. The findings of this feasibility study will be used to inform the design of a larger trial to assess the efficacy of an adapted brief intervention for PTSD in patients with SMI in Botswana. Trial registration: Clinicaltrials.gov registration: NCT04426448. Date of registration: June 7, 2020. [ABSTRACT FROM AUTHOR]

Background: Dizziness is a common complaint that often persists and leads to disability and distress. Several cognitive and behavioural responses may contribute to the neurobiological adaptations that maintain persistent vestibular symptoms. This paper will present the protocol of a two-arm parallel group feasibility randomised controlled trial designed to determine whether a fully powered efficacy trial is achievable by examining the feasibility of recruitment, acceptability and potential benefits of an integrated cognitive behavioural therapy and vestibular rehabilitation (CBT-VR) treatment for people with persistent dizziness. Methods: Forty adult patients will be recruited from a tertiary vestibular clinic with persistent movement–triggered dizziness for 3 months or longer who have moderate–high levels of dizziness handicap. Participants will be 1:1 randomised, using a minimisation procedure, to six sessions of either CBT-VR (intervention arm) or VR only (control arm). Measures will be collected at baseline and 4 months post randomisation. The primary feasibility outcomes include descriptive data on numbers meeting eligibility criteria, rates of recruitment, numbers retained post randomisation, treatment adherence and an acceptability questionnaire. Treatment effects on self-report outcomes will be estimated to determine that 95% confidence intervals for the effects are consistent with anticipated effects and minimum clinically important differences, and to provide information needed for the power calculation of an efficacy trial. A nested qualitative study will be conducted post-intervention (intervention group only) to explore the acceptability of the intervention and identify any areas in need of improvement. Discussion: If a trial of CBT-VR is feasible, acceptability data will be used to enhance the intervention if needed and refine the multicentre RCT protocol. Future studies will need to consider the training required for other physiotherapists to deliver the intervention. Trial registration: ClinicalTrials.gov, ISRCTN 10420559 [ABSTRACT FROM AUTHOR]

Background: Displaced victims of interpersonal violence, such as refugees, asylum seekers, and victims of sexual exploitation, are growing in numbers and are often suffering from a post-traumatic stress disorder (PTSD). At the same time, these victims are known to benefit less from trauma-focused therapy (TFT) and to be less compliant to treatment. The objective of this paper is to describe the rationale and research protocol of an ongoing trial that aims to evaluate different variables that might influence the feasibility of TFT for the study population. Specifically, perceived daily stress, emotion regulation, and mood are investigated as predictors of change in PTSD symptoms during a trauma-focused therapy (narrative exposure therapy (NET)). The feasibility of administering measures tapping these constructs repeatedly during treatment will also be evaluated. Methods/design: Using an observational treatment design, 80 displaced victims of interpersonal violence will be measured before, during, and after partaking in NET. Several questionnaires tapping PTSD plus the aforementioned possible predictors of PTSD change will be administered: Post-traumatic Stress Disorder Checklist-5, Perceived Stress Scale, Difficulties in Emotion Regulation Scale-18 (pre-test, post-test, and follow-up),subscale impulsivity of the Difficulties in Emotion Regulation Scale-18, Perceived Stress Scale short version, Primary Care Post-traumatic Stress Disorder and a single Mood item (each session). Multilevel modelling will be used to examine the relation between the possible predictors and treatment outcome. Discussion: The present study is the first to examine the interplay of facilitating and interfering factors possibly impacting treatment feasibility and effectiveness in displaced victims of interpersonal violence with PTSD receiving NET, using repeated measures. The current study can help to improve future treatment based on individual characteristics. Trial registration: Netherlands Trial Register: NTR7353, retrospectively registered. Date of registration: July 11, 2018. [ABSTRACT FROM AUTHOR]

Background: Untreated heterozygous familial hypercholesterolaemia (FH) causes high low-density lipoprotein cholesterol (LDL-C) levels and increased cardiovascular disease (CVD) risk. Despite pharmacological treatment, many treated individuals remain at higher CVD risk than non-affected individuals. This may be due to LDL-C targets not being met and presence of other CVD risk factors. Adhering to dietary and physical activity (PA) recommendations developed for individuals with FH may further reduce CVD risk. However, there is insufficient research to support the efficacy of adhering to these guidelines on LDL-C and other CVD risk factors. The need for studies to investigate the effectiveness of nutrition and PA interventions in the FH population has been widely recognised and recommended. This paper describes the protocol of a pilot, randomised controlled trial designed to evaluate the feasibility and acceptability of a specifically developed nutrition and PA intervention aimed at improving the dietary intakes and PA levels of families with FH. Methods: A two-arm randomised waitlist-controlled pilot trial will be conducted across three National Health Service (NHS) sites in England, UK. Twenty-four young people with FH, aged 10–18 years, and their affected parent, will be recruited and randomly assigned to the intervention or waitlist and usual care control. The primary aim is to provide evidence for the feasibility and acceptability of delivering the intervention, explored quantitatively (rates of recruitment, retention and outcome measure completeness) and qualitatively (qualitative interviews). The secondary aim is to provide evidence for the potential efficacy of the intervention on dietary intake, PA, sedentary time, body composition, CVD risk factors and quality of life determined at baseline and endpoint assessments. The intervention will involve an hour-long consultation with a dietitian at baseline and four follow-up contacts across the 12-week intervention. It has been specifically developed for use with individuals with FH and incorporates behavioural change techniques to target identified enablers and barriers to adherence in this population. Discussion: This trial will estimate the feasibility and acceptability of the nutrition and PA intervention delivered to young people and parents with FH. If appropriate, this study can be used to inform the design of an adequately powered definitive trial. Trial registration: ISRCTN, ISRCTN24880714. Registered 07/06/2018, http://www.isrctn.com/ISRCTN24880714. [ABSTRACT FROM AUTHOR]

Background: The portability and multiple functionalities of mobile devices make them well suited for collecting field data for naturalistic research, which is often beset with complexities in recruitment and logistics. This paper describes the implementation of a research protocol using mobile devices to study nurses' exchanges of patient information at change of shift. Methods: Nurses from three medical and surgical units of an acute care teaching hospital in Montreal, Canada, were invited to participate. On 10 selected days, participants were asked to record their handoffs using mobile devices and to complete paper questionnaires regarding these exchanges. Nurse acceptance of mobile devices was assessed using a 30-item technology acceptance questionnaire and focus group interviews. The principal feasibility indicator was whether or not 80 complete handoffs could be collected on each unit. Results: From October to December 2017, 63 of 108 eligible nurses completed the study. Results suggest that the use of mobile devices was acceptable to nurses, who felt that the devices were easy to use but did not improve their job performance. The principal feasibility criterion was met, with complete data collected for 176, 84, and 170 of the eligible handoffs on each unit (81% of eligible handoffs). The research protocol was acceptable to nurses, who felt the study's demands did not interfere with their clinical work. Conclusions: The research protocol involving mobile devices was feasible and acceptable to nurses. Nurses felt the research protocol, including the use of mobile devices, required minimal investment of time and effort. This suggests that their decision to participate in research involving mobile devices was based on their perception that the study protocol and the use of the device would not be demanding. Further work is needed to determine if studies involving more sophisticated and possibly more demanding technology would be equally feasible and acceptable to nurses. [ABSTRACT FROM AUTHOR]

Background: Displaced victims of interpersonal violence, such as refugees, asylum seekers, and victims of sexual exploitation, are growing in numbers and are often suffering from a post-traumatic stress disorder (PTSD). At the same time, these victims are known to benefit less from trauma-focused therapy (TFT) and to be less compliant to treatment. The objective of this paper is to describe the rationale and research protocol of an ongoing trial that aims to evaluate different variables that might influence the feasibility of TFT for the study population. Specifically, perceived daily stress, emotion regulation, and mood are investigated as predictors of change in PTSD symptoms during a trauma-focused therapy (narrative exposure therapy (NET)). The feasibility of administering measures tapping these constructs repeatedly during treatment will also be evaluated. Methods/design: Using an observational treatment design, 80 displaced victims of interpersonal violence will be measured before, during, and after partaking in NET. Several questionnaires tapping PTSD plus the aforementioned possible predictors of PTSD change will be administered: Post-traumatic Stress Disorder Checklist-5, Perceived Stress Scale, Difficulties in Emotion Regulation Scale-18 (pre-test, post-test, and follow-up),subscale impulsivity of the Difficulties in Emotion Regulation Scale-18, Perceived Stress Scale short version, Primary Care Post-traumatic Stress Disorder and a single Mood item (each session). Multilevel modelling will be used to examine the relation between the possible predictors and treatment outcome. Discussion: The present study is the first to examine the interplay of facilitating and interfering factors possibly impacting treatment feasibility and effectiveness in displaced victims of interpersonal violence with PTSD receiving NET, using repeated measures. The current study can help to improve future treatment based on individual characteristics. Trial registration: Netherlands Trial Register: NTR7353, retrospectively registered. Date of registration: July 11, 2018. [ABSTRACT FROM AUTHOR]

Background: Displaced victims of interpersonal violence, such as refugees, asylum seekers, and victims of sexual exploitation, are growing in numbers and are often suffering from a post-traumatic stress disorder (PTSD). At the same time, these victims are known to benefit less from trauma-focused therapy (TFT) and to be less compliant to treatment. The objective of this paper is to describe the rationale and research protocol of an ongoing trial that aims to evaluate different variables that might influence the feasibility of TFT for the study population. Specifically, perceived daily stress, emotion regulation, and mood are investigated as predictors of change in PTSD symptoms during a trauma-focused therapy (narrative exposure therapy (NET)). The feasibility of administering measures tapping these constructs repeatedly during treatment will also be evaluated. Methods/design: Using an observational treatment design, 80 displaced victims of interpersonal violence will be measured before, during, and after partaking in NET. Several questionnaires tapping PTSD plus the aforementioned possible predictors of PTSD change will be administered: Post-traumatic Stress Disorder Checklist-5, Perceived Stress Scale, Difficulties in Emotion Regulation Scale-18 (pre-test, post-test, and follow-up),subscale impulsivity of the Difficulties in Emotion Regulation Scale-18, Perceived Stress Scale short version, Primary Care Post-traumatic Stress Disorder and a single Mood item (each session). Multilevel modelling will be used to examine the relation between the possible predictors and treatment outcome. Discussion: The present study is the first to examine the interplay of facilitating and interfering factors possibly impacting treatment feasibility and effectiveness in displaced victims of interpersonal violence with PTSD receiving NET, using repeated measures. The current study can help to improve future treatment based on individual characteristics. Trial registration: Netherlands Trial Register: NTR7353, retrospectively registered. Date of registration: July 11, 2018. [ABSTRACT FROM AUTHOR]

Background: Living with type 1 diabetes (T1D) is demanding, and emotional problems may impair ability for diabetes self-management. Thus, diabetes guidelines recommend regular assessment of such problems. Using patient-reported outcome measures (PROMs) to assess diabetes-related distress and psychological well-being is considered useful. It has been proposed that future work should examine the use of PROMs to support the care of individual patients and improve the quality of health services. To our knowledge, the use of PROMs has not been systematically evaluated in diabetes care services in Norway. Electronically captured PROMs can be directly incorporated into electronic patient records. Thus, the study's overall aim was to examine the feasibility and acceptability of capturing PROMs electronically on a touchscreen computer in clinical diabetes practice. Methods: Adults with T1D age ≥ 40 years completed PROMs on a touchscreen computer at Haukeland University Hospital's diabetes outpatient clinic. We included 46 items related to diabetes-related distress, self-perceived diabetes competence, awareness of hypoglycaemia, occurrence of hyperglycaemia, hypoglycaemia and fluctuating glucose levels, routines for glucose monitoring, general well-being and health-related quality of life. Participants subsequently completed a paper-based questionnaire regarding comprehension and relevance of the PROMs, acceptance of the number of items and willingness to complete electronic PROMs annually. We wrote field notes in the outpatient clinic based on observations and comments from the invited participants. Results: During spring 2017, 69 participants (50.7% men), age 40 to 74 years, were recruited. Generally, the touchscreen computer functioned well technically. Median time spent completing the PROMs was 8 min 19 s. Twenty-nine (42.0%) participants completed the PROMs without missing items, with an 81.4% average instrument completion rate. Participants reported that the PROMs were comprehensible (n = 62) and relevant (n = 46) to a large or very large degree, with an acceptable number of items (n = 51). Moreover, 54 were willing to complete PROMs annually. Participants commented that the focus on living with diabetes was valued. Conclusions: Capturing PROMs on a touchscreen computer in an outpatient clinic was technically and practically feasible. The participants found the PROMs to be relevant and acceptable with a manageable number of items, and reported willingness to complete PROMs annually. [ABSTRACT FROM AUTHOR]

Background: Clinical trials of physical activity and rehabilitation interventions can be challenging. Pilot or feasibility studies can be conducted prior to a definitive randomized controlled trial (RCT), to improve the chances of conducting a high-quality RCT of a physical activity intervention. Main body: Physical activity interventions or trials present unique challenges at the population, intervention, comparator and outcome levels. At each level, we present guidance for researchers on the design considerations for pilot or feasibility studies of physical activity interventions. When it comes to defining study population, physical activity trials often exclude participants with certain health conditions or other characteristics (e.g., age, gender) because of uncertainty of the safety of the exercise intervention or presumed differences in responsiveness, at the expense of trial generalizability. A pilot trial could help investigators determine refined inclusion and exclusion criteria to balance safety, adequate recruitment, and generalizability. At the intervention level, because exercise can be a complex intervention, pilot trials allow investigators to evaluate participant adherence and instructor fidelity to the intervention and participant experience. At the comparator level, control group dissatisfaction and post-randomization drop-out can occur, because of the desire to be randomized to the exercise group, and the difficulty with blinding to group allocation; an active control or deception could be used. Finally, at the outcome level, there should be an emphasis on the pilot or feasibility outcomes such as recruitment rate, adherence to exercise, and retention or fidelity, than the efficacy of the exercise intervention. Conclusion: Physical activity and rehabilitation researchers can use pilot and feasibility studies to enhance the rigor of future trials, while also publishing the results of their pilot work to move the field forward. Researchers in this field are encouraged to use published reporting guidelines for pilot and feasibility studies and to consider the challenges discussed in this paper. [ABSTRACT FROM AUTHOR]