Mixed-methods randomised study exploring the feasibility and acceptability of eye-movement desensitisation and reprocessing for improving the mental health of traumatised survivors of intensive care following hospital discharge: protocol.

INTRODUCTION: Post-traumatic symptoms are common among patients discharged from intensive care units (ICUs), adversely affecting well-being, increasing healthcare utilisation and delaying return to work. Non-pharmacological approaches (eg, music, therapeutic touch and patient diaries) have been suggested as candidate interventions and trauma-focused psychological interventions have been endorsed by international bodies. Neither category of intervention is supported by definitive evidence of long-term clinical effectiveness in patients who have been critically ill. This study assesses the feasibility and acceptability of using eye-movement desensitisation and reprocessing (EMDR) to improve the mental health of ICU survivors. METHODS AND ANALYSIS: EMERALD is a multicentre, two-part consent, pilot feasibility study, recruiting discharged ICU survivors from three hospitals in the UK. We are gathering demographics and measuring post-traumatic symptoms, anxiety, depression and quality of life at baseline. Two months after discharge, participants are screened for symptoms of post-traumatic stress disorder (PTSD) using the Impact of Events Scale-Revised (IES-R). Patients with IES-R scores<22 continue in an observation arm for 12 month follow-up. IES-R scores≥22 indicate above-threshold PTSD symptoms and trigger invitation to consent for part B: a randomised controlled trial (RCT) of EMDR versus usual care, with 1:1 randomisation. The study assesses feasibility (recruitment, retention and intervention fidelity) and acceptability (through semistructured interviews), using a theoretical acceptability framework. Clinical outcomes (PTSD, anxiety, depression and quality of life) are collected at baseline, 2 and 12 months, informing power calculations for a definitive RCT, with quantitative and qualitative data convergence guiding RCT refinements. ETHICS AND DISSEMINATION: This study has undergone external expert peer review and is funded by the National Institute for Health and Care Research (grant number: NIHR302160). Ethical approval has been granted by South Central-Hampshire A Research Ethics Committee (IRAS number: 317291). Results will be disseminated through the lay media, social media, peer-reviewed publication and conference presentation. TRIAL REGISTRATION NUMBER: NCT05591625.

Patient experiences of the Long COVID-Optimal Health Programme: a qualitative interview study in community settings.

BACKGROUND: Long COVID (LC) symptoms persist 12 weeks or more beyond the acute infection. To date, no standardised diagnostic or treatment pathways exist. However, a holistic approach has been recommended. This study explored participants' experiences of a Long COVID-Optimal Health Programme (LC-OHP); a psychoeducational self-efficacy programme. AIM: To explore perceptions and experiences of people with LC regarding the LC-OHP and identify suggestions to further improve the programme. DESIGN & SETTING: Qualitative study with patients with LC recruited through community settings. METHOD: This study is part of a wider randomised controlled trial. Eligible participants were aged ≥18 years, have LC, and attended a minimum of five LC-OHP sessions plus a booster session. We interviewed those randomised to the intervention group. Interviews were conducted by an independent researcher and thematically analysed to identify common, emerging themes. RESULTS: Eleven participants were interviewed, mostly women from a White British ethnic group (n = 10). Four main themes were identified, reflecting programme benefits and suggestions for improvement. The programme demonstrated potential for assisting patients in managing their LC, including physical health and mental wellbeing. Participants found the programme to be flexible and provided suggestions to adapting it for future users. CONCLUSION: Findings support the acceptability of the LC-OHP to people living with LC. The programme has shown several benefits in supporting physical health and mental wellbeing. Suggestions made to further adapt the programme and improve its delivery will be considered for future trials.

A Parent-child yoga intervention for reducing attention deficits in children with congenital heart disease: the Yoga for Little Hearts Feasibility Study Protocol.

INTRODUCTION: Preschoolers and school-aged children with congenital heart disease (CHD) are at higher risk of attention deficit hyperactivity disorder (ADHD) compared with the general population. To this day, no randomised controlled trial (RCT) aiming to improve attention has been conducted in young children with CHD. There is emerging evidence indicating that parent-child yoga interventions improve attention and reduce ADHD symptoms in both typically developing and clinical populations. METHODS AND ANALYSIS: This is a single-blind, two-centre, two-arm trial during which 24 children with CHD and their parents will be randomly assigned to (1) a parent-child yoga intervention in addition to standard clinical care or (2) standard clinical care alone. All participants will undergo standardised assessments: (1) at baseline, (2) immediately post-treatment and (3) 6 months post-treatment. Descriptive statistics will be used to estimate the feasibility and neurodevelopmental outcomes. This feasibility study will evaluate: (1) recruitment capacity; (2) retention, drop-out and withdrawal rates during the yoga programme and at the 6-month follow-up; (3) adherence to the intervention; (4) acceptability of the randomisation process by families; (5) heterogeneity in the delivery of the intervention between instructors and use of home-based exercises between participants; (6) proportion of missing data in the neurodevelopmental assessments and (7) SD of primary outcomes of the full RCT in order to determine the future appropriate sample size. ETHICS AND DISSEMINATION: Ethical approval has been obtained by the Research Ethics Board of the Sainte-Justine University Hospital. The findings will be disseminated in peer-reviewed journals and conferences and presented to the Canadian paediatric grand round meetings. TRIAL REGISTRATION NUMBER: NCT05997680.

Intravenous Magnesium: Prompt Use for Asthma in Children Treated in the Emergency Department (IMPACT-ED): Protocol for a Multicenter Pilot Randomized Controlled Trial.

BACKGROUND: Children managed for asthma in an emergency department (ED) may be less likely to be hospitalized if they receive intravenous magnesium sulfate (IVMg). Asthma guidelines recommend IVMg for severely sick children but note a lack of evidence to support this recommendation. All previous trials of IVMg in children with asthma have been too small to answer whether IVMg is effective and safe. A few major questions remain about IVMg. First, it has not been tested early in the course of ED treatment, when the impact on hospitalization would be greatest. Second, the clinical impact of hypotension, a known adverse effect of IVMg, has not been well characterized in previous research. Third, no trials have compared different IVMg doses or serial serum magnesium (total and ionized) concentrations to optimize dosing, so the most effective dose is unknown. A large, conclusive, randomized, placebo-controlled clinical trial of IVMg might be challenging due to the need to enroll and complete study procedures quickly, a lack of understanding of blood pressure changes after IVMg, and a lack of pharmacologic information to guide the optimal doses of IVMg to be tested. Therefore, a pilot study to inform the above gaps is warranted before conducting a definitive trial. OBJECTIVE: The objectives of this study are to (1) demonstrate the feasibility of enrolling children with severe acute asthma in the ED in a multicenter, randomized controlled trial of a placebo, low-dose IVMg, or high-dose IVMg; (2) demonstrate the feasibility of timely delivery of study medication, assessment of blood pressure, and evaluation of adverse events in a standardized protocol; and (3) externally validate a previously constructed pharmacokinetic model and develop a combined pharmacokinetic/pharmacodynamic model for IVMg using magnesium (total and ionized) serum concentrations and their correlation with measures of efficacy and safety. METHODS: This pilot trial tests procedures and gathers information to plan a definitive trial. The pilot trial will enroll as many as 90 children across 3 sites, randomize each child to 1 of 3 study arms, measure blood pressure frequently, and collect 3 blood samples from each participant with corresponding clinical asthma scores. RESULTS: The project was funded by the National Heart, Lung, and Blood Institute (1 R34HL152047-2) in March 2022. Enrollment began in September 2022, and 43 children have been enrolled as of April 2023. We will submit the results for publication in late 2023. CONCLUSIONS: The results of this study will guide the planning of a large, definitive, multicenter trial powered to evaluate if IVMg reduces hospitalization. Blood pressure measurements will inform a monitoring plan for the larger trial, and blood samples and asthma scores will be used to validate pharmacologic models to select the optimal dose of IVMg to be evaluated in the definitive trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05166811; https://clinicaltrials.gov/ct2/show/NCT05166811. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48302.

Trauma-specific mindfulness-based cognitive therapy for women with post-traumatic stress disorder and a history of domestic abuse: intervention refinement and a randomised feasibility trial (coMforT study).

BACKGROUND: Women who have experienced domestic violence and abuse (DVA) are at increased risk of developing post-traumatic stress disorder (PTSD) and complex PTSD (CPTSD). In 2014-2015, we developed a prototype trauma-specific mindfulness-based cognitive therapy curriculum (TS-MBCT) for the treatment of PTSD in a DVA population. This study aimed to refine the prototype TS-MBCT and evaluate the feasibility of conducting a randomised controlled trial (RCT) testing its effectiveness and cost-effectiveness. METHODS: Intervention refinement phase was informed by evidence synthesis from a literature review, qualitative interviews with professionals and DVA survivors, and a consensus exercise with experts in trauma and mindfulness. We tested the refined TS-MBCT intervention in an individually randomised parallel group feasibility trial with pre-specified progression criteria, a traffic light system, and embedded process and health economics evaluations. RESULTS: The TS-MBCT intervention consisted of eight group sessions and home practice. We screened 109 women in a DVA agency and recruited 20 (15 TS-MBCT, 5 self-referral to National Health Service (NHS) psychological treatment), with 80% follow-up at 6 months. Our TS-MBCT intervention had 73% uptake, 100% retention, and high acceptability. Participants suggested recruitment via multiple agencies, and additional safety measures. Randomisation into the NHS control arm did not work due to long waiting lists and previous negative experiences. Three self-administered PTSD/CPTSD questionnaires produced differing outcomes thus a clinician administered measure might work better. We met six out of nine feasibility progression criteria at green and three at amber targets demonstrating that it is possible to conduct a full-size RCT of the TS-MBCT intervention after making minor amendments to recruitment and randomisation procedures, the control intervention, primary outcomes measures, and intervention content. At 6 months, none of the PTSD/CPTSD outcomes ruled out a clinically important difference between trial arms indicating that it is reasonable to proceed to a full-size RCT to estimate these outcomes with greater precision. CONCLUSIONS: A future RCT of the coMforT TS-MBCT intervention should have an internal pilot, recruit from multiple DVA agencies, NHS and non-NHS settings, have an active control psychological treatment, use robust randomisation and safety procedures, and clinician-administered measures for PTSD/CPTSD. TRIAL REGISTRATION: ISRCTN64458065 11/01/2019.

A virtual, group-based mindfulness intervention for midlife and older women with low libido lowers sexual distress in a randomized controlled pilot study.

BACKGROUND: Distressing low libido is common among women and has significant negative impacts; mindfulness has shown promise to increase sexual desire in women with low libido, but existing interventions are not tailored to midlife and older women. AIM: We adapted a mindfulness intervention to meet the needs of this population and conducted a pilot randomized controlled trial to assess feasibility and acceptability. METHODS: Women aged ≥45 years with low libido were randomized to the mindfulness intervention or an education group that met over videoconferencing. The intervention included mindfulness instruction and practice, group discussion, and education on sexuality and aging. The education group included general information on menopause and health. OUTCOMES: We defined feasibility by the number of screened women who enrolled and completed their group. We defined acceptability as satisfaction with the group and likelihood of recommending it to another woman with low libido. We assessed sexual function (Female Sexual Function Index) and sexual distress (Female Sexual Distress Scale-Revised) at 6 weeks postconclusion. RESULTS: Of 81 women screened, 31 were randomized to mindfulness and 30 to education. Eighteen women in the intervention group and 23 in the control group attended at least 1 session. Time conflict was the main reason for nonattendance. Of the 41 women who started attending groups, 37 (90%) attended at least 5 sessions. In the mindfulness group, 73% of women were very or extremely satisfied. Women in the mindfulness group were more likely to recommend it to another person with low libido as compared with those in the education group (P = .031); 67% said that they would probably or definitely recommend it. There were no significant changes in sexual function in either group (mean Female Sexual Function Index score, 22.6 to 18.6 [P = .101] with mindfulness and 21.2 to 19.7 [P = .537] with education). Women in the mindfulness group had significant improvements in sexual distress (mean Female Sexual Distress Scale-Revised score, 27.1 to 19.7; P = .021) while women in the education group did not (19.0 to 15.8; P = .062). CLINICAL IMPLICATIONS: Mindfulness may reduce sexual distress in older women with low libido. STRENGTHS AND LIMITATIONS: This is the first trial testing mindfulness for midlife and older women with low libido. CONCLUSION: A virtual mindfulness intervention for midlife and older women with low libido is feasible and acceptable and appears to improve sexual distress as compared with an education control; these findings provide data that can be used to design a larger clinical trial.

A feasibility Randomised Controlled Trial as a first step towards evaluating the effectiveness of a digital health dashboard in preventive child health care: a mixed methods approach.

BACKGROUND: Within preventive Child Health Care (CHC), the 360°CHILD-profile has been developed. This digital tool visualises and theoretically orders holistic health data in line with the International Classification of Functioning, Disability and Health. It is anticipated that evaluating the effectiveness of the multifunctional 360°CHILD-profile within the preventive CHC-context is complex. Therefore, this study aimed at investigating the feasibility of RCT procedures and the applicability of potential outcome measures for assessing the accessibility and transfer of health information. METHODS: During the first introduction of the 360°CHILD-profile in CHC practice, a feasibility RCT with an explanatory-sequential mixed methods design was executed. CHC professionals (n=38) recruited parents (n=30) who visited the CHC for their child (age 0-16). Parents were randomised to "care as usual" (n=15) or "care as usual with, in addition, the availability of a personalised 360°CHILD-profile during 6 months" (n=15). Quantitative data on RCT feasibility were collected on recruitment, retention, response, compliance rates and outcome data on accessibility and transfer of health information (n=26). Subsequently, thirteen semi-structured interviews (5 parents, 8 CHC professionals) and a member check focus group (6 CHC professionals) were performed to further explore and gain a deeper understanding of quantitative findings. RESULTS: Integration of qualitative and quantitative data revealed that the recruitment of parents by CHC professionals was problematic and influenced by organisational factors. The used randomisation strategy, interventions and measurements were executable within the setting of this specific study. The outcome measures showed skewed outcome data in both groups and a low applicability to measure accessibility and transfer of health information. The study revealed points to reconsider regarding the randomisation and recruitment strategy and measures in the next steps. CONCLUSIONS: This mixed methods feasibility study enabled us to gain a broad insight into the feasibility of executing an RCT within the CHC context. Trained research staff should recruit parents instead of CHC professionals. Measures, potentially for evaluating 360°CHILD-profile's effectiveness, need further exploration and thorough piloting before proceeding with the evaluation process. Overall findings revealed that executing an RCT within the context of evaluating 360°CHILD-profile's effectiveness in the CHC setting will be much more complex, time-consuming and costly than expected. Thereby, the CHC context requires a more complex randomisation strategy than executed during this feasibility study. Alternative designs including mixed methods research must be considered for the next phases of the downstream validation process. TRIAL REGISTRATION: NTR6909; https://trialsearch.who.int/ .

Movement retraining programme in young soccer and rugby football players: A feasibility and proof of concept study.

INTRODUCTION: Movement screening to identify abnormal movement patterns can inform development of effective interventions. The primary objective of this study was to evaluate the feasibility of using a movement screening tool in combination with a tailored movement control retraining programme in young soccer and rugby football players. A secondary objective was to investigate changes in movement control patterns post-intervention, to provide proof of concept (PoC) for movement retraining. METHODS: 52 male amateur players, including 34 soccer players (mean age 15 ± 2 years) and 18 rugby players (mean age 15 ± 1 years) participated. They were screened for movement control ability using a shortened version of the Hip and Lower Limb Movement Screening (Short-HLLMS) and completed an eight-week movement control retraining programme. Evaluation of feasibility included consent from players invited, adherence, attendance at the exercise sessions, drop-out and adverse events. Short-HLLMS total score and The Copenhagen Hip and Groin Outcome Score (HAGOS) were analysed to provide PoC for retraining movement control. RESULTS: feasibility outcomes were favourable. Significant statistical changes occurred post-intervention in the Short-HLLMS total score (paired-samples t-test) and in three HAGOS subscales (symptoms, physical function in daily living and in sport and recreation) (Wilcoxon-Signed Rank Test) in both groups. CONCLUSIONS: Feasibility of using the Short-HLLMS in combination with a movement control retraining programme in soccer and rugby players was promising. The data provided PoC for the potential application of a shortened version of the HLLMS to evaluate changes in movement control and to inform targeted motor control programmes.

Feasibility and acceptability of e-learning to upskill diabetes educators in supporting people experiencing diabetes distress: a pilot randomised controlled trial.

BACKGROUND: Diabetes distress is a commonly experienced negative emotional response to the ongoing burden of diabetes. Holistic diabetes care, including attention to diabetes distress, is recommended in clinical guidelines, yet not routinely implemented. Diabetes health professionals have highlighted lack of training as a barrier to implementation of psychological care. Therefore, we developed an e-learning: 'Diabetes distress e-learning: A course for diabetes educators' to address this need. This pilot study aimed to examine the feasibility of evaluating the e-learning in a randomised controlled trial study, the acceptability of the e-learning to credentialled diabetes educators (CDEs); and preliminary evidence of its effect upon CDEs' diabetes distress-related knowledge, motivation, confidence, behavioural skills, and barriers to implementation. METHODS: A pilot, unblinded, 2-armed, parallel group randomised controlled trial. Participants were recruited during a 4-month timeframe. Eligible participants were CDEs for ≥ 1 year providing care to ≥ 10 adults with type 1 or type 2 diabetes per week. Participants were randomly allocated (1:1 computer automated) to 1 of 2 learning activities: diabetes distress e-learning (intervention) or diabetes distress chapter (active control). They had 4 weeks to access the activity. They completed online surveys at baseline, 2-week and 12-week follow-up. RESULTS: Seventy-four eligible CDEs (36 intervention, 38 active control) participated. At baseline, recognition of the clinical importance of diabetes distress was high but knowledge and confidence to provide support were low-to-moderate. Engagement with learning activities was high (intervention: 83%; active control: 92%). Fifty-five percent returned at least 1 follow-up survey. All 30 intervention participants who returned the 2-week follow-up survey deemed the e-learning high quality and relevant. Systemic barriers (e.g., financial limitations and access to mental health professionals) to supporting people with diabetes distress were common at baseline and follow-up.  CONCLUSIONS: The e-learning was acceptable to CDEs. The study design was feasible but needs modification to improve follow-up survey return. The e-learning showed potential for improving diabetes distress-related knowledge, confidence and asking behaviours, but systemic barriers to implementation remained. Systemic barriers need to be addressed to facilitate implementation of support for diabetes distress in clinical practice. Future larger-scale evaluation of the e-learning is warranted.

Feasibility, Acceptability, and Efficacy of Mindfulness Training in People With Upper Motor Neuron Disorders: A Systematic Review.

OBJECTIVES: This systematic review aims to gain a comprehensive understanding of the feasibility, acceptability, and efficacy of mindfulness-based interventions (MBIs) on depression, anxiety, fatigue, and health-related quality of life among individuals with upper motor neuron disorders (UMNDs). DATA SOURCES: PubMed, PsycINFO, Excerpta Medica Database, and Cumulative Index to Nursing and Allied Health Literature were searched for relevant studies published between January 2001 and June 2021. STUDY SELECTION: Clinical trials published in English evaluating MBIs in adults with the 4 most common UMNDs (multiple sclerosis, brain injury including stroke, spinal cord injury, amyotrophic lateral sclerosis) were included. DATA EXTRACTION: Two reviewers independently performed the risk of bias assessment using standardized tools and extracted desired data electronically. DATA SYNTHESIS: A total of 44 studies were included: 26 randomized controlled trials, 10 nonrandomized controlled trials, and 8 pre-post intervention studies. The average ± SD duration of MBIs was 8±2 weeks. On average, 85%±14% of participants completed the MBI, and the retention rate at follow-up was 80%±16%. Only 14% of the studies delivered MBIs virtually, and feasibility metrics were similar to in-person studies. Among studies reporting acceptability data, most participants reported satisfaction with the MBI. Randomized controlled trials that evaluated the effects of MBI on depression, anxiety, fatigue, and quality of life revealed greater relative improvement in these outcomes among MBI participants compared with controls, with differences greater when compared with passive control than active control participants. None of the studies included in this review studied dose response. CONCLUSIONS: Based on current data, MBIs are feasible and offer a promising approach to address the biopsychosocial needs of individuals with UMNDs. MBIs are associated with a high acceptance rate among participants, with notable improvements in depression, anxiety, fatigue, and quality of life post intervention. Future studies are needed to evaluate alternate models of delivery of MBIs and the dose-response relationship.

The role of intra-operative void score during transurethral resection of prostate as a marker of efficacy: a feasibility study.

BACKGROUND: To assess the feasibility of a novel intra-operative void scoring technique. To determine if intra-operative void score (VS) could act as a marker for post-operative success following TURP. METHODS: Fifteen patients undergoing TURP were included in this single-centre feasibility study. All patients had indwelling urinary catheters for recurrent retention due to benign prostatic hyperplasia (BPH). In theatre, immediately before- and after TURP, an intra-operative VS was measured and graded 0-5. Primary outcomes were the feasibility of measuring intra-operative VS and its accuracy in predicting surgical outcome. RESULTS: A combined pre- and post-score with a threshold ≥6 correctly predicted 82% of those who were catheter free (sensitivity) and 100% of those who were not catheter free (specificity) at follow up and the positive predictive value was 100% and negative predictive value 60%. CONCLUSION: Intra-operative void score during TURP is simple, reproducible, fast and requires minimal resources. In TURP it may predict successful outcomes by identifying patients who will be catheter free post-operatively as opposed to those who will be catheter dependent despite the procedure.

Delivering a holistic hospital-to-home framework to support family caregivers of persons with dementia: Protocol for a feasibility study.

AIM: To evaluate the feasibility of the Carer Matters holistic hospital-to-home framework for family caregivers of people with dementia. BACKGROUND: Family caregivers of persons with dementia face a unique blend of stressors, from behavioural management to navigating the healthcare system. It is important to provide support and assistance to help caregivers cope to enable a sustained capacity for caregiving. This led to our establishment of Carer Matters, the first holistic caregiver-centric hospital-to-home framework of support for caregivers of persons with dementia in Singapore. METHODS: A multimethod study design will be used. We will assess the programme's feasibility and effectiveness using a Theory of Change approach, with findings synthesized using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. Our study will involve six inpatient wards of a 1700-bedded acute care hospital over 12 months. Qualitative data will be obtained from interviews of stakeholders-caregivers, healthcare professionals, hospital leaders and community leaders. Quantitative data will be collected from programme logs, surveys and evaluation forms that capture self-reported levels of mastery, anxiety, burden, and depression. Funding has been approved by the Geriatric Education and Research Institute (GERI) Intramural Project Grant (GERI Ref: GERI1626) on May 2020 for this study (£103,659), to be conducted from December 2020 to June 2022. DISCUSSION: The stresses faced by caregivers of persons with dementia are wide and complex, necessitating a multi-faceted caregiver-oriented solution to provide sustained support, empower better management and continued capacity to care. Our study would provide insights on the feasibility and effectiveness of a caregiver-centric support programme stretching from the hospital into the community. IMPACT: These findings will provide a blueprint on how to implement a hospital-to-home patient-caregiver framework and provide policymakers, clinicians, and advocacy groups with critical insights on the potential patient-caregiver-healthcare system outcomes that can be derived.

A peer-delivered intervention to reduce harm and improve the well-being of homeless people with problem substance use: the SHARPS feasibility mixed-methods study.

BACKGROUND: For people experiencing homelessness and problem substance use, access to appropriate services can be challenging. There is evidence that development of trusting relationships with non-judgemental staff can facilitate service engagement. Peer-delivered approaches show particular promise, but the evidence base is still developing. This study tested the feasibility and acceptability of a peer-delivered intervention, through 'Peer Navigators', to support people who are homeless with problem substance use to address a range of health and social issues. OBJECTIVES: The study objectives were to design and implement a peer-delivered, relational intervention to reduce harms and improve health/well-being, quality of life and social functioning for people experiencing homelessness and problem substance use, and to conduct a concurrent process evaluation to inform a future randomised controlled trial. DESIGN: A mixed-methods feasibility study with concurrent process evaluation was conducted, involving qualitative interviews [staff interviews (one time point), n = 12; Peer Navigator interviews (three or four time points), n = 15; intervention participant interviews: first time point, n = 24, and second time point, n = 10], observations and quantitative outcome measures. SETTING: The intervention was delivered in three outreach services for people who are homeless in Scotland, and three Salvation Army hostels in England; there were two standard care settings: an outreach service in Scotland and a hostel in England. PARTICIPANTS: Participants were people experiencing homelessness and problem substance use (n = 68) (intervention). INTERVENTION: This was a peer-delivered, relational intervention drawing on principles of psychologically informed environments, with Peer Navigators providing practical and emotional support. MAIN OUTCOME MEASURES: Outcomes relating to participants' substance use, participants' physical and mental health needs, and the quality of Peer Navigator relationships were measured via a 'holistic health check', with six questionnaires completed at two time points: a specially created sociodemographic, health and housing status questionnaire; the Patient Health Questionnaire-9 items plus the Generalised Anxiety Disorder-7; the Maudsley Addiction Profile; the Substance Use Recovery Evaluator; the RAND Corporation Short Form survey-36 items; and the Consultation and Relational Empathy Measure. RESULTS: The Supporting Harm Reduction through Peer Support (SHARPS) study was found to be acceptable to, and feasible for, intervention participants, staff and Peer Navigators. Among participants, there was reduced drug use and an increase in the number of prescriptions for opioid substitution therapy. There were reductions in risky injecting practice and risky sexual behaviour. Participants reported improvements to service engagement and felt more equipped to access services on their own. The lived experience of the Peer Navigators was highlighted as particularly helpful, enabling the development of trusting, authentic and meaningful relationships. The relationship with the Peer Navigator was measured as excellent at baseline and follow-up. Some challenges were experienced in relation to the 'fit' of the intervention within some settings and will inform future studies. LIMITATIONS: Some participants did not complete the outcome measures, or did not complete both sets, meaning that we do not have baseline and/or follow-up data for all. The standard care data sample sizes make comparison between settings limited. CONCLUSIONS: A randomised controlled trial is recommended to assess the effectiveness of the Peer Navigator intervention. FUTURE WORK: A definitive cluster randomised controlled trial should particularly consider setting selection, outcomes and quantitative data collection instruments. TRIAL REGISTRATION: This trial is registered as ISRCTN15900054. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 14. See the NIHR Journals Library website for further project information.

People who are homeless have worse physical and mental health, and higher rates of drug/alcohol (substance) use, than the general population. For people experiencing these challenges, completely stopping the use of substances can be difficult. Harm reduction services can be useful in reducing risks. Approaches delivered by people who have had similar experiences (peers) are also promising. Some research has highlighted the importance of trusting relationships with service staff. More research is needed on how all of these should work with people who are homeless and who use substances. This study consisted of four 'Peer Navigators' providing practical and emotional support to a group of people who are homeless and use substances to help improve their quality of life and health. The Peer Navigators had similar past experiences. The Peer Navigators were hired, and worked with around 15 'participants' each, for 2­12 months. They were based in third-sector homelessness residential and outreach services in Scotland and England. The Peer Navigators developed relationships with participants. They worked with (and often accompanied) them to access services, such as substance use treatment, health care, housing and welfare/benefits. The Peer Navigators had access to a small budget to pay for essentials, including food and bus fares. The relationship between the Peer Navigators and participants was most important, so the Peer Navigators spent time getting to know and listening to them. The aim was to understand if this intervention could be delivered to individuals experiencing these challenges. This study was not designed to know if the intervention worked; a larger study is needed for that. Despite some challenges, the participants were able to make positive changes to their lives, and they valued working with their Peer Navigator. The Peer Navigators enjoyed their roles and staff generally supported the intervention. The next step is to conduct more research to assess if this intervention can make a difference.

Results of a feasibility randomised controlled trial of osteopathy on neck-shoulder pain in computer users.

BACKGROUND: Computer use is a well-known source of chronic pain, leading to absenteeism and reduced productivity and well-being. This study evaluated the feasibility of conducting a full-scale randomised controlled trial. Several methodological variables defined trial feasibility. MATERIALS AND METHODS: Thirty adults, daily computer users reporting pain, were recruited. Data collection took place at LABIOMEP. Participants were randomised into 1 of 3 parallel groups and received either osteopathic, sham or no treatment. Only the volunteers were blind to group assignments. The primary objective was to study the feasibility and acceptability of the protocol. RESULTS: Of 77 participants interested, 30 were included and randomised into three groups of ten. All participants concluded the study, and all the data was analysed. The feasibility outcomes were deemed appropriate. No adverse events or severe side effects were reported or identified. CONCLUSION: Studying the efficacy of osteopathic consultation on computer users by conducting an RCT is feasible and safe. With adjustments, a full-scale study can be designed. TRIAL REGISTRATION: ClinicalTrials.gov with the identifier: NCT04501575. Date registered August 06, 2020.

Twelve-section ultrasonic screening diagnosis method for neonatal complex congenital heart disease in primary hospitals at county level / 中华围产医学杂志

Objective:To investigate the feasibility of "twelve-section ultrasonic screening diagnosis method" in screening for neonatal complex congenital heart disease (CHD) in primary hospitals.Methods:This is a prospective study. A total of 71 580 newborns were screened for CHD using the "twelve-section ultrasonic screening diagnosis method" from four pilot units in Hebei province, which were Bo'ai Hospital of Huanghua Development Zone, Traditional Chinese Medicine Hospital of Fengning County, Maternity & Child Healthcare Hospital of Tang Country, and Maternity & Child Healthcare Hospital of Rongcheng Country, from November 2015 to December 2019. Another 262 children with CHD were enrolled, including 39 with complex CHD. These cases received ultrasonography at four pilot units above and then were transferred to CHD Screening Diagnosis and Treatment Center of Hebei Children's Hospital (our center) prior to the implementation of "twelve-section ultrasonic screening diagnosis method" from June 2012 to June 2014, who were all confirmed by surgery. Set the diagnosis results of our center as the gold standard, the sensitivity, specificity, and diagnostic consistency rate in screening for complex CHD cases were calculated. Receiver operating characteristic (ROC) analysis and Chi-square test were used to compare and analyze the sensitivity for screening neonatal complex CHD before and after implementing the method. The screening results of complex CHD after implementing the method between the pilot units and our center as well as between the four pilot units were compared and analyzed using Chi-square test. Results:A total of 553 (0.77%) CHD cases were detected by the "twelve-section ultrasound screening diagnosis method", including 66 cases of complex CHD and 487 cases simple CHD. Among the cases screened using the method, there were three false negative cases (one case with total anomalous pulmonary venous drainage, one with abnormal coronary artery originating from pulmonary artery, and one with atresia of distal to the left subclavian artery, aortic arch and left aortic arch of double-arch), one false positive case (false echo loss of aortopulmonary septal that was misdiagnosed as aortopulmonary septal defect), five cases of misdiagnosis (one common pulmonary venous atresia case that was misdiagnosed as total anomalous pulmonary venous drainage, one persistent stenosis of the fifth aortic arch that was misdiagnosed as coarctation of aorta, one pulmonary artery sling that was misdiagnosed as absence of left pulmonary artery, one severe coarctation of aorta that was misdiagnosed as interruption of aortic arch, and one aortic isthmus atresia that was misdiagnosed as coarctation of aorta), and all were complex CHD cases. A total of 68 cases (12.3%) of complex CHD were confirmed by our center. The overall sensitivity, specificity, and diagnostic consistency rate of screening were 95.6% (65/68), 99.8% (484/485), and 86.8% (59/68), respectively and the area under ROC curve was 0.98. Before the implementation, the overall sensitivity, specificity, and diagnostic coincidence rates of ultrasonic screening for complex CHD were 69.2%(27/39), 95.5%(213/223), and 61.5% (24/39), respectively, and the area under ROC curve was 0.82. The sensitivity of complex CHD screening was significantly increased after implementing the method ( χ2=14.28, P<0.05). There was no significant statistical significance in the sensitivity for screening complex CHD after the implementation between the pilots and our center or between the four pilots (all P>0.05). Conclusions:"Twelve-section ultrasonic screening diagnosis method" is suitable for the screening of neonatal complex CHD in hospitals at the county level. However patients with some special types of complex CHD are recommended to be transferred for a more accurate diagnosis.

Acupuncture in addition to standard conservative treatment for overactive bladder; a feasibility trial for a randomized controlled study.

AIMS: This study aims to assess the feasibility of an randomized controlled trial (RCT) to test treatment efficacy of acupuncture for symptoms of overactive bladder syndrome (OAB), a common long-term condition with physical, psychological, social and sexual consequences. METHODS: A total of 30 participants were recruited and randomized to either standard conservative management for OAB or standard conservative management plus acupuncture. Standard care consisted of individually tailored advice regarding bladder health, pelvic floor exercises and lifestyle adjustments. The intervention group received 6 sessions of acupuncture over an 8-week period. Outcomes measured included adherence to the study protocol, recruitment rate, participant attrition rate and adverse events. A 3-day bladder diary and Incontinence Questionnaire-short form questionnaire were used to assess symptoms. The ICEpop CAPability measure for Adults measure was used to assess well-being. Outcomes were collected at baseline, after 8 weeks of intervention and 6 weeks after completing intervention. An exit questionnaire captured participant experience data. RESULTS: Comparison of the two groups at baseline did not detect statistically significant differences in demographics and symptom profile. A total of 23 participants completed all study proceedures. Recruitment was completed in 11 months, quicker than anticipated. No serious adverse events occurred; minor adverse events were recorded in 11/114 (9.6%) treatments. A total of seven participants failed to complete one or more study proceedures with an overall attrition rate of 23.3%. CONCLUSIONS: Most participants completed all aspects of the study and found the protocol acceptable. The interventions appear safe and well tolerated. The concept of a large-scale RCT with a similar protocol was proven and appears feasible based on this pilot work.

Needle-free injection: Dental infiltration anesthesia.

This study aimed to develop an optimal Needle-Free Liquid Jet Injection (NFLJI) technique for dental infiltration anesthesia and evaluate its clinical safety and feasibility. The fluid dynamics of NFLJI in the dentoalveolar region were investigated using soft tissue phantoms supported by rigid glass. NFLJIs were performed at different incident angles and recorded using a high-speed camera. Accordingly, an optimal NFLJI for infiltration anesthesia was developed and validated on cadavers, then assessed in two pilot Randomized Controlled Trials (RCT): one for validating the safety of optimal NFLJI technique, the other for evaluating its feasibility and safety. High-speed videos showed that perpendicular NFLJIs induced significantly more regurgitation than oblique NFLJIs, which was confirmed in cadavers. Clinical trials revealed that perpendicular NFLJIs induced a high risk of bleeding (83.3%) and laceration (83.3%), whereas oblique NFLJIs induced a low risk of bleeding (33.3%) and laceration (16.7%). Moreover, the preliminary success rates of oblique NFLJIs and needle injections were both 83.3%. The recruitment took 3-5 weeks with a rate of 100%. Oblique NFLJIs could be a promising approach for dental infiltration anesthesia, causing minimal drug regurgitation with a relatively low risk of complication. The pilot RCTs confirmed the feasibility for conducting a non-inferiority RCT.

A pilot randomized controlled trial of dialectical behavior therapy (DBT) for reducing craving and achieving cessation in patients with marijuana use disorder: feasibility, acceptability, and appropriateness.

OBJECTIVE: To conduct a pilot RCT investigating the feasibility, acceptability, and preliminary efficacy of dialectical behavioral therapy (DBT) for marijuana cessation and craving reduction. METHODS: Sixty-one patients with marijuana use disorder diagnoses were randomly assigned to a DBT group or a control group (psycho-education). Patients completed measures at pre-intervention, post-intervention, and at two-month follow-up. The Marijuana Craving Questionnaire (MCQ) and marijuana urine test kits were used to assess craving and abstinence respectively. RESULTS: The feasibility of DBT was significantly higher than control group feasibility. In the DBT 29/30 participants completed all sessions (96% retention) and 24/31 control group participants completed all sessions (77% retention) (χ2 = 4.95, p = 0.02). Moreover, 29/30 (96%) participants in the DBT group completed the two-month follow-up and 20/31 (64.5%) control group members completed the two-month follow-up (χ2 = 9.97, p = 0.002). The results showed that patients in the DBT group had significantly higher intervention acceptability rates (16.57 vs. 9.6) than those in the control group. This pattern was repeated for appropriateness rates (p < 0.05). The overall results for craving showed that there was no significant difference between the groups (F = 3.52, p > 0.05), although DBT showed a significant reduction in the "emotionality" subscale compared to the control group (F = 19.94, p < 0.05). To analyze cessation rates, DBT was compared to the control group at the posttest (46% vs. 16%) and follow-up (40% vs. 9.5%) and the results confirmed higher effectiveness in the DBT group for cessation (p < 0.05). Furthermore, among those who had lapsed, participants in the DBT group had fewer consumption days than those in the control group (p < 0.05). CONCLUSIONS: DBT showed feasibility, acceptability, and promising efficacy in terms of the marijuana cessation rate. CLINICAL TRIAL REGISTRATION: Thailand Registry of Clinical Trials, TCTR20200319007.

A mindful yoga intervention for children with severe asthma: A pilot study.

INTRODUCTION: Children with severe asthma may benefit from non-pharmacological approaches to symptom management, yet little is known regarding the impact of mind-body approaches such as mindful yoga in this population. This pilot study examined the tolerability, feasibility, acceptability and immediate effects of a mindful yoga intervention in children with severe asthma. METHOD: Fifteen children ages 7-11 with severe asthma participated in a single mindful yoga session, followed by semi-structured interviews with the child and caregiver. Vital signs and pulmonary function tests were collected pre- and post-intervention. RESULTS: All children reported positive experiences and caregivers were generally supportive of their participation. One child experienced self-limited bronchoconstriction with asthma symptoms. There was no significant change in lung function or vital signs after the mindful yoga session. DISCUSSION: Our results warrant additional larger studies to evaluate the safety and benefits of mindful yoga in children with severe asthma.

Feasibility of the Internet Attachment-Based Compassion Therapy in the General Population: Protocol for an Open-Label Uncontrolled Pilot Trial.

BACKGROUND: Compassion-based interventions delivered over the internet are showing promising results for the promotion of psychological health and well-being. Several studies have highlighted their feasibility, acceptance, and preliminary efficacy. However, this is an incipient field of research, and to the best of our knowledge, there are no data available from Spanish-speaking countries. OBJECTIVE: The aim of this study is to investigate the feasibility, acceptance, and preliminary efficacy of the Internet Attachment-Based Compassion Therapy (iABCT), a web-based version of the Attachment-Based Compassion Therapy, in Spanish speakers from the general population. METHODS: This feasibility study features a single-arm, uncontrolled, within-group design with an embedded qualitative and quantitative process evaluation at baseline, immediately after the intervention and at the 3-month follow-up. A minimum of 35 participants from the general population will be allocated to iABCT. Feasibility measures will include attrition rate, patterns of use of the web-based system, and participants' acceptability, usability, and opinion. The primary outcome was measured using the Pemberton Happiness Index. Secondary outcomes were measured using the Compassion Scale, Self-Compassion Scale, Forms of Self-Criticizing/Attacking and Self-Reassuring Scale-Short form, Five Facets of Mindfulness Questionnaire, Relationships Questionnaire, General Health Questionnaire, Non-Attachment Scale, International Positive and Negative Affect Schedule Short Form, Purpose-In-Life Test, and difficulties regarding the practice of compassion (Compassion Practice Quality Questionnaire). Mixed models will be used to evaluate primary and secondary outcome measures. A qualitative content analysis of the participants' qualitative responses will also be performed. RESULTS: Enrollment started in February 2020 and will be finished in April 2020. Data analysis will start in October 2020. CONCLUSIONS: To our knowledge, this study will, for the first time, show data on the feasibility, acceptability, and preliminary efficacy of web-based compassion (and self-compassion) training-that is, the adapted iABCT-in Spanish speakers from the general population. Further aspects of their implementation (ie, facilitators, barriers, and unwanted effects) and mechanisms of change will be investigated. This study will allow the revision and fine-tuning of the developed intervention, study design, and planning procedures, as well as the initiation of a future randomized controlled trial. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03918746. Registered on April 17, 2019. Protocol version 1, 6 March 2019. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/16717.