Acceptability Of Intervention Research Articles

The Sleep Course: An inclusive trial examining the feasibility, acceptability, and preliminary efficacy of a digital sleep intervention for adults with self-reported sleep difficulties

Cognitive Behavioural Therapy for Insomnia (CBTi) is a well-established first-line treatment for insomnia and sleep difficulties, yet numerous barriers hinder its widespread adoption. One potential criticism of the existing evidence base for CBTi is that many trials exclude participants that would commonly be seen in in primary care, such as those aged over 65, with comorbid health conditions, or prescribed sleep medication. The current pilot study therefore aimed to assess the acceptability and efficacy of a brief, digitally delivered sleep intervention, the Sleep Course using a broad range of participants. Participants (n = 74) completed the 6-week, 4-lesson intervention alongside measures of sleep disturbance, sleep-related impairment, depression, anxiety and sleep-wake patterns (via sleep diary). Generalized estimating equations analysis modelled change in participants' outcomes from pre- to post-treatment and 3-month follow-up, and subgroup analyses explored the role of possible moderators (e.g., age over 65, co-morbidities, and concurrent prescription medication use). The intervention was associated with good rates of satisfaction (79 %) and lesson completion (70 %). Results showed significant and large reductions in insomnia, sleep disturbance and associated symptoms (e.g., d = 1.06–1.37 change in insomnia symptoms). Evidence of high acceptability and clinical improvement was found irrespective of age, physical comorbidity, and sleep medication use. However, there was evidence of less improvement among those taking medications or having tried psychological treatment in the past. These results provide strong preliminary evidence for the intervention as an acceptable, efficacious and scalable treatment for a broad range of participants with sleep difficulties. Larger randomised controlled trials are needed.

Feasibility and acceptability of a web-intervention to prevent alcohol and cannabis-impaired driving among adolescents in driver education

Abstract Background Adolescents increasingly view cannabis as a substance with limited harm. Their propensity to engage in risky driving, combined with their relative driving inexperience, places adolescents at heightened risk for harm resulting from impaired driving. Driver education provides an opportunity to help prevent and reduce these risks, yet few interventions address cannabis-impaired driving, especially impairment from simultaneous use of both cannabis and alcohol. Methods We adapted a single-session primary care brief intervention (CHAT) for driver education programs. First, we conducted two focus groups with adolescents aged 15–17 years (n = 6; n = 5) enrolled in driver education programs in Michigan and Colorado. Their feedback was integrated into a prototype of an online intervention called webCHAT that focuses on preventing alcohol and cannabis-impaired driving. Next, we recruited a new sample of adolescents who user tested webCHAT (n = 8) and provided qualitative and survey feedback. We analyzed qualitative data using classic content analysis and grouped themes according to the feasibility and acceptability of webCHAT. Results Participants suggested that webCHAT should have adolescent narrators in short, informal, and interactive videos. In satisfaction surveys (n = 8), 88% of participants would recommend webCHAT to a friend and 88% reported that they learned helpful skills regarding impaired driving. General acceptability was also reflected in interviews (n = 6; 100% would recommend the intervention to a friend, 100% indicated overall positive impressions, and 67% stated it was easy to use). Participants reported that it was helpful to learn about the negative effects of both cannabis and alcohol on driving behavior, voicing that webCHAT would help adolescents make more informed decisions. Conclusions Soliciting adolescent perspectives is critical when developing interventions targeting cannabis use because of increasingly permissive attitudes and perceptions of minimal risk associated with use. The current study highlights how feedback can help increase both the feasibility and acceptability of interventions.

Yoga-Based Group Intervention for Inpatients with Schizophrenia Spectrum Disorders-Feasibility, Acceptability, and Preliminary Outcomes of a Rater-Blinded Randomized Controlled Trial.

The efficacy of yoga as an adjunctive treatment for schizophrenia spectrum disorders (SSD) has garnered interest. While yoga may positively influence various symptom domains, further investigation is needed due to the limited number, quality, and generalizability of studies. This study assessed the feasibility and acceptability (primary outcome) of a yoga-based group intervention (YoGI) developed in a participatory approach and explored its preliminary effectiveness. In addition to the primary outcomes, this preregistered randomized controlled trial examined rater-blinded general psychopathology, positive- and negative symptoms, and self-rated depression, anxiety, stress, body mindfulness, mindfulness, psychological flexibility, cognition, social functioning, quality of life, and medication regime at baseline and postintervention as secondary outcomes. Fifty inpatients with SSD received either TAU (n = 25) or YoGI + TAU (n = 25) for four weeks. Outcomes showed 95% protocol adherence of YoGI, feasibility, and retention rates of 91% and 94%, respectively, and a dropout rate of 6%. ANCOVA revealed significant between-group postintervention improvements for YoGI + TAU in positive symptoms, depression, cognitive fusion, and a mindfulness subscale. Medium-to-large pre- to postintervention effects were found for body mindfulness, positive, negative, and general psychopathology, cognitive fusion, depression, anxiety, stress, quality of life, and attention in YoGI + TAU, while within-group changes were consistently smaller in TAU. No severe adverse events were reported. This trial supports the feasibility and acceptability of YoGI for inpatients with SSD and provides preliminary evidence of YoGI's benefits beyond TAU. Further robust, multicentric RCTs are warranted to deepen our understanding of YoGI's therapeutic potential and inform clinical interventions for SSD.

A Video-Based Communication Intervention for Fecal Ostomy Surgery (CI-oSurg): Protocol for Open Pilot Testing to Improve Intervention Acceptability and Feasibility.

Approximately 100,000 patients undergo fecal ostomy operations annually across the United States. This patient population experiences high surgical complication rates and poor biopsychosocial outcomes. Surgical teams are not trained to address the psychosocial needs that often arise during recovery after fecal ostomy surgery. This study aims to refine and establish the acceptability and usability of the Communication Intervention for fecal ostomy Surgery (CI-oSurg), a web-based communication intervention aimed at reducing distress among patients recovering from ostomy surgery. We describe the proposed study design, methodology, and training protocol. We will conduct an open pilot (n=24 patients and n=8 clinicians) of video-based training to first identify the level and types of distress patients are experiencing. Next, patients will view web videos that address frequent challenges faced by ostomy patients, considering practical management and emotional and adaptation concerns. Qualitative one-to-one semistructured interviews will be conducted with participants to explore the acceptability and feasibility of the program and refine the intervention and study procedures. This study has been approved by the Mass General Brigham Institutional Review Board. Study funding has been obtained, and recruitment is planned for the fall of 2024. Through this study, we will refine CI-oSurg, a web-based communication intervention focused on reducing distress after ostomy surgery, to improve intervention acceptability and usability. These improvements will allow us to establish the usability and acceptability of the intervention before efficacy testing to determine the ability of this intervention to reduce distress after fecal ostomy surgery. ClinicalTrials.gov NCT06320002; https://clinicaltrials.gov/study/NCT06320002. PRR1-10.2196/60575.

Preferences and Feasibility of Long-Acting Technologies for the Treatment of Hepatitis C Virus: A Survey of Patients in Diverse Low- and Middle-Income Countries.

Despite available curative treatments, global rates of hepatitis C virus (HCV) infection persist with significant burden in low- and middle-income countries (LMICs). Long-acting (LA) antiviral products are in development. This study explored the challenges and opportunities in LA-HCV treatment across three LMICs: Egypt, Ethiopia and India. The survey focused on understanding barriers and facilitators to treatment, with emphasis on LA treatment preferences. Four-hundred respondents completed a survey including demographics, HCV treatment history and preferences for injections, implants and microarray patches (MAPs) compared to pills. Overall, 78% of respondents were willing to receive injections, 43% were willing to receive implants and 55% were willing to receive MAPs. Marked heterogeneity in acceptability of non-oral treatments was observed. Among respondents who had not previously received HCV treatment, 94%, 43%, and 75% were willing to receive injections, implants, or MAPs, respectively. In contrast, among those already cured by oral HCV treatment, 61%, 40% and 43% were willing to receive injections, implants or MAPs. Other characteristics associated with willingness to receive an injection included urban residence, younger age, male sex, higher education level and taking pills for any reason (all results p < 0.001). The most common concern for all LA modalities was lack of effectiveness. Prior experience with injection or implant increased willingness to receive any LA modality (p < 0.001). Coupled with a point-of-care HCV diagnostic test, availability of and willingness to receive HCV treatment delivered by a LA formulation could simplify and expand treatment access in LMICs and contribute towards global HCV elimination goals.

Treatment of prehypertension among adults with HIV: a randomized clinical trial

Objective: Elevated blood pressure (BP), even at prehypertensive levels, increases cardiovascular disease risk among people with HIV (PWH); yet international guidelines in low-income countries recommend treatment initiation at BP at least 140/90 mmHg. We determined the efficacy, feasibility, and acceptability of treating prehypertension in PWH in Haiti. Design: An unblinded randomized clinical trial (enrolled April 2021–March 2022) with 12-month follow-up. Setting: GHESKIO Centres, Port-au-Prince, Haiti. Participants: Two hundred fifty adults with HIV with prehypertension (SBP 120–138 or DBP 80–89) not on medication, aged 18–65 years, virally suppressed, and without pregnancy, diabetes, or kidney disease. Intervention: Participants were randomized to treatment (amlodipine 5 mg) or control (no amlodipine unless two BP ≥140/90 mmHg). Main outcome measure: Primary outcome was mean change in SBP between intervention versus control groups from enrollment to 12 months. Results: Among 250 adults, median age was 49 years, 40.8% were women. Baseline median BP was 129/78 mmHg intervention versus 128/77 mmHg control. After 12 months, the difference in mean change between study groups for SBP was -5.9 mmHg [95% confidence interval (95% CI) -8.8 to -3.0] and for DBP was -5.5 mmHg (95% CI -7.9 to -3.2). At 12 months, 5.6% intervention and 23.0% control participants developed incident hypertension (hazard ratio 0.18; 95% CI 0.07–0.47). There were no differences in viral load suppression at 12 months or drug-related serious adverse events. Intervention acceptability was high among providers and participants in qualitative interviews. Conclusion: In PWH in a resource-poor setting, prehypertension treatment was feasible, acceptable, and effective in reducing mean SBP and incident hypertension. Registration: Clinicaltrials.gov NCT04692467

Mapping global public perspectives on mRNA vaccines and therapeutics.

The development and rollout of mRNA vaccines during COVID-19 marked a significant advancement in vaccinology, yet public hesitation to vaccination was prevalent, indicating the potential risk that future mRNA-based medical innovations will fail to be adopted. Utilizing a combined approach of large language models with manual validation and unsupervised machine learning, we conducted a social listening analysis to assess attitudes towards mRNA vaccines and therapeutics on Twitter from June 2022 to May 2023, contrasting online perspectives with data from the Vaccine Adverse Event Reporting System. Our findings reveal widespread negative sentiment and a global lack of confidence in the safety, effectiveness, and trustworthiness of mRNA vaccines and therapeutics, with frequent discussions of severe vaccine side effects, rumors, and misinformation. This underscores the need for targeted communication strategies to foster acceptance of medical treatments and strengthen public trust in order to enhance societal resilience to future health challenges.

Protocol for a mixed methods process evaluation for a randomised controlled trial to improve shared decision-making about, and uptake of, osteoporosis medicines: the iFraP study

Background High quality shared decision-making (SDM) conversations involve people with or at risk of osteoporosis and clinicians working together to decide, where appropriate, which evidence-based medicines best fit the person’s life, beliefs, and values. The improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprises a computerised Decision Support Tool (DST), clinician training package and information resources, designed for use in UK Fracture Liaison Service (FLS) consultations. The iFraP intervention will be tested in a pragmatic, parallel-group, individual randomised controlled trial in patients referred to four FLSs in England. This mixed methods process evaluation aims to assess which components of iFraP were delivered and how (fidelity), whether iFraP results in a change in osteoporosis drug treatment initiation rates and how, and how context affects implementation of iFraP and outcomes. Methods We will collect quantitative data using (1) Case Report Forms completed by FLS clinicians; (2) self-reported questionnaires completed by patient participants; and (3) DST analytic data. We will collect qualitative data using (1) semi-structured interviews with patients who receive the iFraP intervention in their FLS appointment, FLS clinicians delivering iFraP appointments, and primary care clinicians that have consulted with a patient following their iFraP FLS appointment; and (2) FLS consultation recordings. A triangulation protocol will be used to integrate the quantitative and qualitative findings to generate novel insights about the intervention under evaluation. Discussion The process evaluation, alongside the trial, will help to understand what elements of the iFraP intervention were delivered and how, the mechanisms of impact and how context affected implementation and outcomes, and intervention acceptability. Mixed methods interpretation will lead to further insights about the implementation of SDM and DSTs in-practice. Trial registration ISRCTN: 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407

Reducing UVR Exposure in Pregnant Women and Infants: A Pilot Study.

Sun protection during pregnancy is critical for both maternal and infant skin cancer prevention, yet gaps remain in addressing this behavior in pre and postnatal settings. This pilot study aimed to evaluate the feasibility and acceptability of a peer-led intervention for expectant mothers' sun protection behaviors for themselves and their newborns and examine the preliminary effects on mothers' skin cancer knowledge, attitudes, and sun protection behaviors for themselves and their infants. Expectant mothers were recruited from medical clinics and community settings and were asked to complete surveys and interviews. The intervention, informed by the Cognitive-Social Health Information Processing model, consisted of two peer coach-led remote sessions. The majority of mothers (81%) attended both intervention sessions and reported increased understanding of (88%) and improved sun protection practices for themselves (79%; such as wearing sunscreen and reapplying sunscreen while outside). Additionally, 89% agreed that SUNRISE content is beneficial for new mothers. Moreover, maternal self-efficacy for implementing sun protection, intention to implement sun-safe behaviors for their infants, and knowledge of infant skin cancer prevention also increased with large effect sizes (d = 0.8-1.3). Mothers reported significantly decreased barriers to sun safety pre- to post-intervention. Feasibility of recruitment and delivery of a peer-led intervention focused on sun safety in women and their infants was high, and the intervention was acceptable to participating women. Mothers improved their sun protection behaviors over time, and implementation of sun protection behaviors for their infants was high. Intervention efficacy with a larger and more diverse sample is warranted, with longer follow-up.

Night Shift Work and Sleep Experiences in Older Night Shift Nurses.

Working at night leads to misalignment between the biological clock and the work/sleep schedule, resulting in sleepiness and impaired performance during the night shift and poor quality, shortened sleep during the day; this is greatly impaired in older individuals. To describe night work and sleep experiences from the perspective of older (aged 50-65) nurses. Seven virtual focus groups were formed comprising 19 older nurses who worked regular 8-hour night shifts (at least 6 consecutive hours between midnight and 6 am) to learn about their shift work and sleep experiences. Two facilitators and 2 research assistants independently reviewed and coded the transcripts using qualitative content analysis. Nine themes were identified in 3 domains: (a) night shift challenges and difficulties, including first night shift is most difficult; never feel rested working nights; and personal health concerns and benefits from working nights; (b) sleep challenges and difficulties, including inconsistent sleep timing when switching between nights and days; extended (24+ hours) time awake before and after consecutive nights; difficulty maintaining long and sound daytime sleep; and napping before night shifts for better performance; and (c) family and social challenges and support, including childcare, family, personal obligations, and social activities affect sleep; aging of self and children influences sleep and prioritization of sleep. The findings help understand challenges and struggles to obtain adequate sleep and safe work performance in older night shift nurses. These insignts are critical for designing and implementing feasible and acceptable interventions to improve sleep in this high-risk occupational group.

Intervention development and optimisation of a multi-component digital intervention for the monitoring and management of hypertensive pregnancy: the My Pregnancy Care Intervention.

Hypertensive disorders of pregnancy affect around 10% of pregnancies and remain a major cause of maternal and foetal morbidity and mortality. Trials have shown that self-monitoring blood pressure during pregnancy is safe, but self-monitoring alone does not improve blood pressure control or pregnancy outcomes. This study aimed to develop and optimise a multicomponent intervention to support blood pressure monitoring, hypertension management and urine testing within current care pathways. Relevant literature, input from patient and public contributors (PPI) and stakeholder groups, and the researcher's previous experience were used to develop an initial intervention. Think-aloud interviews and focus groups with women from diverse backgrounds with lived experience of hypertension in pregnancy and healthcare professionals provided feedback on the intervention prototype (n = 29). The MRC Framework for Developing Complex Interventions guided the processes to optimise the intervention's acceptability and maximise engagement. A detailed tabulation of participants' views and logic models was produced using the COM-B model of Behaviour Change. The prototype intervention was acceptable and viable to both pregnant women with experience of hypertensive pregnancy and healthcare professionals. Emerging themes centred on how the intervention could be optimised within current National Health Service care pathways and the lives of pregnant women to support behaviour change. Key target behaviours to support the intervention included increasing understanding of blood pressure management, engagement with the intervention, monitoring blood pressure and urine and taking appropriate actions based on those readings. This informed the development of recommendations involving clear action timelines for women and evidence-based guidance to support decision-making by healthcare professionals. The findings were used to produce the multi-component My Pregnancy Care intervention, consisting of a smartphone application and an information leaflet to support blood pressure self-monitoring and proteinuria self-testing, self-management of antihypertensive medication and smartphone application use. This research provided comprehensive insight into the needs of pregnant women with hypertension and their healthcare teams regarding self-monitoring and management of blood pressure. This supported the development of a tailored multi-component digital intervention that addresses barriers to blood pressure self-management by being user-friendly, persuasive and acceptable. It is hoped that the intervention will support the monitoring and management process, collaboration between healthcare professionals and women, clinical action and improved clinical outcomes.

Effectiveness and Feasibility of Digital Pulmonary Rehabilitation in Patients Undergoing Lung Cancer Surgery: Systematic Review and Meta-Analysis.

Pulmonary rehabilitation (PR) has been shown to effectively support postsurgical recovery in patients with lung cancer (LC) at various stages. While digital PR programs offer a potential solution to traditional challenges, such as time and space constraints, their efficacy and feasibility for patients undergoing LC surgery remain unclear. This systematic review aims to assess the feasibility and effectiveness of digital PR programs for individuals undergoing LC surgery. A systematic review was conducted, retrieving data from 6 English and 4 Chinese databases from their inception to January 1, 2024. References in related studies were also manually reviewed. The primary outcomes assessed were physical capacity, lung function, and the incidence of postoperative pulmonary complications (PPCs). The secondary outcomes were compliance, hospital stay, chest tube duration, anxiety, depression, and quality of life. Where applicable, recruitment and withdrawal rates were also evaluated. Meta-analysis and descriptive analysis were used to assess the outcomes. A total of 5 randomized controlled trials and 6 quasi-experimental studies (n=1063) were included, with 4 studies being included in the meta-analyses. Our meta-analyses revealed that digital PR reduced the decline in 6-minute walk distance (6-MWD) by an average of 15 m compared with routine PR programs from admission to discharge, demonstrating a clinically significant improvement in physical capacity (mean difference -15.00, 95% CI -25.65 to -4.34, P=.006). Additionally, digital PR was associated with a reduction (26/58, 45%) in the likelihood of PPCs (risk ratio 0.45, 95% CI 0.30-0.66, P<.001) and a reduction of 1.53 days in chest tube duration (mean difference -1.53, 95% CI -2.95 to -0.12, P=.03), without a statistically significant effect on postoperative hospital stay (mean difference -1.42, 95% CI -3.45 to 0.62, P=.17). Descriptive analyses suggested that digital PR has the potential to improve knowledge, lung function, quality of life, and self-efficacy, while reducing depression and anxiety. Notably, digital PR was found to be a safe, feasible, and acceptable supplementary intervention. Despite challenges with low recruitment, digital PR enhanced exercise compliance, increased patient satisfaction, and lowered dropout rates. This systematic review is the first comprehensive analysis to suggest that digital PR is a safe, feasible, acceptable, and effective intervention for promoting recovery in patients with LC after surgery. Digital PR has the potential to be a valuable supplement, expanding access to traditional PR programs. Future research should prioritize the development of interactive and inclusive digital solutions tailored to diverse age groups and educational backgrounds. Rigorous studies, including large-scale, high-quality randomized controlled trials with detailed protocols and robust methodologies, are needed to assess the short-, medium-, and long-term efficacy of digital PR, ensuring reproducibility in future research. PROSPERO CRD42023430271; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=430271.

Task-sharing to promote caregiver mental health, positive parenting practices, and violence prevention in vulnerable families in Sierra Leone: a pilot feasibility study.

The prevalence of household violence in low- and middle-income countries (LMICs) is high, and exposure to violence has significant adverse effects on both mental health and child development across generations. Evidence-based services to improve parenting practices and reduce household violence in LMICs are scarce, particularly across rural regions of West Africa. This study explored the feasibility, acceptability, and potential benefits of an evidence-based home-visiting intervention to promote early childhood development and reduce household violence-the Family Strengthening Intervention for Early Childhood Development and Violence-Prevention (FSI-ECD + VP)-among vulnerable families in rural regions of Sierra Leone. Eighty dual-caregiver households in the Makeni region of Sierra Leone were included in the study (N = 160 caregivers; 73% female). Eligibility criteria included having at least one child aged 6-36 months and elevated scores (> 62.5) on the Difficulties in Emotion Regulation Scale (DERS). Community Health Workers (CHWs) employed in the Makeni region completed a 3-week FSI-ECD + VP training. Families were randomized to receive either the FSI-ECD + VP or treatment as usual (TAU). Research assistants blinded to treatment assignment assessed caregiver mental health, caregiver-child interactions, and household violence at baseline, post-intervention, and 3-month follow-up time points. Triangulation of quantitative and qualitative data showed that caregivers, CHWs, and supervisors generally perceived the intervention as beneficial, feasible, and acceptable. Mixed effects models showed that caregivers who received the FSI-ECD + VP had significantly improved caregiver-child relationship outcomes compared to TAU as assessed by the Home Observation for Measurement of the Environment and the Observation of Caregiver-Child Interactions at post-intervention. Preliminary data also suggests that caregivers receiving the FSI-ECD + VP were less likely to have experienced intimate partner physical violence during the post-intervention period, and had lower symptoms of anxiety and depression at 3-month follow-up. FSI-ECD + VP delivery by CHWs in Sierra Leone may be feasible and acceptable; it may also help improve caregiver-child interactions and reduce the likelihood of household violence among vulnerable families with young children. Task-sharing approaches may help increase acceptability and access to evidence-based behavioral interventions that promote early childhood development and violence prevention among families in rural regions of Sierra Leone and other similar settings. The study is registered in clinicaltrials.gov (NCT03045640; 07/22/2020). This study follows the Consort 2010 guidelines for reporting of clinical trials.

Exploring how to widen the acceptability of public health interventions: a systematic review protocol

IntroductionHealth interventions that require significant change to individual lifestyles or social norms can pose a challenge for widespread public acceptability and uptake. At the same time, over the last two...

The Comprehensive Resilience-building psychosocial Intervention (CREST) for people with dementia in the community: a feasibility and acceptability study

BackgroundA dementia diagnosis can lead to a decline in cognitive, social, and physical health, but people with dementia can live meaningful lives and participate actively in society with psychosocial support. This single-arm, non-randomised feasibility study explored the feasibility and acceptability of a Comprehensive REsilience-building psychoSocial intervenTion (CREST) for people with dementia, their caregivers, General Practitioners (GPs), and the public.MethodsNine people with dementia and their primary caregivers living in the community (n = 9 dyads) completed the CREST intervention which had three components (cognitive stimulation therapy [CST], physical exercise, and dementia education). Quantitative secondary outcomes were assessed at baseline and following the 15-week intervention; qualitative interviews were conducted during and post-intervention. All study components were assessed against pre-defined criteria, to determine the feasibility of conducting a future definitive trial.ResultsRecruitment of people with dementia and their caregiver was a significant challenge and led to considerable delays to the onset and conduct of the intervention. Only 13% of eligible GP practices agreed to assist in recruitment and achieved a 6% enrolment rate; a community-based recruitment strategy proved more effective, yielding a 29% enrolment rate. However, once recruited, participants maintained high attendance and adherence to the content of each component with average adherence rates of 98% for CST, exercise sessions and caregiver education. Adherence to secondary exercise measures was lower, with home exercise diary completion at 37% and Fitbit wear adherence at 80% during the day and 67% at night. The people with dementia felt their concentration and fitness had improved over the 15-week intervention and particularly enjoyed the social aspects (e.g. group classes, exercising with partners from the community). Caregivers felt they had better knowledge and understanding following their education component and reported that the social aspects (interacting and sharing experiences with each other) were important. Overall, participants reported that the three components of the intervention were feasible and acceptable. In addition, the quantitative measures and health economic tools employed were feasible. However, the secondary elements of the exercise component (recording home exercise diaries and Fitbit use) were not considered feasible. Overall, pre-defined criteria for progression to a definitive intervention were fulfilled in terms of acceptability, retention and fidelity but not recruitment.ConclusionWhile overall, the CREST intervention was feasible and acceptable to participants, significant difficulties with recruitment of people with dementia and their caregiver through GP practices impacted the viability of delivering the intervention. Recruitment through community-based groups proved a more feasible option and further work is needed to overcome barriers to recruiting this cohort before a larger-scale trial can be conducted.Trial registrationISRCTN25294519.

Preliminary Feasibility of a Novel Mind-Body Program to Prevent Persistent Concussion Symptoms Among Young Adults With Anxiety: Nonrandomized Open Pilot Study.

Concussions are common, particularly among young adults, and often are associated with persistent, debilitating, and hard-to-treat symptoms. Anxiety and concussion symptoms often amplify each other, and growing evidence indicates that anxiety plays a key role in symptoms persistence after concussion. Targeting anxiety early after concussion may be a promising means of helping prevent persistent concussion symptoms in this population. We developed the Toolkit for Optimal Recovery after Concussion (TOR-C), the first mind-body program tailored for young adults with a recent concussion and anxiety, aiming to prevent persistent concussion symptoms. This study aims to conduct an open pilot of TOR-C to test preliminary feasibility, signal of change in measures, and treatment perceptions. Five young adults (aged 18-24 years) attended 4 weekly one-on-one live video sessions with a clinician. Participants completed questionnaires measuring treatment targets (ie, pain catastrophizing, mindfulness, fear avoidance, limiting behaviors, and all-or-nothing behaviors) and outcomes (ie, postconcussive symptoms, physical function, anxiety, depression, and pain) at baseline, immediately following the intervention, and 3 months after intervention completion. At the conclusion of the program, participants attended a qualitative interview and provided feedback about the program to help optimize study content and procedures. Feasibility markers were excellent for credibility and expectancy (5/5, 100% of participants scored above the credibility and expectancy scale midpoint), client satisfaction (4/5, 80% of participants scored above the Client Satisfaction Questionnaire midpoint), therapist adherence (97% adherence), acceptability of treatment (5/5, 100% of participants attended 3 or more sessions), adherence to homework (87% home practice completion), and feasibility of assessments (no measures fully missing). The feasibility of recruitment was good (5/7, 71% of eligible participants agreed to participate). There were preliminary signals of improvements from pre-post comparisons in treatment targets (d=0.72-2.20) and outcomes (d=0.41-1.38), which were sustained after 3 months (d=0.38-2.74 and d=0.71-1.63 respectively). Exit interviews indicated overall positive perceptions of skills and highlighted barriers (eg, busyness) and facilitators (eg, accountability) to engagement. TOR-C shows preliminary feasibility, is associated with a signal of improvement in treatment targets and outcomes, and has the potential to support recovery from concussion. The quantitative findings along with the qualitative feedback obtained from the exit interviews will help optimize TOR-C in preparation for an upcoming randomized controlled trial of TOR-C versus an active control condition of health education for concussion recovery. RR2-10.2196/25746.

Empowering Dementia Communication via Virtual Reality AI-Driven Simulations

The use of effective communication skills is essential for direct care workers to provide quality care for persons living with dementia (PLWD) in long-term service and support settings (LTSS). However, direct care workers often report feeling unprepared, lacking competence in care, and fear interacting with PLWD. This proof-of-concept study proposes Virtual reality Communication Training Optimizing Real-world Interactions (VICTORI) intervention, aiming to develop and evaluate the usability, acceptability, and preliminary effectiveness of virtual reality (VR) simulated communication training for direct care workers using artificial intelligence (AI)-generated patients with dementia. Care-related and social communication scenarios in dementia care will be developed, based on current literature, our validated communication instrument, and AI technology. Six modules consisting of pre-briefing, simulation facilitation, and de-briefing will be developed, refined, and evaluated based on an advisory board of experts and direct care workers’ quantitative and qualitative feedback. To test the usability, acceptability, and effectiveness of the VICTORI intervention, we will use a single group pre- and post-test intervention design, integrating quantitative measures and qualitative semi-structured interviews in this mixed-methods study. Thirty direct care workers will be recruited at two LTSS in North Texas. Direct care workers will participate in six VR-AI simulation commu-nication training sessions that include communication with AI-generated patients, real-time feedback, and detailed evaluation of communication behaviors. Each simulation will be recorded to further evaluate the partici-pant’s communication skills using the Dyadic Communi-cation Observational coding scheme in Dementia care (DCODE). Additionally, participants' potential side effects during VR simulation will be assessed using continuous physiological data and self-reported questionnaires at each simulation session. Communication knowledge and com-petence in dementia care will be assessed before and after training using self-reported questionnaires. Direct care workers will also be interviewed to assess acceptability and satisfaction with the VICTORI training. This proposal will introduce innovative training methods that leverage AI technology into communication training in dementia care. Objective assessments, including AI-based feedback, physiological data, and observational assessments, ensure the reliability and validity of the data to evaluate plausibility of VICTORI intervention.

‘Thanks, but no thanks’: The public's response to engagement with NHS Talking Therapies – a salutary tale?

AbstractObjectivesThe English NHS Talking Therapies has been hailed as a world leader in demonstrating outcomes, generating 1.76 million referrals in the year 2022–2023, with a claimed 49.9% recovery rate, but there has been a dearth of independent evaluations. Importantly, there have been no published data on those who only attended one assessment/treatment session. This also applies to public services internationally. The issue of the acceptability of psychological treatment has not been addressed.MethodThe user‐friendliness of NHS Talking Therapies was examined, drawing on unpublished data revealed following a Freedom Of Information request response to the author in June 2024. These data are set alongside the service's published data to give a more comprehensive view of real‐world outcomes and whether it should be a template for other countries to follow.ResultsAlmost half (45%) do not complete treatment, and for completers, the results are no better than for placebo. The diagnostic status of almost a third (29.1%) who attend just one session is unknown. The numbers of people who attend one assessment/ treatment session is approximately half of those who attend two or more treatment sessions, but the ratio varies by disorder.ConclusionNHS Talking Therapies' engagement difficulties casts serious doubt on the service's claim to be a ‘world beater’. There is no evidence that NICE‐compliant evidence‐based psychological treatments have been delivered. While this model has been widely adopted in the UK, this should not be transferred to other service systems without contextualisation and evidence on whether/how some of its components could be implemented in those settings.

A Randomized Feasibility Study of Rehabilitation Targeting Upper Extremity Function and Participation Using Hippotherapy and the Equine Environment for Children with Cerebral Palsy and Autism Spectrum Disorder.

Introduction: Children with upper extremity neuromotor impairments often have decreased participation in life activities. Hippotherapy and rehabilitation in the equine environment might be effective in targeting participation, given the community context and natural activity involvement. This randomized controlled feasibility trial assessed recruitment, retention, treatment fidelity, and acceptability of rehabilitation using hippotherapy and the equine environment, targeting upper extremity function and participation for children with neuromotor impairments to inform a larger trial. Methods: This 6-month trial occurred in Ohio, June-December 2021. Participants were 6-17 years old with upper extremity neuromotor impairment (and primary diagnosis of cerebral palsy and/or autism). Participants were randomized into treatment or waitlist control using REDCap. Treatment was 16 h (4 h/week/4 weeks) of rehabilitation using hippotherapy and the equine environment. Control participants completed a 4-week waiting period, then received the treatment. Recruitment, screening, enrollment, attendance, and retention were tracked. Nonblinded assessments of body structures and functions, activity, and participation were administered pre- and postcontrol and treatment. Assessment measure completion, treatment fidelity, and acceptability were recorded. Results: Twenty-six participants were screened between July and October 2021; 77% (20/26) met inclusion criteria; 70% (14/20) enrolled and randomized: 6 control and 8 treatment. Two withdrew after randomization and one was excluded for fear of horses. In total, n = 5 control and n = 6 treatment completed initial assessment. Retention was 80% (4/5) control and 83% (5/6) treatment, just below the a priori criteria (85%). Assessment measure completion was variable (77%-100%) and replacement of some should be considered before advancing to a clinical trial. Treatment fidelity and acceptability were moderate to high. There were no adverse events from study participation. Conclusions: Results demonstrated preliminary evidence of fidelity and acceptability of rehabilitation using hippotherapy and the equine environment for children with upper extremity neuromotor impairments. Some changes should be made to improve enrollment, retention, and outcome measure completion before advancing to a definitive trial. Trial registration: ClinicalTrials.gov identifier: NCT0653068. Trial funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development, Foundation for Physical Therapy Research, American Academy of Cerebral Palsy and Developmental Medicine, and Pedal With Pete Foundation.

The Context of the Emergency Department as a Location for a Smoking Cessation Intervention-Process Evaluation Findings From the Cessation of Smoking Trial in the Emergency Department Trial.

Hospital emergency departments (ED) offer an opportunity to engage with large numbers of people who smoke to prompt cessation, although the acceptability of opportunistic intervention in this context has been questioned. This process evaluation study was embedded into the Cessation of Smoking Trial in the Emergency Department (COSTED) randomized controlled trial and sought to explore the context of intervention delivery within the ED. Qualitative interviews were conducted with participants and staff across six EDs participating in the COSTED randomized controlled trial. Interview data were thematically analyzed specifically exploring contextual influences. Data were triangulated with ethnographic observations. In participant interviews (N = 34), it was acceptable overall to receive a brief opportunistic smoking cessation intervention in the ED. Contextual factors are impacted at a range of levels. At the micro level participant views and experiences combined with staff tailoring were important. Being given an e-cigarette starter kit by a "credible source" helped to legitimize vaping for smoking cessation and gave confidence in personal ability to switch away from tobacco. At the meso level, adaptations to intervention delivery were made in response to the context of the ED. Stop smoking advisors (N = 11) had to adapt and deliver the intervention flexibly depending on space and clinical need. At the macro level, hospital policies supportive of vaping legitimized the approach. Smoking cessation outcomes reported in the main trial across sites were very similar because of the high credibility, acceptability, and flexible approach to delivering the COSTED intervention in the ED. Attending a hospital ED is the right time and place to receive smoking cessation intervention, even for those not motivated to quit. People are willing to receive intervention, and clinical staff are willing to support intervention delivery. Despite challenges, overall the context is helpful in supporting people to switch away from tobacco. The intervention, with flexible and tailored implementation, is adaptable to different ED contexts. This suggests that wider implementation across NHS Trusts of the effective COSTED intervention is feasible and will ultimately support smoking cessation for people attending EDs, who may not otherwise have sought support.