A pilot randomised controlled trial of acceptance and commitment therapy for medication decision-making and quality of life in women with breast cancer: The ACTION trial.

OBJECTIVE: Non-adherence to adjuvant endocrine therapy (AET) in women with breast cancer is common and associated with medication side-effects and distress. We co-designed an Acceptance and Commitment Therapy intervention (ACTION) to enhance medication decision-making and quality of life (QoL). We undertook a pilot trial of ACTION to inform the feasibility of a phase III trial, and to examine intervention acceptability. METHODS: This was a multi-site, exploratory, two-arm, individually randomised external pilot trial. Women with early breast cancer prescribed AET were randomised (1:1) to receive usual care (UC) or UC + ACTION. The ACTION intervention comprised a remotely delivered one-to-one ACT session followed by three group sessions delivered by clinical psychologists, alongside a website containing ideas for the self-management of side effects. RESULTS: Of the 480 women screened for eligibility, 260 (54.2%) were approached and 79 (30.4%) randomised. 71 (89.9%) women provided data at 3-month and 70 (88.6%) at 6-month 40 women were randomised to receive UC + ACTION and 32 (80.0%) completed the intervention. Most (75.0%) accessed the website at least once. ACTION was acceptable to participants (Borkovec & Nau Scale: mean = 7.8 [SD = 2.7] out of 10). Signals of effectiveness in favour of the UC + ACTION arm were observed for medication adherence (Adherence Starts with Knowledge questionnaire-12), QoL (work and social adjustment scale), health-related QoL (functional assessment of cancer therapy[FACT] general and FACT-ES-19/23), distress (generalised anxiety disorder -7, patient health questionnaire-9) and psychological flexibility (valuing questionnaire). CONCLUSIONS: The ACTION intervention was acceptable to patients. There were promising signals for effectiveness on primary and secondary outcomes. A phase III randomised controlled trial is feasible. TRIAL REGISTRATION: ISRCTN12027752.

In-person versus remote (mHealth) delivery for a responsive parenting intervention in rural Kenya: a cluster randomized controlled trial.

BACKGROUND: An estimated 43% of children under age 5 in low- and middle-income countries (LMICs) experience compromised development due to poverty, poor nutrition, and inadequate psychosocial stimulation. Numerous early childhood development (ECD) parenting interventions have been shown to be effective at improving ECD outcomes, at least in the short-term, but they are (a) still too expensive to implement at scale in low-resource and rural settings, and (b) their early impacts tend to fade over time. New approaches to deliver effective ECD parenting interventions that are low-cost, scalable, and sustainable are sorely needed. METHODS: Our study will experimentally test a traditional in-person group-based delivery model for an evidence-based ECD parenting intervention against a hybrid-delivery model that increasingly substitutes in-person meetings with remote (mHealth) delivery via smartphones, featuring audiovisual content and WhatsApp social interactions and learning. We will assess the relative effectiveness and cost of this hybrid-delivery model compared to in-person delivery and will extend the interventions over two years to increase their ability to sustain changes in parenting behaviors and ECD outcomes longer-term. Our evaluation design is a cluster Randomized Controlled Trial (cRCT) across 90 villages and approximately 1200 households. Midline and endline surveys collected 12 and 24 months after the start of the interventions, respectively, will examine short- and sustained two-year intention-to-treat impacts on primary outcomes. We will also examine the mediating pathways using mediation analysis. We hypothesize that a hybrid-delivery ECD intervention will be lower in cost, but remote interactions among participants may be an inferior substitute for in-person visits, leaving open the question of the most cost-effective program. DISCUSSION: Our goal is to determine the best model to maximize the intervention's reach and sustained impacts to improve child outcomes. By integrating delivery into the ongoing operations of local Community Health Promoters (CHPs) within Kenya's rural health care system, and utilizing new low-cost technology, our project has the potential to make important contributions towards discovering potentially scalable, sustainable solutions for resource-limited settings. TRIAL REGISTRATION: NCT06140017 (02/08/2024) AEARCTR0012704.

Cost-effectiveness of cognitive behavioural and personalized exercise interventions for reducing fatigue in inflammatory rheumatic diseases.

OBJECTIVES: To estimate the cost-effectiveness of a cognitive behavioural approach (CBA) or a personalized exercise programme (PEP), alongside usual care (UC), in patients with inflammatory rheumatic diseases who report chronic, moderate to severe fatigue. METHODS: A within-trial cost-utility analysis was conducted using individual patient data collected within a multicentre, three-arm randomized controlled trial over a 56-week period. The primary economic analysis was conducted from the UK National Health Service (NHS) perspective. Uncertainty was explored using cost-effectiveness acceptability curves and sensitivity analysis. RESULTS: Complete-case analysis showed that, compared with UC, both PEP and CBA were more expensive [adjusted mean cost difference: PEP £569 (95% CI: £464, £665); CBA £845 (95% CI: £717, £993)] and, in the case of PEP, significantly more effective [adjusted mean quality-adjusted life year (QALY) difference: PEP 0.043 (95% CI: 0.019, 0.068); CBA 0.001 (95% CI: -0.022, 0.022)]. These led to an incremental cost-effectiveness ratio (ICER) of £13 159 for PEP vs UC, and £793 777 for CBA vs UC. Non-parametric bootstrapping showed that, at a threshold value of £20 000 per QALY gained, PEP had a probability of 88% of being cost-effective. In multiple imputation analysis, PEP was associated with significant incremental costs of £428 (95% CI: £324, £511) and a non-significant QALY gain of 0.016 (95% CI: -0.003, 0.035), leading to an ICER of £26 822 vs UC. The estimates from sensitivity analyses were consistent with these results. CONCLUSION: The addition of a PEP alongside UC is likely to provide a cost-effective use of health care resources.

Synchronous Web-Based Psychotherapy for Mental Disorders From a Health Quality Perspective: Scoping Review.

BACKGROUND: The COVID-19 pandemic necessitated rapid changes to health care delivery, including a shift from in-person to digitally delivered psychotherapy. While these changes helped ensure timely psychotherapy provision, many concerns exist, including clinical, cultural, practical, privacy, and security issues. OBJECTIVE: This scoping review systematically mapped existing peer-reviewed research on synchronous, therapist-delivered web-based psychotherapy for individuals with a diagnosed mental illness. Data were analyzed through the lens of the Alberta Quality Matrix for Health (AQMH) to assess to what degree this literature addresses key indicators of health care quality. This analysis aided in the identification and organization of knowledge gaps with regard to web-based psychotherapies, highlighting potential disparities between previously prioritized dimensions of care and those requiring further attention. METHODS: This review adhered to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines. We included peer-reviewed primary research studies in the English language investigating synchronous, therapist-delivered remote psychotherapy delivered to adults (aged 18 years and older) with a Diagnostic and Statistical Manual of Mental Disorders or International Statistical Classification of Diseases diagnosed mental illness. All other citations were excluded. Relevant studies were identified through MEDLINE, APA PsycINFO, Embase (OVID), Web of Science: Core Collection (Clarivate), Cochrane Library (Wiley), and Scopus (Elsevier) databases. Databases were searched on March 18, 2021. For every publication that was taken into consideration, the data were charted independently by 2 reviewers, and in the event of a discrepancy, the principal investigator validated the choice of either extractor. Results were thematically described according to the 6 AQMH dimensions: acceptability, accessibility, appropriateness, effectiveness, efficiency, and safety. RESULTS: From 13,209 publications, 48 articles were included, largely from North American studies. Most studies measured treatment effectiveness (n=48, 100%) and acceptability (n=29, 60%) health quality dimensions. Over 80% (40/48) of studies investigated either a cognitive or exposure intervention for either posttraumatic stress disorder or a mood or anxiety disorder, generally indicating comparable results to in-person therapy. Safety (n=5, 10%) was measured in fewer studies, while treatment accessibility, appropriateness, and efficiency were not explicitly measured in any study, although these dimensions were mentioned as a future direction, hypothesis, or potential outcome. CONCLUSIONS: In relation to web-based therapist-delivered psychotherapies for those with a diagnosed mental illness, important aspects of health care quality (accessibility, appropriateness, efficiency, and safety) have received little scientific examination, underscoring a need to address these gaps. There are also significant issues related to the generalizability of this literature, including the underrepresentation of many geographic regions, cultures, populations, clinical contexts, and psychotherapy modalities. Qualitative research in underrepresented populations and settings may uncover important patient and contextual factors important for the future implementation of quality web-based psychotherapy.

TIDieR-telehealth: precision in reporting of telehealth interventions used in clinical trials - unique considerations for the Template for the Intervention Description and Replication (TIDieR) checklist.

BACKGROUND: Recent international health events have led to an increased proliferation of remotely delivered health interventions. Even with the pandemic seemingly coming under control, the experiences of the past year have fueled a growth in ideas and technology for increasing the scope of remote care delivery. Unfortunately, clinicians and health systems will have difficulty with the adoption and implementation of these interventions if ongoing and future clinical trials fail to report necessary details about execution, platforms, and infrastructure related to these interventions. The purpose was to develop guidance for reporting of telehealth interventions. METHODS: A working group from the US Pain Management Collaboratory developed guidance for complete reporting of telehealth interventions. The process went through 5-step process from conception to final checklist development with input for many stakeholders, to include all 11 primary investigators with trials in the Collaboratory. RESULTS: An extension focused on unique considerations relevant to telehealth interventions was developed for the Template for the Intervention Description and Replication (TIDieR) checklist. CONCLUSION: The Telehealth Intervention guideline encourages use of the Template for the Intervention Description and Replication (TIDieR) checklist as a valuable tool (TIDieR-Telehealth) to improve the quality of research through a reporting guide of relevant interventions that will help maximize reproducibility and implementation.

Remote Delivery of Yoga Interventions Through Technology: Scoping Review.

BACKGROUND: The popularity of yoga and the understanding of its potential health benefits have recently increased. Unfortunately, not everyone can easily engage in in-person yoga classes. Over the past decade, the use of remotely delivered yoga has increased in real-world applications. However, the state of the related scientific literature is unclear. OBJECTIVE: This scoping review aimed to identify gaps in the literature related to the remote delivery of yoga interventions, including gaps related to the populations studied, the yoga intervention characteristics (delivery methods and intervention components implemented), the safety and feasibility of the interventions, and the preliminary efficacy of the interventions. METHODS: This scoping review was conducted in accordance with the PRISMA-ScR (Preferred Reporting Item for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Scientific databases were searched throughout April 2021 for experimental studies involving yoga delivered through technology. Eligibility was assessed through abstract and title screening and a subsequent full-article review. The included articles were appraised for quality, and data were extracted from each article. RESULTS: A total of 12 studies of weak to moderate quality were included. Populations varied in physical and mental health status. Of the 12 studies, 10 (83%) implemented asynchronous delivery methods (via prerecorded material), 1 (8%) implemented synchronous delivery methods (through videoconferencing), and 1 (8%) did not clearly describe the delivery method. Yoga interventions were heterogeneous in style and prescribed dose but primarily included yoga intervention components of postures, breathing, and relaxation and meditation. Owing to the heterogeneous nature of the included studies, conclusive findings regarding the preliminary efficacy of the interventions could not be ascertained. CONCLUSIONS: Several gaps in the literature were identified. Overall, this review showed that more attention needs to be paid to yoga intervention delivery methods while designing studies and developing interventions. Decisions regarding delivery methods should be justified and not made arbitrarily. Studies of high methodological rigor and robust reporting are needed.

Remotely Delivered Interventions to Support Women With Symptoms of Anxiety in Pregnancy: Mixed Methods Systematic Review and Meta-analysis.

BACKGROUND: Symptoms of anxiety are common in pregnancy, with severe symptoms associated with negative outcomes for women and babies. Low-level psychological therapy is recommended for women with mild to moderate anxiety, with the aim of preventing an escalation of symptoms and providing coping strategies. Remotely delivered interventions have been suggested to improve access to treatment and support and provide a cost-effective, flexible, and timely solution. OBJECTIVE: This study identifies and evaluates remotely delivered, digital, or web-based interventions to support women with symptoms of anxiety during pregnancy. METHODS: This mixed methods systematic review followed a convergent segregated approach to synthesize qualitative and quantitative data. The ACM Digital Library, Allied and Complementary Medicine Database, Applied Social Sciences Index and Abstracts, Centre for Reviews and Dissemination database, the Cochrane Central Register of Controlled Trials, the Cochrane Library, CINAHL, Embase, Health Technology Assessment Library, IEEE Xplore, Joanna Briggs Institute, Maternity and Infant Care, MEDLINE, PsycINFO, and the Social Science Citation Index were searched in October 2020. Quantitative or qualitative primary research that included pregnant women and evaluated remotely delivered interventions reporting measures of anxiety, fear, stress, distress, women's views, and opinions were included. RESULTS: Overall, 3 qualitative studies and 14 quantitative studies were included. Populations included a general antenatal population and pregnant women having anxiety and depression, fear of childbirth, insomnia, and preterm labor. Interventions included cognitive behavioral therapy, problem solving, mindfulness, and educational designs. Most interventions were delivered via web-based platforms, and 62% (8/13) included direct contact from trained therapists or coaches. A meta-analysis of the quantitative data found internet-based cognitive behavioral therapy and facilitated interventions showed a beneficial effect in relation to the reduction of anxiety scores (standardized mean difference -0.49, 95% CI -0.75 to -0.22; standardized mean difference -0.48, 95% CI -0.75 to -0.22). Due to limitations in the amount of available data and study quality, the findings should be interpreted with caution. Synthesized findings found some evidence to suggest that interventions are more effective when women maintain regular participation which may be enhanced by providing regular contact with therapists or peer support, appropriate targeting of interventions involving components of relaxation and cognitive-based skills, and providing sufficient sessions to develop new skills without being too time consuming. CONCLUSIONS: There is limited evidence to suggest that women who are pregnant may benefit from remotely delivered interventions. Components of interventions that may improve the effectiveness and acceptability of remotely delivered interventions included providing web-based contact with a therapist, health care professional, or peer community. Women may be more motivated to complete interventions that are perceived as relevant or tailored to their needs. Remote interventions may also provide women with greater anonymity to help them feel more confident in disclosing their symptoms.

Mesenchymal stem cell mediates cardiac repair through autocrine, paracrine and endocrine axes.

In the past decade, despite key advances in therapeutic strategies following myocardial infarction, none can directly address the loss of cardiomyocytes following ischemic injury. Cardiac cell-based therapy is at the cornerstone of regenerative medicine that has shown potential for tissue repair. Mesenchymal stem cells (MSC) represent a strong candidate to heal the infarcted myocardium. While differentiation potential has been described as a possible avenue for MSC-based repair, their secreted mediators are responsible for the majority of the ascribed prohealing effects. MSC can either promote their own survival and proliferation through autocrine effect or secrete trophic factors that will act on adjacent cells through a paracrine effect. Prior studies have also documented beneficial effects even when MSCs were remotely delivered, much akin to an endocrine mechanism. This review aims to distinguish the paracrine activity of MSCs from an endocrine-like effect, where remotely transplanted cells can promote healing of the injured myocardium.

Developing thinking around mental health science: the example of intrusive, emotional mental imagery after psychological trauma.

INTRODUCTION: One route to advancing psychological treatments is to harness mental health science, a multidisciplinary approach including individuals with lived experience and end users (e.g., Holmes, E. A., Craske, M. G., & Graybiel, A. M. (2014). Psychological treatments: A call for mental-health science. Nature, 511(7509), 287-289. doi:10.1038/511287a). While early days, we here illustrate a line of research explored by our group-intrusive imagery-based memories after trauma. METHOD/RESULTS: We illustrate three possible approaches through which mental health science may stimulate thinking around psychological treatment innovation. First, focusing on single/specific target symptoms rather than full, multifaceted psychiatric diagnoses (e.g., intrusive trauma memories rather than all of posttraumatic stress disorder). Second, investigating mechanisms that can be modified in treatment (treatment mechanisms), rather than those which cannot (e.g., processes only linked to aetiology). Finally, exploring novel ways of delivering psychological treatment (peer-/self-administration), given the prevalence of mental health problems globally, and the corresponding need for effective interventions that can be delivered at scale and remotely for example at times of crisis (e.g., current COVID-19 pandemic). CONCLUSIONS: These three approaches suggest options for potential innovative avenues through which mental health science may be harnessed to recouple basic and applied research and transform treatment development.

The Feasibility of Remotely Delivered Exercise Session in Adults With Alzheimer's Disease and Their Caregivers.

Adults with Alzheimer's disease (AD) and their caregivers represent a segment of the population with low levels of moderate-intensity physical activity (MPA) and limited options for increasing MPA. The purpose of this study was to evaluate the feasibility of a group video conference approach for increasing MPA in adults with AD and their caregivers. Adults with AD and their caregivers attended 30-min group exercise sessions three times per week for 12 weeks. Exercise sessions and support sessions were delivered in their homes on a tablet computer over video conferencing software. Nine adults with AD/caregiver dyads enrolled, and seven completed the 12-week intervention. Adults with AD attended 77.3% of the group exercise sessions, and caregivers attended 79.2% of group exercise sessions. Weekly MPA increased in both adults with AD (49%) and caregivers (30%). Exercise delivered by group video conferencing is a feasible and potentially effective approach for increasing MPA in adults with AD and their caregivers.

In-person versus remote (mHealth) delivery for a responsive parenting intervention in rural Kenya: A cluster randomized controlled trial.

Background: An estimated 43% of children under age 5 in low- and middle-income countries (LMICs) experience compromised development due to poverty, poor nutrition, and inadequate psychosocial stimulation. Numerous early childhood development (ECD) parenting interventions have been shown to be effective at improving ECD outcomes, at least in the short-term, but they are a) still too expensive to implement at scale in low-resource and rural settings, and b) their early impacts tend to fade over time. New approaches to deliver effective ECD parenting interventions that are low-cost, scalable, and sustainable are sorely needed. Methods: Our study will experimentally test a traditional in-person group-based delivery model for an evidence-based ECD parenting intervention against a hybrid-delivery model that increasingly substitutes in-person meetings for a remote (mHealth) delivery via smartphones, featuring audiovisual content and WhatsApp social interactions and learning. We will assess the relative effectiveness and cost of this hybrid-delivery model against purely in-person delivery and will extend the interventions over two years to increase their ability to sustain changes in parenting behaviors and ECD outcomes longer-term. Our evaluation design is a cluster Randomized Controlled Trial (cRCT) across 90 villages and approximately 1200 households. Midline and endline surveys collected 12 and 24 months after the start of the interventions, respectively, will examine short- and sustained two-year intention-to-treat impacts on primary outcomes. We will also examine the mediating pathways using Mediation Analysis. We hypothesize that a hybrid-delivery ECD intervention will be lower cost, but remote interactions among participants may be an inferior substitute for in-person visits, leaving open the question of the most cost-effective program. Discussion: Our goal is to determine the best model to maximize the intervention's reach and sustained impacts to improve child outcomes. By integrating delivery into the ongoing operations of local Community Health Promoters (CHPs) within Kenya's rural health care system, and utilizing new low-cost technology, our project has the potential to make important contributions towards discovering potentially scalable, sustainable solutions for resource-limited settings. Trial Registration: NCT06140017 (02/08/2024) AEARCTR0012704.

Enhancing body image satisfaction and well-being among early adolescents: Feasibility and preliminary outcomes of the mind. body. voice. program.

Although most research has emphasized high-school and college-aged women, body dissatisfaction and eating disorder behavior are also a concern for middle-school girls. We partnered with Girls Inc., a community-based organization to explore feasibility and preliminary outcomes of the mind. body. voice. (m.b.v.) program with a middle-school-aged cohort. The program was collaboratively designed with youth, focusing on body image satisfaction, disordered eating risk factors, and mental health and well-being. The work occurred during the COVID-19 pandemic, offering a unique opportunity to assess the promise of the program under difficult extenuating circumstances. In an open-trial design, we assessed change from pre- to post-program administered with two cohorts, one delivered remotely in 2020 (n = 17) and one in-person in 2021 (n = 13). Findings indicated that participation in the m.b.v. program was associated among both cohorts with significant decreases in negative body judgment and adherence to cultural appearance biases, and significant increases in body awareness, agency, and positive self-regard, as well as significant reductions in negative affect. Results support the feasibility and promise of both remote and in-person administration of the program targeting young adolescents, and in partnership with a well-established community-based organization.

Device-based 24-hour movement behaviours in adult phase III cardiac rehabilitation service-users during the COVID-19 pandemic: a mixed-methods prospective observational study.

PURPOSE: To examine changes in device-based 24-hour movement behaviours (MB), and facilitators and barriers to physical activity (PA) and exercise, during remotely-delivered cardiac rehabilitation (RDCR). MATERIALS AND METHODS: This prospective observational study used wrist-worn GENEActiv accelerometers to assess MB of 10 service-users (63 ± 10 years) at the start, middle, and end of three-months of RDCR. Barriers and facilitators to PA and exercise were explored through self-report diaries and analysed using content analysis. RESULTS: At start, service-users were sedentary for 12.6 ± 0.7 h · day-1 and accumulated most PA at a light-intensity (133.52 ± 28.57 min · day-1) - neither changed significantly during RDCR. Sleep efficiency significantly reduced from start (88.80 ± 4.2%) to the end (86.1 ± 4.76%) of CR, with values meeting health-based recommendations (≥85%). Barriers to RDCR exercise included exertional discomfort and cardiac symptoms, and reduced confidence when exercising alone. Setting meaningful PA goals, self-monitoring health targets, and having social support, facilitated PA and exercise during RDCR. CONCLUSIONS: Our RDCR programme failed to elicit significant changes in MB or sleep. To increase the likelihood of successful RDCR, it is important to promote a variety of exercise and PA options, target sedentary time, and apply theory to RDCR design, delivery, and support strategies.

Practitioners should work with service-users to understand how best to support them to maximise the benefit(s) of remotely/hybrid delivered services.Facilitating easy (and regular) access to health professionals during remotely/hybrid delivered cardiac rehabilitation (CR) will support the development of service-users' physical activity (PA) and exercise self-efficacy (i.e., confidence).Remotely/hybrid delivered CR should be informed by theory and/or behaviour change techniques to support increased PA, reduced sedentary time and improved sleep during and after CR.It is important to include strategies to reduce sedentary time in addition to targeting PA and exercise in remotely-delivered CR.

Implementation of Virtual Yoga Shared Medical Appointment (VYSMA) Pilot at an Academic Medical Center Within a Mixed-Diagnosis Oncology Population.

Yoga is highly sought after by people seeking oncology care, endorsed by clinical practice guidelines, and supported by leading cancer organizations, yet barriers related to access, time, cost, and availability of quality providers remain. Shared medical appointments (SMA), a group healthcare model where patients with similar medical conditions participate in a collective appointment with healthcare providers, are associated with increased access to quality care, patient satisfaction, and clinician satisfaction. We piloted a unique insurance-covered virtual yoga SMA series to assess feasibility and acceptability in a mixed-diagnosis population. In this prospective cohort pilot, a trauma-informed Hanna Somatic Yoga instructor and an integrative medicine physician co-led yoga SMAs via live web-based conferencing. SMA content included conscious self-regulation through mind-body practices including breathing, movement, visualization, meditation, chanting, and guided relaxation. Qualitative and quantitative data were gathered to assess satisfaction with the 88 sessions offered over 33 months. Sixty-nine participants with diverse demographics attended a total of 500 visits. Class attendance ranged from 2-11 participants (mean 6 participants). Participants attended a mean of 7 sessions (range 1-63 sessions), with 63% attending > 1 session. Participants' diagnoses/symptoms included cancer (77%), anxiety/depression (38%), and pain (38%). Preseries, participants reported pain, weakness, neuropathy, lymphedema, insomnia, and fatigue. Postseries survey results suggested improvements in anxiety/fear, pain, fatigue, poor sleep, neuropathy, brain fog, isolation, weakness, inflexibility, and poor balance. Postseries, participants also reported incorporating mindfulness, breathing techniques, somatic skills, weight training, and yoga into their daily routines, with 91% reporting that their goals had been met. Participants appreciated remote delivery, learning new skills, community, and the instructors. This virtual yoga SMA series in a diverse population with mixed diagnoses was feasible, acceptable to participants, and showed promising positive impact. A larger randomized controlled trial with longer follow-up is recommended.

Baseline Characteristics in the Remote Diet Intervention to REduce long-COVID Symptoms Trial (ReDIRECT).

Background: The persistence of symptoms for ≥12 weeks after a COVID-19 infection is known as Long COVID (LC), a condition with unclear pathophysiology and no proven treatments to date. Living with obesity is a risk factor for LC and has symptoms which may overlap with and aggravate LC. Methods: ReDIRECT is a remotely delivered trial assessing whether weight management can reduce LC symptoms. We recruited people with LC and BMI >27kg/m 2. The intervention was delivered remotely by dietitians, with online data collection (medical and dietary history, COVID-19 infection and vaccination, body composition, LC history/symptoms, blood pressure, quality of life, sociodemographic data). Participants self-selected the dominant LC symptoms they most wanted to improve from the intervention. Results: Participants (n=234) in England (64%) and Scotland (30%) were mainly women (85%) of white ethnicity (90%), with 13% living in the 20% most deprived areas, a mean age of 46 (SD10) years, and median BMI of 35kg/m 2 (IQR 32-40). Before starting the study, 30% reported more than one COVID-19 infection (82% confirmed with one or more positive tests). LC Diagnosis was mainly by GPs (71%), other healthcare professionals (9%), or self-diagnosed (21%). The median total number of symptoms was 6 (IQR 4-8). Self-selected dominant LC symptoms included fatigue (54%), breathlessness (16%), pain (12%), anxiety/depression (1%) and "other" (17%). At baseline, 82% were taking medication, 57% reported 1+ other medical conditions. Quality of life was poor; 20% were on long-term sick leave or reduced working hours. Most (92%) reported having gained weight since contracting COVID-19 (median weight change +11.5 kg, range -11.5 to +45.3 kg). Conclusions: Symptoms linked to LC and overweight are diverse and complex. Remote trial delivery enabled rapid recruitment across the UK yet certain groups (e.g. men and those from ethnic minority groups) were under-represented. Trial registration: ISRCTN registry ( ISRCTN12595520, 25/11/2021).

Long COVID (LC, symptoms lasting 12 weeks or more after a COVID-19 infection) is a poorly understood condition, with no proven treatments. Living with obesity increases the risk of developing LC; symptoms of obesity overlap and aggravate those of LC. The ReDIRECT study tests, in people living with both LC and overweight, whether weight management can reduce LC symptoms. The study involves total diet replacement (with porridge, soups and shakes) for 12 weeks and is delivered remotely, with dietitian support via internet and/or phone. Researchers collected all data via online forms (medical and diet history, COVID-19 infection and vaccination, weight, height, LC history and symptoms, blood pressure, quality of life, and other demographic data). Each participant selected the LC symptom they most wanted to see improve. Participants (n=234) lived across the UK, were mainly women (85%) of white ethnicity (90%), with 13% living in the 20% most deprived areas. Their average age was 46 years old with an average body mass index (BMI) of 35kg/m ². Diagnosis of LC was mainly by GPs (71%), other healthcare professionals (9%), or self-diagnosed (21%). Participants reported on average 6 symptoms each, identifying fatigue (54%), breathlessness (16%), pain (12%), anxiety/depression (1%) and "other" (17%) as the symptom they would most like to see improve. At the start of the study, most (82%) were taking medication, half (57%) reported 1+ other medical conditions. Quality of life was poor, and 20% were on long-term sick leave or reduced working hours. Most (92%) reported gaining weight since contracting COVID-19, on average +11.5 kg. The baseline characteristics of ReDIRECT study participants show that symptoms linked to LC and overweight are diverse and complex. The study being "remote" means that recruitment was rapid and across the UK, yet certain groups (e.g. men and those from ethnic minority groups) were under-represented.

Adapting the National Diabetes Prevention Program: Learning from Lifestyle Coach strategies and adjustments during the COVID-19 pandemic in the United States.

Background: The National Diabetes Prevention Program (National DPP) is an evidence-based lifestyle intervention successfully disseminated across the United States. Some adaptations have been made to address real-world needs, including during the COVID-19 pandemic. This study aims to qualitatively describe adaptations Lifestyle Coaches made in response to the pandemic. Methods: Between May and June 2021, Lifestyle Coaches (n = 300) from organizations across the United States answered open-ended survey questions about adjustments implemented during the pandemic. Survey responses were descriptively coded and codes were grouped into categories. Results: Nearly all coaches transitioned the format of their class from in-person to remote delivery (93.0 %; n = 279). Other commonly-reported strategies included adjusting contact with participants (48.0 %; n = 144), increasing support for participants (36.7 %; n = 110), and tailoring materials (28.3 %; n = 85). Conclusions: Maintaining these adaptations may address barriers to engagement in the National DPP and improve access to the program. Increased support for emotional symptoms and ensuring a patient-centered approach to care are particularly promising strategies.

Employing user-centered design and education sciences to inform training of diabetes survival skills.

Background: Patients newly diagnosed with diabetes mellitus (diabetes), who require insulin must acquire diabetes "survival" skills prior to discharge home. COVID-19 revealed considerable limitations of traditional in-person, time-intensive delivery of diabetes education and survival skills training (diabetes survival skills training). Furthermore, diabetes survival skills training has not been designed to meet the specific learning needs of patients with diabetes and their caregivers, particularly if delivered by telehealth. The objective of the study was to identify and understand the needs of users (patients newly prescribed insulin and their caregivers) to inform the design of a diabetes survival skills training, specifically for telehealth delivery, through the application of user-centered design and adult learning and education principles. Methods: Users included patients newly prescribed insulin, their caregivers, and laypersons without diabetes. In semi-structured interviews, users were asked about experienced or perceived challenges in learning diabetes survival skills. Interviews were audio-recorded and transcribed. Investigators performed iterative rounds of coding of interview transcripts utilizing a constant comparative method to identify themes describing the dominant challenges users experienced. Themes were then mapped to adult learning and education principles to identify novel educational design solutions that can be applied to telehealth-based learning. Results: We interviewed 18 users: patients (N = 6, 33 %), caregivers (N = 4, 22 %), and laypersons (N = 8, 44 %). Users consistently described challenges in understanding diabetes survival skills while hospitalized; in preparing needed supplies to execute diabetes survival skills; and in executing diabetes survival skills at home. The challenges mapped to three educational strategies: (1) spiral learning; (2) repetitive goal directed practice and feedback, which have the potential to translate into design solutions supporting remote/virtual learning; and (3) form fits function organizer, which supports safe organization and use of supplies to execute diabetes survival skills independently. Conclusion: Learning complex tasks, such as diabetes survival skills, requires time, repetition, and continued support. The combination of a user-centered design approach to uncover learning needs as well as identification of relevant adult learning and education principles could inform the design of more user-centered, feasible, effective, and sustainable diabetes survival skills training for telehealth delivery.

Exploring the Feasibility and Acceptability of Telehealth Qi Gong Shared Medical Appointments: A Novel Approach to Expand Access.

Background: Research on Qi Gong (QG) supports promising health benefits. Both interest and use of QG in U.S. adults has increased over the past decade. Shared Medical Appointments (SMAs) are a novel, cost-effective, and time efficient health care delivery approach associated with patient and clinician satisfaction. Objectives: A telehealth delivered QG SMA was pilot tested among a diverse demographic population within an integrative medicine practice at an academic medical center to assess feasibility and acceptability. Methods: This was a feasibility/acceptability pilot study conducted at a large New York City academic medical center's Integrative Health and Wellness center from January to July 2023. A QG instructor-acupuncturist and an integrative medicine physician-acupuncturist co-led 3 separate series (5 Element QG, Eight-Section Brocade, and Joint-Mobilizing/Sinew Strengthening exercises) of weekly 30-45-minute sessions of QG SMA on a weekday afternoon via telemedicine. The first session included an overview of QG and Traditional Chinese Medicine (TCM) research while follow-up sessions included a check-in, didactic demonstration followed by QG practice, and a debrief to answer questions. Video links were provided for home practice. Surveys assessing satisfaction were sent pre/post series. Results: 18 sessions of QG SMA were offered over a 6-month period. A total of 40 unique participants from diverse demographics (gender, race/ethnicity, primary residence) attended, for a total of 197 virtual visits. A total of 20 participants enrolled in Series 1 (8 weeks), 23 enrolled in Series 2 (7 weeks), and 16 enrolled in Series 3 (3cweeks). For each session, group attendance ranged from 8-16 with an average of 11 participants. Attendance was high with participants attending an average of 72% of the sessions. Participants attended 88% of the first 8-week series, 54% of the second 7-week series, and 60% of the third series. Participant interest persisted over time with 35% of the 40 participants attending more than 1 series, and 12.5% attending all 3 series. Participants' diagnoses and health symptoms included pain (62.5%), cancer (45%) anxiety/depression (40%), cardiovascular disease (CVD) or metabolic conditions (32.5%), gastrointestinal (GI) symptoms/diagnoses (27.5%), stress (22.5%), osteopenia/osteoporosis (17.5%), and insomnia (17.5%). Pre-series [n = 27] participants endorsed symptoms including sleep disturbances, fatigue, pain, stress, weakness, GI symptoms, psychological symptoms, hot flashes, and brain fog. Post-program survey results [n = 11] suggested QG program addressed common symptoms including fatigue, insomnia, anxiety, stress, pain, weakness, and gastrointestinal symptoms. Participants reported incorporating QG, breathing techniques, and meditation into their daily routine. All participants reported their goals were met and that they would recommend the program to others. Regarding delivery preferences, 73% preferred telehealth, 27% hybrid, and none preferred in-person. Participants appreciated the format, new skills, community, and instructors. Conclusion: While the Virtual QG SMA series provided to diverse demographic population with mixed diagnoses is feasible, acceptable, and shows promising positive impact in this pilot, caution in interpreting the data is advised due to the low response rate of the post-program survey. Robust studies with longer follow-ups are recommended.

A qualitative exploration of patients' experience of mobile telephone-delivered contingency management to promote adherence to supervised methadone.

INTRODUCTION: Despite an increasing evidence base for mobile telephone-delivered contingency management (mCM), there had been no previous qualitative exploration of patients' experience of receiving mCM and the factors that might influence that experience and outcome in a UK setting. The aim of this study was to understand patients' views and experience of receiving mCM by exploring their beliefs, expectations and perceived benefits within the context of the UK's first mCM intervention. METHODS: Qualitative interviews (N = 15) were conducted with patients undergoing opioid agonist treatment in a UK drug treatment service and receiving mCM to encourage adherence with supervised methadone as part of an existing study. Interviews were conducted at two time points and analysed using Framework to explore patients' expectations and beliefs during the early stage of the intervention (2 weeks) and their perceived benefits and experience at the end of the intervention (12 weeks). RESULTS: The mCM was perceived as a motivator, providing validation of achievement, and involving discreet and positive interactions. Perceived benefits included enhanced methadone adherence, reduced drug use and the development of a supportive and non-judgemental connection that resembled a therapeutic alliance. DISCUSSION AND CONCLUSIONS: The mechanisms underpinning contingency management appeared to operate in the absence of human interaction, and the mCM intervention was deemed to be meaningful, acceptable and well received by patients. These findings not only provide support for the application of mCM in this context but also offer insight into the factors that influence outcomes and should be considered in the development of future mCM interventions.

Non-clinically trained facilitators' experiences of remote psychosocial interventions for older adults with memory loss and their family carers.

BACKGROUND: Dementia is the seventh leading cause of global mortality, with cases increasing. Psychosocial interventions might help prevent dementia and improve quality of life. Although it is cost-effective for non-clinically trained staff to deliver these, concerns are raised and little is known about the resulting impact on staff, especially for remote interventions. AIMS: To explore how non-clinically trained facilitators experienced delivering remote, one-to-one and group-based psychosocial interventions with older adults with memory loss and their family carers, under training and supervision. METHOD: We conducted a secondary thematic analysis of interviews with non-clinically trained facilitators, employed by universities, the National Health Service and third-sector organisations, who facilitated either of two manualised interventions: the APPLE-Tree group dementia prevention for people with mild memory loss or the NIDUS-Family one-to-one dyadic intervention for people living with dementia and their family carers. RESULTS: The overarching theme of building confidence in developing therapeutic relationships was explained with subthemes that described the roles of positioning expertise (subtheme 1), developing clinical skills (subtheme 2), peer support (subtheme 3) in enabling this process and remote delivery as a potential barrier to it (subtheme 4). CONCLUSIONS: Non-clinically trained facilitators can have positive experiences delivering remote psychosocial interventions with older adults. Differences in life experience could compound initial fears of being 'in at the deep end' and 'exposed' as lacking expertise. Fears were allayed by experiencing positive therapeutic relationships and outcomes, and by growing confidence. For this to happen, appropriate training and supervision is needed, alongside accounting for the challenges of remote delivery.