Background Loneliness is a growing public health issue that has been exacerbated in vulnerable groups during the COVID-19 pandemic. Computer agents are capable of delivering psychological therapies through the internet; however, there is limited research on their acceptability to date. Objective The objectives of this study were to evaluate (1) the feasibility and acceptability of a remote loneliness and stress intervention with digital human delivery to at-risk adults and (2) the feasibility of the study methods in preparation for a randomized controlled trial. Methods A parallel randomized pilot trial with a mixed design was conducted. Participants were adults aged 18 to 69 years with an underlying medical condition or aged 70 years or older with a Mini-Mental State Examination score of >24 (ie, at greater risk of developing severe COVID-19). Participants took part from their place of residence (independent living retirement village, 20; community dwelling, 7; nursing home, 3). Participants were randomly allocated to the intervention or waitlist control group that received the intervention 1 week later. The intervention involved completing cognitive behavioral and positive psychology exercises with a digital human facilitator on a website for at least 15 minutes per day over 1 week. The exercises targeted loneliness, stress, and psychological well-being. Feasibility was evaluated using dropout rates and behavioral observation data. Acceptability was evaluated from behavioral engagement data, the Friendship Questionnaire (adapted), self-report items, and qualitative questions. Psychological measures were administered to evaluate the feasibility of the trial methods and included the UCLA Loneliness Scale, the 4-item Perceived Stress Scale, a 1-item COVID-19 distress measure, the Flourishing Scale, and the Scale of Positive and Negative Experiences. Results The study recruited 30 participants (15 per group). Participants were 22 older adults and 8 younger adults with a health condition. Six participants dropped out of the study. Thus, the data of 24 participants were analyzed (intervention group, 12; waitlist group, 12). The digital human intervention and trial methods were generally found to be feasible and acceptable in younger and older adults living independently, based on intervention completion, and behavioral, qualitative, and some self-report data. The intervention and trial methods were less feasible to nursing home residents who required caregiver assistance. Acceptability could be improved with additional content, tailoring to the population, and changes to the digital human’s design. Conclusions Digital humans are a promising and novel technological solution for providing at-risk adults with access to remote psychological support during the COVID-19 pandemic. Research should further examine design techniques to improve their acceptability in this application and investiga...

Background: Psychological comorbidities are common in patients with disorders of gut-brain interaction (DGBIs) and are often linked with poorer patient outcomes. Likewise, extensive research has shown a bidirectional association between psychological factors and gastrointestinal symptoms, termed the gut-brain axis. Consequently, assessing and managing mental wellbeing, in an integrated care pathway, may lead to improvements in symptoms and quality of life for some patients. This study aimed to explore patients' and gastroenterology clinicians' opinions on integrating psychometrics into routine DGBI testing. Methods: Semi-structured interviews were conducted with 16 patients with a gastroduodenal DGBI and 19 clinicians who see and treat these patients. Interviews were transcribed verbatim and analysed using inductive, reflexive thematic analysis. Results: Three key clinician themes were developed: (1) psychology as part of holistic care, emphasising the importance of a multidisciplinary approach; (2) the value of psychometrics in clinical practice, highlighting their potential for screening and expanding management plans; and (3) navigating barriers to utilising psychometrics, addressing the need for standardisation and external handling to maintain the therapeutic relationship. Four key patient themes were also developed: (1) the utility of psychometrics in clinical care, reflecting the perceived benefits; (2) openness to psychological management, indicating patients' willingness to explore psychological treatment options; (3) concerns with psychological integration, addressing potential stigma and fear of labelling; and (4) the significance of clinician factors, emphasising the importance of clinician bedside manner, knowledge, and collaboration. Conclusions: The themes generated from the interviews indicated that patients and clinicians see value in integrating psychometrics into routine DGBI testing. Despite potential barriers, psychometrics would advance the understanding of a patient's condition and facilitate holistic and multidisciplinary management. Recommendations for navigating challenges were provided, and considering these, patients and clinicians supported the use of psychometrics as mental health screening tools for patients with gastroduodenal DGBIs.

BACKGROUND Loneliness is a growing public health issue that has been exacerbated in vulnerable groups during the COVID-19 pandemic. Computer agents are capable of delivering psychological therapies through the internet, however, there is little research on their acceptability to date. OBJECTIVE The objectives of this study were to evaluate: (1) the feasibility and acceptability of a remote loneliness and stress intervention with digital human delivery to at-risk adults; and (2) the feasibility of the trial methods in preparation for a randomised controlled trial. METHODS A parallel, randomised pilot trial with a mixed design was conducted. Participants were adults aged 18–69 years with an underlying medical condition, or aged 70 years or older with a >24 MMSE score (i.e., at greater risk of developing severe COVID-19). Participants took part from their place of residence (20= independent living retirement village, 7= community dwelling, 3= nursing home). Participants were randomly allocated to the intervention or waitlist control group, who received the intervention one week later. The intervention involved completing cognitive behavioural (e.g., psychoeducation on stress awareness, deep breathing) and positive psychology exercises with a digital human facilitator on a website for at least 15-minutes per day over one week. The exercises used evidence-based strategies to improve loneliness, stress, and psychological well-being. Feasibility was evaluated using dropout rates and behavioural observation data. Acceptability was evaluated using behavioural engagement data, the Friendship Questionnaire (adapted), self-report items and qualitative questions. Psychological outcomes were measured to evaluate feasibility of trial methods and included loneliness (UCLA Loneliness Scale), stress (Perceived Stress Scale), COVID-19 distress, well-being (Flourishing Scale), and affect (Scale of Positive and Negative Experiences). RESULTS 30 participants (15 per group) were recruited. Participants were 22 older adults, and 8 younger adults with a health condition. 6 participants dropped out of the study. 24 participants’ data were analysed (12= intervention group; 12= waitlist group). The digital human intervention and trial methods were generally found to be feasible and acceptable in younger and older adults living independently. Slow internet speed reduced intervention feasibility for some participants. Suggestions for improvement included: additional content, tailoring to the population, and changes for the digital human’s design. The intervention and trial methods were less feasible to nursing home residents who required caregiver assistance. CONCLUSIONS The digital human was a feasible and acceptable way of delivering a remote loneliness and stress intervention to at-risk adults during the COVID-19 pandemic. The intervention and trial methods were most feasible for people living independently. Support was found for further testing of digital humans to deliver remote psychological interventions. Findings will inform expansion of intervention content and the design of a randomised controlled trial to evaluate intervention effectiveness. CLINICALTRIAL Australia New Zealand Clinical Trials Registry (ANZCTR): ACTRN12620000786998

Objective: Cognitive behavioural therapy (CBT) is increasingly used to manage Disorders of Gut-Brain Interaction (DGBIs). This systematic review aimed to review the evidence for the effectiveness of CBT-based interventions for patients with gastroduodenal DGBIs. Methods: Medline, Embase, PubMed, Cochrane Central, and Scopus were searched in July 2022. Studies were included if they investigated the effects of a CBT-based intervention on gastrointestinal symptoms and/or psychological outcomes pre- and post-intervention in patients with gastroduodenal DGBIs. Case studies, studies not in English, and studies with patients under 18 years were excluded. Results were synthesised narratively, and standardised effect sizes were calculated where possible. Results: Nine studies (seven RCTs and two pre/post studies) were identified, with data reported in 10 articles (total N=602). The studies investigated patients with functional dyspepsia (n=7), rumination syndrome (n=1), and supragastric belching (n=1). The studies had heterogeneous interventions, methodologies, and outcomes, precluding meta-analysis, as well as a moderate-high risk of bias and high drop-outs rates. Findings demonstrated decreased gastrointestinal symptoms and improved anxiety, depression, and quality of life, from pre- to post-intervention, with medium to large effect sizes for symptoms and small to large effect sizes for psychological outcomes. Efficacy was maintained at follow-up, up to one year later. Conclusions: This review suggests promising evidence that CBT effectively improves gastrointestinal symptoms and psychological outcomes in patients with gastroduodenal DGBIs. However, heterogeneity, risk of bias, and lack of statistical reporting were noted, indicating the need for more robust research and standardisation.