Development and validation of the Alimetry Gut-Brain Wellbeing Survey: a novel patient-reported mental health scale for patients with chronic gastroduodenal symptoms.

Objective: There is currently a lack of validated questionnaires designed specifically to assess mental health within patients with chronic gastroduodenal symptoms. This research describes the multi-phase process used to develop and validate a novel mental health scale for patients with chronic gastroduodenal symptoms, the Alimetry® Gut-Brain Wellbeing (AGBW) Survey. Methods: A patient-centered multi-phase process was implemented. In Phase 1, the most relevant concepts for this patient population were selected from existing mental health scales, using data from 79 patients. In Phase 2, an interdisciplinary panel of experts generated scale items. In Phase 3, the scale underwent pre-testing with gastroenterologists (n = 9), health psychologists (n = 3), and patients (n = 12), with feedback incorporated over multiple rounds. Lastly, the psychometric properties of the scale were assessed in a sample of 311 patients via an online survey. Results: The AGBW Survey comprises a patient preface, 10 close-ended questions, and an optional open-ended question. This multidimensional scale assesses general mental health, alongside specific subscales relating to depression, stress, and anxiety. The subscale and total scores demonstrated high internal consistency (α = 0.91 for the total scale; α = 0.72-0.86 for subscales) and good convergent, divergent, concurrent validity, and known groups validity, with large effect sizes. Conclusion: The AGBW Survey is a brief, valid, and reliable scale for assessing mental health in patients with chronic gastroduodenal symptoms. It can be used as a tool to complement physiological tests and has the potential to guide psychological referrals, inform multidisciplinary management, and evaluate treatment outcomes.

Cognitive behavioural therapy-based interventions for gastroduodenal disorders of gut-brain interaction: A systematic review.

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.

A Digital Human for Delivering a Remote Loneliness and Stress Intervention to At-Risk Younger and Older Adults During the COVID-19 Pandemic: Randomized Pilot Trial.

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 investigate intervention effectiveness in a randomized controlled trial. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry ACTRN12620000786998; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380113.