Aims: Acceptable and accessible interventions are needed to address 'psychological insulin resistance', which is a common barrier to insulin uptake among adults with type 2 diabetes (T2D). Our aim was to test the feasibility of a randomised controlled trial (RCT) study design and acceptability of a theoretically grounded, psycho-educational, web-based resource to reduce negative insulin appraisals among adults with T2D.
IntroductionPsychological barriers to insulin therapy are associated with the delay of clinically indicated treatment intensification for people with type 2 diabetes (T2D), yet few evidence-based interventions exist to address these barriers. We describe the protocol for a randomised controlled trial (RCT) examining the efficacy of a novel, theoretically grounded, psychoeducational, web-based resource designed to reduce psychological barriers to insulin among adults with non-insulin treated T2D: ‘Is insulin right for me?’.Methods and analysisDouble-blind, parallel group RCT. A target sample of N=392 participants (n=196/arm) will be randomised (1:1) to ‘Is insulin right for me?’ (intervention) or widely available online resources (control). Eligible participants include adults (18–75 years), residing in Australia, currently taking oral hypoglycaemic agents to manage T2D. They will be primarily recruited via invitations and reminders from the national diabetes registry (from a purposefully selected sample of N≥12 000). Exclusion criteria: experience of self-administered injectable; previously enrolled in pilot RCT; ‘very willing’ to start insulin as baseline. Outcomes will be assessed via online survey at 2 weeks and 6 months. Primary outcome between-group: difference in mean negative Insulin Treatment Appraisal Scores (ITAS negative) at 2-week and 6-month follow-up. Secondary outcomes: between-group differences in mean positive insulin appraisals (ITAS positive) and percentage difference in intention to commence insulin at follow-up time points. All data analyses will be conducted according to the intention-to-treat principle.Ethics and disseminationDeakin University Human Research Ethics Committee (2020–073). Dissemination via peer-reviewed journals, conferences and a plain-language summary.Trial registration numberACTRN12621000191897; Australian and New Zealand Clinical Trials Registry.
There is increasing evidence that the COVID‐19 pandemic has had substantial mental health impacts for adolescents. Yet, few definitive studies have investigated which adolescents were at higher risk of poor mental health and well‐being during the pandemic. Data were drawn from the Childhood to Adolescence Transition Study, a prospective cohort study of students in Australia (N = 1211). Prevalence of mental health outcomes (depressive symptoms, anxiety symptoms, self‐harm and good subjective well‐being) was estimated in school Years 5–12, where Years 11 (2020) and 12 (2021) coincided with the pandemic. The age‐ and sex‐adjusted relative risk of each mental health outcome for each priority group during the pandemic were estimated. During the pandemic, over 50% of study participants reported depressive symptoms, and one quarter reported anxiety symptoms. There was a decrease in good subjective well‐being compared with pre‐pandemic years, while self‐harm prevalence remained similar. History of mental health problems, school disengagement and frequent peer victimisation increased the risk of experiencing mental health problems during the pandemic. Schools play a central role in maintaining the mental health and good subjective well‐being of students, and this is particularly important during periods of social disruption, such as the COVID‐19 pandemic.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.