Background:Fear of cancer recurrence (FCR) is a prevalent and debilitating condition that effects around 60% of people living with cancer. It is severe, persistent, and imposes a significant financial burden on the healthcare system. Given FCR's profound impact on mental health and quality of life, adopting targeted interventions to mitigate its effects is essential. This study reports on the efficacy of MindOnLine, an online mindfulness program, for people living with-and beyond-breast, prostate or colorectal cancer, in reducing FCR, anxiety and depression. Methods:Randomized controlled trial (1:1) comparing MindOnline with a waitlist group (ANZCTR: 12620000645954). Eligibility criteria: ≥18 years, living in Australia, completed active treatment/surveillance for stages 1-3 breast, prostate or CRC, within the last 5 years, had internet access, and a Fear of Cancer Recurrence Inventory (FCRI) severity score ≥13. MindOnLine was a self-directed, brief, online 9-week program, with a new module unlocked each week. The intervention incorporated education, mindfulness practices, and meditation, to promote awareness and emotion regulation. Data were captured at baseline, 9-weeks and 9-months post-randomization. Linear mixed models assessed MindOnLine's impact on the primary (FCRI total score) and secondary (anxiety (GAD-7), depression (PHQ-9)) outcomes. Findings:Between October 2020 and June 2023, 434 participants randomized, of which 58% had breast, 26% prostate and 16% colorectal cancer; 70% were female; 50% were aged ≥60 years; and 67.5% resided in metropolitan areas. At 9-weeks, MindOnLine decreased the FCRI total score (-5.61, 95% CI [-8.61, -2.61], p < 0.001); anxiety (-1.29 [-2.15, -0.43], p = 0.003) and depression (-1.47 [-2.34, -0.61], p < 0.001) scores, compared to the waitlist group. Intervention effects were sustained at 9-months (FCRI: -5.06 [-8.61, -1.52]; p = 0.005; anxiety: -1.22 [-2.21, -0.24], p = 0.015; depression: -1.09 [-2.03, -0.16], p = 0.022). Interpretation:Our findings demonstrate that a self-directed, brief, online mindfulness-based program mitigates moderate or severe fear of cancer recurrence. Further research is necessary to guide the development of future services, policies and practices by identifying how online mindfulness programs can be customized to effectively support diverse population groups, ensuring the programs are effective and accessible and impactful, regardless of their personal circumstances or geographical location. Funding:This study was funded by the National Health and Medical Research Council (NHMRC) Partnership Grant ID APP1179317, with partner cash contributions from the Department of Health, Victoria, Epworth HealthCare and Western Health.

Smartphone apps that target alcohol problems report mixed effectiveness data, which may be explained by a lack of evidence-based content and user-centred design (UCD). This paper presents the development of ReplaceIt, a smartphone application co-designed to reduce risky drinking using an evidence-based UCD framework. Initial steps included a systematic review of existing apps, interviews with end-users, and evidence-based intervention design by our multidisciplinary team, resulting in a prototype of the app. Next, the app's key components—goal setting, self-monitoring with feedback, and implementation intention strategies—were refined through co-design with end-users using a think-aloud study and iterative pilot testing. Refinement included the introduction of a module to enhance user interaction with implementation intentions, simplified instructions, and enhanced user engagement features. The resulting ReplaceIt app was then in an excellent position to undergo efficacy testing, with high usability scores and positive user reception suggesting strong potential for reducing risky drinking behaviours. Overall, the UCD framework proved essential in developing an app that aligns with user preferences and behaviours, ultimately enhancing its functionality and potential efficacy.

BACKGROUND The bidirectional relationship between inflammatory bowel disease (IBD) flare-ups and depression/anxiety symptoms has prompted investigations into psychotherapy to improve health-related quality of life (HRQoL) by targeting depression and anxiety. Acceptance commitment therapy (ACT) is effective in improving symptoms of depression and anxiety in people with chronic diseases, yet minimal research has examined ACT's effectiveness for IBD. This study examines the feasibility, acceptability, and preliminary efficacy of the ACTforIBD program, an online program codesigned with consumers to deliver ACT to those with IBD. METHODS Adults with IBD and symptoms of mild-moderate distress were randomized to ACTforIBD or an active control (psychoeducation) condition. Participants completed 8 weekly, 1-hour sessions, 4 of which were therapist facilitated. Feasibility was based on recruitment and retention and acceptability was derived from postprogram satisfaction measures. Preliminary efficacy was determined by group differences in rate of change in study outcomes from baseline to postprogram. RESULTS Of 62 participants (89% women, 11% men; mean age  33 years), 55 completed the program (ACTforIBD: n = 26 [83.9%]; active control: n = 29 [93.5%]). Adherence and acceptability were high in the ACTforIBD group, with 80% of participants completing all self-directed modules and 78% of participants expressing satisfaction with the program. Significant and marginally significant group × time interactions were found for anxiety symptoms (b = -1.89; 95% confidence interval, -3.38 to -0.42) and psychological HRQoL (b = -0.04; 95% confidence interval, -0.07 to 0.01), showing decreased anxiety and increased psychological HRQoL in the intervention group. CONCLUSIONS ACTforIBD is feasible, acceptable, and improved anxiety symptoms, and psychological HRQoL. This highlights the need for a full-scale randomized controlled trial to further examine the program's efficacy.

Abstract Background Management of type 1 diabetes (T1D) requires the use of insulin, which can cause hypoglycaemia (low blood glucose levels). While most hypoglycaemic episodes can be self-treated, all episodes can be sudden, inconvenient, challenging to prevent or manage, unpleasant and/or cause unwanted attention or embarrassment. Severe hypoglycaemic episodes, requiring assistance from others for recovery, are rare but potentially dangerous. Repeated exposure to hypoglycaemia can reduce classic warning symptoms (‘awareness’), thereby increasing risk of severe episodes. Thus, fear of hypoglycaemia is common among adults with T1D and can have a negative impact on how they manage their diabetes, as well as on daily functioning, well-being and quality of life. While advances in glycaemic technologies and group-based psycho-educational programmes can reduce fear, frequency and impact of hypoglycaemia, they are not universally or freely available, nor do they fully resolve problematic hypoglycaemia or associated worries. This study aims to determine the effectiveness of a fully online, self-directed, scalable, psycho-educational intervention for reducing fear of hypoglycaemia: the Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment (HypoPAST) programme. Methods A 24-week, two-arm, parallel-group, hybrid type 1 randomised controlled trial, conducted remotely (online and telephone). Australian adults (≥ 18 years) with self-reported T1D and fear of hypoglycaemia will be recruited, and allocated at random (1:1) to HypoPAST or control (usual care). The primary outcome is the between-group difference in fear of hypoglycaemia (assessed using HFS-II Worry score) at 24 weeks. A sample size of N = 196 is required to detect a 9-point difference, with 90% power and allowing for 30% attrition. Multiple secondary outcomes include self-reported psychological, behavioural, biomedical, health economic, and process evaluation data. Data will be collected at baseline, 12 and 24 weeks using online surveys, 2-week ecological momentary assessments, website analytics and semi-structured interviews. Discussion This study will provide evidence regarding the effectiveness, cost-effectiveness and acceptability of a novel, online psycho-educational programme: HypoPAST. Due to the fully online format, HypoPAST is expected to provide an inexpensive, convenient, accessible and scalable solution for reducing fear of hypoglycaemia among adults with T1D. Trial registration Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12623000894695 (21 August 2023).

OBJECTIVE:The bidirectional relationship between disease activity and mental health in inflammatory bowel disease (IBD) has prompted investigations into the efficacy of psychotherapies, such as mindfulness-based interventions (MBI), for improving biopsychosocial outcomes. Therefore, the aim is to examine the feasibility, acceptability, and preliminary efficacy of an online-delivered, self-directed MBI, adapted to individuals with IBD and psychological distress, in comparison to wait-list control (WLC). METHODS:50 adults with IBD were randomized to WLC (N = 25) or intervention (N = 25) groups. The intervention (MIND4IBD program) consisted of six, weekly, 15-min videos (with guided meditations). Feasibility was examined through recruitment and retention rates, while acceptability was examined through intervention satisfaction ratings and qualitative feedback. Preliminary efficacy was examined using linear mixed models for group differences in outcomes between baseline and post-intervention. RESULTS:Primary Outcomes. The retention rate for the WLC group was 92 %, while the retention rate for the intervention group was 48 %. However, 16 % of participants allocated to the intervention group never began the intervention, therefore this resulted in a retention rate of 71 % of participants who began the intervention. Acceptability was high with an average intervention satisfaction rating of 83/100. SECONDARY OUTCOMES:When compared with the WLC, the MIND4IBD program improved total mindfulness levels (b = 0.29, 95 %CI [0.11,0.47], p = 0.004) with a large effect size (β = 0.54, b = 0.19, 95 %CI [0.04,0.34], p = 0.014). Themes based on participants' intervention feedback included: 1) beginning of journey with mindfulness, 2) the beneficial impact of mindfulness, 3) why adapting the intervention to IBD is important, 4) views on program delivery, and 5) mixed reactions to AI generated presenters. CONCLUSION:MIND4IBD is feasible and acceptable for individuals with IBD and psychological distress. Participants' total mindfulness levels increased significantly in the intervention group compared to WLC. Most participants provided positive intervention feedback. These findings warrant a full-scale RCT to determine MIND4IBD's efficacy for IBD.

INTRODUCTION:The bidirectional relationship between disease activity and mental health in inflammatory bowel disease (IBD) has prompted investigations into the efficacy of psychotherapeutic interventions such as acceptance and commitment therapy (ACT) on biopsychosocial outcomes. We aimed to examine the efficacy of an ACT program (intervention) in comparison with a cognitive behavioral therapy-informed psychoeducation program (active control) for individuals with IBD and coexistent psychological distress. Both programs were delivered online through a hybrid format (i.e., therapist-led and participant-led sessions). METHODS:A total of 120 adults with IBD were randomized to either the intervention (N = 61) or active control groups (N = 59). Efficacy was determined using linear mixed models for group differences, in rate of changes in study outcomes, between baseline, postintervention, and 3-month follow-up. RESULTS:The primary outcome health-related quality of life significantly improved in the intervention group when compared with the active control group, with a significantly different rate of change observed from baseline to postintervention ( t [190] = 2.15, P = 0.033) in favor of the intervention group with a medium effect size (β = 0.41, mean difference = 0.07, 95% confidence interval 0.01-0.12, P = 0.014). Similarly, the secondary outcome Crohn's disease activity significantly reduced in the intervention group when compared with the active control group, with a significantly different rate of change observed from baseline to 3-month follow-up ( t [90] = -2.40, P = 0.018) in favor of the intervention group with a large effect size (β = -0.77, mean difference = -9.43, 95% confidence interval -13.72 to -5.13, P < 0.001) ( P = 0.014). Furthermore, when observing the rate of change in outcomes over time for the groups separately, anxiety symptoms and pain significantly improved in the intervention group only, and conversely, ulcerative colitis activity and stress symptoms significantly improved in the active control group only. All other outcomes (N = 14) significantly improved over time in both groups including IBD activity, gastrointestinal unhelpful thinking patterns, visceral anxiety, fatigue interference, fatigue severity, fatigue frequency, psychological inflexibility, self-efficacy, resilience, current health status, depression symptoms, IBD control, and pain catastrophizing; however, these changes were not significantly different between the groups. DISCUSSION:Both programs were of benefit to people with IBD and distress. However, ACT offers a significant added benefit for health-related quality of life and self-reported Crohn's disease activity and may be a useful adjuvant therapy in integrated IBD care.

Introduction Diets low in vegetables are a main contributor to the health burden experienced by young adults in rural communities. Digital health interventions provide an accessible delivery model that can be personalised to meet the diverse preferences of young adults. A personalisable digital vegetable intake intervention (Veg4Me) was codesigned to meet the needs of young adults living in rural communities. This study will determine the feasibility of delivering a personalised Veg4Me programme and compare preliminary effects with a non-personalised Veg4Me (control).Methods and analysis A 12-week assessor-blinded, two-arm, parallel randomised controlled trial will be undertaken from August 2023 until April 2024. A total of 150 eligible and consenting young adults (18–35 years; eat<5 serves of vegetables/day; have an internet connected mobile device/computer) living in Loddon Campaspe or Colac Otway Shire in Victoria, Australia, will be randomised to receive 12 weeks of personalised (intervention) or non-personalised (control) support to increase vegetable intake via a free web application (app; Veg4Me). The primary outcome is feasibility (recruitment, participation and retention rates). Secondary outcomes are user engagement, usability and experience, as well as vegetable intake, eating habits and digital health equity. Process evaluation will be conducted in a subsample of participants using semistructured interviews. Descriptive statistics will be presented for the personalised and non-personalised groups at baseline and 12 weeks. Generalised linear models will be used to evaluate group differences in outcomes. Interviews will be transcribed and analysed thematically.Ethics and dissemination All procedures involving human subjects were approved by Deakin University’s Human Ethics Advisory Group—Health (HEAG-H 06_2023) on 6 March 2023. Dissemination events will be held in the City of Greater Bendigo and the Colac Otway Shire. Summaries of the results will be disseminated to participants via email. Results will be disseminated to the scientific community through peer-reviewed publications and conference presentations.Trial registration number Australia New Zealand Clinical Trials Registry, ACTRN12623000179639p, prospectively registered on 21 February 2023, according to the World Health Organizational Trial Registration Data Set. Universal Trial Number U1111-1284-9027.

IntroductionInflammatory bowel disease (IBD) involves an abnormal immune response to healthy gut bacteria. When a person develops IBD, their susceptibility to anxiety and/or depression increases. The ACTforIBD programme, specifically designed for people with IBD and comorbid psychological distress, draws on acceptance and commitment therapy (ACT), which promotes acceptance of situations that cannot be solved such as persistent physical symptoms. There are no ACT trials for IBD using an active control group or a telemedicine approach, which is important to improve accessibility, particularly in the context of the ongoing COVID-19 pandemic. The ACTforIBD programme is administered online with a 4-hour therapist involvement per participant only; if successful it can be widely implemented to improve the well-being of many individuals with IBD.Methods and analysisOur team have codesigned with consumers the ACTforIBD programme, an 8-week intervention of 1-hour sessions, with the first three sessions and the last session delivered one-to-one by a psychologist, and the other sessions self-directed online. This study aims to evaluate the feasibility and preliminary efficacy of ACTforIBD to reduce psychological distress in patients with IBD. Using a randomised controlled trial, 25 participants will be randomised to ACTforIBD, and 25 patients to an active control condition.Ethics and disseminationThis protocol has been approved by Deakin University Research Ethics Committee in September 2021 (Ref. 2021-263) and the New Zealand Central Health and Disability Ethics Committee in December 2021 (Ref. 2021 EXP 11384). The results of this research will be published in peer-reviewed journals and shared with various stakeholders, including community members, policy-makers and researchers, through local and international conferences.Trial registration numberACTRN12621001316897.

INTRODUCTION:Fear of cancer recurrence (FCR) is a common condition among cancer survivors that can lead to significant levels of distress, anxiety and depression. Online mindfulness programmes may provide the mechanism to support cancer survivors manage FCR and distress, and improve people's well-being over the short, medium and long term. The primary aim of this study is to determine the potential efficacy of MindOnLine, a 9 session mindfulness-based programme for survivors of breast, prostate and colorectal cancer. A formal economic programme will also be conducted.METHODS AND ANALYSIS:A single-blind randomised controlled trial to determine the efficacy and cost-efficacy of a MindOnLine programme for cancer survivors. A total of 400 people living with cancer will be recruited via online advertisements on social media platforms, peak consumer advocacy groups or through outpatient services at healthcare providers across Victoria, Australia. People will be randomly allocated to either the MindOnLine programme (n=200) or waitlist control (n=200). Participant assessments will occur at baseline, at 9 weeks and 9-month follow-up. The primary outcome is change in Fear of Recurrence Index Score total score between baseline and 9 weeks; secondary outcomes are changes in depression and anxiety, quality of life and mindfulness. The economic analysis comprises a cost-consequences analysis where all outcomes will be compared with costs.ETHICS AND DISSEMINATION:Ethics approval was obtained from the Peter MacCallum Cancer Centre (20-53) and Deakin University (2020-284). All participants will be required to provide written informed consent. Findings will be disseminated in peer reviewed journals and among key stakeholder organisations including hospitals, cancer and community organisations and Government. If successful the project will be rolled out nationally with a formal implementation plan.TRIAL REGISTRATION NUMBER:Australian New Zealand Clinical Trials Registry (12620000645954); Pre-results. Registered 6 June 2020, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379520&isReview=true.

Background Diabetes distress is a commonly experienced negative emotional response to the ongoing burden of diabetes. Holistic diabetes care, including attention to diabetes distress, is recommended in clinical guidelines, yet not routinely implemented. Diabetes health professionals have highlighted lack of training as a barrier to implementation of psychological care. Therefore, we developed an e-learning: ‘Diabetes distress e-learning: A course for diabetes educators’ to address this need. This pilot study aimed to examine the feasibility of evaluating the e-learning in a randomised controlled trial study, the acceptability of the e-learning to credentialled diabetes educators (CDEs); and preliminary evidence of its effect upon CDEs’ diabetes distress-related knowledge, motivation, confidence, behavioural skills, and barriers to implementation. Methods A pilot, unblinded, 2-armed, parallel group randomised controlled trial. Participants were recruited during a 4-month timeframe. Eligible participants were CDEs for ≥ 1 year providing care to ≥ 10 adults with type 1 or type 2 diabetes per week. Participants were randomly allocated (1:1 computer automated) to 1 of 2 learning activities: diabetes distress e-learning (intervention) or diabetes distress chapter (active control). They had 4 weeks to access the activity. They completed online surveys at baseline, 2-week and 12-week follow-up. Results Seventy-four eligible CDEs (36 intervention, 38 active control) participated. At baseline, recognition of the clinical importance of diabetes distress was high but knowledge and confidence to provide support were low-to-moderate. Engagement with learning activities was high (intervention: 83%; active control: 92%). Fifty-five percent returned at least 1 follow-up survey. All 30 intervention participants who returned the 2-week follow-up survey deemed the e-learning high quality and relevant. Systemic barriers (e.g., financial limitations and access to mental health professionals) to supporting people with diabetes distress were common at baseline and follow-up. Conclusions The e-learning was acceptable to CDEs. The study design was feasible but needs modification to improve follow-up survey return. The e-learning showed potential for improving diabetes distress-related knowledge, confidence and asking behaviours, but systemic barriers to implementation remained. Systemic barriers need to be addressed to facilitate implementation of support for diabetes distress in clinical practice. Future larger-scale evaluation of the e-learning is warranted.

Diabetes distress is a common negative emotional response to the ongoing burden of living with diabetes. Elevated diabetes distress is associated with impaired diabetes self-management and quality of life yet rarely identified and addressed in clinical practice. Health professionals report numerous barriers to the provision of care for diabetes distress, including lack of skills and confidence, but few diabetes distress training opportunities exist. The purpose of this paper is to describe how we utilized Intervention Mapping to plan the development, implementation, and evaluation of a novel diabetes distress e-learning program for diabetes educators, to meet a well-documented need and significant gap in diabetes care. A multidisciplinary team (combining expertise in research, health and clinical psychology, diabetes education, nursing, tertiary education, and website architecture) developed a diabetes distress e-learning program. We followed a six-step process (logic model of the problem, program outcomes and objectives, program design, program production, program implementation plan, and evaluation plan) known as Intervention Mapping. The program is underpinned by educational and psychological theory, including Bloom's Taxonomy of Educational Objectives and social cognitive theory. We developed a short (estimated 4 h) e-learning program for diabetes educators, which draws on the content of the Diabetes and Emotional Health handbook and toolkit. It integrates a 7As model, which provides a stepwise approach to identifying and addressing diabetes distress. Our diabetes distress e-learning program has been developed systematically, guided by an Intervention Mapping approach. In the next phase of the project, we will trial the e-learning.