Effects of 12-Week Freestyle Libre 2.0 in Children with Type 1 Diabetes and Elevated HbA1c: A Multicenter Randomized Controlled Trial.

Objective: To investigate whether intermittently scanned continuous glucose monitoring (isCGM) reduced glycated hemoglobin (HbA1c) compared with capillary self-monitored capillary blood glucose (SMBG) in children with type 1 diabetes (T1D) and elevated glycemic control. Research Design and Methods: This multicenter 12-week 1:1 randomized, controlled, parallel-arm trial included 100 participants with established T1D aged 4-13 years (mean 10.9 ± 2.3 years) naive to isCGM and with elevated HbA1c 7.5%-12.2% [58-110 mmol/mol] [mean HbA1c was 9.05 (1.3)%] [75.4 (13.9) mmol/mol]. Participants were allocated to 12-week intervention (isCGM; FreeStyle Libre 2.0; Abbott Diabetes Care, Witney, United Kingdom) (n = 49) or control (SMBG; n = 51). The primary outcome was the difference in change of HbA1c from baseline to 12 weeks. Results: There was no evidence of a difference between groups for change in HbA1c at 12 weeks (0.23 [95% confidence interval; CI: -0.21 to 0.67], P = 0.3). However, glucose-monitoring frequency increased with isCGM +4.89/day (95% CI 2.97-6.81; P < 0.001). Percent time below range (TBR) <3.9 mmol/L (70-180 mg/dL) was reduced with isCGM -6.4% (10.6 to -4.2); P < 0.001. There were no differences in within group changes for Parent or Child scores of psychosocial outcomes at 12 weeks. Conclusions: For children aged 4-13 years with elevated Hba1c isCGM led to improvements in glucose testing frequency and reduced time below range. However, isCGM did not translate into reducing Hba1c or psychosocial outcomes compared to usual care over 12-weeks. The trial is registered within the Australian New Zealand Trial Registry on February 19, 2020 (ACTRN12620000190909p; ANZCTR.org.au) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1237-0090).

Exploring the views of adolescents with type 1 diabetes on digital mental health interventions: What functionality and content do they want?

BACKGROUND: Adolescents with type 1 diabetes (T1D) experience higher rates of psychological disorders compared with their healthy peers. As poor psychological health has been associated with suboptimal glycaemic control and more frequent complications, there is an urgent need to develop more 'clinically usable' interventions. Digital mental health interventions offer unique advantages compared with in-person interventions; however, what adolescents with T1D want in terms of content and functionality is poorly understood. Accordingly, the current study conducted focus groups to examine the views of adolescents with T1D regarding digital mental health interventions. METHODS: Four focus groups were conducted, including 16 adolescents with T1D, ranging from 13 to 17 years in age (69% female). Transcripts were analysed using directed content analysis to examine (1) 'what adolescents dislike about existing digital mental health interventions?' and (2) 'what adolescents want in future digital mental health interventions?'. RESULTS: Findings provide a preliminary understanding of what adolescents dislike and also the type of content and functional features, which may be important to include in digital mental health programs for this population, such as a peer support feature (reported by 16 of 16), emotion and diabetes check-in feature (11 of 16) and diabetes-relevant content (12 of 16). CONCLUSIONS: Early data suggest that digital mental health interventions should include a significant peer support element, diabetes-relevant content and examples, and check-in on their mental health and diabetes self-management regularly, while avoiding fixed responses or modules and non-age-appropriate content. Based on these findings, a digital intervention is currently being developed.

Predictors of parental stress from admission to discharge in the neonatal special care unit.

BACKGROUND: Exacerbated parental stress during a stay in the neonatal intensive care unit can negatively impact the development of the hospitalized infant, strain the dyadic relationship and put parents at risk for poor mental health. It is therefore important to identify risk factors of stress throughout the duration of a hospitalization. This longitudinal study aimed to investigate sources of stress for mothers and fathers who had a baby in the neonatal special care unit. METHODS: Parents of 57 singletons and 11 twins (68 infants) admitted to a neonatal special care unit (46% for prematurity) were recruited. Sixty-four mothers and 20 fathers were assessed at admission, and 60 mothers and 16 fathers at discharge. Participants reported their satisfaction with hospital information and completed the Perceived Stress Scale, the Brief Illness Perception Questionnaire and the Dyadic Adjustment Scale. RESULTS: Parents demonstrated similar stress trajectories, with stress on average declining over time. Higher maternal stress at admission was associated with a belief that the baby's illness would have a longer timeline, lower perceptions of treatment efficacy and lower satisfaction with the information received from medical staff. Younger age and lower levels of education predicted higher maternal stress at discharge. Fathers had higher stress at discharge when they were older, had a baby born at younger gestation and felt they had less control. At admission, information satisfaction was positively associated with parental beliefs about treatment efficacy and understanding the infant's condition. At discharge, information satisfaction was negatively associated with beliefs about illness severity and the likely time frame of the illness. CONCLUSION: The findings highlight that parents' perceptions of their baby's illness and treatment at admission and discharge have a significant association with stress. Clinical staff can use these factors to identify parents who are at risk of exhibiting a greater level of stress over the hospitalization period.

A systematic review of gratitude interventions: Effects on physical health and health behaviors.

OBJECTIVE: Gratitude interventions are easy-to-deliver, offering promise for use in clinical-care. Although gratitude interventions have consistently shown benefits to psychological wellbeing, the effects on physical health outcomes are mixed. This systematic review aims to synthesize gratitude intervention studies which assessed physical health and health behavior outcomes, as well as evaluate study quality, comment on their efficacy, and provide directions for future research. METHODS: Relevant studies were identified through searches conducted in PsycINFO, MedLine, Embase and Cochrane Library databases, up until August 2019. Only studies that evaluated a gratitude intervention, randomly assigned participants to gratitude and control conditions, and assessed objective and subjective measures of physical health and health behaviors were included. The Revised Cochrane risk-of-bias (RoB2) tool was used to assess risk of bias. RESULTS: Of the 1433 articles found, 19 were included in the review. Subjective sleep quality was improved in 5/8 studies. Improvements in blood pressure, glycemic control, asthma control and eating behavior were understudied yet demonstrated improvements (all 1/1). Other outcome categories remain understudied and mixed, such as inflammation markers (1/2) and self-reported physical symptoms (2/8). The majority of studies showed some risk of bias concerns. CONCLUSIONS: Although it was suggested gratitude interventions may improve subjective sleep quality, more research is still needed to make firm conclusions on the efficacy of gratitude interventions on improving health outcomes. Further research focusing on gratitude's link with sleep and causal mechanisms is needed, especially in patient populations where more 'clinically-usable' psychosocial interventions are urgently needed.

Protocol for a feasibility study: a brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating.

INTRODUCTION: Adolescents with type 1 diabetes are at a higher risk of developing psychiatric disorders, particularly eating disorders, compared with their healthy peers. In turn, this increases the risk for sub-optimal glycaemic control and life-threatening diabetes-related complications. Despite these increased risks, standard diabetes care does not routinely provide psychological support to help prevent or reduce mental health risks. There is an urgent need to develop 'clinically usable' psychosocial interventions that are acceptable to patients and can be realistically integrated into clinical care. This study aims to examine the feasibility and acceptability of a brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating behaviour. METHODS AND ANALYSIS: This feasibility study will examine the effectiveness of a brief self-compassion intervention, compared with a waitlist control group. Participants aged 12-16 years will be recruited from three diabetes outpatient clinics in Auckland, New Zealand. The brief self-compassion intervention is adapted from the standardised 'Making Friends with Yourself' intervention and will be delivered in a group format over two sessions. Apart from examining feasibility and acceptability through the flow of participants through the study and qualitative questions, we will assess changes to disordered eating behaviour (primary outcome), self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control (secondary outcomes). Such data will be used to calculate the required sample size for a fully powered randomised controlled trial. ETHICS AND DISSEMINATION: This trial has received ethics approval from the Health and Disability Ethics Committee (research project number A+8467). Study results will be disseminated through peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER: ANZCTR (12619000541101).

Probiotics and Maternal Mental Health: A Randomised Controlled Trial among Pregnant Women with Obesity.

Poor maternal mental health has been associated with a myriad of pregnancy and child health complications. Obesity in pregnancy is known to increase one's risk of experiencing poor maternal mental health and associated physical and mental health complications. Probiotics may represent a novel approach to intervene in poor mental health and obesity. We conducted this pre-specified secondary analysis of the Healthy Mums and Babies (HUMBA) randomised controlled trial to investigate whether probiotics would improve maternal mental health outcomes up to 36 weeks of pregnancy. Two-hundred-and-thirty pregnant women with obesity (BMI ≥ 30.0 kg/m2) were recruited and randomised to receive probiotic (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12, minimum 6.5 × 109 CFU) or placebo capsules. Depression, anxiety, and functional health and well-being were assessed at baseline (120-176 weeks' gestation) and 36 weeks of pregnancy. Depression scores remained stable and did not differ between the probiotic (M = 7.18, SD = 3.80) and placebo groups (M = 6.76, SD = 4.65) at 36 weeks (p-values > 0.05). Anxiety and physical well-being scores worsened over time irrespective of group allocation, and mental well-being scores did not differ between the two groups at 36 weeks. Probiotics did not improve mental health outcomes in this multi-ethnic cohort of pregnant women with obesity.

Predicting patient reassurance after colonoscopy: The role of illness beliefs.

OBJECTIVE: Failure to effectively reassure patients can lead to patients becoming distressed and seeking further medical care. Whilst existing studies have identified that patients' psychological and demographic characteristics can impact patient reassurance, little research has explored specific predictors of patient reassurance following a colonoscopy. This study investigates demographic and psychological predictors of patient reassurance after receiving normal test results following a colonoscopy. METHODS: Eighty-five participants receiving colonoscopies due to gastrointestinal symptoms were recruited from two endoscopy clinics. Patients provided demographic information and completed questionnaires assessing illness perceptions, health-related anxiety, hypochondriasis, somatisation and state and trait anxiety prior to the colonoscopy, as well as reassurance the day after the colonoscopy. Seventy-three participants provided complete data and were included in the analyses. Pearson's correlations and hierarchical linear regression were conducted to examine the associations between the baseline variables and patient reassurance after the colonoscopy. RESULTS: Health-related anxiety, hypochondriasis and four items from the Brief Illness Perceptions Questionnaire (consequence, identity, concern, and emotional response beliefs) were negatively correlated with reassurance (r's ranged from -0.28 to -0.54, P < .05). The hierarchical linear regression demonstrated that in the fully adjusted model, only consequence beliefs (i.e. negative beliefs regarding the impact of gastrointestinal symptoms) remained a robust predictor of reassurance (ß = -0.56, P = .005). CONCLUSION: This study extends existing research on patient reassurance and is the first study to demonstrate that illness beliefs predicted reassurance following a colonoscopy. These findings suggest that targeting consequence beliefs may be a useful intervention for improving patient reassurance following clinical investigations.

A randomized controlled trial of cognitive behaviour therapy to improve glycaemic control and psychosocial wellbeing in adolescents with type 1 diabetes.

We evaluated a cognitive behaviour therapy-based programme to improve glycaemic control and psychosocial wellbeing in adolescents with type 1 diabetes. A total of 147 adolescents aged 13-16 years were randomized to the intervention (n = 73) or standard care (n = 74). The primary outcome was glycaemic control at 3 and 12 months post randomization, and secondary measures were stress, self-efficacy and quality of life. Mixed-effects regression models were used to assess differences in means between groups at each time point. There was little evidence of differences in glycaemic control between groups. However, psychosocial wellbeing improved in the intervention group compared to the control group. Recommendations for future programmes are discussed. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12608000368336).