State anxiety and cortisol reactivity to skydiving in novice versus experienced skydivers

Previous studies have suggested that skydiving, a naturalistic stressor, is associated with increases in self-reported stress, anxiety and cortisol levels. However, it has not been established whether this stress reactivity is altered as a function of repeated exposure to skydiving. This is of interest due to previous observations that cortisol reactivity becomes habituated with repeated exposure to laboratory stressors, however, few studies have investigated such habituation to naturalistic stressors. State anxiety and cortisol reactivity to skydiving were measured in 11 first-time skydivers and 13 experienced skydivers (≥ 30 jumps, mean jumps = 397.6), who were to complete a solo skydive. The novice skydivers reported significantly greater levels of state anxiety prior to the jump; however, there were no differences in pre-jump levels of salivary cortisol. Both groups exhibited significantly elevated salivary cortisol levels immediately post-jump, relative to i) pre-jump and ii) recovery. However, the two groups were indistinguishable with regard to their cortisol reactivity to the skydive. These findings support previous research demonstrating that skydiving elicits acute cortisol activation. Further, they suggest that i) cortisol reactivity does not habituate in experienced jumpers, and ii) that there is lack of concordance between self-reported levels of anxiety and biological stress reactivity in experienced skydivers

Glucose absorption and gastric emptying in critical illness

Introduction: Delayed gastric emptying occurs frequently in critically ill patients and has the potential to adversely affect both the rate, and extent, of nutrient absorption. However, there is limited information about nutrient absorption in the critically ill, and the relationship between gastric emptying (GE) and absorption has hitherto not been evaluated. The aim of this study was to quantify glucose absorption and the relationships between GE, glucose absorption and glycaemia in critically ill patients. Methods: Studies were performed in nineteen mechanically ventilated critically ill patients and compared to nineteen healthy subjects. Following 4 hours fasting, 100 ml of Ensure, 2 g 3-Omethyl glucose (3-OMG) and ⁹⁹mTc sulphur colloid were infused into the stomach over 5 minutes. Glucose absorption (plasma 3- OMG), blood glucose levels and GE (scintigraphy) were measured over four hours. Data are mean ± SEM. A P-value 0.51; P < 0.05). Conclusions In critically ill patients; (i) the rate and extent of glucose absorption are markedly reduced; (ii) GE is a major determinant of the rate of absorption, but does not fully account for the extent of impaired absorption; (iii) blood glucose concentration could be one of a number of factors affecting GE.Marianne J Chapman, Robert JL Fraser, Geoffrey Matthews, Antonietta Russo, Max Bellon, Laura K Besanko, Karen L Jones, Ross Butler, Barry Chatterton and Michael Horowit

Economic evaluation of a dietary intervention for adults with major depression (the "SMILES" trial)

BackgroundRecently, the efficacy of dietary improvement as a therapeutic intervention for moderate to severe depression was evaluated in a randomised controlled trial. The SMILES trial demonstrated a significant improvement in Montgomery&ndash;&Aring;sberg Depression Rating Scale scores favouring the dietary support group compared with a control group over 12 weeks. We used data collected within the trial to evaluate the cost-effectiveness of this novel intervention.MethodsIn this prospective economic evaluation, sixty-seven adults meeting DSM-IV criteria for a major depressive episode and reporting poor dietary quality were randomised to either seven sessions with a dietitian for dietary support or to an intensity matched social support (befriending) control condition. The primary outcome was Quality Adjusted Life Years (QALYs) as measured by the AQoL-8D, completed at baseline and 12 week follow-up (endpoint) assessment. Costs were evaluated from health sector and societal perspectives. The time required for intervention delivery was costed using hourly wage rates applied to the time in counselling sessions. Food and travel costs were also included in the societal perspective. Data on medications, medical services, workplace absenteeism and presenteesim (paid and unpaid) were collected from study participants using a resource-use questionnaire. Standard Australian unit costs for 2013/2014 were applied. Incremental cost-effectiveness ratios (ICERs) were calculated as the difference in average costs between groups divided by the difference in average QALYs. Confidence intervals were calculated using a non-parametric bootstrap procedure.ResultsCompared with the social support condition, average total health sector costs were $856 lower (95$2591 lower (95% CI -3591 to &minus;&thinsp;198) for those receiving dietary support. These differences were driven by lower costs arising from fewer allied and other health professional visits and lower costs of unpaid productivity. Significant differences in mean QALYs were not found between groups. However, 68 and 69% of bootstrap iterations showed the dietary support intervention was dominant (additional QALYs at less cost) from the health sector and societal perspectives.ConclusionsThis novel dietary support intervention was found to be likely cost-effective as an adjunctive treatment for depression from both health sector and societal perspectives.<br /

Evaluating telehealth lifestyle therapy versus telehealth psychotherapy for reducing depression in adults with COVID-19 related distress: the curbing anxiety and depression using lifestyle medicine (CALM) randomised non-inferiority trial protocol

BACKGROUND: There is increasing recognition of the substantial burden of mental health disorders at an individual and population level, including consequent demand on mental health services. Lifestyle-based mental healthcare offers an additional approach to existing services with potential to help alleviate system burden. Despite the latest Royal Australian New Zealand College of Psychiatrists guidelines recommending that lifestyle is a ‘first-line’, ‘non-negotiable’ treatment for mood disorders, few such programs exist within clinical practice. Additionally, there are limited data to determine whether lifestyle approaches are equivalent to established treatments. Using an individually randomised group treatment design, we aim to address this gap by evaluating an integrated lifestyle program (CALM) compared to an established therapy (psychotherapy), both delivered via telehealth. It is hypothesised that the CALM program will not be inferior to psychotherapy with respect to depressive symptoms at 8 weeks. METHODS: The study is being conducted in partnership with Barwon Health’s Mental Health, Drugs & Alcohol Service (Geelong, Victoria), from which 184 participants from its service and surrounding regions are being recruited. Eligible participants with elevated psychological distress are being randomised to CALM or psychotherapy. Each takes a trans-diagnostic approach, and comprises four weekly (weeks 1-4) and two fortnightly (weeks 6 and 8) 90-min, group-based sessions delivered via Zoom (digital video conferencing platform). CALM focuses on enhancing knowledge, behavioural skills and support for improving dietary and physical activity behaviours, delivered by an Accredited Exercise Physiologist and Accredited Practising Dietitian. Psychotherapy uses cognitive behavioural therapy (CBT) delivered by a Psychologist or Clinical Psychologist, and Provisional Psychologist. Data collection occurs at baseline and 8 weeks. The primary outcome is depressive symptoms (assessed via the Patient Health Questionnaire-9) at 8 weeks. Societal and healthcare costs will be estimated to determine the cost-effectiveness of the CALM program. A process evaluation will determine its reach, adoption, implementation and maintenance. DISCUSSION: If the CALM program is non-inferior to psychotherapy, this study will provide the first evidence to support lifestyle-based mental healthcare as an additional care model to support individuals experiencing psychological distress. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12621000387820, Registered 8 April 2021

The SMILES trial: An important first step

The SMILES trial was the first intervention study to test dietary improvement as a treatment strategy for depression. Molendijk et al. propose that expectation bias and difficulties with blinding might account for the large effect size. While we acknowledge the issue of expectation bias in lifestyle intervention trials and indeed discuss this as a key limitation in our paper, we observed a strong correlation between dietary change and change in depression scores, which we argue is consistent with a causal effect and we believe unlikely to be an artefact of inadequate blinding. Since its publication, our results have been largely replicated and our recent economic evaluation of SMILES suggests that the benefits of our approach extend beyond depression. We argue that the SMILES trial should be considered an important, albeit preliminary, first step in the field of nutritional psychiatry research

A randomised controlled trial of dietary improvement for adults with major depression (the 'SMILES' trial)

Correction to this article published: Jacka, FN, O'Neil, Adrienne, Opie, Rachelle, Itsiopoulos, Catherine, Cotton, SM, Mohebbi, M, Castle, David J, Dash, Sarah (external link), Mihalopoulos, Cathrine, Chatterton, Mary Lou, Brazionis, Laima, Dean, OM, Hodge, A. M and Berk, Michael (2018) Correction to: A randomised controlled trial of dietary improvement for adults with major depression (the 'SMILES' trial). BMC Medicine, 16 (1). ISSN 1741-701

Correction to: A randomised controlled trial of dietary improvement for adults with major depression (the 'SMILES' trial)

The original version of this paper [1] did not specify that a website was used in the final year of recruitment, in addition to the other stated recruitment methods. Corrigendum to: Jacka, FN, O'Neil, Adrienne, Opie, Rachelle, Itsiopoulos, Catherine, Cotton, Sue, Mohebbi, M, Castle, David, Dash, Sarah , Mihalopoulos, Cathrine, Chatterton, Mary Lou, Brazionis, Laima, Dean, OM, Hodge, Allison M and Berk, Michael (2017) A randomised controlled trial of dietary improvement for adults with major depression (the 'SMILES' trial). BMC Medicine, 15. ISSN 1741-701

Efficacy and Safety of Repeated Subcutaneous Ketamine Injections for Treatment Resistant Depression - The KADS Study: A Randomised, Double-Blind, Comparator-Controlled Trial

Background Prior trials suggest that intravenous racemic ketamine is a highly effective for treatment-resistant depression (TRD), but phase 3 trials of racemic ketamine are needed. Aims To assess the acute efficacy and safety of a 4-week course of subcutaneous racemic ketamine in participants with TRD. Trial registration: ACTRN12616001096448 at www.anzctr.org.au. Method This phase 3, double-blind, randomised, active-controlled multicentre trial was conducted at seven mood disorders centres in Australia and New Zealand. Participants received twice-weekly subcutaneous racemic ketamine or midazolam for 4 weeks. Initially, the trial tested fixed-dose ketamine 0.5 mg/kg versus midazolam 0.025 mg/kg (cohort 1). Dosing was revised, after a Data Safety Monitoring Board recommendation, to flexible-dose ketamine 0.5-0.9 mg/kg or midazolam 0.025-0.045 mg/kg, with response-guided dosing increments (cohort 2). The primary outcome was remission (Montgomery-Åsberg Rating Scale for Depression score ≤10) at the end of week 4. Results The final analysis (those who received at least one treatment) comprised 68 in cohort 1 (fixed-dose), 106 in cohort 2 (flexible-dose). Ketamine was more efficacious than midazolam in cohort 2 (remission rate 19.6% v. 2.0%; OR = 12.1, 95% CI 2.1-69.2, P = 0.005), but not different in cohort 1 (remission rate 6.3% v. 8.8%; OR = 1.3, 95% CI 0.2-8.2, P = 0.76). Ketamine was well tolerated. Acute adverse effects (psychotomimetic, blood pressure increases) resolved within 2 h. Conclusions Adequately dosed subcutaneous racemic ketamine was efficacious and safe in treating TRD over a 4-week treatment period. The subcutaneous route is practical and feasible

A randomised, controlled trial of a dietary intervention for adults with major depression (the "SMILES" trial): study protocol

Despite increased investment in its recognition and treatment, depression remains a substantial health and economic burden worldwide. Current treatment strategies generally focus on biological and psychological pathways, largely neglecting the role of lifestyle. There is emerging evidence to suggest that diet and nutrition play an important role in the risk, and the genesis, of depression. However, there are limited data regarding the therapeutic impact of dietary changes on existing mental illness. Using a randomised controlled trial design, we aim to investigate the efficacy and cost-efficacy of a dietary program for the treatment of Major Depressive Episodes. <br /