The Study of Ketamine for Youth Depression (SKY-D): study protocol for a randomised controlled trial of low-dose ketamine for young people with major depressive disorder.

BACKGROUND: Existing treatments for young people with severe depression have limited effectiveness. The aim of the Study of Ketamine for Youth Depression (SKY-D) trial is to determine whether a 4-week course of low-dose subcutaneous ketamine is an effective adjunct to treatment-as-usual in young people with major depressive disorder (MDD). METHODS: SKY-D is a double-masked, randomised controlled trial funded by the Australian Government's National Health and Medical Research Council (NHMRC). Participants aged between 16 and 25 years (inclusive) with moderate-to-severe MDD will be randomised to receive either low-dose ketamine (intervention) or midazolam (active control) via subcutaneous injection once per week for 4 weeks. The primary outcome is change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) after 4 weeks of treatment. Further follow-up assessment will occur at 8 and 26 weeks from treatment commencement to determine whether treatment effects are sustained and to investigate safety outcomes. DISCUSSION: Results from this trial will be important in determining whether low-dose subcutaneous ketamine is an effective treatment for young people with moderate-to-severe MDD. This will be the largest randomised trial to investigate the effects of ketamine to treat depression in young people. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ID: ACTRN12619000683134. Registered on May 7, 2019. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377513 .

A pilot randomised controlled trial of the Peer Tree digital intervention targeting loneliness in young people: a study protocol.

BACKGROUND: Young people are vulnerable to experiencing problematic levels of loneliness which can lead to poor mental health outcomes. Loneliness is a malleable treatment target and preliminary evidence has shown that it can be addressed with digital platforms. Peer Tree is a strength-based digital smartphone application aimed at reducing loneliness. The study aim is to reduce loneliness and assess the acceptability, usability, and feasibility of Peer Tree in young people enrolled at university. METHODS: This will be a pilot randomised controlled trial (RCT) comparing a strength-based digital smartphone application (Peer Tree) with a control condition. Forty-two young people enrolled at university will be recruited for this pilot RCT. Participants with suicidal ideation or behaviours, acute psychiatric symptoms in the past month, or a current diagnosis of a mood or social anxiety disorder will be excluded. Allocation will be made on a 1:1 ratio and will occur after the initial baseline assessment. Assessments are completed at baseline, at post-intervention, and at follow-up. Participants in the control condition complete the same three assessment sessions. The primary outcome of the study will be loneliness. Depression, social anxiety, quality of life, acceptability, usability, feasibility, and safety of Peer Tree will also be measured as secondary outcomes. DISCUSSION: This trial will report the findings of implementing Peer Tree, a smartphone application aimed at reducing loneliness in university students. Findings from this trial will highlight the initial efficacy, acceptability, and feasibility of using digital positive psychology interventions to reduce subthreshold mental health concerns. Findings from this trial will also describe the safety of Peer Tree as a digital tool. Results will contribute evidence for positive psychology interventions to address mental ill-health. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ACTRN12619000350123. Registered on 6 March 2020.

A Global Longitudinal Study Examining Social Restrictions Severity on Loneliness, Social Anxiety, and Depression.

Purpose: Social restrictions and government-mandated lockdowns implemented worldwide to kerb the SARS-CoV-2 virus disrupted our social interactions, behaviours, and routines. While many studies have examined how the pandemic influenced loneliness and poor mental health, such as depression, almost none have focussed on social anxiety. Further, how the change in social restrictions affected change in mental-health and well-being has not yet been explored. Methods: This is a longitudinal cohort study in community dwellers who were surveyed across three timepoints in the first six months of the pandemic. We measured loneliness, social anxiety, depression, and social restrictions severity that were objectively coded in a sample from Australia, United States, and United Kingdom (n = 1562) at each time point. Longitudinal data were analysed using a multivariate latent growth curve model. Results: Loneliness reduced, depression marginally reduced, and social anxiety symptoms increased as social restrictions eased. Specific demographic factors (e.g., younger age, unemployment, lower wealth, and living alone) all influenced loneliness, depression, and social anxiety at baseline. No demographic factors influenced changes for loneliness; we found that those aged over 25 years reduced faster on depression, while those younger than 25 years and unemployed increased faster on social anxiety over time. Conclusion: We found evidence that easing social restrictions brought about additional burden to people who experienced higher social anxiety symptoms. As country-mandated lockdown and social restrictions eased, people are more likely report higher social anxiety as they readjust into their social environment. Mental health practitioners are likely to see higher levels of social anxiety in vulnerable communities even as social restrictions ease.