Testing the Effectiveness of a Mobile Smartphone App Designed to Improve the Mental Health of Junior Physicians: Protocol for a Randomized Controlled Trial.

BACKGROUND: Shift (Black Dog Institute) is the first mobile health smartphone app created to support the mental health of junior physicians. Junior physicians experience demanding work conditions, leading to high levels of psychological distress and burnout. However, they are often concerned about the potential career impacts of seeking mental health support. The confidentiality and ease of access of digital interventions may be particularly suited to address these concerns. The Shift app provides therapeutic and psychoeducational content and strategies contextualized for the specific needs of physicians in training. App content includes information on mental health, help seeking, mindfulness, and common workplace-related concerns of junior physicians. OBJECTIVE: This study aims to test, at scale, the effectiveness of Shift among junior physicians working in Australia using a randomized controlled trial design. The primary aim is to examine whether junior physicians using Shift experience a reduction in depressive symptoms compared with a waitlist control group. The secondary aim is to examine whether the app intervention group experiences improvements in anxiety, work and social functioning, help seeking, quality of life, and burnout compared with the control group. METHODS: A total of 778 junior physicians were recruited over the internet through government and nongovernment medical organizations across Australia, as well as through paid social media advertisements. They were randomly allocated to one of 2 groups: (1) the intervention group, who were asked to use the Shift app for a period of 30 days, or (2) the waitlist control group, who were placed on a waitlist and were asked to use the app after 3 months. Participants completed psychometric measures for self-assessing mental health and wellbeing outcomes, with assessments occurring at baseline, 1 month after completing the baseline period, and 3 months after completing the baseline period. Participants in the waitlist control group were asked to complete an additional web-based questionnaire 1 month after receiving access to the app or 4 months after completing the baseline survey. Participants took part in the study on the internet; the study was completely automated. RESULTS: The study was funded from November 2022 to December 2024 by the New South Wales Ministry of Health. Data collection for the study occurred between January and August 2024, with 780 participants enrolling in the study during this time. Data analysis is underway; the effectiveness of the intervention will be estimated on an intention-to-treat basis using a mixed-model, repeated measures analysis. Results are expected to be submitted for publication in 2025. CONCLUSIONS: To the best of our knowledge, this is the first randomized controlled trial to examine the effectiveness of a mobile health smartphone app specifically designed to support the mental health of junior physicians. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry ACTRN12623000664640; https://tinyurl.com/7xt24dhk. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/58288.

Mental health training for physicians supervising resident physicians: a cluster randomised controlled trial.

OBJECTIVE: To evaluate an online training program for physician supervisors with the aim of promoting a mentally healthy workplace by improving their use of both responsive and preventive mental health support strategies. STUDY DESIGN: Cluster randomised, waitlist-controlled trial. SETTING, PARTICIPANTS: Royal Australasian College of Physicians fellows who were supervising at least one resident physician in any of the 31 primary health networks in Australia and 20 district health boards in New Zealand (health network clusters). INTERVENTION: A brief online skills-based mental health training program, comprising twelve modules grouped into three topics: common mental illnesses; helping trainees you are concerned about (responsive strategies); and minimising mental health risks at work (preventive strategies). MAIN OUTCOME MEASURES: Change between baseline and the 3-month assessment in self-reported recommended supervisor behaviours; differences between intervention and control groups in recommended behaviour scores three weeks, three months, and six months after the program. RESULTS: Ninety physicians from 20 health network clusters were allocated to the intervention group, 88 physicians from 22 clusters to the control group. Intervention group participants reported greater positive change in behaviour across the study period than those in the control group (mixed model repeated measures analysis, group × time interaction: P < 0.001). The mean change in self-reported supervisory behaviour score was higher for the intervention than the control group at the 3-week (mean difference in score, 1.6; 95% confidence interval [CI], 0.8-2.4), 3-month (0.9; 95% CI, 0.2-1.6), and 6-month assessments (1.9; 95% CI, 1.1-2.7). The mean change in self-reported responsive behaviour score was also greater for the intervention group at the 3-week (mean difference, 2.3; 95% CI, 1.5-3.1), 3-month (1.0; 95% CI, 0.2-1.9), and 6-month assessments (2.0; 95% CI, 1.1-2.9); differences in the mean change in preventive behaviour scores were statistically significant at the 3-week (mean difference, 1.1; 95% CI, 0.1-2.2) and 6-month assessments (1.8; 95% CI, 0.8-2.8), but not the 3-month assessment (0.8; 95% CI, -0.1 to 1.7). CONCLUSIONS: Brief online mental health training for senior physicians can lead to changes in their self-reported behaviour for supporting the mental health needs of resident physicians. Whether this leads to better mental health for resident physicians should be investigated. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12619001496101 (prospective).

Potential mental health-related harms associated with the universal screening of anxiety and depressive symptoms in Australian secondary schools.

BACKGROUND: Anxiety and depressive disorders typically emerge in adolescence and can be chronic and disabling if not identified and treated early. School-based universal mental health screening may identify young people in need of mental health support and facilitate access to treatment. However, few studies have assessed the potential harms of this approach. This paper examines some of the potential mental health-related harms associated with the universal screening of anxiety and depression administered in Australian secondary schools. METHODS: A total of 1802 adolescent students from 22 secondary schools in New South Wales, Australia, were cluster randomised (at the school level) to receive either an intensive screening procedure (intervention) or a light touch screening procedure (control). Participants in the intensive screening condition received supervised self-report web-based screening questionnaires for anxiety, depression and suicidality with the follow-up care matched to their symptom severity. Participants in the light touch condition received unsupervised web-based screening for anxiety and depression only, followed by generalised advice on help-seeking. No other care was provided in this condition. Study outcomes included the increased risk of anxiety, depression, psychological distress, decreased risk of help-seeking, increased risk of mental health stigma, determined from measures assessed at baseline, 6 weeks post-baseline, and 12 weeks post-baseline. Differences between groups were analysed using mixed effect models. RESULTS: Participants in the intensive screening group were not adversely affected when compared to the light touch screening condition across a range of potential harms. Rather, participants in the intensive screening group were found to have a decreased risk of inhibited help-seeking behaviour compared to the light touch screening condition. CONCLUSIONS: The intensive screening procedure did not appear to adversely impact adolescents' mental health relative to the light touch procedure. Future studies should examine other school-based approaches that may be more effective and efficient than universal screening for reducing mental health burden among students. Trial registration Australian and New Zealand Clinical Trials Registry (ACTRN12618001539224) https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375821 .

Codesigned online cognitive bias modification of interpretations for anxiety and depression in children: study protocol of a randomised controlled trial.

INTRODUCTION: Previous research has shown that cognitive bias modification of interpretations (CBM-I) may be a promising intervention for anxiety in youth; however, results are mixed. Given the high comorbidity between anxiety and depression in youth, it is surprising that no child studies have targeted biases associated with both. This study aims to evaluate the effectiveness and acceptability of an online CBM-I intervention (Mindmaster) for children with symptom scores of anxiety or depression above a borderline or clinical threshold. The intervention has been codesigned with children, parents and mental health professionals to promote user engagement. METHODS AND ANALYSIS: The study is a randomised controlled trial, with two parallel arms. Participants are 143 children aged 8-10 years with scores of anxiety and/or depressive symptoms above a borderline or clinical threshold. They will be allocated to either the intervention group or the waitlist control group. The intervention consists of 2 weeks of online CBM-I training, with four sessions (10-15 min) per week. Outcome assessments will be conducted at baseline, 4 weeks after baseline (post-training/post-waitlist) and 8 weeks after baseline (follow-up) for the intervention group only. The primary outcome is interpretation bias. Secondary outcomes are anxiety and depressive symptoms and life interference. Analyses will be conducted within an intention-to-treat framework using mixed models for repeated measures. ETHICS AND DISSEMINATION: The study was approved by the University of New South Wales Human Research Ethics Committee (HC220758). Findings will be reported to (1) participating families; (2) presented at scientific conferences and (3) disseminated to peer-review publications. Data will be available from the corresponding author on request. TRIAL REGISTRATION NUMBER: ACTRN12622001493730.

Job Loss Due to COVID-19: A Longitudinal Study of Mental Health, Protective and Risk Factors.

The COVID-19 pandemic had a devastating impact on unemployment, which-compounded by the additional stressors associated with the pandemic-had considerable mental health impact. The current study examined the trajectory of mental health amongst those experiencing pandemic-related job loss, alongside the impact of risk and protective factors. Data were obtained from 374 Australian participants who were allocated to a waitlist control arm of a randomised control trial. The outcome variables assessed at baseline and six-month follow-up consisted of depression, anxiety, and suicidality. The assessed risk and protective factors were age, gender, relationship status, education, exercise frequency, COVID-related stress, dispositional resilience, and coping self-efficacy. Re-employment by follow-up was used as a covariate. Overall, there were decreases in depression and anxiety symptoms, and partial evidence of decreased suicidality, demonstrating an apparent capacity for individuals to better cope with their circumstances over time. Demographics and exercise had no effect on changes in mental health. Those with high COVID-related stress, low resilience, and low coping self-efficacy had worse mental health at baseline, although exhibited significantly greater improvements in mental health over time. Obtaining re-employment by follow-up did not predict changes in mental health. The present results offer an optimistic picture of recovery for those experiencing pandemic-related job loss, even for those with the most substantial risk and severity. The likely protective role played by Australian social welfare policies over the course of the study is explored. Stress around one's broader sociocultural or economic circumstances, perceived resilience, and coping self-efficacy are valuable targets for intervention.

Contrast Clearance Analysis (CCA) to Assess Viable Tumour following Stereotactic Radiosurgery (SRS) to Brain Metastasis in Non-Small Cell Lung Cancer (NSCLC).

BACKGROUND AND OBJECTIVE: Brain metastases are common in lung cancer and increasingly treated using targeted radiotherapy techniques such as stereotactic radiosurgery (SRS). Using MRI, post-SRS changes may be difficult to distinguish from progressive brain metastasis. Contrast clearance analysis (CCA) uses T1-weighted MRI images to assess the clearance of gadolinium and can be thus used to assess vascularity and active tumours. DESIGN AND METHODS: We retrospectively assessed CCAs in 62 patients with non-small cell lung cancer (NSCLC) undergoing 104 CCA scans in a single centre. RESULTS: The initial CCA suggested the aetiology of equivocal changes on standard MRI in 80.6% of patients. In all patients whose initial CCA showed post-SRS changes and who underwent serial CCAs, the initial diagnosis was upheld with the serial imaging. In only two cases of a presumed progressive tumour on the initial CCA, subsequent treatment for radionecrosis was instigated; a retrospective review and re-evaluation of the CCAs show that progression was reported where a thin rim of rapid contrast clearance was seen, and this finding has been subsequently recognised as a feature of post-treatment change on CCAs. The lack of concordance with CCA findings in those who underwent surgical resection was also found to be due to the over-reporting of the thin blue rim as disease in the early cases of CCA use and, in three cases, potentially related to timelines longer than 7 days prior to surgery, both factors being unknown during the early implementation phase of CCA at our centre but subsequently learned. CONCLUSIONS: Our single-centre experience shows CCA to be feasible and useful in patients with NSCLC in cases of diagnostic uncertainty in MRI. It has helped guide treatment in the majority of patients, with subsequent outcomes following the implementation of the treatment based on the results, suggesting correct classification. Recommendations from our experience of the implementation include the careful consideration of the thin rim of the rapid contrast clearance and the timing of the CCA prior to surgery for suspected brain metastasis progression.

Participant comprehension and acceptability of enhanced versus text-only electronic informed consent: an innovative qualitative pilot study.

BACKGROUND: The use of electronic informed consent (eIC) in decentralized trials offers a pragmatic approach to enrolling participants across multiple geographic areas. METHODS: Using a randomized, cross-over study design, we conducted a qualitative descriptive evaluation of two eIC approaches-text-only eIC and enhanced eIC-in a mock hypertension Phase III clinical trial. We assessed participant comprehension and acceptability (usability, satisfaction, and eIC preference). RESULTS: A total of 24 individuals with hypertension participated in the study: 12 reviewed the text-only eIC first, followed by the enhanced eIC, and 12 reviewed the enhanced eIC first, followed by the text-only eIC. The study population was diverse in gender, age, race, and geographic location. We found no descriptive differences in participant comprehension and satisfaction between the two eIC approaches. However, more participants preferred the enhanced eIC, and participants indicated that the digital elements were personable and made them feel more informed, engaged, comfortable, and prepared to participate in clinical research. CONCLUSIONS: Our findings suggest that enhancing the eIC process with digital elements may have beneficial outcomes among potential participants beyond comprehension and satisfaction.

Psychometric properties of the Distress Questionnaire-5 (DQ5) for measuring psychological distress in adolescents.

Screening for psychological distress may assist in identifying at-risk adolescents. While several measures of adolescent psychological distress have been used, most have limited or suboptimal psychometric properties. This study aimed to assess the psychometric properties of the Distress Questionnaire-5 (DQ5), a brief measure of psychological distress, in a large community-based sample of adolescents. Data for the study (n = 3117) were drawn from the baseline and 6-week follow-up assessments of the Future Proofing Study, which collected data from three cohorts of Year 8 students (M = 13.9 years; 48% female) between August 2019 and May 2022. Participants completed the DQ5 at each measurement occasion, as well as measures of depression, generalised and social anxiety, and suicidal ideation. The DQ5 had good fit to a unidimensional construct, with standardised factor loadings ranging between 0.69 and 0.90. The scale had strong criterion (AUC ranged from 0.84 to 0.93) and predictive (AUC ranged from 0.81 to 0.87) validity when compared against indicators for depression, generalised anxiety, social anxiety and suicidal ideation. The DQ5 cut-point of ≥14 had 80% sensitivity and 90% specificity for identifying adolescents meeting symptom thresholds for any of the assessed mental health conditions. Changes in DQ5 scores over 6 weeks had moderate associations with changes in other symptom scales, suggesting sensitivity to change. In conclusion, the DQ5 demonstrates strong psychometric properties and is a reliable measure of psychological distress in adolescents. Given its brevity and ease of interpretation, the DQ5 could be readily used in schools to screen for psychological distress in students.

A randomized wait-list controlled trial of Men in Mind: Enhancing mental health practitioners' self-rated clinical competencies to work with men.

Improved engagement of men in psychotherapy is an essential element in improving male health outcomes. This trial examined whether the Men in Mind intervention improved practitioners' self-rated clinical competencies to engage and respond to male clients in therapy. A parallel, single-blind, wait-list randomized controlled trial was conducted with Australian-based mental health practitioners, currently administering psychotherapy to males, fluent in English, and not currently completing their undergraduate degree. Participants were randomly assigned 1:1, through variable-sized blocks stratified by gender, to either the intervention (Men in Mind) or wait-list control. Men in Mind was offered as a self-led 6-week, five-module online program to upskill practitioners to engage and respond to male clients. The primary outcome was self-reported competency in engaging men in psychotherapy, measured by the Engaging Men in Therapy Scale (EMITS) at 6 weeks. All analyses were by intention-to-treat. Between January 16 and March 17, 2022, 587 participants were randomly assigned to the intervention (n = 300) or wait-list control (n = 287). In total, 492 (84%) participants completed the primary endpoint assessment at 6 weeks. Men in Mind demonstrated a large effect of improved EMITS scores compared to the control group (d = 2.63, 95% CI [2.39, 2.87], p < .001). Men in Mind was effective at increasing mental health practitioners' self-reported efficacy to work with men, which is potentially a key change mechanism in their ability to improve health outcomes for male clients. A limitation of the trial was the use of a bespoke, self-reported primary outcome, while a strength was the gender-responsive intervention design. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

The Addition of Fish Oil to Cognitive Behavioral Case Management for Youth Depression: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial.

BACKGROUND: Clinical trials suggest that long-chain omega-3 polyunsaturated fatty acids (n-3 PUFAs) (fish oil) may reduce depressive symptoms in adults with major depressive disorder. Therefore, n-3 PUFAs may be a potential treatment for depression in youth. METHODS: Participants were 15- to-25 year-old individuals with major depressive disorder who sought care in one of three government-funded mental health services for young people in metropolitan Melbourne, Perth, or Sydney, Australia. Participants were randomly assigned in a double-blind, parallel-arm design to receive either fish oil (840 mg of eicosapentaenoic acid and 560 mg of docosahexaenoic acid) or placebo capsules as adjunct to cognitive behavioral case management. All participants were offered 50-minute cognitive behavioral case management sessions every 2 weeks delivered by qualified therapists (treatment as usual) at the study sites during the intervention period. The primary outcome was change in the interviewer-rated Quick Inventory of Depressive Symptomatology, Adolescent Version, score at 12 weeks. Erythrocyte n-3 PUFA levels were assessed pre-post intervention. RESULTS: A total of 233 young people were randomized to the treatment arms: 115 participants to the n-3 PUFA group and 118 to the placebo group. Mean change from baseline in the Quick Inventory of Depressive Symptomatology score was -5.8 in the n-3 PUFA group and -5.6 in the placebo group (mean difference, 0.2; 95% CI, -1.1 to 1.5; p = .75). Erythrocyte PUFA levels were not associated with depression severity at any time point. The incidence and severity of adverse events were similar in the two groups. CONCLUSIONS: This placebo-controlled trial and biomarker analysis found no evidence to support the use of fish oil for treatment in young people with major depressive disorder.

Understanding suicidal transitions in Australian adults: protocol for the LifeTrack prospective longitudinal cohort study.

BACKGROUND: The factors that influence transition from suicidal ideation to a suicide attempt or remission of suicidal thoughts are poorly understood. Despite an abundance of research on risk factors for suicidal ideation, no large-scale longitudinal population-based studies have specifically recruited people with suicidal ideation to examine the mechanisms underlying critical transitions to either suicide attempt or recovery from suicidal ideation. Without longitudinal data on the psychological, behavioural, and social determinants of suicide attempt and the remission of suicidal ideation, we are unlikely to see major gains in the prevention of suicide. AIM: The LifeTrack Project is a population-based longitudinal cohort study that aims to identify key modifiable risk and protective factors that predict the transition from suicidal ideation to suicide attempt or remission of suicidal ideation. We will assess theory-informed risk and protective factors using validated and efficient measures to identify distinct trajectories reflecting changes in severity of suicidal ideation and transition to suicide attempt over three years. METHODS: A three-year prospective population-based longitudinal cohort study will be conducted with adults from the general Australian population who initially report suicidal ideation (n = 842). Eligibility criteria include recent suicidal ideation (past 30 days), aged 18 years or older, living in Australia and fluent in English. Those with a suicide attempt in past 30 days or who are unable to participate in a long-term study will be excluded. Participants will be asked to complete online assessments related to psychopathology, cognition, psychological factors, social factors, mental health treatment use, and environmental exposures at baseline and every six months during this three-year period. One week of daily measurement bursts (ecological momentary assessments) at yearly intervals will also capture short-term fluctuations in suicidal ideation, perceived burdensomeness, thwarted belongingness, capability for suicide, and distress. CONCLUSION: This study is intended to identify potential targets for novel and tailored therapies for people experiencing suicidal ideation and improve targeting of suicide prevention programs. Even modest improvements in current treatments may lead to important reductions in suicide attempts and deaths. STUDY REGISTRATION: Australian New Zealand Clinical Trials Registry identifier: ACTRN12623000433606.

Qualitative differences in perspective on children's quality of life between children with cerebral palsy and their parents.

BACKGROUND: Cerebral palsy (CP) is one of the most common childhood disabilities, impacting many areas of a child's life. Increasingly, quality of life (QOL) measures are used to capture holistic wellbeing of children with CP. However most validated QOL measures for children are based on adult perspective only, with limited focus on child perspective. Conceptual differences between children's and adults' definitions of QOL may reflect different underlying QOL models which contribute to measurement score divergence. This qualitative study investigated the conceptual meaning of QOL for children with CP, comparing child and parent perspectives. Eighteen families completed 8 child interviews and 18 parent interviews. Children (11 boys, 7 girls) represented the spectrum of motor functioning, with comorbidities including epilepsy, intellectual disability, and communication impairments. Child and parent interviews were analysed separately using constructivist grounded theory methods and then findings were integrated to examine similarities and differences. RESULTS: All participants sought child inclusion in social activities, education, and recreation, requiring negotiation, adaptations, and advocacy. Five conceptual categories emerged from child interviews: socialising, play, negotiating limitations, self-identity, and developing agency. This reflected an individual model of QOL supporting child development goals. Parent interview findings revealed concepts related to child-specific QOL (day-to-day functioning and enabling child goals), as well as parent and family functioning concepts aligned to models of "family QOL", embracing impacts of family relationships and the interdependence of QOL among family members. CONCLUSIONS: This study identified similarities and differences in child and parent perceptions of QOL for the child with CP. Children provided insights into the importance of play and peer support, and their developing self-identity and sense of agency. Self-directed free play, especially, was identified by children but not parents as a central everyday activity promoting wellbeing and social inclusion. Parents discussed family functioning and aspects outside of child sight, such as managing time and financial resources. Relying on parents' perspective alone to model child QOL misses valuable information that children contribute. Equally, child report alone misses parent experiences that directly influence child QOL. There is value in incorporating family QOL into parent reports while developing a conceptually separate child self-report QOL instrument.

Predictive Value of Early Inflammatory Markers in Trauma Patients Based on Transfusion Status.

INTRODUCTION: Seven key inflammatory biomarkers were recently found to be associated with the risk of mortality in a multicenter study of massively transfused patients. The aim of this prospective single-center study was to determine which of these early inflammatory markers could predict 30-d mortality among all critically injured trauma patients. METHODS: Serum samples were collected at 6, 24, and 72 h from 238 consecutive patients admitted to the intensive care unit following traumatic injury. Inflammatory markers syndecan-1, eotaxin, IL-1ra, IL-6, IL-8, IL-10, IP-10, and MCP-1 were analyzed via multiplex enzyme-linked immunosorbent assay. Subgroup analysis was performed for patients undergoing massive transfusion (≥5 red blood cells), submassive transfusion (1-4 red blood cells), or no transfusion during the first 4 h postinjury. The primary outcome of 30-d survival was modeled as a function of each biomarker and confounders using repeat measures logistic regression. RESULTS: Patients had a median age of 51.3 y [33.7, 70.2], 70.6% were male, 17.4% experienced penetrating trauma, and had a median injury severity score of 22 [14, 33]. IL-1ra, IL-8, IL-10, and MCP-1 were significantly increased during the first 72 h in nonsurvivors (n = 31). Elevated IL-1ra, IL-8, IL-10, and MCP-1 at 6 h postinjury were associated with 30-d mortality. By contrast, serum syndecan-1 and eotaxin levels were not associated with mortality at any time point. IL-8 and lactate were increased at 6 h in 30-d nonsurvivors for patients receiving submassive transfusion (n = 78). CONCLUSIONS: Early evaluations of IL-1ra, IL-8, IL-10, and IP-10 within 6 h of injury are useful predictors of 30-d mortality. Subgroup analysis suggests that transfusion status does not significantly affect early inflammatory markers. LEVEL OF EVIDENCE: Level III, prognostic/epidemiological.

Selective Prevention of Depression in Workers Using a Smartphone App: Randomized Controlled Trial.

BACKGROUND: There is increasing evidence that depression can be prevented; however, universal approaches have had limited success. Appropriate targeting of interventions to at-risk populations has been shown to have potential, but how to selectively determine at-risk individuals remains unclear. Workplace stress is a risk factor for depression and a target for intervention, but few interventions exist to prevent depression among workers at risk due to heightened stress. OBJECTIVE: This trial aimed to evaluate the efficacy of a smartphone-based intervention in reducing the onset of depression and improving related outcomes in workers experiencing at least moderate levels of stress. METHODS: A randomized controlled trial was conducted with participants who were currently employed and reported no clinically significant depression and at least moderate stress. The intervention group (n=1053) were assigned Anchored, a 30-day self-directed smartphone app-based cognitive behavioral- and mindfulness-based intervention. The attention-control group (n=1031) were assigned a psychoeducation website. Assessment was performed via web-based self-report questionnaires at baseline and at 1-, 3-, and 6-month postbaseline time points. The primary outcome was new depression caseness aggregated over the follow-up period. The secondary outcomes included depressive and anxiety symptoms, stress, well-being, resilience, work performance, work-related burnout, and quality of life. Analyses were conducted within an intention-to-treat framework using mixed modeling. RESULTS: There was no significant between-group difference in new depression caseness (z score=0.69; P=.49); however, those in the Anchored arm had significantly greater depressive symptom reduction at 1 month (Cohen d=0.02; P=.049) and 6 months (Cohen d=0.08; P=.03). Anchored participants also showed significantly greater reduction in anxiety symptoms at 1 month (Cohen d=0.07; P=.04) and increased work performance at 1 month (Cohen d=0.07; P=.008) and 6 months (Cohen d=0.13; P=.01), compared with controls. Notably, for Anchored participants completing at least two-thirds of the intervention, there was a significantly lower rate of depression onset (1.1%, 95% CI 0.0%-3.7%) compared with controls (9.0%, 95% CI 6.8%-12.3%) at 1 month (z score=4.50; P<.001). Significant small to medium effect sizes for most secondary outcomes were seen in the highly engaged Anchored users compared with controls, with effects maintained at the 6-month follow-up for depressive symptoms, well-being, stress, and quality of life. CONCLUSIONS: Anchored was associated with a small comparative reduction in depressive symptoms compared with controls, although selective prevention of case-level depression was not observed in the intention-to-treat analysis. When users adequately engaged with the app, significant findings pertaining to depression prevention, overall symptom reduction, and functional improvement were found, compared with controls. There is a need for a greater focus on engagement techniques in future research. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000178943; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378592.

Adolescent peer support for mental health problems: evaluation of the validity and reliability of the Mental Health Support Scale for Adolescents.

BACKGROUND: The Mental Health Support Scale for Adolescents (MHSSA) is a criterion-referenced measure of adolescents' supportive intentions towards peers with mental health problems, which was developed for use in evaluations of adolescent mental health interventions, such as the teen Mental Health First Aid (tMHFA) program. The present study aimed to examine the validity and reliability of the MHSSA. METHODS: A sample of 3092 school students (Mean ± SD: 15.9 ± 0.4 years old) and 65 tMHFA Instructors (the adult group with known expertise in tMHFA) completed the 12 items of the MHSSA. A sub-sample of 1201 students repeated the scale after a 3-4-week interval. Item concordance rates with the tMHFA Action Plan across helpful and harmful intentions scales were calculated. Scale reliabilities were assessed using agreement coefficients from a single test administration and test-retest reliability measured by intraclass correlation coefficients. The mean differences of MHSSA scores of students and Instructors were compared using independent samples t-tests, while convergent validity was tested via correlations of the scale with validated measures of confidence in providing help, social distance and personal stigma. RESULTS: The average score of Instructors was significantly higher than that of students. The scale was positively associated with confidence in providing help, whilst negatively associated with social distance and dimensions of personal stigma. All scales of MHSSA had high agreement coefficients (all > 0.80) and fair to good test-retest reliability over 3-4 weeks. CONCLUSIONS: The MHSSA shows evidence of validity and reliability for use among adolescents for evaluating the quality of intentions to help peers with mental health problems.

Correction: Preliminary Investigation of Shift, a Novel Smartphone App to Support Junior Doctors' Mental Health and Well-being: Examination of Symptom Progression, Usability, and Acceptability After 1 Month of Use.

[This corrects the article DOI: 10.2196/38497.].

Protocol for a bandit-based response adaptive trial to evaluate the effectiveness of brief self-guided digital interventions for reducing psychological distress in university students: the Vibe Up study.

INTRODUCTION: Meta-analytical evidence confirms a range of interventions, including mindfulness, physical activity and sleep hygiene, can reduce psychological distress in university students. However, it is unclear which intervention is most effective. Artificial intelligence (AI)-driven adaptive trials may be an efficient method to determine what works best and for whom. The primary purpose of the study is to rank the effectiveness of mindfulness, physical activity, sleep hygiene and an active control on reducing distress, using a multiarm contextual bandit-based AI-adaptive trial method. Furthermore, the study will explore which interventions have the largest effect for students with different levels of baseline distress severity. METHODS AND ANALYSIS: The Vibe Up study is a pragmatically oriented, decentralised AI-adaptive group sequential randomised controlled trial comparing the effectiveness of one of three brief, 2-week digital self-guided interventions (mindfulness, physical activity or sleep hygiene) or active control (ecological momentary assessment) in reducing self-reported psychological distress in Australian university students. The adaptive trial methodology involves up to 12 sequential mini-trials that allow for the optimisation of allocation ratios. The primary outcome is change in psychological distress (Depression, Anxiety and Stress Scale, 21-item version, DASS-21 total score) from preintervention to postintervention. Secondary outcomes include change in physical activity, sleep quality and mindfulness from preintervention to postintervention. Planned contrasts will compare the four groups (ie, the three intervention and control) using self-reported psychological distress at prespecified time points for interim analyses. The study aims to determine the best performing intervention, as well as ranking of other interventions. ETHICS AND DISSEMINATION: Ethical approval was sought and obtained from the UNSW Sydney Human Research Ethics Committee (HREC A, HC200466). A trial protocol adhering to the requirements of the Guideline for Good Clinical Practice was prepared for and approved by the Sponsor, UNSW Sydney (Protocol number: HC200466_CTP). TRIAL REGISTRATION NUMBER: ACTRN12621001223820.

The effects of a sleep-focused smartphone application on insomnia and depressive symptoms: a randomised controlled trial and mediation analysis.

BACKGROUND: Rates of depression are increasing among adolescents. A novel way to reduce depression is by improving sleep. We evaluated whether an app-based intervention for insomnia improved sleep and depression, and whether changes in insomnia mediated changes in depression. METHODS: We conducted a 2-arm single-blind randomised controlled trial at the Black Dog Institute in Australia. Adolescents 12-16 years experiencing insomnia symptoms were randomly allocated to receive Sleep Ninja, an app-delivered cognitive behavioural therapy program for insomnia, or to an active control group involving weekly text message sleep tips. Assessments took place at baseline, 6 weeks (post-intervention) and 14 weeks (post-baseline). Co-primary outcomes were symptoms of insomnia and depression at post-intervention (primary endpoint). Intent-to-treat analyses were conducted. The trial is registered with the Australian and New Zealand Clinical Trials Registry, number ACTRN12619001462178. RESULTS: Between October 25, 2019, and September 6, 2020, 264 participants were randomised to receive Sleep Ninja (n = 131) or to the control group (n = 133). Relative to the control group, those allocated to the intervention reported a greater reduction in insomnia symptoms at 6 weeks (95% CI: -2.96 to -0.41, d = .41) and 14 weeks (95% CI: -3.34 to -0.19, d = .39), and a greater reduction in depression symptoms at 6 weeks (95% CI: -3.46 to -0.56, d = .28) but not 14 weeks (p < 1). Change in insomnia mediated change in depression. No adverse events were reported. CONCLUSIONS: An app-delivered program for insomnia could be a practical, non-stigmatising and scalable way to reduce symptoms of insomnia and depression among adolescents experiencing difficulties getting enough good quality sleep.