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.

Universal depression prevention: An umbrella review of meta-analyses.

Depression is a disabling, highly prevalent, frequently chronic, and difficult-to-treat disorder with an immense cognitive, social, and economic burden. Given that many of the advances in other non-communicable disorders like cancer have been in prevention rather than treatment, the prevention of depression is currently an unmet public health priority. We sought to provide an overview of the meta-analytic literature through conducting a systematic umbrella review of universally delivered preventive interventions for depression. The search was conducted on March 18, 2021 utilising the following databases (all accessed through EBSCOHost); Allied and Complementary Medicine Database, CINAHL Complete, Global Health, Health Source: Nursing/Academic Edition, MEDLINE Complete and APA PsychArticles. The following search terms related to depression, prevention, and trial study design. Two authors independently screened articles and a third resolved discrepancies. Eligibility criteria sought to identify meta-analyses that investigated the prevention of depression (i.e., reduced incidence) through intervention studies that were universal, in that they were designed to be delivered to entire populations Six meta-analyses on psychological interventions, two school-based meta-analyses, and one eHealth meta-analysis were included in this umbrella review. Findings indicated that all identified studies were of good quality and one was of fair quality. One previous meta-review that examined physical activity to prevent depression was included in results, comprising eight meta-analyses. Preventive interventions have primarily and successfully utilized psychological therapeutic components, delivered at the school, community, and workplace settings. Both school- and eHealth-based interventions hold some utility for depression prevention. There is meta-analytic evidence that physical activity is efficacious for depression prevention. However, universal prevention is inconsistently defined. There is a pressing need for well-designed randomized controlled preventative interventions for depression before recommendations can be universally accepted with convincing level of evidence.

Edge of the Present: A Virtual Reality Tool to Cultivate Future Thinking, Positive Mood and Wellbeing.

Depression and suicidality are characterized by negative imagery as well as impoverished positive imagery. Although some evidence exists supporting the link between positive imagery and enhanced mood, much work needs to be done. This study explored the impact of an immersive virtual reality experience (Edge of the Present-EOTP) on an individual's mood, state of well-being, and future thinking. Using a 10-min mixed reality experience, 79 individuals explored virtual landscapes within a purposefully built, physical room. A pre and post survey containing mental health measures were administered to each participant. An optional interview following the virtual work was also conducted. The results indicated that positive mood and well-being increased significantly post-intervention. Hopelessness scores and negative mood decreased, whilst sense of presence was very high. This pilot study is among the first to assess the feasibility of a mixed reality experience as a potential platform for depression and suicide prevention by increasing well-being and mood as well as decreasing hopelessness symptoms.

A Pilot Evaluation of a Smartphone Application for Workplace Depression.

Interventions delivered via mobile apps show particular promise in tackling the burden of common mental disorders. Appropriately targeting these interventions to at-risk populations is critical to their success. This pilot study aimed to assess the usability, feasibility, acceptability, and preliminary effects of an app-based intervention designed to target depressive symptoms in a stressed working population. Anchored, a smartphone app including a 30-day program of mindfulness and cognitive and behavioural therapeutic components, was tested in a pre-post pilot study with participants recruited via social media advertisements. Eligible participants (N = 81) were Australian adults who were employed and reported elevated stress levels on a single-item screening measure. Follow-up assessment occurred 5 weeks after baseline. The primary outcome measure was change in depressive symptoms, with secondary outcomes measuring change in anxiety, wellbeing, stress, resilience, exercise, alcohol use, absenteeism, and work performance. User feedback and in-app data were analysed to assess engagement and intervention adherence. At follow-up, there were significant reductions in depressive symptoms (t61 = 6.35; p < 0.001) and anxiety symptoms (t60 = 7.35; p < 0.001), along with significantly reduced cases of likely new onset depression compared to baseline (24% vs. 6%, p = 0.012). Significant improvements were also seen in wellbeing (t60 = -5.64; p < 0.001), resilience (t60 = -3.89; p < 0.001), stress (t61 = 11.18; p < 0.001), and alcohol use (t60 = 3.40; p = 0.001). Participants reported no significant changes in work performance, absenteeism or exercise. There were satisfactory levels of app usability, feasibility, and acceptability. Most participants found the app easy to use (93.2%), understood the app content well (83.0%), and rated the app highly or very highly overall (72.9%). User feedback suggestions were predominantly focused on improving app navigation and user interface. This pilot study provides encouraging evidence that Anchored has potentially beneficial effects, and is usable, feasible, and acceptable as an app-based intervention for the working population experiencing elevated stress. Further testing of Anchored in a randomised controlled trial is required to investigate its efficacy as an intervention for workplace mental ill-health.

Self-management in young adults with bipolar disorder: Strategies and challenges.

BACKGROUND: Early adoption of effective self-management strategies for bipolar disorder (BD) results in better clinical outcomes and increased quality of life. Therefore, facilitation of these strategies in young adults who are early in their illness course is vital. However, an understanding of self-management practices and needs of young adults with BD is lacking. This study explores young adult's perspectives of disorder self-management practices and challenges. METHODS: Young adults with BD completed an online survey about disorder management strategies and challenges. Self-management was investigated through self-report and ratings of literature-derived strategies. Results were analysed using descriptive statistics and qualitative thematic analysis. RESULTS: Eighty-nine participants aged 18-30 (M=24.4; SD=3.9) completed the survey. Adherence to treatment, disorder psychoeducation, and sleep-management were the strategies rated most helpful. Six participant-reported self-management strategies were identified (1) Maintaining a healthy lifestyle; (2) Treatment attendance and adherence; (3) Participation in meaningful activities; (4) Engagement with social support; (5) Meditation and relaxation practices; and (6) Symptom monitoring. The most common self-management challenges experienced by young adults concerned the nature of the disorder, interpersonal relationships, and stigma. LIMITATIONS: Participants likely represent a sub-set of young adults engaged with healthcare and therefore may not be representative of the population. CONCLUSIONS: Strategies reported vital by those successfully managing their disorder are not adequately utilised by young adults with BD. Both differences in strategy use and perceived self-management challenges represent important areas of clinical support and intervention. This increased understanding will help facilitate self-management skill development in this population.

The Beyond Ageing Project Phase 2--a double-blind, selective prevention, randomised, placebo-controlled trial of omega-3 fatty acids and sertraline in an older age cohort at risk for depression: study protocol for a randomized controlled trial.

BACKGROUND: Late-life depression is associated with high rates of morbidity, premature mortality, disability, functional decline, caregiver burden and increased health care costs. While clinical and public health approaches are focused on prevention or early intervention strategies, the ideal method of intervention remains unclear. No study has set out to evaluate the role of neurobiological agents in preventing depressive symptoms in older populations at risk of depression. METHODS/DESIGN: Subjects with previously reported sub-threshold depressive symptoms, aged 60 to 74 years, will be screened to participate in a single-centre, double-blind, randomised controlled trial with three parallel groups involving omega-3 fatty acid supplementation or sertraline hydrochloride, compared with matching placebo. Subjects will be excluded if they have current depression or suicide ideation; are taking antidepressants or any supplement containing omega-3 fatty acid; or have a prior history of stroke or other serious cerebrovascular or cardiovascular disease, neurological disease, significant psychiatric disease (other than depression) or neurodegenerative disease. The trial will consist of a 12 month treatment phase with follow-up at three months and 12 months to assess outcome events. At three months, subjects will undergo structural neuroimaging to assess whether treatment effects on depressive symptoms correlate with brain changes. Additionally, proton spectroscopy techniques will be used to capture brain-imaging markers of the biological effects of the interventions. The trial will be conducted in urban New South Wales, Australia, and will recruit a community-based sample of 450 adults. Using intention-to-treat methods, the primary endpoint is an absence of clinically relevant depression scores at 12 months between the omega-3 fatty acid and sertraline interventions and the placebo condition. DISCUSSION: The current health, social and economic costs of late-life depression make prevention imperative from a public health perspective. This innovative trial aims to address the long-neglected area of prevention of depression in older adults. The interventions are targeted to the pathophysiology of disease, and regardless of the effect size of treatment, the outcomes will offer major scientific advances regarding the neurobiological action of these agents. The main results are expected to be available in 2017. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12610000032055 (12 January 2010).

Australian mental health consumers' priorities for research: qualitative findings from the SCOPE for Research project.

BACKGROUND: There is growing acceptance of the importance of the consumer viewpoint in mental health research. Previous studies have identified differences in research priorities between researchers and mental health consumers in Australia defined broadly. However, little is known about the research priorities of consumers with specific mental health conditions. OBJECTIVE: The aim of this study was to explore Australian mental health consumers' priorities for depression and bipolar disorder research. DESIGN: Focus groups with consumers and individual telephone interviews with consumer advocates. Participants were asked to discuss the topics they believed were priorities for depression or bipolar disorder research. Transcripts were thematically analysed using NVivo 7. SETTING AND PARTICIPANTS: Ten people with depression and 19 with bipolar disorder participated in face-to-face focus groups held in three Australian capital cities. Five participants with each disorder participated in online focus groups. Five Australian consumer advocates with experience of depression and six with experience of bipolar disorder were individually interviewed by telephone. RESULTS: Participants raised a broad variety of topics for research. The most salient themes included the need for research on medication, and lifestyle and psychosocial influences on depression and bipolar disorder. CONCLUSIONS: Participants' priorities reflect an interest in a holistic approach to mental health research that examines the influences of everyday life and psychosocial influences both on the development and on the management of these disorders. Their focus was on research that explores individualized care and the active role that consumers can play in their own care and recovery.

The Y-Worri Project: study protocol for a randomised controlled trial.

BACKGROUND: Anxiety disorders are one of the most common psychological problems in adolescents. The school system has been identified as an ideal setting for the implementation of prevention and early intervention programs for anxiety; however, few programs are routinely delivered in schools and little is known about the best delivery methods. The aim of the current project is two-fold: to test the effectiveness of an intervention program for anxiety relative to a control condition, and to compare two methods of implementing the program. METHODS/DESIGN: This study is a three-arm cluster randomised controlled trial consisting of a wait-list control condition and two intervention conditions evaluating the effectiveness of an Internet-based program for preventing generalised anxiety. The first intervention condition will involve classroom teachers supervising student completion of the intervention program, while the second intervention condition will involve the classroom teacher and an education officer from the local youth mental health centre supervising the program's completion. At least 30 schools from across Australia will be recruited to the trial, with adolescents aged between 14 and 18 years invited to participate. Participants in the intervention conditions will complete the e-couch Anxiety and Worry program during class periods over six weeks. The primary outcome measure will be a scale reflecting the number and severity of generalised anxiety symptoms, while secondary outcomes will be symptoms of depression, social anxiety and anxiety sensitivity. Data will be collected at pre-intervention, post-intervention, 6- and 12-month follow-up. Intention-to-treat analyses will be conducted. DISCUSSION: If demonstrated effective, a new service delivery model for the implementation of mental health programs in schools could be indicated. Such a model would significantly contribute to the mental health of young people in Australia by providing preventive interventions for mental health problems and consequently reducing the need for clinical services. TRIAL REGISTRATION: The Australian New Zealand Clinical Trials Registry ACTRN12610001103055.

Oral folic acid and vitamin B-12 supplementation to prevent cognitive decline in community-dwelling older adults with depressive symptoms--the Beyond Ageing Project: a randomized controlled trial.

BACKGROUND: Evidence remains unclear as to whether folic acid (FA) and vitamin B-12 supplementation is effective in reducing depressive symptoms. OBJECTIVES: The objective was to determine whether oral FA + vitamin B-12 supplementation prevented cognitive decline in a cohort of community-dwelling older adults with elevated psychological distress. DESIGN: A randomized controlled trial (RCT) with a completely crossed 2 × 2 × 2 factorial design comprising daily oral 400 µg FA + 100 µg vitamin B-12 supplementation (compared with placebo), physical activity promotion, and depression literacy with comparator control interventions for reducing depressive symptoms was conducted in 900 adults aged 60-74 y with elevated psychological distress (Kessler Distress 10-Scale; scores >15). The 2-y intervention was delivered in 10 modules via mail with concurrent telephone tracking calls. Main outcome measures examined change in cognitive functioning at 12 and 24 mo by using the Telephone Interview for Cognitive Status-Modified (TICS-M) and the Brief Test of Adult Cognition by Telephone (processing speed); the Informant Questionnaire on Cognitive Decline in the Elderly was administered at 24 mo. RESULTS: FA + vitamin B-12 improved the TICS-M total (P = 0.032; effect size d = 0.17), TICS-M immediate (P = 0.046; d = 0.15), and TICS-M delayed recall (P = 0.013; effect size d = 0.18) scores at 24 mo in comparison with placebo. No significant changes were evident in orientation, attention, semantic memory, processing speed, or informant reports. CONCLUSION: Long-term supplementation of daily oral 400 µg FA + 100 µg vitamin B-12 promotes improvement in cognitive functioning after 24 mo, particularly in immediate and delayed memory performance. This trial was registered at clinicaltrials.gov as NCT00214682.

No clear potentiation of antidepressant medication effects by folic acid+vitamin B12 in a large community sample.

BACKGROUND: Observational studies link low folate levels to depressive symptoms and to poor antidepressant medication response. Evidence supports a role for folate in potentiating the effect of antidepressant medications. AIM: This prospective study examines the effects of folic acid+vitamin B12 supplementation and antidepressant medication in a community-based study of older adults with depressive symptoms. METHOD: A randomised controlled trial investigated the effectiveness of a medicinal and two behavioural preventive interventions over a two year period. The medicinal intervention compared dietary supplementation of 400 mcg/d folic acid+100 mcg/d vitamin B12 to placebo. Self reported use of antidepressant medication over two years was recorded. Participants were screened for psychological distress using the Kessler Distress 10-Scale (K-10; >15 eligible) and the main outcome measure was change in depressive symptoms on the Patient Health Questionnaire-9 (PHQ-9) at six weeks, six, 12 and 24 months. Nine hundred adults aged 60-74 years were included in the analysis, of whom 209 (23.2%) reported antidepressant use during the follow-up period. RESULTS: A mixed model repeated measures analysis of variance for reduction in depressive symptoms found no significant three-way interaction between supplement group and antidepressant use over time on the PHQ-9 [F4, 825.1=0.32, p=0.87]. A small interaction between supplement group and antidepressant use over time was found for K-10 scores (F4, 799.5=2.50, p=0.0414). CONCLUSIONS: There was little evidence for the potentiation of antidepressant medication by folic acid+B12 supplementation on depressive symptomatology. Further research should examine whether effects might be found at higher folic acid dosages or among clinical populations.

Mental health literacy, folic acid and vitamin B12, and physical activity for the prevention of depression in older adults: randomised controlled trial.

BACKGROUND: Few randomised controlled trials (RCTs) have examined potential preventive agents in high-risk community populations. AIMS: To determine whether a mental health literacy intervention, the promotion of physical activity, or folic acid plus vitamin B(12) reduce depression symptoms in community-dwelling older adults with elevated psychological distress. METHOD: An RCT with a completely crossed 2 x 2 x 2 factorial design: (400 mcg/d folic acid + 100 mcg/d vitamin B(12) v. placebo)x(physical activity v. nutrition promotion control)x(mental health literacy v. pain information control). The initial target sample size was 2000; however, only 909 adults (60-74 years) met the study criteria. Interventions were delivered by mail with telephone calls. The main outcome was depressive symptoms on the Patient Health Questionnaire (PHQ-9) at 6 weeks, 6, 12 and 24 months. The Clinicaltrials.gov registration number is NCT00214682. RESULTS: The drop-out rate was low (13.5%) from randomisation to 24-month assessment. Neither folic acid + B(12) (F(3,856) = 0.83, P = 0.476) nor physical activity (F(3,856) = 1.65, P = 0.177) reduced depressive symptoms at any time point. At 6 weeks, depressive symptoms were lower for the mental health literacy intervention compared with its control condition (t(895) = 2.04, P = 0.042). CONCLUSIONS: Mental health literacy had a transient effect on depressive symptoms. Other than this, none of the interventions significantly reduced symptoms relative to their comparator at 6 weeks or subsequently. Neither folic acid plus B(12) nor physical activity were effective in reducing depressive symptoms.

Effectiveness of treatments for depression in older people.

OBJECTIVE: To conduct a systematic review of the evidence for the effectiveness of a range of possible treatments for depression in older people. DATA SOURCES: Literature search using the PubMed, PsycInfo and Cochrane Library databases. DATA SYNTHESIS: Treatments that have been suggested to be effective for depression were grouped under three categories: medical treatments, psychological treatments, and lifestyle changes/alternative treatments. We describe each treatment, review the studies of its effectiveness in people aged > or = 60 years, and give a rating of the level of evidence. CONCLUSIONS: The treatments with the best evidence of effectiveness are antidepressants, electroconvulsive therapy, cognitive behaviour therapy, psychodynamic psychotherapy, reminiscence therapy, problem-solving therapy, bibliotherapy (for mild to moderate depression) and exercise. There is limited evidence to support the effectiveness of transcranial magnetic stimulation, dialectical behaviour therapy, interpersonal therapy, light therapy (for people in nursing homes or hospitals), St John's wort and folate in reducing depressive symptoms.

Effectiveness of complementary and self-help treatments for anxiety disorders.

OBJECTIVES: To review the evidence for the effectiveness of complementary and self-help treatments for anxiety disorders. DATA SOURCES: Systematic literature search using PubMed, PsycLit, and the Cochrane Library. DATA SYNTHESIS: 108 treatments were identified and grouped under the categories of medicines and homoeopathic remedies, physical treatments, lifestyle, and dietary changes. We give a description of the 34 treatments (for which evidence was found in the literature searched), the rationale behind the treatments, a review of studies on effectiveness, and the level of evidence for the effectiveness studies. CONCLUSIONS: The treatments with the best evidence of effectiveness are kava (for generalised anxiety), exercise (for generalised anxiety), relaxation training (for generalised anxiety, panic disorder, dental phobia and test anxiety) and bibliotherapy (for specific phobias). There is more limited evidence to support the effectiveness of acupuncture, music, autogenic training and meditation for generalised anxiety; for inositol in the treatment of panic disorder and obsessive-compulsive disorder; and for alcohol avoidance by people with alcohol-use disorders to reduce a range of anxiety disorders.

Use of medications to enhance memory in a large community sample of 60-64 year olds.

BACKGROUND: There are no existing epidemiological data on use of medications to enhance memory. METHOD: A community survey was carried out in Canberra and Queanbeyan, Australia, of an electoral roll sample of 2551 adults aged 60-64 years. Data collected included self-reports of using medications to enhance memory, tests of memory and other cognitive functions, anxiety, depression, physical health and use of other medications. RESULTS: 2.8% of the sample reported using medications to enhance memory, the main ones being gingko biloba, vitamin E, bacopa (brahmi), and folic acid/B vitamins. Users were more likely to be female, to have subjective memory problems and to use other psychotropic medications. However, they did not differ in memory performance, anxiety, depression or physical health. DISCUSSION: Some older people are using complementary medications to improve their memory or prevent memory loss, despite the lack of strong evidence for their effectiveness. These people show no objective evidence of memory impairment.

Association of obesity with anxiety, depression and emotional well-being: a community survey.

OBJECTIVE: To investigate the association of obesity with anxiety, depression and emotional well-being (positive and negative affect) in three age groups. METHODS: A cross-sectional survey was carried out in Canberra and the neighbouring town of Queanbeyan, Australia, with a random sample from the electoral roll of 2,280 persons aged 20-24, 2,334 aged 40-44, and 2,305 aged 60-64. RESULTS: Self-reported height and weight were used to classify participants as underweight (body mass index of less than 18.5), acceptable weight (18.5 to less than 25), overweight (25 to less than 30) or obese (30 and over). Obesity in women was associated with more anxiety and depression symptoms and less positive affect, but there were only weak and inconsistent associations in men. When factors that might mediate any association were controlled (physical ill health, lack of physical activity, poorer social support, less education and financial problems), a different picture emerged, with the underweight women having more depression and negative affect and the obese and overweight women tending to have better mental health than the acceptable weight group. Controlling for physical ill health alone accounted for the association of obesity with anxiety and depression in women. CONCLUSIONS: Obesity has an association with anxiety, depression and lower well-being in women, but not in men. The results are consistent with physical ill health playing a mediating role. IMPLICATION: Reducing obesity in the population is unlikely to have any direct effect on mental health or emotional well-being.

Effectiveness of complementary and self-help treatments for depression.

OBJECTIVES: To review the evidence for the effectiveness of complementary and self-help treatments for depression. DATA SOURCES: Systematic literature search using PubMed, PsycLit, the Cochrane Library and previous review papers. DATA SYNTHESIS: Thirty-seven treatments were identified and grouped under the categories of medicines, physical treatments, lifestyle, and dietary changes. We give a description of each treatment, the rationale behind the treatment, a review of studies on effectiveness, and the level of evidence for the effectiveness studies. RESULTS: The treatments with the best evidence of effectiveness are St John's wort, exercise, bibliotherapy involving cognitive behaviour therapy and light therapy (for winter depression). There is some limited evidence to support the effectiveness of acupuncture, light therapy (for non-seasonal depression), massage therapy, negative air ionisation (for winter depression), relaxation therapy, S-adenosylmethionine, folate and yoga breathing exercises. CONCLUSION: Although none of the treatments reviewed is as well supported by evidence as standard treatments such as antidepressants and cognitive behaviour therapy, many warrant further research.