Protocol for a randomised controlled trial evaluating the effect of a CBT-I smartphone application (Sleep Ninja®) on insomnia symptoms in children.

BACKGROUND: Sleep is necessary for healthy development and mental wellbeing. Despite this, many children do not get the recommended duration of sleep each night, and many experience sleep problems. Although treatable, existing interventions for sleep disturbance are time-consuming, burdensome for families, and focus on providing behavioural strategies to parents rather than upskilling children directly. To address this gap, we modified Sleep Ninja®, an evidence-based cognitive behavioural therapy for insomnia (CBT-I) smartphone app for adolescent sleep disturbance, to be appropriate for 10 to 12 year olds. Here, we describe the protocol for a randomised controlled trial to evaluate the effect of Sleep Ninja on insomnia and other outcomes, including depression, anxiety, sleep quality, and daytime sleepiness, and explore effects on the emergence of Major Depressive Disorder (MDD), compared to an active control group. METHODS: We aim to recruit 214 children aged 10 to 12 years old experiencing disturbed sleep. Participants will be screened for inclusion, complete the baseline assessment, and then be randomly allocated to receive Sleep Ninja, or digital psychoeducation flyers (active control) for 6-weeks. The primary outcome, insomnia symptoms, along with depression, anxiety, sleep quality, and daytime sleepiness will be assessed at 6-weeks (primary endpoint), 3-months, and 9-months post-baseline (secondary and tertiary endpoints, respectively). A mixed model repeated measures analytic approach will be used to conduct intention-to-treat analyses to determine whether reductions in insomnia and secondary outcomes are greater for those receiving Sleep Ninja relative to the control condition at the primary and secondary endpoints. The difference in relative risk for MDD onset will be explored at 9-months and compared between conditions. DISCUSSION: This is the first clinical trial examining the effects of a CBT-I smartphone app in children experiencing sleep disturbance. Results will provide empirical evidence about the effects of Sleep Ninja on insomnia and other mental health outcomes. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12623000587606). UNIVERSAL TRIAL NUMBER: U1111-1294-4167.

Protocol for a randomised controlled trial evaluating the effectiveness of a CBT-based smartphone application for improving mental health outcomes in adolescents: the MobiliseMe study.

BACKGROUND: Depression is a leading cause of disability in adolescents, however few receive evidence-based treatment. Despite having the potential to overcome barriers to treatment uptake and adherence, there are very few CBT-based smartphone apps for adolescents. To address this gap, we developed ClearlyMe®, a self-guided CBT smartphone app for adolescent depression and anxiety. ClearlyMe® consists of 37 brief lessons containing core CBT elements, accessed either individually or as part of a 'collection'. Here, we describe the protocol for a randomised controlled trial aiming to evaluate the effect of ClearlyMe® on depressive symptoms and secondary outcomes, including engagement, anxiety and wellbeing, when delivered with and without guided support compared to an attention matched control. METHODS: We aim to recruit 489 adolescents aged 12-17 years with mild to moderately-severe depressive symptoms. Participants will be screened for inclusion, complete the baseline assessment and are then randomly allocated to receive ClearlyMe® (self-directed use), ClearlyMe® with guided SMS support (guided use) or digital psychoeducation (attention-matched control). Depressive symptoms and secondary outcomes will be assessed at 6-weeks (primary endpoint) and 4-months post-baseline (secondary endpoint). Engagement, conceptualised as uptake, adherence and completion, will also be assessed 6-weeks post-baseline. Mixed-effects linear modelling will be used to conduct intention-to-treat analyses to determine whether reductions in depressive symptoms and secondary outcomes are greater for conditions receiving ClearlyMe® relative to control at 6-weeks and 4-months post-baseline and greater for intervention adherers relative to non-adherers. To minimise risk, participants will be encouraged to use the Get Help section of the app and can also opt to receive a call from the team clinical psychologist at baseline, and at the 6-week and 4-month post-baseline assessments when reporting suicidal ideation. DISCUSSION: This is the first clinical trial examining a CBT smartphone app specifically designed for adolescent depression. It will provide empirical evidence on the effects of ClearlyMe® on depressive symptoms when used with and without guided support. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12622000131752). UNIVERSAL TRIAL NUMBER: U1111-1271-8519.

Antidepressant use and its relationship with current symptoms in a population-based sample of older Australians.

BACKGROUND: Australia has the second highest per capita users of antidepressants globally, and their use is pronounced in older Australians. A better understanding of antidepressant use in older adults is important because the elderly are often prescribed multiple drugs, without review, for long periods. METHODS: This study analysed questionnaire data obtained from the Personality and Total Health through life project. Individual respondent data was linked to Pharmaceutical Benefits Scheme (PBS) records. Associations between self-reported medicine use and current symptoms with antidepressant dispensing were examined. RESULTS: 1275 participants aged over 65 were included in the final analysis. One hundred and forty-six (11.5%) participants were dispensed an antidepressant within the specified timeframe. Of those, 38.4% self-reported that they use medicine for depression, 12.3% for anxiety, 17.8% for both depression and anxiety, 6.2% for sleep problems and 3.4% for pain. One fifth of those dispensed an antidepressant did not self-report use of the medicine. Being female or reporting symptoms of depression, anxiety or suicidality were significant predictors of being on an antidepressant. Increasing pain severity was also associated with increased likelihood of being on an antidepressant. LIMITATIONS: We have presented a cross-sectional analysis, which can only provide associations between current symptoms and medicine use. We have only assessed respondents who received their scripts with PBS concession, which limits generalizability. CONCLUSION: Our analysis highlights the high use of antidepressants in the elderly for various reasons. Our findings also uncovered a high amount of under-reporting of antidepressant use by respondents.

A blended face-to-face and smartphone intervention for suicide prevention in the construction industry: protocol for a randomized controlled trial with MATES in Construction.

BACKGROUND: Construction workers are at elevated risk of suicide. MATES in Construction (MATES) is one of the few suicide prevention programs that explicitly address this problem. The MATES program includes an integrated system of services that supports prevention, early intervention and recovery (i.e., primary, secondary and tertiary prevention) for mental health problems among construction workers. In this protocol, we describe a proposed evaluation of MATESmobile, an electronic platform which will be accessed by workers who have undergone MATES training. METHODS/DESIGN: In this protocol, we describe a Randomised Controlled Trial (RCT) which seeks to assess whether MATESmobile results in improved literacy regarding suicide prevention, and improved help-seeking and help-offering attitudes among those who have attended MATES training. Secondary outcomes include changes in suicide ideation, suicide attempt and psychological distress. Workers will be recruited prior to MATES face-to-face training. In total, 295 workers will be randomly assigned to the intervention condition (MATESmobile + face-to-face training) and 295 will be randomly allocated to the control (face-to-face training). The intervention will run for 8 weeks. Assessments will be run immediately post intervention, and at 3, 6, and 12 months DISCUSSION: MATESmobile offers the potential to reinforce and enhance the effects of face-to-face training, resulting in greater skills and knowledge in suicide prevention, as well as a reduction in suicidality and distress. TRIAL REGISTRATION: This trial is registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12619000625178 ; 26 April 2019).

Assessing distress in the community: psychometric properties and crosswalk comparison of eight measures of psychological distress.

BACKGROUND: Many measures are available for measuring psychological distress in the community. Limited research has compared these scales to identify the best performing tools. A common metric for distress measures would enable researchers and clinicians to equate scores across different measures. The current study evaluated eight psychological distress scales and developed crosswalks (tables/figures presenting multiple scales on a common metric) to enable scores on these scales to be equated. METHODS: An Australian online adult sample (N = 3620, 80% female) was administered eight psychological distress measures: Patient Health Questionnaire-4, Kessler-10/Kessler-6, Distress Questionnaire-5 (DQ5), Mental Health Inventory-5, Hopkins Symptom Checklist-25 (HSCL-25), Self-Report Questionnaire-20 (SRQ-20) and Distress Thermometer. The performance of each measure in identifying DSM-5 criteria for a range of mental disorders was tested. Scale fit to a unidimensional latent construct was assessed using Confirmatory Factor Analysis (CFA). Finally, crosswalks were developed using Item Response Theory. RESULTS: The DQ5 had optimal performance in identifying individuals meeting DSM-5 criteria, with adequate fit to a unidimensional construct. The HSCL-25 and SRQ-20 also had adequate fit but poorer specificity and/or sensitivity than the DQ5 in identifying caseness. The unidimensional CFA of the combined item bank for the eight scales showed acceptable fit, enabling the creation of crosswalk tables. CONCLUSIONS: The DQ5 had optimal performance in identifying risk of mental health problems. The crosswalk tables developed in this study will enable rapid conversion between distress measures, providing more efficient means of data aggregation and a resource to facilitate interpretation of scores from multiple distress scales.

The impact of suicidality on health-related quality of life: A latent growth curve analysis of community-based data.

OBJECTIVE: The subjective burden of suicidality on mental and physical health-related quality of life (HRQoL) remains to be examined. Eight-year trajectories of mental and physical components of HRQoL were compared for suicidal and non-suicidal participants at baseline. The effect of poor mental and/or physical HRQoL on subsequent suicidality was also investigated. METHOD: Randomly-selected community data (W1=7485; W2=6715; W3=6133) were analysed with multivariate latent growth curve (LGC) and logistic regression models. RESULTS: Adjusted LGC modelling identified that baseline ideation was associated with poorer mental, but better physical HRQoL at baseline (b=-3.93, 95% CI=-4.75 to -3.12; b=1.38, 95% CI=0.53-2.23, respectively). However, ideation was associated with a declining physical HRQoL trajectory over 8 subsequent years (b=-0.88, 95% CI=-1.42 to -0.35). Poorer mental HRQoL was associated with higher odds of ideation onset (OR=0.98, 95% CI=0.96-0.99). LIMITATIONS: Frequency of data collection was four-yearly, while suicidality was reported for the previous 12-months; analyses did not control for physical health problems at baseline, baseline depression may have influenced physical QoL; suicidality was assessed with binary measures; and, prior analyses of attrition over time showed those with poorer health were less likely to continue participating in the study. CONCLUSIONS: Suicidality has differential longitudinal effects on mental and physical HRQoL. Findings emphasise the considerable subjective HRQoL burden upon suicidal individuals. HRQoL may be useful to compare relative social and economical impacts.

Predictors of personal, perceived and self-stigma towards anxiety and depression.

BACKGROUND: Stigma towards individuals experiencing a mental illness is associated with a range of negative psychological, social and financial outcomes. Factors associated with stigma remain unclear; the relationship between stigma and various personal factors may depend on both the type of disorder being stigmatised and what type of stigma is assessed. Different forms of stigma include personal stigma (negative attitudes towards others), perceived stigma (perceived attitudes of others) and self-stigma (self-attribution of others' negative attitudes). METHOD: Three hundred and fifty university students and members of the general public completed an online survey assessing contact with and knowledge of both depression and anxiety, age, gender, current depression and anxiety symptoms, and personal, perceived and self-stigma for both depression and anxiety. RESULTS: Greater contact with, and knowledge of that illness predicted lower personal stigma for both anxiety and depression. Participants with greater levels of current depression symptomatology and females, reported higher perceived stigma towards depression. Males reported higher personal stigma for anxiety. For both anxiety and depression, higher current symptomatology was associated with greater levels of self-stigma towards the illness. CONCLUSIONS: Findings confirm the role of contact and knowledge in personal stigma for both disorders, consistent with previous findings. This finding also supports evidence that interventions addressing these factors are associated with a decline in personal stigma. However, lack of relationship between contact with, and knowledge of a mental illness and perceived and self-stigma for either depression or anxiety suggests that these factors may not play a major role in perceived or self-stigma. The identification of symptomatology as a key factor associated with self-stigma for both anxiety and depression is significant, and has implications for community-wide interventions aiming to increase help-seeking behaviour, as well as individual treatment strategies for clinicians. Further research should examine whether these relationships hold for groups with clinically diagnosed depression and anxiety disorders.

Predictors and moderators of response to internet-delivered Interpersonal Psychotherapy and Cognitive Behavior Therapy for depression.

BACKGROUND: By identifying which predictors and moderators lead to beneficial outcomes, accurate selection of the best initial treatment will have significant benefits for depressed individuals. METHOD: An automated, fully self-guided randomized controlled internet-delivered noninferiority trial was conducted comparing two new interventions (Interpersonal Psychotherapy [IPT; n=620] and Cognitive Behavioral Therapy [CBT; n=610]) to an active control intervention (MoodGYM; n=613) over a period of 4 weeks to spontaneous visitors of an internet-delivered therapy website (e-couch). A range of putative predictors and moderators (socio-demographic characteristics [age, gender, marital status, education level], clinical characteristics [depression/anxiety symptoms, disability, quality of life, medication use], skills [mastery and dysfunctional attitudes] and treatment preference) were assessed using internet-delivered self-report measures at baseline and immediately following treatment and at six months follow-up. Analyses were conducted using Mixed Model Repeated Measures (MMRM). RESULTS: Female gender, lower mastery and lower dysfunctional attitudes predicted better outcome at post-test and/or follow-up regardless of intervention. No overall differential effects for condition on depression as a function of outcome were found. However, based on time-specific estimates, a significant interaction effect of age was found. For younger people, internet-delivered IPT may be the preferred treatment choice, whereas older participants derive more benefits from internet-delivered CBT programs. LIMITATIONS: Although the sample of participants was large, power to detect moderator effects was still lacking. CONCLUSIONS: Different e-mental health programs may be more beneficial for specific age groups. The findings raise important possibilities for increasing depression treatment effectiveness and improving clinical practice guidelines for depression treatment of different age groups.