Study protocol for ELders AT Ease (ELATE): a cluster randomised controlled trial of cognitive behaviour therapy to reduce depressive symptoms in aged care residents.

BACKGROUND: This protocol describes a study of the effectiveness of cognitive behaviour therapy (CBT) for reducing depressive symptoms in older adults living in residential aged care (RAC) facilities in Australia. Depressive symptoms are highly prevalent in this population, yet the benefits of CBT for reducing such symptoms in RAC facilities have not been widely investigated. Elders at Ease (ELATE) is a 16-session CBT intervention designed for implementation in RAC facilities. The intervention includes cognitive, behavioural and reminiscence strategies and is delivered by mental health trainees (MHTs) in collaboration with RAC facility staff and residents' family. METHODS AND ANALYSIS: ELATE will be evaluated using a cluster randomised trial comparing outcomes for residents who participate in the intervention with those living in usual care control facilities. The participants are RAC residents aged 65 years or above, with depressive symptoms (Patient Health Questionnaire-2 ≥ 3) and normal cognition or mild cognitive impairment (Standardised Mini Mental Status Examination ≥ 21). They are assessed at four time points: baseline prior to randomisation (T1), mid-treatment (T2; 2.5 months post randomisation), post-treatment (T3; 5 months post-randomisation) and 3-month follow-up (T4; 8 months post randomisation). The primary outcome is change in depressive symptoms between T1 and T3. Secondary outcomes are depressive symptoms at T4, anxiety, suicide ideation, sleep problems, quality of life, staff and family knowledge of late-life depression, stress levels and efficacy in caring for residents, and MHT levels of geropsychology competencies. Residents receiving the intervention are hypothesised to report a greater decrease in depressive symptoms between T1 and T3 compared to residents receiving usual care. The primary analysis is a regression, clustered over site to account for correlated readings, and independent variables are condition and depressive symptoms at T1. A cost-utility analysis is also undertaken. DISCUSSION: ELATE is a comprehensive CBT intervention for reducing depressive symptoms in RAC residents. It is designed to be implemented in collaboration with facility staff and residents' families, individually tailored to residents with normal cognition to mild cognitive impairment and delivered by trainee therapists. ELATE offers a model that may be widely applicable across the RAC sector. TRIAL REGISTRATION: Trial registered with the Australian and New Zealand Clinical Trial Registry (ANZCTR) Number ACTRN12619001037190, prospectively registered on 22 July 2019.

Factor structure and psychometric properties of the Pittsburgh Sleep Quality Index in community-based adolescents.

Study Objectives: The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses general sleep quality. This study aimed to validate the single-factor scoring structure and related psychometric properties in the English language version of the PSQI in community-based adolescents. Methods: Participants were 889 (352 males, 39.6%) students (age M = 15.71 ± 1.57; 12.08-18.92 years) recruited from 14 Australian secondary schools. Participants completed the PSQI, Center for Epidemiological Studies-Depression (CES-D) scale, and Spence Children's Anxiety Scale (SCAS). Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) of PSQI component scores were performed on two independent random half-samples (i.e. cross-validation approach). The internal consistency of PSQI components and convergent validity of the PSQI global score with CES-D and SCAS total scores were also assessed. Results: EFA yielded a single-factor model. CFA of the single-factor model in a separate sample yielded acceptable model fit to the data after important relationships were modeled. Namely, modification indices suggested improved model fit by correlating residual scores of PSQI components of sleep duration and sleep efficiency, and sleep efficiency and sleep latency. Internal consistency was acceptable (Cronbach's α = 0.73). The PSQI global score had moderate-to-large positive correlations with CES-D (r = 0.58) and SCAS (r = 0.45) total scores, demonstrating good convergent validity with emotional problems as predicted. Conclusions: The findings validate the single-factor scoring structure of the PSQI in an adolescent sample and highlight important covariation between poor sleep duration, efficiency, and latency in this age group. Further validation studies are required to determine an appropriate PSQI clinical cut-off score for adolescents.

Who benefits from adolescent sleep interventions? Moderators of treatment efficacy in a randomized controlled trial of a cognitive-behavioral and mindfulness-based group sleep intervention for at-risk adolescents.

BACKGROUND: The aim of this study was to test moderators of therapeutic improvement in an adolescent cognitive-behavioral and mindfulness-based group sleep intervention. Specifically, we examined whether the effects of the program on postintervention sleep outcomes were dependent on participant gender and/or measures of sleep duration, anxiety, depression, and self-efficacy prior to the interventions. METHOD: Secondary analysis of a randomized controlled trial conducted with 123 adolescent participants (female = 59.34%; mean age = 14.48 years, range 12.04-16.31 years) who had elevated levels of sleep problems and anxiety symptoms. Participants were randomized into either a group sleep improvement intervention (n = 63) or group active control 'study skills' intervention (n = 60). The sleep intervention ('Sleep SENSE') was cognitive behavioral in approach, incorporating sleep education, sleep hygiene, stimulus control, and cognitive restructuring, but also had added anxiety-reducing, mindfulness, and motivational interviewing elements. Components of the active control intervention ('Study SENSE') included personal organization, persuasive writing, critical reading, referencing, memorization, and note taking. Participants completed the Pittsburgh Sleep Quality Index (PSQI), Spence Children's Anxiety Scale (SCAS), Center for Epidemiologic Studies Depression Scale (CES-D), and General Self-Efficacy Scale (GSE) and wore an actigraph and completed a sleep diary for five school nights prior to the interventions. Sleep assessments were repeated at postintervention. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12612001177842; http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12612001177842&isBasic=True). RESULTS: The results showed that compared with the active control intervention, the effect of the sleep intervention on self-reported sleep quality (PSQI global score) at postintervention was statistically significant among adolescents with relatively moderate to high SCAS, CES-D, and GSE prior to the intervention, but not among adolescents with relatively low SCAS, CES-D, and GSE prior to the intervention. The results were consistent across genders. However, the effects of the sleep intervention on actigraphy-measured sleep onset latency and sleep diary-measured sleep efficiency at postintervention were not dependent on actigraphy-measured total sleep time, SCAS, CES-D, or GSE prior to the intervention. CONCLUSIONS: This study provides evidence that some sleep benefits of adolescent cognitive-behavioral sleep interventions are greatest among those with higher levels of anxiety and depressive symptoms, suggesting that this may be an especially propitious group to whom intervention efforts could be targeted. Furthermore, adolescents with lower levels of self-efficacy may need further targeted support (e.g. additional motivational interviewing) to help them reach treatment goals.

A cognitive-behavioral and mindfulness-based group sleep intervention improves behavior problems in at-risk adolescents by improving perceived sleep quality.

OBJECTIVE: The aim of this study was to test whether a cognitive-behavioral and mindfulness-based group sleep intervention would improve behavior problems in at-risk adolescents, and whether these improvements were specifically related to improvements in sleep. METHOD: Secondary analysis of a randomized controlled trial conducted with 123 adolescent participants (female = 60%; mean age = 14.48, range 12.04-16.31 years) who had high levels of sleep problems and anxiety symptoms. Participants were randomized into either a sleep improvement intervention (n = 63) or an active control "study skills" intervention (n = 60). Participants completed sleep and behavior problems questionnaires, wore an actiwatch and completed a sleep diary for five school nights, both before and after the intervention. RESULTS: Parallel multiple mediation models showed that postintervention improvements in social problems, attention problems, and aggressive behaviors were specifically mediated by moderate improvements in self-reported sleep quality on school nights, but were not mediated by moderate improvements in actigraphy-assessed sleep onset latency or sleep diary-measured sleep efficiency on school nights. CONCLUSION: This study provides evidence, using a methodologically rigorous design, that a cognitive-behavioral and mindfulness-based group sleep intervention improved behavior problems in at-risk adolescent by improving perceived sleep quality on school nights. These findings suggest that sleep interventions could be directed towards adolescents with behavior problems. CLINICAL TRIAL REGISTRATION: This study was part of The SENSE Study (Sleep and Education: learning New Skills Early). URL: ACTRN12612001177842; http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12612001177842&isBasic=True.

The SENSE Study: Treatment Mechanisms of a Cognitive Behavioral and Mindfulness-Based Group Sleep Improvement Intervention for At-Risk Adolescents.

Objectives: The aim of this study was to test whether a cognitive behavioral and mindfulness-based group sleep intervention would improve sleep and anxiety on school nights in a sample of at-risk adolescents. We also examined whether benefits to sleep and anxiety would be mediated by improvements in sleep hygiene awareness and presleep hyperarousal. Methods: Secondary analysis of a randomized controlled trial conducted with 123 adolescent participants (female = 60%; mean age = 14.48) who had high levels of sleep problems and anxiety symptoms. Participants were randomized into a sleep improvement intervention (n = 63) or active control "study skills" intervention (n = 60). Preintervention and postintervention, participants completed the Pittsburgh Sleep Quality Index (PSQI), Spence Children's Anxiety Scale (SCAS), Sleep Beliefs Scale (SBS), and Presleep Hyperarousal Scale (PSAS) and wore an actiwatch and completed a sleep diary for five school nights. Results: The sleep intervention condition was associated with significantly greater improvements in actigraphy-measured sleep onset latency (SOLobj), sleep diary measured sleep efficiency (SEsubj), PSQI, SCAS, SBS, and PSAS, with medium to large effect sizes. Improvements in the PSQI and SCAS were specifically mediated by the measured improvements in the PSAS that resulted from the intervention. Improvements in SOLobj and SEsubj were not specifically related to improvements in any of the putative treatment mechanisms. Conclusions: This study provides evidence that presleep arousal but not sleep hygiene awareness is important for adolescents' perceived sleep quality and could be a target for new treatments of adolescent sleep problems.

Sleep Duration and Sleep Quality: Associations With Depressive Symptoms Across Adolescence.

This study explored whether short sleep duration and sleep quality mediate the relationship between age and depressive symptoms. For comparison, we also explored whether depressive symptoms mediate the relationship between age and short sleep duration and sleep quality. The sample comprised 741 adolescents (63.5% female, mean age 15.78 years, range 11.92-19.67 years) in grades 7-12 from 11 secondary schools in metropolitan Melbourne, Australia. Students completed the Pittsburgh Sleep Quality Index (PSQI) and Center for Epidemiologic Studies Depression Scale (CES-D). Path analyses suggested that short sleep duration significantly mediated the relationship between age and depressive symptoms. Poor sleep quality also significantly mediated this relationship when sleep quality was defined by subjective judgement, but not sleep disturbance, sleep efficiency, or sleep onset latency. Depressive symptoms significantly mediated the relationship between age and short sleep duration and sleep quality (subjective judgement, sleep disturbance, sleep efficiency, and sleep onset latency). These findings suggest that the population-wide increase in depressive symptoms across adolescence is partially mediated by sleep-related developmental changes. They also highlight the importance of examining specific sleep problems when investigating the relationship between sleep and mood in this age group.

The SENSE study: Post intervention effects of a randomized controlled trial of a cognitive-behavioral and mindfulness-based group sleep improvement intervention among at-risk adolescents.

OBJECTIVE: Sleep problems are a major risk factor for the emergence of mental health problems in adolescence. The aim of this study was to investigate the post intervention effects of a cognitive-behavioral/mindfulness-based group sleep intervention on sleep and mental health among at-risk adolescents. METHOD: A randomized controlled trial (RCT) was conducted across High schools in Melbourne, Australia. One hundred forty-four adolescents (aged 12-17 years) with high levels of anxiety and sleeping difficulties, but without past or current depressive disorder, were randomized into either a sleep improvement intervention or an active control 'study skills' intervention. Both programs consisted of 7 90-min-long group sessions delivered over 7 weeks. One hundred twenty-three participants began the interventions (female = 60%; mean age = 14.48, SD = 0.95), with 60 in the sleep condition and 63 in the control condition. All participants were required to complete a battery of mood and sleep questionnaires, 7 days of wrist actigraphy (an objective measure of sleep), and sleep diary entry at pre- and-post intervention. RESULTS: The sleep intervention condition was associated with significantly greater improvements in subjective sleep (global sleep quality [with a medium effect size], sleep onset latency, daytime sleepiness [with small effect sizes]), objective sleep (sleep onset latency [with a medium effect size]), and anxiety (with a small effect size) compared with the control intervention condition. CONCLUSION: The SENSE study provides evidence that a multicomponent group sleep intervention that includes cognitive-behavioral and mindfulness-based therapies can reduce sleep initiation problems and related daytime dysfunction, along with concomitant anxiety symptoms, among at-risk adolescents. (PsycINFO Database Record

Nocturnal indicators of increased cardiovascular risk in depressed adolescent girls.

Depression is an independent risk factor for cardiovascular disease in adults, and recent literature suggests preclinical signs of cardiovascular risk are also present in depressed adolescents. No study has examined the effect of clinical depression on cardiovascular factors during sleep. This study examined the relationship between clinical depression and nocturnal indicators of cardiovascular risk in depressed adolescent girls from the general community (13-18 years old; 11 clinically depressed, eight healthy control). Continuous beat-to-beat finger arterial blood pressure and heart rate were monitored via Portapres and electrocardiogram, respectively. Cardiovascular data were averaged over each hour for the first 6 h of sleep, as well as in 2-min epochs of stable sleep that were then averaged within sleep stages. Data were also averaged across 2-min epochs of pre-sleep wakefulness and the first 5 min of continuous non-rapid eye movement sleep to investigate the blood pressure dipping response over the sleep-onset period. Compared with controls, depressed adolescents displayed a similar but significantly elevated blood pressure profile across sleep. Depressed adolescents had significantly higher systolic and diastolic blood pressure and mean arterial pressures across the entire night (P < 0.01), as well as during all sleep stages (P < 0.001). Depressed adolescents also had higher blood pressure across the sleep-onset period, but the groups did not differ in the rate of decline across the period. Higher blood pressure during sleep in depressed adolescent females suggests that depression has a significant association with cardiovascular functioning during sleep in adolescent females, which may increase risk for future cardiovascular pathology.

The SENSE Study (Sleep and Education: learning New Skills Early): a community cognitive-behavioural therapy and mindfulness-based sleep intervention to prevent depression and improve cardiac health in adolescence.

BACKGROUND: Sleep problems are a major risk factor for the emergence of depression in adolescence. The aim of this study was to test whether an intervention for improving sleep habits could prevent the emergence of depression, and improve well-being and cardiovascular indices amongst at-risk adolescents. METHODS/DESIGN: A longitudinal randomised controlled trial (RCT) is being conducted across Victorian Secondary Schools in Melbourne, Australia. Adolescents (aged 12-17 years) were defined as at-risk for depression if they reported high levels of anxiety and sleep problems on in-school screening questionnaires and had no prior history of depression (assessed by clinical diagnostic interview). Eligible participants were randomised into either a sleep improvement intervention (based on cognitive behavioral and mindfulness principles) or an active control condition teaching study skills. Both programs consisted of seven 90 minute-long sessions over seven weeks. All participants were required to complete a battery of mood and sleep questionnaires, seven-days of actigraphy, and sleep diary entry at pre- and post-intervention. Participants also completed a cardiovascular assessment and two days of saliva collection at pre-intervention. Participants will repeat all assessments at two-year follow up (ongoing). DISCUSSION: This will be the first efficacy trial of a selective group-based sleep intervention for the prevention of depression in an adolescent community sample. If effective, the program could be disseminated in schools and greatly improve health outcomes for anxious adolescents. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12612001177842. Date of Registration: 06-Nov-2012.

Early physiological markers of cardiovascular risk in community based adolescents with a depressive disorder.

BACKGROUND: Depression is recognised as an independent cardiovascular risk factor in adults. Identifying this relationship early on in life is potentially important for the prevention of cardiovascular disease (CVD). This study investigated whether clinical depression is associated with multiple physiological markers of CVD risk in adolescents from the general community. METHODS: Participants aged 12-18 years were recruited from the general community and screened for depressive symptoms. Individuals with high and low depressive symptoms were administered a diagnostic interview. Fifty participants, 25 with a current depressive episode and 25 matched healthy controls, subsequently completed cardiovascular assessments. Variables assessed were automatic brachial and continuous beat-to-beat finger arterial blood pressure, heart rate, vascular functioning by pulse amplitude tonometry following reactive hyperaemia and pulse transit time (PTT) at rest. Blood samples were collected to measure cholesterol, glucose and glycohaemoglobin levels and an index of cumulative risk of traditional cardiovascular risk factors was calculated. RESULTS: Depressed adolescents had a significantly lower reactive hyperaemia index and shorter PTT, suggesting deterioration in vascular integrity and structure. Higher fasting glucose and triglyceride levels were also observed in the depressed group, who also had higher cumulative risk scores indicative of increased engagement in unhealthy behaviours and higher probability of advanced atherosclerotic lesions. LIMITATIONS: The sample size and number of males who completed all cardiovascular measures was small. CONCLUSIONS: Clinically depressed adolescents had poorer vascular functioning and increased CVD risk compared to controls, highlighting the need for early identification and intervention for the prevention of CVD in depressed youth.

Acute phase protein and cytokine levels in serum and saliva: a comparison of detectable levels and correlations in a depressed and healthy adolescent sample.

Recent research has examined associations between inflammation and mental health, and has increasingly focused on utilising younger samples to characterise the temporal relationship between inflammatory responses and the emergence of other symptoms. These studies have typically used blood to measure inflammation, although rates of detection for many inflammatory markers appear to be low. Saliva is a safe and low-cost alternative, and adult research has shown that levels of some salivary markers correlate well with those in serum. However, no research has examined this association in young people. This study examined 16 inflammatory markers in serum and saliva in 17 depressed adolescents and 18 healthy controls, aged 13-18 years. In general, detection rates were higher in saliva compared to in serum. When non-detectable levels were excluded, serum levels of C-reactive protein (CRP) correlated with salivary CRP (r=0.424, p=0.015), and this correlation appeared to only exist for those individuals with high levels of serum CRP (r=0.599, p=0.014). However, when non-detectable levels were included as zero, salivary levels of CRP, interleukin (IL)-2, IL-12p70, and interferon (IFN)-γ correlated with their serum counterparts. No significant clinical group differences in any acute phase proteins or cytokines were present. This study suggests that saliva can be used to measure inflammation in studies with adolescent participants, especially CRP, as it appears to correlate with systemic inflammation for those individuals who are expected to have high levels of inflammation. Implications for future directions in research on salivary inflammatory markers are discussed.