The SENSE Study (Sleep and Education: learning New Skills Early): long-term outcomes of a randomised controlled trial of a cognitive-behavioural and mindfulness-based group sleep intervention to prevent depression and improve anxiety in at-risk adolescents

© 2019 Dr. Monika Bianca RanitiObjective: Depression is one of the most common and debilitating mental health problems and its incidence dramatically increases during adolescence. Accumulating evidence suggests that adolescent depression can be prevented with psychosocial interventions, but there is still insufficient evidence to support their widespread implementation. Notably, there is a need for randomised controlled trials of novel interventions that are delivered to community-based adolescents identified to be at-risk for developing depression (i.e., targeted prevention) rather than the general adolescent population (i.e., universal prevention). Improving sleep represents a promising and innovative therapeutic target for the prevention of adolescent depression. Not only are sleep problems, including insufficient and poor-quality sleep, common during adolescence, they also tend to precipitate the onset of depression. Further, sleep interventions may be especially effective if they are delivered to adolescents experiencing anxiety. Anxiety, particularly generalised anxiety, and sleep problems often co-occur, and anxiety is also a risk factor for the development of depression. Evidence from a small but growing number of studies indicates that multicomponent cognitive-behavioural and mindfulness-based sleep interventions can improve sleep in adolescent samples. However, few studies have investigated depression and anxiety outcomes, particularly using randomised controlled designs, active control comparison conditions, extended follow-up periods, a multi-method assessment of sleep (i.e., subjective and objective measures) and mental health (i.e., diagnosis and symptoms) outcomes, and in community-based samples. Notably, no randomised controlled trial has investigated whether a sleep intervention can prevent the first onset of major depressive disorder (MDD) in adolescents. The current study was designed to address these gaps in the literature. The primary aim of the study was to investigate the long-term efficacy of a seven-week cognitive-behavioural and mindfulness-based group sleep intervention for the targeted prevention of first onset MDD and improvement of depressive symptoms over a two-year follow-up period in community-based adolescents experiencing concurrent high levels of anxiety symptoms and sleep problems (i.e., ‘at-risk’ for depression). Given the association between sleep and anxiety, notably generalised anxiety disorder (GAD), and dearth of adolescent sleep intervention studies investigating anxiety outcomes, the secondary and exploratory aim of the study was to investigate the long-term efficacy of the sleep intervention for preventing the incidence of GAD and improving anxiety symptoms over a two-year follow-up period. Importantly, the study aimed to demonstrate that any beneficial effects to depression and/or anxiety outcomes occurred via the putative mechanism of improvements to subjective and objective indices of sleep. As best can be determined, the research reported in this thesis represents the only attempt to date to prevent first onset MDD by improving sleep in an adolescent sample, and the only randomised controlled trial of an adolescent sleep intervention to examine anxiety outcomes over a two-year follow-up period. It was predicted that, compared to adolescents allocated to the active control (study skills) intervention, adolescents allocated to the sleep treatment intervention would: show greater improvements in subjective and objective indices of sleep (i.e., reduced sleep onset latency, increased total sleep time, better overall sleep quality, and reduced weekday bedtime intra-individual variability and weekday-to-weekend bedtime shift) immediately following the intervention and over the two-year follow-up period; be less likely to develop first onset MDD during, and would report lower levels of depressive symptoms at, the two-year follow-up (primary outcomes); and would be less likely to develop new onset GAD during, and would report lower levels of anxiety symptoms at, the two-year follow-up (secondary outcomes). Further, it was predicted that any beneficial long-term effects for depression and anxiety outcomes (i.e., lower incidence of MDD or GAD and/or reduction in depressive and anxiety symptoms) would be significantly mediated by improvements in sleep associated with the sleep treatment intervention (i.e., sleep improvements immediately post-intervention and/or over the two-year follow-up period). Methods: Participant recruitment and eligibility assessments occurred from January 2013 to June 2014. A school-based screening (n = 1491) was conducted at 23 secondary schools (14 Government, 4 Catholic, 5 Independent) in metropolitan Melbourne, Australia, to identify community-based adolescents with high levels of self-reported sleeping problems (score > 4 on the Pittsburgh Sleep Quality Index; PSQI) and anxiety symptoms (score > 32 males/ > 38 female on the Spence Children’s Anxiety Scale; SCAS). Consenting participants who met screening criteria (n = 218) completed semi-structured diagnostic clinical interview (Kiddie-Schedule for Affective Disorders and Schizophrenia for school-age children-Present and Lifetime version; K-SADS-PL) at the University of Melbourne, primarily to exclude individuals (n = 30) with a lifetime history of MDD, consistent with the study’s aim to prevent first onset depression. Eligible participants (n = 144) were randomised (1:1 allocation on an individual basis, and conditions were balanced for age, gender and presence or absence of current anxiety disorder at baseline) to either a seven-week, face-to-face, multicomponent cognitive-behavioural and mindfulness-based group sleep improvement treatment intervention (Sleep SENSE; n = 71) or an attention-matched active control study skills intervention (Study SENSE; n = 73). The Sleep SENSE intervention aimed to address common sleep problems including insufficient sleep duration, prolonged sleep onset, and variability in sleep timing, and included anxiety management components to assist with managing anxiety during the pre-sleep period. Mental health and sleep were assessed using: the K-SADS-PL (for MDD and GAD diagnosis); the Center for Epidemiologic Studies-Depression scale (CES-D; depressive symptoms); the SCAS (anxiety symptoms); the PSQI (self-reported sleep onset latency, total sleep time, overall sleep quality); and week-long actigraphy with sleep diary (objective sleep onset latency, total sleep time, weekday bedtime intra-individual variability, and weekday-to-weekend bedtime shift). Assessments occurred on three occasions–pre-intervention, post-intervention, and two-years after the completion of the intervention. All outcome assessments were administered by researchers who were blind to participants’ intervention assignment. Statistical analyses: All analyses used a modified intention-to-treat approach. Specifically, the final analysed sample (n = 122, sleep treatment n = 62, control intervention n = 60; 60% female; M age = 14.5 years, SD = 0.95, range 12.04 to 16.31 years) included participants who were eligible for and started the interventions, including those who dropped out of the interventions or were lost to follow-up (n = 13) but excluded participants who were identified as ineligible after randomisation (n = 2) and those who were randomised but never started the interventions (sleep treatment n = 10, control intervention n = 10). Latent growth curve modelling with multiple mediation analysis was used to test the effect of condition (i.e., sleep treatment or control intervention) on the long-term depression (i.e., presence or absence of MDD diagnosis, and severity of depressive symptoms) and anxiety (i.e., presence or absence of GAD diagnosis, and severity of anxiety symptoms) outcomes via improvements in the seven sleep variables immediately post-intervention (i.e., ‘initial status’ which was centred at the post-intervention time point) and over the two-year follow-up period (i.e., average linear ‘rate of change’ scaled to represent change per year). That is, the latent growth process of a sleep variable (i.e., the latent variables of initial status and rate of change) was used the mediator in the tested models. In total, 28 separate models were estimated using Mplus (Version 7) software using maximum likelihood estimation with robust standard errors. Results: Regarding the primary outcomes, there was no statistical evidence that the sleep treatment intervention improved subjective or objective indices of sleep immediately post-intervention or over the two-year follow-up period, or significantly predicted the presence or absence of major depressive disorder during, or reductions in depressive symptoms at, the two-year follow-up, relative to the active control intervention. Regarding the secondary outcome, the sleep treatment intervention did not significantly predict reductions on anxiety symptoms at two-year follow-up. However, the sleep treatment intervention significantly reduced the conditional odds of having GAD during the two-year follow-up period by a factor of seven on average, relative to the active control intervention, although confidence intervals suggested a small effect. There were no statistically significant indirect effects in any of the model investigated. Regardless of condition, participants’ subjective (B = -1.77, 95% CI [-3.47, -0.07]) and objective (B = -4.53, 95% CI [-7.96, -1.10]) sleep onset latency and subjective total sleep time (B = -0.18, 95% CI [-0.31, -0.05]) decreased over time, and weekday bedtime intra-individual variability increased over time (B = 7.99, 95% CI [2.11, 13.86]). In addition, poorer subjective sleep quality (B = 1.46, 95% CI [0.38, 2.54]) and less objective total sleep time (B = -3.31, 95% CI [-6.33, -0.28]) immediately post-intervention predicted depressive symptoms at two-year follow-up, and reductions in weekday bedtime intra-individual variability over time were associated with a decreased likelihood of GAD during the two-year follow-up (B = -0.52, 95% CI [-0.86, -0.18]). Conclusions: Together, the findings do not support the long-term efficacy of a targeted multicomponent cognitive-behavioural and mindfulness-based group sleep intervention for the improvement of sleep problems and prevention of first onset major depressive disorder in a community-based sample of at-risk adolescents. However, they tentatively suggest that anxiety may be more responsive to the sleep intervention than depression. In the context of a robust study design, the findings are hypothesis-generating and raise important considerations for the design of future clinical trials investigating the role of adolescent sleep interventions on emerging psychopathology. Funding: Australian National Health and Medical Research Council Grant (APP1027076). Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN12612001177842; prospectively registered on 6th November 2012).

Difficoltà e risorse in bambini e adolescenti con DSA. Un confronto tra genitori e insegnanti

Lo studio analizza la presenza di problemi internalizzanti ed esternalizzanti in studenti con disturbi specifici dell'apprendimento (DSA) in relazione alle loro capacità di adattamento. Sono, inoltre, analizzati i livelli di accordo tra genitori e insegnanti nella valutazione di questi problemi. Hanno partecipato genitori e insegnanti di 28 studenti (F=20) tra i 7 e i 17 anni (M=11.36; DS=2.97). I genitori hanno valutato il funzionamento degli studenti coinvolti attraverso la Child Behavior Check List 6-18 (CBCL 6-18, Achenbach & Rescorla, 2001), gli insegnanti con il Teacher Report Form 6-18 (TRF 6-18, Achenbach & Rescorla, 2001). L’adattamento scolastico risulta avere un ruolo protettivo per i problemi internalizzanti (β=-.526, p<.01) ed esternalizzanti (β=-.510, p<.05). Inoltre, genitori e insegnanti sono più concordi nell’individuare problemi esternalizzanti (.029<k<.274) che internalizzanti (.222<k<.455). Si discutono le implicazioni per la promozione del benessere a scuola degli studenti con DSA.The study analyzed the internalizing and externalizing problems in a group of students with learning disabilities (LD) taking into account their school adjustment. Furthermore, teachers/parents agreement on students' problems was investigated as well. Participants were parents and teachers of 28 students (F=20) aged 7 to 17 years old (M=11.36; DS=2.97). Parents evaluated students’ functioning with the Child Behavior CheckList 6-18 (CBCL 6-18, Achenbach & Rescorla, 2001), while teachers with the Teacher Report Form 6-18 (TRF 6-18, Achenbach & Rescorla, 2001). School adjustment was a protective factor for internalizing (β=-.526, p<.01) and externalizing (β=-.510, p<.05) problems. Moreover, parents and teachers reached a better agreement when considering externalizing problems (.029<k<.274) than internalizing ones (.222<k<.455). Implications about wellbeing promotion of students with LD are discussed

Exploration of a novel mask system in the treatment of sleep disordered breathing in paediatric patients

Introduction: Polysomnography (PSG) in the home has advantages over in-laboratory PSG, but one important disadvantage is the inability of current devices to record lights off (Loff) and on times and thus important indices such as sleep onset latency and sleep efficiency cannot be determined. This study evaluates the characteristics of a prototype light sensor (Compumedics) used with a portable PSG device (SomtePSG, Compumedics), and its utility in the home where light conditions are uncontrolled and it is impractical to calibrate the light sensor to the conditions in each individual home. \ud \ud Methods: Three examples of the light sensor were exposed to incandescent light at a range of controlled light levels to determine their signal characteristics. Twenty-four home PSGs were analysed to explore the characteristics of the light sensor signal in the home. \ud \ud Results: The table below shows the results for the sensor signal characteristics. The light sensor allowed a discernable Loff to be identified in 19 of 24 home PSGs, and in these 19, the mean difference between patient reported and light sensor Loff was 1.2 min (SD 16.6, range -23 to +50). \ud \ud Discussion: The light sensor signals were found to have good sensitivity and linearity, low drift and record a range of lux appropriate for the home setting. When used in home PSG, these light sensors were able to establish Loff in the majority of PSGs. The wide range of differences between patient reported and sensor Loff demonstrates the importance of objective determination of Loff in home PSG, particularly for studies where accurate measurements of Loff dependant indices such as sleep onset latency are needed

The impact of an outdoor adventure program on positive adolescent development: a controlled crossover trial

This paper describes a quasi-experimental crossover trial of an outdoor adventure program for Year 9 school students in Australia. Previous studies have reported a range of positive outcomes of outdoor camps and adventure programs, but cautious interpretation of some claims may be warranted due to limitations in research methods. This study examines a purpose-designed, seven-day outdoor adventure program intended to promote positive adjustment in young people. A total of 335 participants (aged 14–16 years) were recruited from across two Victorian secondary schools. In year 1 (2015), students from school A were recruited to the outdoor program while students from school B were recruited to a control group. In the second year (2016) the roles of each school were switched (crossed over). Outcome measures assessed on five occasions included a range of self-reported social and emotional health indicators. While quantitative analyses did not find support for positive, universal effects of our program, qualitative information gathered across the course of the study suggested that the outdoor program may have been both impactful and positive for some students. This complex picture suggests that effects of the outdoor adventure experience were quite variable amongst participants. Reasons for this pattern of findings are discussed, including the possibility that our quantitative measures may have been insensitive to some benefits. Future work should examine salient moderators of the beneficial effects of outdoor adventure experiences

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

The morning cortisol to CRP ratio prospectively predicts first-onset depression in at risk adolescents

Early onset adolescent depression is related to poor prognosis and a range of psychiatric and medical comorbidities later in life, making the identification of a priori risk factors for depression highly important. Increasingly, dysregulated levels of immune and neuroendocrine markers, such as C-reactive protein (CRP) and cortisol, have been demonstrated as both precursors to and consequences of depression. However, longitudinal research with adolescent populations is limited and demonstrates mixed immuno-endocrine-depression links. This study explored the putative bidirectional relationship between salivary measures of cortisol and CRP, including the novel Cort:CRP ratio, and depression

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 electrocardio-gram, 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 morning cortisol to CRP ratio prospectively predicts first-onset depression in at risk adolescents

Early onset adolescent depression is related to poor prognosis and a range of psychiatric and medical comorbidities later in life, making the identification of a priori risk factors for depression highly important. Increasingly, dysregulated levels of immune and neuroendocrine markers, such as C-reactive protein (CRP) and cortisol, have been demonstrated as both precursors to and consequences of depression. However, longitudinal research with adolescent populations is limited and demonstrates mixed immuno-endocrine-depression links. This study explored the putative bidirectional relationship between salivary measures of cortisol and CRP, including the novel Cort:CRP ratio, and depression. Participants from the randomized control trial ‘Sleep and Education: learning New Skills Early’ (SENSE) Study were 122 adolescents at risk for depression (73 females) aged 12 to 16 years (M=12.71 years, SD=1.01 years) assessed at baseline (T1), post-intervention (T2), and a two-year follow-up (T3). Logistic regression results demonstrated that adolescents with higher T1 Cort:CRPmorn ratio levels were two-fold more likely to develop a first-onset depressive disorder from T2 to T3 as compared to adolescents with lower Cort:CRPmorn ratio levels, β=0.73, t(36)=2.15, p=.04, OR=2.08. This effect was not moderated by treatment condition (β=-1.38, t(13)=-1.33, p=.20) and did not change when controlling for known risk factors for depression, including sex, age, body-mass index, socio-economic status, T1 anxiety disorder, nor T1 sleep disturbance, anxiety, or depressive symptoms (β=0.91, t(31)=2.14, p=.04). Results highlight potential immuno-endocrine dysregulation as an underlying risk factor for adolescent first-onset depression, and may inform the development of targeted, preventative biobehavioral treatment strategies for youth depression

Salivary C-reactive protein among at-risk adolescents: A methods investigation of out of range immunoassay data

Inflammatory markers including C-Reactive Protein (CRP) are increasingly used within research and clinical settings. Yet, varying methodologies for cleaning immunoassay data with out of range (OOR) samples may alter characteristic levels of CRP, thereby obscuring interpretation and reliability. This study investigated the influence of eight immunoassay OOR data treatment techniques on salivary CRP (sCRP) samples from at-risk adolescents. Participants from the ‘Sleep and Education: learning New Skills Early’ (SENSE) Study were 86 adolescents at-risk for depression (50 female), aged 14.29 years (SD=1.04). ANOVA results showed no statistically significant differences in average morning (F(7, 590)=1.24, p=.28) and evening (F(7, 599)=1.29, p=.25) values produced by each OOR data cleaning technique. However, varying techniques produced differences in the magnitude of Pearson’s correlations between consecutive saliva samples (r’s between .27 – .78), and influenced the significance of a sCRP diurnal pattern; two techniques produced statistically higher morning than evening sCRP levels (t(85)=2.70, p=.01 and t(85)=2.67, p=.01), whereas six techniques failed to find statistical differences between morning and evening sCRP levels (p’s &gt;.05). Varying techniques also produced statistically divergent associations between sCRP and age and depressive symptoms. Results from this study provide evidence for the temporal stability of sCRP among adolescents, show winsorization as an effective OOR data management technique, and highlight the influence of methodological decisions in cleaning salivary biomarker data and the need for consistency within the field

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.

ObjectiveSleep 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.MethodA 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.ResultsThe 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.ConclusionThe 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 Recor