Preventing postpartum insomnia: findings from a three-arm randomised controlled trial of Cognitive Behavioural Therapy for Insomnia, a responsive bassinet, and sleep hygiene.

STUDY OBJECTIVES: Insomnia symptoms are common during the perinatal period and are linked to adverse outcomes. This single-blind 3-arm randomised controlled trial examined whether two interventions targeting different mechanisms prevent postpartum insomnia. METHODS: Participants were nulliparous females 26-32 weeks gestation with Insomnia Severity Index (ISI) scores≥8, recruited in Australia and randomised 1:1:1 to: (a) a responsive bassinet designed to support infant sleep and reduce maternal sleep disruption until 6 months postpartum (RB), (b) therapist-assisted cognitive behavioural therapy for insomnia (CBT-I) delivered during pregnancy and postpartum, or (c) a sleep hygiene booklet (control; CTRL). Outcomes were assessed at baseline (T1), 35-36 weeks gestation (T2), and 2, 6, and 12 months postpartum (T3-T5). The primary outcome was ISI scores averaged T3-T5. Primary analyses were regressions controlling for baseline outcomes. RESULTS: 127 participants (age M±SD=32.62±3.49) were randomised (RB=44, CBT-I=42, CTRL= 41). Both interventions were feasible and well-accepted, with few related adverse events reported. Compared to CTRL, the average ISI across T3-T5 was lower for CBT-I (p=.014, effect size [ES]=0.56, medium) but not RB (p=.270, ES=0.25, small). Exploratory findings on maternal insomnia diagnosis, sleep disturbance, sleep-related impairment, beliefs and attitudes about sleep, depression, anxiety, as well as infant sleep outcomes were also presented. CONCLUSIONS: CBT-I but not RB reduced prenatal insomnia (very large effect) and prevented postpartum insomnia (medium effect). Further research is needed to examine the effects of both CBT-I and RB on other outcomes such as sleep-related wellbeing, postpartum depression, and maternal postpartum sleep duration.

Does providing feedback and guidance on sleep perceptions using sleep wearables improve insomnia? Findings from "Novel Insomnia Treatment Experiment": a randomized controlled trial.

STUDY OBJECTIVES: Insomnia is a disorder diagnosed based on self-reported sleep complaints. Differences between self-reported and sensor-based sleep parameters (sleep-wake state discrepancy) are common but not well-understood in individuals with insomnia. This two-arm, parallel-group, single-blind, superiority randomized-controlled trial examined whether monitoring sleep using wearable devices and providing support for interpretation of sensor-based sleep data improved insomnia symptoms or impacted sleep-wake state discrepancy. METHODS: A total of 113 (age M = 47.53; SD = 14.37, 64.9% female) individuals with significant insomnia symptoms (Insomnia Severity Index(ISI) ≥10) from the community were randomized 1:1 (permuted block randomization) to receive 5 weeks (1) Intervention (n = 57): feedback about sensor-based sleep (Fitbit and EEG headband) with guidance for data interpretation and ongoing monitoring, and (2) Control (n = 56): sleep education and hygiene. Both groups received one individual session and two check-in calls. The ISI (primary outcome), sleep disturbance (SDis), sleep-related impairment (SRI), depression, and anxiety were assessed at baseline and post-intervention. RESULTS: In total, 103 (91.2%) participants completed the study. Intention-to-treat multiple regression with multiple imputations showed that after controlling for baseline values, compared to the Control group (n = 51), the Intervention group (n = 52) had lower ISI (p = .011, d = 0.51) and SDis (p = .036, d = 0.42) post-intervention, but differences in SRI, depression, anxiety, and sleep-wake state discrepancy parameters (total sleep time, sleep onset latency, and wake after sleep onset) were not meaningful (P-values >.40). CONCLUSIONS: Providing feedback and guidance about sensor-based sleep parameters reduced insomnia severity and sleep disturbance but did not alter sleep-wake state discrepancy in individuals with insomnia more than sleep hygiene and education. The role of sleep wearable devices among individuals with insomnia requires further research. CLINICAL TRIAL REGISTRATION: The Novel Insomnia Treatment Experiment (NITE): the effectiveness of incorporating appropriate guidance for sleep wearables in users with insomnia. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378452, Australia New Zealand Clinical Trials Registry: ACTRN12619001636145.

Improving perinatal sleep via a scalable cognitive behavioural intervention: findings from a randomised controlled trial from pregnancy to 2 years postpartum.

BACKGROUND: Sleep disturbance is common in gestational parents during pregnancy and postpartum periods. This study evaluated the feasibility and efficacy of a scalable cognitive behavioural therapy (CBT) sleep intervention tailored for these periods. METHODS: This is a two-arm, parallel-group, single-blind, superiority randomised controlled trial. Nulliparous females without severe medical/psychiatric conditions were randomised 1:1 to CBT or attention- and time-matched control. All participants received a 1 h telephone session and automated multimedia emails from the third trimester until 6 months postpartum. Outcomes were assessed with validated instruments at gestation weeks 30 (baseline) and 35 (pregnancy endpoint), and postpartum months 1.5, 3, 6 (postpartum endpoint), 12 and 24. RESULTS: In total, 163 eligible participants (age M ± s.d. = 33.35 ± 3.42) were randomised. The CBT intervention was well accepted, with no reported adverse effect. Intention-to-treat analyses showed that compared to control, receiving CBT was associated with lower insomnia severity and sleep disturbance (two primary outcomes), and lower sleep-related impairment at the pregnancy endpoint (p values ⩽ 0.001), as well as at 24 months postpartum (p ranges 0.012-0.052). Group differences across the first postpartum year were non-significant. Participants with elevated insomnia symptoms at baseline benefitted substantially more from CBT (v. control), including having significantly lower insomnia symptoms throughout the first postpartum year. Group differences in symptoms of depression or anxiety were non-significant. CONCLUSIONS: A scalable CBT sleep intervention is efficacious in buffering against sleep disturbance during pregnancy and benefitted sleep at 2-year postpartum, especially for individuals with insomnia symptoms during pregnancy. The intervention holds promise for implementation into routine perinatal care.

Treating postpartum insomnia: a three arm randomised controlled trial of cognitive behavioural therapy and light dark therapy.

BACKGROUND: Insomnia symptoms are common during the postpartum period, yet interventions remain scarce. This trial aimed to simultaneously examine the efficacy of cognitive behavioural therapy (CBT) and light dark therapy (LDT), targeting different mechanisms, against treatment-as-usual (TAU), in reducing maternal postpartum insomnia symptoms. METHODS: This three-arm randomised controlled trial recruited from the general community in Australia. Nulliparous females 4-12 months postpartum with self-reported insomnia symptoms [Insomnia Severity Index (ISI) scores >7] were included; severe medical/psychiatric conditions were excluded. Participants were randomised 1:1:1 to CBT, LDT, or TAU stratified by ISI (< or ⩾14) and infant age (< or ⩾8 months). Participants and principal investigators were unblinded. Six-week interventions were delivered via digital materials and telephone. The primary outcome was insomnia symptoms (ISI), assessed pre-, midpoint-, post- (primary endpoint), and one-month post-intervention. Analyses were intention-to-treat using latent growth models. RESULTS: 114 participants (CBT = 39, LDT = 36, TAU = 39; Mage = 32.20 ± 4.62 years) were randomised. There were significantly greater reductions in ISI scores in CBT and LDT (effect sizes -2.01 and -1.52 respectively, p < 0.001) from baseline to post-intervention compared to TAU; improvements were maintained at follow-up. Similar effects were observed for self-reported sleep disturbance. There were greater reductions in fatigue in CBT (effect size = 0.85, p < 0.001) but not LDT (p = 0.11) compared to TAU. Changes in sleepiness, depression, and anxiety were non-significant compared to TAU (all p > 0.08). Four participants (11%) in the LDT group reported headaches, dizziness, or nausea; no others reported adverse events. CONCLUSIONS: Therapist-assisted CBT and LDT were feasible during the first postpartum year; data at post-intervention and 1-month follow-up support their safety and efficacy in reducing postpartum insomnia symptoms.

Preventing postpartum insomnia by targeting maternal versus infant sleep: a protocol for a randomized controlled trial (the Study for Mother-Infant Sleep "SMILE").

Symptoms of insomnia are common during the perinatal periods and are linked to adverse parent/infant outcomes. Theories on insomnia development (e.g. 3P model) suggest that significant sleep disruption (e.g. nighttime infant care) can precipitate, while unhelpful sleep-related cognitions/behaviors can perpetuate parental insomnia symptoms. This study aims to examine how two interventions, one addressing infant sleep as the precipitator, the other targeting maternal sleep-related cognitions/behaviors as the perpetuator, might prevent postpartum insomnia. Participants are 114 nulliparous females 26 to 32 weeks gestation, with self-reported insomnia symptoms (Insomnia Severity Index scores ≥ 8). Participants are randomized to one of three conditions and receive: (1) a "responsive bassinet" used until 6 months postpartum, designed to boost/consolidate infant sleep and target infant sleep as a precipitator of insomnia, (2) therapist-assisted cognitive behavioral therapy for insomnia, addressing unhelpful sleep-related cognitions/behaviors as perpetuators of insomnia, or (3) a sleep hygiene booklet (control condition). The primary outcome is maternal insomnia symptoms. Secondary outcomes include maternal sleep duration/quality, mental health (e.g. depression, anxiety), and wellbeing-related variables (e.g. sleep-related impairment). Outcomes are assessed using validated instruments at 26-32 and 35-36 weeks' gestation, and 2, 6, and 12 months postpartum. This study adopts an early-intervention approach and longitudinally compares two distinct approaches to prevent postpartum insomnia in an at-risk population. If interventions are efficacious, findings will demonstrate how interventions targeting different mechanisms mitigate insomnia symptoms in perinatal populations. This will provide empirical evidence for future development of multi-component sleep intervention to improve mother-infant wellbeing. Clinical Trial Registration: The Study for Mother-Infant Sleep (The SMILE Project): reducing postpartum insomnia using an infant sleep intervention and a maternal sleep intervention in first-time mothers. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377927, Australian New Zealand Clinical Trials Registry: ACTRN12619001166167.

Differentiating perinatal Insomnia Disorder and sleep disruption: a longitudinal study from pregnancy to 2 years postpartum.

STUDY OBJECTIVES: Insomnia Disorder diagnoses require persistent sleep complaints despite "adequate sleep opportunity." Significant Perinatal Sleep Disruption makes this diagnosis challenging. This longitudinal study distinguished between Insomnia Disorder and Perinatal Sleep Disruption and their sleep and mental health correlates. METHODS: One hundred sixty-three nulliparous females (age M ± SD = 33.35 ± 3.42) participating in a randomized controlled trial repeated the Insomnia Disorder module of the Duke Structured Interview for Sleep Disorders and Patient-Reported Outcome Measurement Information System measures for sleep and mental health at 30- and 35-weeks' gestation, and 1.5, 3, 6, 12, and 24 months postpartum (944 interviews, 1009 questionnaires completed). We compared clinical features when Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Insomnia Disorder criteria (without the Duration criterion) were: (1) met (Insomnia Disorder), (2) not met only because of the sleep opportunity criteria (Perinatal Sleep Disruption), and (3) not met due to other criteria (Low Complaint). RESULTS: Proportions of Insomnia Disorder were 16.0% and 19.8% during early and late third trimester, and ranged 5.3%-11.7% postpartum. If the sleep opportunity criteria were not considered, rates of Insomnia would be 2-4 times higher (21.4%-40.4%) across time-points. Mixed-effects models adjusting for covariates showed that compared to Low Complaint, both Insomnia Disorder and Perinatal Sleep Disruption scored significantly higher on insomnia and sleep disturbance scales, sleep effort, and sleep-related impairments (p values < .01), but depression and anxiety were comparable (p values > .12). CONCLUSION: Assessing sleep complaints without considering sleep opportunities can result in over-diagnosis of Insomnia Disorder in the perinatal periods. Insomnia Disorder and Perinatal Sleep Disruption were both associated with adverse sleep and mood outcomes, and need to be carefully differentiated and appropriately addressed. Clinical Trial Registration: The SEED Project (Sleep, Eat, Emotions, and Development): A randomized controlled pilot study of a perinatal sleep intervention on sleep and wellbeing in mothers and infants. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371634, Australian New Zealand Clinical Trials Registry: ACTRN12616001462471.

The Role of Light Sensitivity and Intrinsic Circadian Period in Predicting Individual Circadian Timing.

There is large interindividual variability in circadian timing, which is underestimated by mathematical models of the circadian clock. Interindividual differences in timing have traditionally been modeled by changing the intrinsic circadian period, but recent findings reveal an additional potential source of variability: large interindividual differences in light sensitivity. Using an established model of the human circadian clock with real-world light recordings, we investigated whether changes in light sensitivity parameters or intrinsic circadian period could capture variability in circadian timing between and within individuals. Healthy participants (n = 12, aged 18-26 years) underwent continuous light monitoring for 3 weeks (Actiwatch Spectrum). Salivary dim-light melatonin onset (DLMO) was measured each week. Using the recorded light patterns, a sensitivity analysis for predicted DLMO times was performed, varying 3 model parameters within physiological ranges: (1) a parameter determining the steepness of the dose-response curve to light (p), (2) a parameter determining the shape of the phase-response curve to light (K), and (3) the intrinsic circadian period (tau). These parameters were then fitted to obtain optimal predictions of the three DLMO times for each individual. The sensitivity analysis showed that the range of variation in the average predicted DLMO times across participants was 0.65 h for p, 4.28 h for K, and 3.26 h for tau. The default model predicted the DLMO times with a mean absolute error of 1.02 h, whereas fitting all 3 parameters reduced the mean absolute error to 0.28 h. Fitting the parameters independently, we found mean absolute errors of 0.83 h for p, 0.53 h for K, and 0.42 h for tau. Fitting p and K together reduced the mean absolute error to 0.44 h. Light sensitivity parameters captured similar variability in phase compared with intrinsic circadian period, indicating they are viable targets for individualizing circadian phase predictions. Future prospective work is needed that uses measures of light sensitivity to validate this approach.

Ethical issues in using the internet to engage participants in family and child research: A scoping review.

BACKGROUND: The internet is an increasingly popular tool in family and child research that is argued to pose new ethical challenges, yet few studies have systematically assessed the ethical issues of engaging parents and children in research online. This scoping review aims to identify and integrate evidence on the ethical issues reported when recruiting, retaining and tracing families and children in research online, and to identify ethical guidelines for internet research. METHODS: Academic literature was searched using electronic academic databases (Scopus, PsycINFO, Embase, ERIC, CINAHL and Informit) and handsearching reference lists for articles published in English between January 2006 and February 2016. Grey literature was searched using Google to identify relevant ethical guidelines. RESULTS: Sixty-five academic articles were included after screening 3,537 titles and abstracts and 205 full-text articles. Most articles reported using the internet to recruit participants (88%) with few reporting online retention (12%) or tracing (10%). Forty percent commented on ethical issues; the majority did not discuss ethics beyond general consent or approval procedures. Some ethical concerns were specific to engaging minors online, including parental consent, age verification and children's vulnerability. Other concerns applied when engaging any research participant online, including privacy and confidentiality, informed consent and disparities in internet access. Five professional guidelines and 10 university guidelines on internet research ethics were identified. Few academic articles (5%) reported using these guidelines. CONCLUSIONS: Engaging families and children in research online introduces unique challenges requiring careful consideration. While researchers regarded themselves as responsible for ensuring research is conducted ethically, lack of use of available guidelines and limited academic literature suggests internet research is occurring without suitable guidance. We recommend broad dissemination of ethical guidelines and encourage researchers to report the methodological and ethical issues of using the internet to engage families and children in research.