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Objective

Infants who cry a lot, or are unsettled in the night, are common sources of concern for parents and costly problems for health services. The two types of problems have been linked together and attributed to a general disturbance of infant regulation. Yet the infant behaviours involved present differently, at separate ages and times of day. To clarify causation, this study aims to assess whether prolonged crying at 5–6 weeks (the peak age for crying) predicts which infants are unsettled in the night at 12 weeks of age (when most infants become settled at night).

Methods

Data from two longitudinal studies are analysed. Infant crying data were obtained from validated behaviour diaries; sleep-waking data from standard parental questionnaires.

Results

A significant, weak relationship was found between crying at 5–6 weeks and 12-week night waking and signalling in one study, but not the other. Most infants who met the definition for prolonged crying/colic at 5–6 weeks were settled during the night at 12 weeks of age; they were not more likely than other infants to be unsettled.

Conclusions

Most infants who cry a lot at 5–6 weeks of age ‘sleep through the night’ at 12 weeks of age. This adds to evidence that the two types of problematic behaviour have different causes, and that infant sleep-waking problems usually involve maintenance of signalling behaviours rather than a generalised disturbance.

Background

Infant crying and sleep problems (e.g. frequent night waking, difficulties settling to sleep) each affect up to 30% of infants and often co-exist. They are costly to manage and associated with adverse outcomes including postnatal depression symptoms, early weaning from breast milk, and later child behaviour problems. Preventing such problems could improve these adverse outcomes and reduce costs to families and the health care system. Anticipatory guidance-i.e. providing parents with information about normal infant sleep and cry patterns, ways to encourage self-settling in infants, and ways to develop feeding and settling routines before the onset of problems-could prevent such problems. This paper outlines the protocol for our study which aims to test an anticipatory guidance approach.

Methods/Design

750 families from four Local Government Areas in Melbourne, Australia have been randomised to receive the Baby Business program (intervention group) or usual care (control group) offered by health services. The Baby Business program provides parents with information about infant sleep and crying via a DVD and booklet (mailed soon after birth), telephone consultation (at infant age 6-8 weeks) and parent group session (at infant age 12 weeks). All English speaking parents of healthy newborn infants born at > 32 weeks gestation and referred by their maternal and child health nurse at their first post partum home visit (day 7-10 postpartum), are eligible. The primary outcome is parent report of infant night time sleep as a problem at four months of age and secondary outcomes include parent report of infant daytime sleep or crying as a problem, mean duration of infant sleep and crying/24 hours, parental depression symptoms, parent sleep quality and quantity and health service use. Data will be collected at two weeks (baseline), four months and six months of age. An economic evaluation using a cost-consequences approach will, from a societal perspective, compare costs and health outcomes between the intervention and control groups.

Discussion

To our knowledge this is the first randomised controlled trial of a program which aims to prevent both infant sleeping and crying problems and associated postnatal depression symptoms. If effective, it could offer an important public health prevention approach to these common, distressing problems.

Trial registration number

ISRCTN: ISRCTN63834603

Aims: (1) To identify factors at 1 week of age which put infants at risk of failing to sleep through the night at 12 weeks of age. (2) To assess whether a behavioural programme increases the likelihood that these infants will sleep through the night at 12 weeks of age.

Methods: A community sample of 316 newborn infants was employed to identify the risk factors at 1 week of age which increased the likelihood of failing to sleep through the night at 12 weeks of age. Infants who met these risk criteria and were randomly assigned to a behavioural programme were compared with at risk infants in the control group on measures of sleeping, crying, and feeding at 12 weeks of age.

Results: Infants who had a high number (>11) of feeds in 24 hours at 1 week were 2.7 times (95% CI 1.5 to 4.8) more likely than other control group infants to fail to sleep through the night at 12 weeks of age. At 12 weeks, 82% of these at risk infants assigned to the behavioural programme, compared to 61% in the control group, slept through the night. The findings were similar in breast and bottle feeders.

Conclusions: Preventing infant sleeping problems should be more cost effective than treating them after they have arisen. This study provides evidence that it is possible to identify infants who are at risk of failing to sleep through the night at an early age, and that a simple, three step, preventive behavioural programme increases the number who sleep through the night by 21%.

Objective

To compare the effect of a behavioural sleep intervention with written information about normal sleep on infant sleep problems and maternal depression.

Design

Randomised controlled trial.

Setting

Well child clinics, Melbourne, Australia

Participants

156 mothers of infants aged 6-12 months with severe sleep problems according to the parents.

Main outcome measures

Maternal report of infant sleep problem; scores on Edinburgh postnatal depression scale at two and four months.

Intervention

Discussion on behavioural infant sleep intervention (controlled crying) delivered over three consultations.

Results

At two months more sleep problems had resolved in the intervention group than in the control group (53/76 v 36/76, P=0.005). Overall depression scores fell further in the intervention group than in the control group (mean change −3.7, 95% confidence interval −4.7 to −2.7, v −2.5, −1.7 to −3.4, P=0.06). For the subgroup of mothers with depression scores of 10 and over more sleep problems had resolved in the intervention group than in the control group (26/33 v 13/33, P=0.001). In this subgroup depression scores also fell further for intervention mothers than control mothers at two months (−6.0, −7.5 to −4.0, v −3.7, −4.9 to −2.6, P=0.01) and at four months (−6.5, −7.9 to 5.1 v –4.2, –5.9 to −2.5, P=0.04). By four months, changes in sleep problems and depression scores were similar.

Conclusions

Behavioural intervention significantly reduces infant sleep problems at two but not four months. Maternal report of symptoms of depression decreased significantly at two months, and this was sustained at four months for mothers with high depression scores.

What is already known on this topicInfant sleep problems and postnatal depression are both common potentially serious problemsWomen whose infants have sleep problems are more likely to report symptoms of depressionUncontrolled studies in clinical populations suggest that reducing infant sleep problems improves postnatal depression, but there is no good quality evidence in the community for such effectivenessWhat this study addsA brief community based sleep intervention based on teaching the controlled crying method effectively decreased infant sleep problems and symptoms of maternal depression, particularly for “depressed” mothersThe intervention was acceptable to mothers and reduced the need for other sources of help

Background: Infants with neonatal cerebral insults are susceptible to excessive crying as a result of difficulties with self-regulation.

Aims: To compare the effectiveness of swaddling versus massage therapy in the management of excessive crying of infants with cerebral insults.

Methods: Randomised three-week parallel comparison of the efficacy of two intervention methods. Infants with symptoms of troublesome crying and their parents were randomly assigned to a swaddling intervention group (n = 13) or a massage intervention group (n = 12).

Results: The amount of total daily crying decreased significantly in the swaddling group, but did not decrease significantly in the massage group. Infant behavioural profiles and maternal anxiety levels improved significantly in the swaddling group post-intervention. Parents in the swaddling group were more satisfied with the effectiveness of the intervention in reducing crying than parents in the massage group.

Conclusion: Results indicate that swaddling may be more effective than massage intervention in reducing crying in infants with cerebral injuries.

Objectives

To determine whether a community‐delivered intervention targeting infant sleep problems improves infant sleep and maternal well‐being and to report the costs of this approach to the healthcare system.

Design

Cluster randomised trial.

Setting

49 Maternal and Child Health (MCH) centres (clusters) in Melbourne, Australia.

Participants

328 mothers reporting an infant sleep problem at 7 months recruited during October–November 2003.

Intervention

Behavioural strategies delivered over individual structured MCH consultations versus usual care.

Main outcome measures

Maternal report of infant sleep problem, depression symptoms (Edinburgh Postnatal Depression Scale (EPDS)), and SF‐12 mental and physical health scores when infants were 10 and 12 months old. Costs included MCH sleep consultations, other healthcare services and intervention costs.

Results

Prevalence of infant sleep problems was lower in the intervention than control group at 10 months (56% vs 68%; adjusted OR 0.58 (95% CI: 0.36 to 0.94)) and 12 months (39% vs 55%; adjusted OR 0.50 (0.31 to 0.80)). EPDS scores indicated less depression at 10 months (adjusted mean difference −1.4 (−2.3 to −0.4) and 12 months (−1.7 (−2.6 to −0.7)). SF‐12 mental health scores indicated better health at 10 months (adjusted mean difference 3.7 (1.5 to 5.8)) and 12 months (3.9 (1.8 to 6.1)). Total mean costs including intervention design, delivery and use of non‐MCH nurse services were £96.93 and £116.79 per intervention and control family, respectively.

Conclusions

Implementing this sleep intervention may lead to health gains for infants and mothers and resource savings for the healthcare system.

Trial registration

Current Controlled Trial Registry, number ISRCTN48752250 (registered November 2004).

Background

Infant colic, characterised by excessive crying/fussing for no apparent cause, affects up to 20% of infants under three months of age and is a great burden to families, health professionals and the health system. One promising approach to improving its management is the use of oral probiotics. The Baby Biotics trial aims to determine whether the probiotic Lactobacillus reuteri DSM 17938 is effective in reducing crying in infants less than three months old (<13.0 weeks) with infant colic when compared to placebo.

Methods/Design

Design: Double-blind, placebo-controlled randomised trial in Melbourne, Australia. Participants: 160 breast and formula fed infants less than three months old who present either to clinical or community services and meet Wessel’s criteria of crying and/or fussing. Intervention: Oral once-daily Lactobacillus reuteri (1x108 cfu) versus placebo for one month. Primary outcome: Infant crying/fussing time per 24 hours at one month. Secondary outcomes: i) number of episodes of infant crying/fussing per 24 hours and ii) infant sleep duration per 24 hours (at 7, 14, 21, 28 days and 6 months); iii) maternal mental health scores, iv) family functioning scores, v) parent quality adjusted life years scores, and vi) intervention cost-effectiveness (at one and six months); and vii) infant faecal microbiota diversity, viii) infant faecal calprotectin levels and ix) Eschericia coli load (at one month only). Analysis: Primary and secondary outcomes for the intervention versus control groups will be compared with t tests and non-parametric tests for continuous data and chi squared tests for dichotomous data. Regression models will be used to adjust for potential confounding factors. Intention-to-treat analysis will be applied.

Discussion

An effective, practical and acceptable intervention for infant colic would represent a major clinical advance. Because our trial includes breast and formula-fed babies, our results should generalise to most babies with colic. If cost-effective, the intervention’s simplicity is such that it could be widely taken up as a new standard of care in the primary and secondary care sectors.

Trial Registration

Current Controlled Trials ISRCTN95287767

Background

Shaken baby syndrome often occurs after shaking in response to crying bouts. We questioned whether the use of the educational materials from the Period of PURPLE Crying program would change maternal knowledge and behaviour related to shaking.

Methods

We performed a randomized controlled trial in which 1279 mothers received materials from the Period of PURPLE Crying program or control materials during a home visit by a nurse by 2 weeks after the birth of their child. At 5 weeks, the mothers completed a diary to record their behaviour and their infants' behaviour. Two months after giving birth, the mothers completed a telephone survey to assess their knowledge and behaviour.

Results

The mean score (range 0–100 points) for knowledge about infant crying was greater among mothers who received the PURPLE materials (63.8 points) than among mothers who received the control materials (58.4 points) (difference 5.4 points, 95% confidence interval [CI] 4.1 to 6.5 points). The mean scores were similar for both groups for shaking knowledge and reported maternal responses to crying, inconsolable crying and self-talk responses. Compared with mothers who received control materials, mothers who received the PURPLE materials reported sharing information about walking away if frustrated more often (51.5% v. 38.5%, difference 13.0%, 95% CI 6.9% to 19.2%), the dangers of shaking (49.3% v. 36.4%, difference 12.9%, 95% CI 6.8% to 19.0%), and infant crying (67.6% v. 60.0%, difference 7.6%, 95% CI 1.7% to 13.5%). Walking away during inconsolable crying was significantly higher among mothers who received the PURPLE materials than among those who received control materials (0.067 v. 0.039 events per day, rate ratio 1.7, 95% CI 1.1 to 2.6).

Interpretation

The receipt of the Period of PURPLE Crying materials led to higher maternal scores for knowledge about infant crying and for some behaviours considered to be important for the prevention of shaking. (ClinicalTrials.gov trial register no. NCT00175422.)

Purpose of review

Sleep–wake problems such as night wakings, excessive crying, or difficulties in falling asleep are frequent behavioral issues during childhood. Maturational changes in sleep and circadian regulation likely contribute to the development and maintenance of such problems. This review highlights the recent research examining bioregulatory sleep mechanisms during development and provides a model for predicting sleep–wake behavior in young humans.

Recent findings

Findings demonstrate that circadian and sleep homeostatic processes exhibit maturational changes during the first two decades of life. The developing interaction of both processes may be a key determinant of sleep–wake and crying behavior in infancy. Evidence shows that the dynamics of sleep homeostatic processes slow down in the course of childhood (i.e., sleep pressure accumulates more slowly with increasing age) enabling children to be awake for consolidated periods during the day. Another current topic is the adolescent sleep phase delay, which appears to be driven primarily by maturational changes in sleep homeostatic and circadian processes.

Summary

The two-process model of sleep regulation is a valuable framework for understanding and predicting sleep–wake behavior in young humans. Such knowledge is important for improving anticipatory guidance, parental education, and patient care, as well as for developing appropriate social policies.

Aims: To examine the relation between colic and feeding difficulties and their impact on parental functioning for a primarily clinic referred sample.

Methods: Forty three infants (and their mothers) were enrolled between 6 and 8 weeks of age. Infants were divided into two groups, colic (n = 19) and comparison (n = 24), based on a modified Wessel rule of three criteria for colic. Families were assessed at two visits; one occurred in the laboratory and one occurred in a paediatric radiology office. Outcome measures included the clinical assessment of infant oral motor skills, behavioural observation of mother-infant feeding interactions, maternal questionnaires on infant crying, sleeping and feeding behaviours, and the occurrence of gastro-oesophageal reflux (GOR) in the infants using abdominal ultrasound.

Results: Infants in the colic group displayed more difficulties with feeding; including disorganised feeding behaviours, less rhythmic nutritive and non-nutritive sucking, more discomfort following feedings, and lower responsiveness during feeding interactions. Infants in the colic group also had more evidence of GOR based on the number of reflux episodes on abdominal ultrasound as well as maternal report of reflux. Mothers in the colic group reported higher levels of parenting stress.

Conclusions: Results provide the first systematic evidence of feeding problems in a subgroup of infants with colic. Data also illustrate the impact of these difficulties on parental and infant functioning. The association between feeding difficulties and colic suggests the potential for ongoing regulatory problems in infants presenting with clinically significant colic symptoms.

Objectives

Our aim was to establish whether there is an interconnection between the compositional development of the gut microbiota and the amount of fussing and crying in early infancy.

Methods

Behavioral patterns of 89 infants during the 7th and 12th week of life were recorded in parental diaries. Total distress was defined as the sum of daily amounts of crying and fussing. Infants' gut microbiota profiles were investigated by several molecular assays during the first six months of life.

Results

The median (range) duration of total distress among the infants was 106 (0–478) minutes a day during the 7th and 58 (0–448) minutes a day during the 12th week. The proportion of Bifidobacterium counts to total bacterial counts was inversely associated with the amount of crying and fussing during the first 3 months of life (p = 0.03), although the number of Bifidobacterium breve was positively associated with total distress (p = 0.02). The frequency of Lactobacillus spp. at the age of 3 weeks was inversely associated with total infant distress during the 7th week of life (p = 0.02).

Conclusions

Bifidobacterium and Lactobacillus appear to protect against crying and fussing. Identification of specific strains with optimal protective properties would benefit at-risk infants.

In the pediatric literature, excessive crying has been reported solely in association with 3-month colic and is described, if at all, as unexplained crying and fussing during the first 3 months of life. The bouts of crying are generally thought to be triggered by abdominal colic (over-inflation of the still immature gastrointestinal tract), and treatment is prescribed accordingly. According to this line of reasoning, excessive crying is harmless and resolves by the end of the third month without long-term consequences. However, there is evidence that it may cause tremendous distress in the mother-infant relationship, and can lead to disorders of behavioral and emotional regulation at the toddler stage (such as sleep and feeding disorders, chronic fussiness, excessive clinginess, and temper tantrums). Early treatment of excessive crying focuses on parent-infant communication, and parent-infant interaction in the context of soothing and settling the infant to sleep is a promising approach that may prevent later behavioral and emotional disorders in infancy.

Introduction:

Few convincing treatment options have been identified for the excessively crying infant. One explanation may be a lack of identification of patient subgroups. This study used a clinically plausible categorization protocol to subgroup infants and compared changes in symptoms between these subgroups during treatment.

Methods:

An observational cohort design was employed. All infants presenting with excessive infant crying between July 2007 and March 2008 were categorized into three subgroups, (A) infant colic, (B) irritable infant syndrome of musculoskeletal origin (IISMO) and (C) inefficient feeding crying infants with disordered sleep (IFCIDS) based on history and physical findings. Mothers completed questionnaires which rated their own and their child’s characteristics prior to and at the end, of a course of manual therapy. Independent associations between infant subgroups and changes in continuous outcomes (crying, stress, sleep, and consolability) were assessed. Multivariable analysis of covariance was used to identify and control for potential confounders.

Results:

A total of 158 infants were enrolled. There was no significant difference in demographic profile between groups or any significant difference in infant crying or level of maternal stress at the start. Only the putative subgroups were significantly associated with differences in outcomes. In general, colic babies improved the most in consolability and crying.

Conclusion:

Babies with excessive crying should not be viewed as a homogenous group. Treatment outcomes may be improved by targeting appropriate subgroups prior to treatment.

Objectives

To analyse costs and consequences of changing physical activity behaviour due to the “Physical Activity on Prescription” (PAP) programme.

Design

A randomized controlled trial with a four-month intervention, with comparison between intervention and control group.

Intervention

The PAP programme, with exercise twice a week, education, and motivational counselling.

Subjects

525 sedentary individuals, 20–80 years (intervention group n = 268, control group n = 257), with lifestyle-related health problems. A total of 245 returned for the four-month assessment.

Main outcome measure

Programme costs based on intention-to-treat estimations, direct and indirect costs of inactivity, and physical activity behaviour analysed with IPAQ (International Physical Activity Questionnaire), self-reported physical activity, and measures of functional capacity.

Results

The intention-to-treat programme costs for the four-month programme period was SEK (Swedish Kronor) 6475 (€ [Euro] 684) for the intervention group and SEK 3038 (€ 321) for the control group. Of this, healthcare providers’ costs were 24% in the intervention group, and 31% in the control group. The physical activity behaviour was significantly improved in both groups, but no differences were found between the groups.

Implications

The largest share of the PAP programme costs was the participants’ costs. Significant improvements were shown in physical activity behaviour in both groups, but no differences were found between the intervention and control groups. Due to many non-completers, the potential for improvements of the motivating assignment with sedentary individuals in primary healthcare is obvious. Long-term follow-up can determine the sustainability of the results, and can be used in a future cost-effectiveness analysis.

AIMS/BACKGROUND—In a prospective study the degree of distress caused by retinopathy of prematurity (ROP) screening in a cohort of preterm infants was assessed and the modifying effects of nesting in reducing their discomfort was evaluated.
METHODS—38 preterm infants were included in the study. 19 infants were placed in a nest with boundaries (intervention group) and 19 infants were placed on a cot blanket (control group). Observations were made 2 minutes before, throughout, and 2 minutes after ROP examination. The factors observed were crying responses, neurobehavioural activity, and physiological changes (heart rate, oxygen saturation). Recordings were made using a video camera for crying and neurobehavioural activity and an Oxypleth monitor for heart rate and oxygen saturation.
RESULTS—During ROP screening, the total group of 38 infants (nested and non-nested combined) displayed increased neurobehavioural activity (p<0.01) and crying (p<0.01). The increased activity and crying coincided with the invasive part of the procedure. The distress caused by ROP screening was significantly less for the nested group compared with the non-nested group for both movement activity (p<0.01) and crying (p<0.01). The physiological data, heart rate, and oxygen saturation were not statistically significant.
CONCLUSION—ROP screening is distressing for preterm infants. Nesting can significantly reduce this discomfort. The findings in this study are of value in designing more optimal ROP examination schedules for infants.



Chronic sleep disturbance, such as bed refusal, sleep-onset delay, and night waking with crying, affects 15% to 35% of preschool children. Biological factors, particularly arousals associated with recurrent episodes of rapid-eye-movement sleep, render infants vulnerable to repeated awakenings. Parental failure to establish appropriate stimulus control of sleep-related behaviors and parent-mediated contingencies of reinforcement for sleep-incompatible behaviors may shape and maintain infant sleep disturbance. Treatment and prevention strategies are discussed, and research needs are identified.

OBJECTIVES—To investigate the prevalence of infant crying and maternal soothing techniques in relation to ethnic origin and other sociodemographic variables.
DESIGN—A questionnaire survey among mothers of 2-3 month old infants registered at six child health clinics in Amsterdam, the Netherlands.
SUBJECTS—A questionnaire on sociodemographic characteristics and crying behaviour was completed for 1826 of 2180 (84%) infants invited with their parents to visit the child health clinics. A questionnaire on soothing techniques was also filled out at home for 1142 (63%) of these infants.
RESULTS—Overall prevalences of "crying for three or more hours/24 hour day", "crying a lot", and "difficult to comfort" were 7.6%, 14.0%, and 10.3%, respectively. Problematic infant crying was reported by 20.3% of the mothers. Of these infants, only 14% met all three inclusion criteria. Problematic crying occurred less frequently among girls, second and later born children, Surinamese infants, and breast fed infants. Many mothers used soothing techniques that could affect their infant's health negatively. Shaking, slapping, and putting the baby to sleep in a prone position were more common among non-Dutch (especially Turkish) mothers than among Dutch mothers. Poorly educated mothers slapped their baby more often than highly educated mothers.
CONCLUSIONS—Mothers' reports of infant crying and soothing varied sociodemographically. Much harm may be prevented by counselling parents (especially immigrants) on how and how not to respond to infant crying. Health education should start before the child's birth, because certain soothing techniques could be fatal, even when practised for the first time.



The association between asthma and sleep disturbances was assessed as part of a community survey of sleep patterns in children aged 4-48 months. A questionnaire covering the area of past and present sleep and settling behaviour, as well as health history and demographic data, was administered to 752 mothers of children visiting 14 well baby clinics. Fifty one (6.8%) of the children who were diagnosed as having asthma by their paediatricians were compared with the remaining healthy controls (children with perinatal problems, other chronic illnesses, developmental problems, or repeat admissions to hospital were excluded). Thirty nine per cent of the children with asthma and 38% of the normal controls were identified as regular wakers. The number of interrupted nights each week, settling time, and sleep duration were comparable. In the children with asthma an uninterrupted night's sleep was acquired later than in the control group. Parental perception of the severity of the sleep problem was similar in the two groups, as were the calming techniques. It is concluded that this study does not support a significantly increased prevalence of sleep disturbances among young children with asthma compared with their healthy peers.

Background: Settling and night waking problems are particularly prevalent, persistent, and generally considered difficult to treat in children with a learning disability, although intervention trials are few. Scarce resources, however, limit access to proven behavioural treatments.

Aims: To investigate the efficacy of a media based brief behavioural treatment of sleep problems in such children by comparing (1) face-to-face delivered treatment versus control and (2) booklet delivered treatment versus controls.

Methods: The parents of 66 severely learning disabled children aged 2–8 years with settling and/or night waking problems took part in a randomised controlled trial with a wait-list control group. Behavioural treatments were presented either conventionally face-to-face or by means of a 14 page easy to read illustrated booklet. A composite sleep disturbance score was derived from sleep diaries kept by parents.

Results: Both forms of treatment were almost equally effective compared with controls. Two thirds of children who were taking over 30 minutes to settle five or more times per week and waking at night for over 30 minutes four or more times per week improved on average to having such settling or night waking problems for only a few minutes or only once or twice per week (H = 34.174, df = 2, p<0.001). These improvements were maintained after six months.

Conclusions: Booklet delivered behavioural treatments for sleep problems were as effective as face-to-face treatment for most children in this population.

Background

Sleep problems are common, affecting over a third of adults in the United Kingdom and leading to reduced productivity and impaired health-related quality of life. Many of those whose lives are affected seek medical help from primary care. Drug treatment is ineffective long term. Psychological methods for managing sleep problems, including cognitive behavioural therapy for insomnia (CBTi) have been shown to be effective and cost effective but have not been widely implemented or evaluated in a general practice setting where they are most likely to be needed and most appropriately delivered. This paper outlines the protocol for a pilot study designed to evaluate the effectiveness and cost-effectiveness of an educational intervention for general practitioners, primary care nurses and other members of the primary care team to deliver problem focused therapy to adult patients presenting with sleep problems due to lifestyle causes, pain or mild to moderate depression or anxiety.

Methods and design

This will be a pilot cluster randomised controlled trial of a complex intervention. General practices will be randomised to an educational intervention for problem focused therapy which includes a consultation approach comprising careful assessment (using assessment of secondary causes, sleep diaries and severity) and use of modified CBTi for insomnia in the consultation compared with usual care (general advice on sleep hygiene and pharmacotherapy with hypnotic drugs). Clinicians randomised to the intervention will receive an educational intervention (2 × 2 hours) to implement a complex intervention of problem focused therapy. Clinicians randomised to the control group will receive reinforcement of usual care with sleep hygiene advice. Outcomes will be assessed via self-completion questionnaires and telephone interviews of patients and staff as well as clinical records for interventions and prescribing.

Discussion

Previous studies in adults have shown that psychological treatments for insomnia administered by specialist nurses to groups of patients can be effective within a primary care setting. This will be a pilot study to determine whether an educational intervention aimed at primary care teams to deliver problem focused therapy for insomnia can improve sleep management and outcomes for individual adult patients presenting to general practice. The study will also test procedures and collect information in preparation for a larger definitive cluster-randomised trial. The study is funded by The Health Foundation.

Trial Registration

ClinicalTrials.gov ID ISRCTN55001433 –

Background

Bipolar disorder patients often display abnormalities in circadian rhythm, and they are sensitive to irregular diurnal rhythms. CRY2 participates in the core clock that generates circadian rhythms. CRY2 mRNA expression in blood mononuclear cells was recently shown to display a marked diurnal variation and to respond to total sleep deprivation in healthy human volunteers. It was also shown that bipolar patients in a depressive state had lower CRY2 mRNA levels, nonresponsive to total sleep deprivation, compared to healthy controls, and that CRY2 gene variation was associated with winter depression in both Swedish and Finnish cohorts.

Principal Findings

Four CRY2 SNPs spanning from intron 2 to downstream 3′UTR were analyzed for association to bipolar disorder type 1 (n = 497), bipolar disorder type 2 (n = 60) and bipolar disorder with the feature rapid cycling (n = 155) versus blood donors (n = 1044) in Sweden. Also, the rapid cycling cases were compared with bipolar disorder cases without rapid cycling (n = 422). The haplotype GGAC was underrepresented among rapid cycling cases versus controls and versus bipolar disorder cases without rapid cycling (OR = 0.7, P = 0.006−0.02), whereas overrepresentation among rapid cycling cases was seen for AAAC (OR = 1.3−1.4, P = 0.03−0.04) and AGGA (OR = 1.5, P = 0.05). The risk and protective CRY2 haplotypes and their effect sizes were similar to those recently suggested to be associated with winter depression in Swedes.

Conclusions

We propose that the circadian gene CRY2 is associated with rapid cycling in bipolar disorder. This is the first time a clock gene is implicated in rapid cycling, and one of few findings showing a molecular discrimination between rapid cycling and other forms of bipolar disorder.

BACKGROUND: Many studies have suggested that general practitioners fail to detect a substantial minority of their patients who are psychologically distressed, and there is concern about the possible sequelae of this. Individual patients may suffer unresolved problems, and there are potential costs to the health service in consequent recurrent consultations, inappropriate referrals or treatment. Educational interventions based on small groups led by facilitators have been shown to alter the consultation behaviours of general practitioners that are known to be related to accurate detection of psychological distress. AIM: This controlled study aimed to show that, by utilizing a brief self-directed educational intervention focusing on detection of psychological distress, general practitioners can improve their performance significantly. For this purpose, a new educational intervention was designed: the second aim of the study was thus to assess the effectiveness of this specific intervention. METHOD: An educational intervention was designed which focused on skills relevant to detecting psychological distress, using the principles of reflection on general practitioner performance and consultation skill work. It was designed to be used by individual general practitioners without outside support, using a combination of written background material, feedback on performance and analysis of video material. The effectiveness of the intervention was tested by comparing a trial and control cohort of general practitioners, using detection rates as an outcome measure. RESULTS: The detection rate of the general practitioners who underwent the intervention improved significantly compared with their performance before intervention and with that of the control group. CONCLUSION: General practitioners can improve their ability to detect psychological distress in their patients utilizing this self-directed educational approach.

Using PCR with a set of specific oligonucleotide primers to detect cryI-type genes, we were able to screen the cry-type genes of 225 Bacillus thuringiensis soil isolates from Taiwan without much cost in time or labor. Some combinations of cry genes (the cry-type profile) in a single isolate were unique. We identified five distinct profiles of crystal genes from the B. thuringiensis soil isolates from Taiwan. The cry genes included cryIA(a), cryIA(b), cryIA(c), cryIC, cryID, and cryIV. Interestingly, 501 B. thuringiensis isolates (93.5% of the total number that we identified) were isolated from areas at high altitudes. The profiles of cry-type genes were distinct in all isolation areas. The distribution of cry-type genes of our isolates therefore depended on geography. Using PCR footprinting to detect cryIC-type genes, we identified two distinct cryIC footprints from some of our isolates, indicating that these isolates may contain novel cryIC-type genes. B. thuringiensis isolates containing cryIA(a)-, cryIA(b)-, and cryIA(c)-type genes exhibited much greater activity against Plutella xylostella than did other isolates, indicating that multiple cry-type genes may be used as markers for the prediction of insecticidal activities.

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Research indicates that physical exercise can contribute to better sleep quality. This study investigates the six-week influence of a combined intervention on self-rated sleep quality, daytime mood, and quality of life. A nonclinical sample of 114 adults with chronic initiating and the maintaining of sleep complaints participated in the study. The intervention group of 70 adults underwent moderate physical exercise, conducted weekly, plus sleep education sessions. Improvements among participants assigned to the intervention group relative to the waiting-list control group (n = 44) were noted for subjective sleep quality, daytime mood, depressive symptoms and vitality. Derived from PSQI subscores, the intervention group reported increased sleep duration, shortened sleep latency, fewer awakenings after sleep onset, and overall better sleep efficiency compared to controls. The attained scores were well sustained and enhanced over a time that lasted through to the follow-up 18 weeks later. These findings have implications in treatment programs concerning healthy lifestyle approaches for adults with chronic sleep complaints.

Objective

To examine the psychological well-being of mothers following participation in a behavioural modification programme previously shown to improve infant sleep.

Design, setting and participants

A 45 min consultation with either a general practitioner (GP) or trained nurse providing verbal and written information describing sleep physiology in infants and strategies to improve infant sleep. Eighty mothers of infants 6−12 months of age with established infant sleep problems at a single general practice, Adelaide, South Australia.

Main outcome measures

The Depression Anxiety Stress Scale 21 (DASS21) immediately prior to the first consultation and again at follow-up approximately 3 weeks later. The number of infant nocturnal awakenings requiring parental support was also reported by mothers on both occasions.

Results

All measures of maternal well-being and infant nocturnal awakenings improved significantly. The mean number of maximum nocturnal awakenings decreased from 5.0 to 0.5 (mean difference 4.4, 95% CI 3.4 to 5.5). All measures of DASS21 improved significantly. The mean total DASS21 decreased from 29.1 to 14.9 (mean decrease 14.2, 95% CI 10.2 to 18.2); mean depression decreased from 7.9 to 2.8 (mean difference 5.2, 95% CI 3.7 to 6.7); mean anxiety decreased from 4.6 to 2.6 (mean difference 2.0, 95% CI 0.7 to 3.2); mean stress decreased from 16.6 to 9.5 (mean difference 7.0, 95% CI 5.1 to 9.0). The proportion of mothers assessed as having any degree of depression decreased by 85% from 26/80 (32.5%) to 4/80 (5%).

Conclusions

The number of nocturnal awakenings requiring parental support among infants aged 6−12 months significantly decreased following a single consultation on infant sleep physiology and teaching behavioural strategies to improve sleep. Significant improvements in maternal stress, anxiety and depression were also observed.