Nurse-delivered sleep restriction therapy in primary care for adults with insomnia disorder: a mixed-methods process evaluation.

BACKGROUND: Sleep restriction therapy (SRT) is a behavioural therapy for insomnia. AIM: To conduct a process evaluation of a randomised controlled trial comparing SRT delivered by primary care nurses plus a sleep hygiene booklet with the sleep hygiene booklet only for adults with insomnia disorder. DESIGN AND SETTING: A mixed-methods process evaluation in a general practice setting. METHOD: Semi-structured interviews were conducted in a purposive sample of patients receiving SRT, the practice nurses who delivered the therapy, and also GPs or practice managers at the participating practices. Qualitative data were explored using framework analysis, and integrated with nurse comments and quantitative data, including baseline Insomnia Severity Index score and serial sleep efficiency outcomes to investigate the relationships between these. RESULTS: In total, 16 patients, 13 nurses, six practice managers, and one GP were interviewed. Patients had no previous experience of behavioural therapy, needed flexible appointment times, and preferred face-to-face consultations; nurses felt prepared to deliver SRT, accommodating patient concerns, tailoring therapy, and negotiating sleep timings despite treatment complexity and delays between training and intervention delivery. How the intervention produced change was explored, including patient and nurse interactions and patient responses to SRT. Difficulties maintaining SRT, negative attitudes towards treatment, and low self-efficacy were highlighted. Contextual factors, including freeing GP time, time constraints, and conflicting priorities for nurses, with suggestions for alternative delivery options, were raised. Participants who found SRT a positive process showed improvements in sleep efficiency, whereas those who struggled did not. CONCLUSION: SRT was successfully delivered by practice nurses and was generally well received by patients, despite some difficulties delivering and applying the intervention in practice.

Cognitive behavioural therapy for insomnia disorder: Extending the stepped care model.

Despite cognitive behaviour therapy for insomnia (CBT-I) being the first-line intervention for the disorder, it is often not readily available to patients in need. The stepped care model (SCM) represents an approach to facilitating efficient and wide-ranging provision of evidence-based care to those with insomnia. The SCM reflects a pyramid of therapeutics based on CBT-I gradually increasing in clinical intensity and addressing clinical complexity. By applying CBT-I through the SCM it is hoped that the treatment gap can be bridged such that not only more patients can be reached, but that clinical resource can be more effectively distributed, with patients receiving more tailored care as needed. Nevertheless, this should not be done at the risk of a lower quality of care being offered, and high-standard training for clinicians and scrutiny of non-clinician led interventions remains important. As national health laws within European countries have substantial differences, the application of the SCM as it relates to the treatment of insomnia may be challenged by contrasting interpretations. In order that the SCM is appropriately implemented: (a) only evidence-based CBT-I treatments should be promoted within the model; (b) clinicians involved in SCM should be suitably qualified to offer CBT in general, and have appropriate further training in CBT-I; (c) professionals involved in interventions not included in the SCM, but related to it, such as preventive and educational programmes, diagnostic procedures, and pharmacological treatments, should also have good knowledge of the SCM in order to promote correct allocation to the appropriate interventional step.

Sleep Characteristics in the Italian Pediatric Population: A Systematic Review.

OBJECTIVE: During childhood sleep duration, quality and patterns evolve and change greatly and relate strongly to healthy development. This systematic review aims to summarize the literature on sleep characteristics in the Italian pediatric population, adopting a cultural perspective. METHOD: Pubmed, PsycINFO and Medline databases were systematically searched. Eligible studies had to: include Italian children and adolescents; report data for one or more sleep-related variables; be published in English or Italian. RESULTS: Twenty-nine studies were selected including 18551 Italian children or adolescents. Studies were categorized by age group: infancy and toddlerhood (0-3 years); preschool and school age (3-12 years); adolescence (12-18 years) and mixed age groups. Overall, studies showed that the Italian pediatric population present shorter sleep duration and longer sleep onset latency compared to international recommendations. Furthermore, data indicate high prevalence of dysfunctional sleep habits, such as late bed-time (all age groups), involvement of parents during bed-time (infancy and toddlerhood), and high variability between sleep times on week-days vs. weekends (adolescence). Nevertheless, most studies lacked comprehensive data on sleep patterns, focusing instead on isolated variables. CONCLUSION: These results suggest a strong trend among Italian children and adolescents towards unhealthy sleep patterns. Comprehensive data are still lacking and large studies evaluating a broad range of sleep characteristics in Italian pediatric populations are needed. Data strongly suggest that Italian Pediatric Primary Care should place higher focus on sleep problems and implement clinical protocols directed towards improving sleep patterns in children and adolescents.

Isolating the role of time in bed restriction in the treatment of insomnia: a randomized, controlled, dismantling trial comparing sleep restriction therapy with time in bed regularization.

STUDY OBJECTIVES: Sleep restriction therapy (SRT) is one of the most effective treatments for insomnia. Restriction of time in bed (TIB) is assumed to be the central mechanism through which SRT improves sleep consolidation and reduces insomnia symptoms. This hypothesis has never been directly tested. We designed a randomized, controlled, dismantling trial in order to isolate the role of TIB restriction in driving both clinical and polysomnographic sleep outcomes. METHODS: Participants aged 25-55 who met diagnostic criteria for insomnia disorder were block-randomized (1:1) to 4 weeks of SRT or time in bed regularization (TBR), a treatment that involves the prescription of a regular but not reduced TIB. The primary outcome was assessed with the insomnia severity index (ISI) at baseline, 4-, and 12-weeks post-randomization. Secondary outcomes included sleep continuity (assessed via polysomnography, actigraphy, and diary) and quality of life. We performed intention-to-treat analyses using linear mixed models. RESULTS: Fifty-six participants (39 females, mean age = 40.78 ± 9.08) were assigned to SRT (n = 27) or TBR (n = 29). Daily monitoring of sleep via diaries and actigraphy confirmed large group differences in TIB (d range = 1.63-1.98). At 4-weeks post-randomization, the adjusted mean difference for the ISI was -4.49 (d = -1.40) and -4.35 at 12 weeks (d = -1.36), indicating that the SRT group reported reduced insomnia severity relative to TBR. Robust treatment effects in favor of SRT were also found for objective and self-reported sleep continuity variables (d range = 0.40-0.92) and sleep-related quality of life (d = 1.29). CONCLUSIONS: For the first time, we demonstrate that TIB restriction is superior to the regularization of TIB on its own. Our results underscore the centrality of the restriction component in reducing insomnia symptoms and consolidating sleep.

Dealing with sleep problems during home confinement due to the COVID-19 outbreak: Practical recommendations from a task force of the European CBT-I Academy.

In the current global home confinement situation due to the COVID-19 outbreak, most individuals are exposed to an unprecedented stressful situation of unknown duration. This may not only increase daytime stress, anxiety and depression levels, but also disrupt sleep. Importantly, because of the fundamental role that sleep plays in emotion regulation, sleep disturbance can have direct consequences upon next day emotional functioning. In this paper, we summarize what is known about the stress-sleep link and confinement as well as effective insomnia treatment. We discuss those effects of the current home confinement situation that can disrupt sleep but also those that could benefit sleep quality. We suggest adaptions of cognitive behavioural therapy elements that are feasible to implement for those facing changed work schedules and requirements, those with health anxiety and those handling childcare and home-schooling, whilst also recognizing the general limitations imposed on physical exercise and social interaction. Managing sleep problems as best as possible during home confinement can limit stress and possibly prevent disruptions of social relationships.

The European Academy for Cognitive Behavioural Therapy for Insomnia: An initiative of the European Insomnia Network to promote implementation and dissemination of treatment.

Insomnia, the most prevalent sleep disorder worldwide, confers marked risks for both physical and mental health. Furthermore, insomnia is associated with considerable direct and indirect healthcare costs. Recent guidelines in the US and Europe unequivocally conclude that cognitive behavioural therapy for insomnia (CBT-I) should be the first-line treatment for the disorder. Current treatment approaches are in stark contrast to these clear recommendations, not least across Europe, where, if any treatment at all is delivered, hypnotic medication still is the dominant therapeutic modality. To address this situation, a Task Force of the European Sleep Research Society and the European Insomnia Network met in May 2018. The Task Force proposed establishing a European CBT-I Academy that would enable a Europe-wide system of standardized CBT-I training and training centre accreditation. This article summarizes the deliberations of the Task Force concerning definition and ingredients of CBT-I, preconditions for health professionals to teach CBT-I, the way in which CBT-I should be taught, who should be taught CBT-I and to whom CBT-I should be administered. Furthermore, diverse aspects of CBT-I care and delivery were discussed and incorporated into a stepped-care model for insomnia.

Sham sleep feedback delivered via actigraphy biases daytime symptom reports in people with insomnia: Implications for insomnia disorder and wearable devices.

This study investigated whether providing sham feedback about sleep to individuals with insomnia influenced daytime symptom reports, sleep-related attentional bias and psychomotor vigilance. Sixty-three participants meeting DSM-5 criteria for insomnia disorder were recruited from the community. Following baseline assessments and actigraphy briefing, participants were randomised to receive next-day sham feedback on sleep quality ("positive" vs. "negative" sleep efficiency condition). Feedback was delivered at habitual rise-time using an integrated actigraphy-diary watch to simulate wearable device behaviour. Participants completed symptom reports immediately before receiving feedback, and at 12:00 and 15:00 hr, using the experience sampling method. Following this they returned to the laboratory in the evening to complete symptom reports and computerised tests of sleep-related attentional bias and basic psychomotor vigilance. Participants randomised to negative feedback (n = 32) evidenced impaired daytime function (decreased alert cognition [d = 0.79], increased sleepiness/fatigue [d = 0.55]) in the evening compared with those given positive feedback (n = 31). Within-day trajectories revealed that the positive-feedback group, relative to the negative-feedback group, displayed a significantly greater increase in positive mood and alert cognition (from rise-time to 12:00 hr), and significantly greater decrease in sleepiness/fatigue. There were no significant between-group differences on measures of sleep-related attentional bias [d = 0.20] or psychomotor vigilance [d = 0.12]. This controlled experiment shows that sham feedback about sleep biases appraisal of daytime symptoms, highlighting a pathway connecting sleep misperception with daytime features of insomnia. Findings have important implications for wearable devices that claim to measure "objective" sleep yet may provide inaccurate data relative to gold-standard measurement.

The development and initial psychometric evaluation of a measure assessing adherence to prescribed exercise: the Exercise Adherence Rating Scale (EARS).

OBJECTIVES: There is no gold standard for measuring adherence to prescribed home exercise. Self-report diaries are commonly used however lack of standardisation, inaccurate recall and self-presentation bias limit their validity. A valid and reliable tool to assess exercise adherence behaviour is required. Consequently, this article reports the development and psychometric evaluation of the Exercise Adherence Rating Scale (EARS). DESIGN: Development of a questionnaire. SETTING: Secondary care in physiotherapy departments of three hospitals. PARTICIPANTS: A focus group consisting of 8 patients with chronic low back pain (CLBP) and 2 physiotherapists was conducted to generate qualitative data. Following on from this, a convenience sample of 224 people with CLBP completed the initial 16-item EARS for purposes of subsequent validity and reliability analyses. METHODS: Construct validity was explored using exploratory factor analysis and item response theory. Test-retest reliability was assessed 3 weeks later in a sub-sample of patients. RESULTS: An item pool consisting of 6 items was found suitable for factor analysis. Examination of the scale structure of these 6 items revealed a one factor solution explaining a total of 71% of the variance in adherence to exercise. The six items formed a unidimensional scale that showed good measurement properties, including acceptable internal consistency and high test-retest reliability. CONCLUSIONS: The EARS enables the measurement of adherence to prescribed home exercise. This may facilitate the evaluation of interventions promoting self-management for both the prevention and treatment of chronic conditions.

Benzodiazepines May be Worse Than Opioids: Negative Medication Effects in Severe Chronic Pain.

OBJECTIVES: Opioid prescription for noncancer pain is increasing in Europe and the United States. Research and guidance have focused on the potential for dependency and medical side effects with high doses. In contrast, benzodiazepines have received little attention in the chronic pain literature, despite evidence for dependency and cognitive impairment in long-term use. We aimed to examine the relationship between these classes of medication use, mood, and functioning. METHODS: This cross-sectional study included patients (N=229) with disabling chronic pain who were about to start intensive pain rehabilitation. They completed self-report measures of mood, functioning, and responses to pain. We examined each patient's medication use and calculated a single morphine equivalent (ME) dose per person, and a similar diazepam equivalent (DE) dose. We examined the relationship between drug dose, mood, and functioning. RESULTS: Higher DE doses were associated with worse outcomes in most domains. Higher ME doses were more narrowly associated with worse functioning. There was no evidence for any benefit of these drugs; higher doses were not associated with less pain, fear, or disability. Higher ME doses were not more problematic, contrary to our predictions. The combination of opioids and benzodiazepines was associated with particularly poor outcomes for mood. DISCUSSION: This study is the first to examine both opioid and benzodiazepine use together in chronic pain. We found the anticipated negative effects of opioid medication, and particularly consistent associations between benzodiazepine use and poor well-being. Future guidance on chronic pain prescription should focus on restricting benzodiazepine use.