Background: Internet-based interventions for insomnia show promise, but understanding the process variables, such as knowledge acquisition and psychological acceptance, is crucial for enhancing digital adherence and clinical effectiveness. Objective: This study aimed to evaluate the feasibility, adherence, and preliminary clinical signals of 2 therapist-assisted interventions-internet-delivered cognitive behavioral therapy (iCBT) and internet-delivered acceptance and commitment therapy (iACT)-for insomnia in a primary care setting. Methods: This was a pilot randomized controlled trial. Adults seeking help for insomnia (n=18) were recruited via primary care and randomized to either a 5-module iCBT or iACT program delivered via a secure digital platform with weekly therapist feedback. Blinding of participants and therapists was not possible due to the nature of the interventions. Primary outcomes included the Insomnia Severity Index; secondary outcomes included the 9-item Patient Health Questionnaire, 7-item Generalized Anxiety Disorder, and WHO Disability Assessment Schedule. A novel sleep knowledge test was used as a process variable. The data were analyzed using split-plot analyses of variance (intention-to-treat or last observation carried forward and complete case analysis) and nonparametric Friedman and Kruskal-Wallis tests. Results: A total of 18 participants were randomized (iCBT: n=9; iACT: n=9). High attrition was observed, with only 33.3% (n=3) of iCBT and 55.6% (n=5) of iACT participants completing all modules. The iACT group demonstrated a significant within-group reduction in insomnia severity (P=.01, Friedman test), whereas iCBT results were nonsignificant (P=.10, Friedman test). No significant between-group differences were found for any clinical or process variables. Participants rated both treatments as credible (Credibility/Expectancy Questionnaire scores remained stable), though qualitative feedback indicated a need for more flexible, less burdensome content. Conclusions: This pilot study demonstrates that while internet-delivered insomnia treatments are feasible and credible in primary care, high attrition remains a significant barrier. Preliminary signals suggest that iACT may be a viable alternative to iCBT, potentially offering better adherence. Larger, fully powered pilot randomized controlled trials (estimated N=404) with refined recruitment and automated retention strategies are required to determine definitive comparative efficacy and the mediating role of sleep knowledge and acceptance.
INTRODUCTION/AIMS:Physical activity and sleep influence fatigue in myasthenia gravis (MG), and digital health technologies (DHT) enable objective monitoring of these behaviors in daily life. Using this approach, we evaluated whether a lifestyle intervention targeting physical activity or sleep hygiene could reduce fatigue in MG. METHODS:In this three-arm, randomized controlled trial (DIG-MG; NCT05992025), 72 MG patients completed 6 weeks of baseline monitoring with a DHT ring (OURA), followed by 12 weeks of (i) physical activity guidance, (ii) sleep hygiene education, or (iii) observation, and a 6-week follow-up. The primary outcome was the MG Activities of Daily Living (MG-ADL) score 1 week postintervention. Secondary outcomes included Fatigue Severity Scale (FSS) scores; exploratory outcomes were DHT-derived physical activity and sleep parameters. RESULTS:Baseline MG-ADL scores were similar (median: 5.0). Postintervention medians were 4.0 (physical activity), 3.5 (sleep hygiene), and 3.0 (control), with no significant differences (p = 0.073). Clinically meaningful MG-ADL improvement occurred in six, seven, and six participants, respectively. FSS scores showed no group differences (p = 0.992), with clinically relevant improvement in eight participants in each intervention group and five controls. Participants were more physically active than expected: 64.7% exceeded 600 MET-min/week at baseline. DHT adherence was excellent. REM sleep was lower than expected, while deep sleep was preserved. Self-reported data aligned with DHT measurements. DISCUSSION:Digital lifestyle interventions were feasible and well-accepted but did not improve MG-ADL or FSS in this unusually active population. However, DHT-based monitoring may support individualized follow-up, and reduced REM sleep warrants further investigation as a fatigue-related factor.
Background:Insomnia is a pervasive global mental health issue, and interventions based on Cognitive Behavioural Therapy for Insomnia (CBT-I) are the recommended first-line treatment. However, barriers such as language skills often prevent linguistic minority populations from accessing CBT-I, exacerbating a significant treatment gap. FastAsleep is a Swedish brief digital self-guided behavioural intervention for insomnia. Aims:This study aimed to investigate the feasibility of providing FastAsleep in simple English as a proof-of-concept, to enable multilingual access to scalable evidence-based insomnia care for non-Swedish speakers living in Sweden. Methods:We conducted a single-group pilot study recruiting 11 English-speaking participants nationwide in Sweden via online advertisements. The 4-week, self-guided, sleep-restriction-focused intervention required only brief onboarding and follow-up check-ins via phone with study personnel. Adherence data and self-reported outcomes (e.g., insomnia severity, depression, anxiety) were collected digitally, and all time spent by staff on communication was registered. Trial registered at OSF (https://osf.io/ahvf6). Results:The participants were born across ten different countries. Adherence to the intervention was high, and staff time averaged only 30 min per participant. Intervention credibility and English material quality were rated as high. Preliminary outcomes showed large reductions in symptoms of insomnia severity (within-group effect size [95% CI] 1.55 [0.59, 2.47]) and reductions in depression similar to FastAsleep in Swedish, but anxiety reductions were seemingly smaller. Conclusions:The results demonstrate that FastAsleep, as a multilingual approach to digital insomnia care, is feasible and preliminary resource-efficient.
Insomnia is prevalent, emphasizing the need for effective and sustainable treatments. While short-term use of sleep medication is recommended, long-term use remains common, underscoring the necessity for psychological treatments like Cognitive Behavioral Therapy for Insomnia (CBT-I) in clinical practice. This study aimed to evaluate the effectiveness of guided Internet-Based Cognitive Behavioral Therapy for insomnia (ICBT-I) when integrated into general practice. Participants (n = 177) were recruited from 33 primary health care centers (PCCs) and enrolled in an eight-week guided ICBT-I program. Eligible participants were at least 18 years old and reported sleep problems significantly affecting their daily lives. Significant reductions in insomnia were observed, with large improvements in sleep disturbances. ISI scores decreased significantly from pre- to post-treatment (β = 9.368, p < .001, Hedges' g = 1.40). Depression (β = 5.496, g = 0.68) and anxiety (β = 3.982, g = 0.56) also showed moderate improvements (p < .001). All sleep diary measures improved significantly (p < .001), and sleep medication use dropped from 48.6% at pretreatment to 17.5% at posttreatment (p < .001). These findings suggest that guided ICBT-I in primary care effectively reduces insomnia and improves mental health, with outcomes comparable to specialized care.
Insomnia and depression are common, comorbid conditions with cognitive consequences. Cognitive behavioral therapy for insomnia (CBT-I) improves subjective cognition, but effects on objective performance are unclear. This study aims to examine cognitive differences in insomnia with and without comorbid depression, and changes in cognition following CBT-I. This study examined cognitive outcomes in 170 (124 for longitudinal analyses) participants from two randomized clinical trials of internet-delivered 9 or 12 weeks CBT-I for patients with insomnia (n = 78) or comorbid insomnia and depression (n = 92). Cognitive performance was assessed pre- and post-treatment using selected computerized cognitive tests from the CANTAB battery. Linear regression and mixed-effects models were used for evaluation. Following CBT-I, improvements were statistically significant on seven out of 17 outcomes across patients with and without comorbid depression: the Rapid Visual Processing task (correct hits, p < .001, misses, p < .001, latency, p = .040), Stockings of Cambridge (problems solved on first choice, p = .042), and Affective Go/No gGo (commissions, p = .005; omissions, p = .022; affective bias, p = .020). Comorbid depression was not statistically significantly associated with cognitive performance on most tasks. However, on the Spatial Span task, comorbid depression was associated with lower span length (p = .038), fewer attempts (p = .021), and longer latency (p = .030), suggesting impaired spatial working memory in depressed individuals. No statistically significant associations were found between changes in insomnia or depression severity and changes in cognitive performance after treatment. Differences in cognitive performance between patients with insomnia and patients with both insomnia and depression seem very small. CBT-I may be associated with improvements in objective cognitive performance across some domains, including attention, working memory, executive function, and emotional processing. Future research should employ better control for e.g. practice effects, and explore any long-term cognitive effects of CBT-I. The present study reports follow-up analyses based on data from two previously conducted and preregistered clinical trials (ClinicalTrials.gov Identifier: NCT01663844, study registry date 2012-08-03). The current analyses explore additional outcomes not included in the primary endpoints.
Cognitive behavioural therapy for insomnia is the treatment of choice for patients with insomnia, but not all patients benefit, and novel psychological treatment approaches have emerged (e.g. acceptance and commitment therapy). Thus, the aim of the present study was to evaluate whether treatment modality, adherence, insomnia severity, anxiety, depression, beliefs about sleep or acceptance of sleep problems are factors associated with response to psychological insomnia treatment. The sample consisted of 152 adults (115 women; mean age = 40.6 years, SD = 10.2) with chronic insomnia, and they participated in a randomized clinical trial comparing acceptance and commitment therapy for insomnia (as a standalone) with cognitive behavioural therapy for insomnia. The outcome measure was proportion of treatment responders (8 points reduction or more) on the Insomnia Severity Index, assessed at pre- and post-treatment and 6-month follow-up. The predictor variables were assessed at pre-treatment. The final multivariate model showed that undergoing cognitive behavioural therapy for insomnia increased the chances of treatment response at post-treatment by 2.70 times when compared with acceptance and commitment therapy for insomnia (odds ratio = 2.70 [1.14-6.38]). In addition, each additional point in pre-treatment insomnia severity (odds ratio = 1.15 [1.01-1.30]) and dysfunctional beliefs about sleep (odds ratio = 1.02 [1.00-1.05]) scores increased the chances of response at post-treatment. Treatment adherence increased the chances of treatment response at post-treatment by 3.07 times (odds ratio = 3.07 [1.28-7.34]). Finally, each additional point on the Insomnia Severity Index pre-treatment increased the chances of treatment response at the 6-month follow-up (odds ratio = 1.14 [1.01-1.29]). In conclusion, cognitive behavioural therapy for insomnia increases the chance of treatment response compared with acceptance and commitment therapy for insomnia. Moreover, higher adherence, insomnia severity and dysfunctional beliefs about sleep predict treatment outcome in both treatments.
STUDY OBJECTIVES:Insomnia disorder, affecting 10% of the population, poses a significant public health concern and is a risk-factor for many health issues. Cognitive behavioral therapy is first-choice treatment, but the key component-sleep restriction therapy-presents with side effects and adherence challenges. Sleep compression therapy, suggested as a potentially gentler alternative, has never been directly compared to sleep restriction therapy. METHODS:Single-blind trial at the Internet Psychiatry Clinic in Stockholm, Sweden. Patients with insomnia disorder were randomized 1:1 to evaluate non-inferiority of sleep compression therapy to sleep restriction therapy in improving insomnia and to compare important clinical aspects. Primary outcome: self-reported Insomnia Severity Index (ISI), assessed pretreatment, weeks 1-5, and week 10. Non-inferiority analysis based on intent-to-treat analyses with multiple imputation and mixed effects models. RESULTS:Adults with insomnia (n = 234; mean age 44.3 [SD = 13.7] years, 173 [73.4%] female) received treatment as a 10-week highly structured, therapist-guided online program, to strengthen experimental integrity and treatment fidelity. Both treatments improved insomnia severity with large effects. Sleep compression therapy failed to show non-inferiority with a conservative limit of 1.6 ISI-points (95% CI: -0.01, 1.70), gave statistically significantly smaller improvements (p = .006), and was associated with slower improvements despite better adherence and somewhat less side effects. CONCLUSIONS:This direct comparison and well-controlled trial provides empirically based support for clinicians to prioritize sleep restriction therapy over sleep compression therapy, while the latter can be a valid alternative when sleep restriction therapy cannot be used. CLINICAL TRIAL:CompRest-a Comparison Between Sleep Compression and Sleep Restriction for Treating Insomnia. URL: https://clinicaltrials.gov/study/NCT02743338?term=NCT02743338&rank=1. REGISTRATION:NCT02743338.
Digital self-help can improve access to mental health care, but poor engagement limits effectiveness. This single-blind 2 x 2 x 2 factorial randomized controlled trial examined whether an optimized graphical user interface (GUI), automated reminders (AR), and an adaptive treatment strategy (ATS) improved engagement and outcomes in a digital self-help insomnia intervention. Adults (N = 447) with moderate to severe insomnia were randomized to combinations of the factors. The GUI improved self-rated engagement, sleep log activity, login frequency, and usability. AR increased sleep log activity and logins, while ATS improved satisfaction. All three combined significantly improved insomnia symptoms (d = 0.50). No severe adverse effects were reported. Clinicians spent 13.74 min on average on the ATS. Statistical analyses included linear and multilevel regression. Factors were effect coded. Intervention design can enhance engagement and outcomes, requiring minimal clinician time. Pre-registered 2023-04-11 (ClinicalTrials.gov, NCT05826002). Funded by the Swedish Ministry of Health and Social Affairs, grant number: S2018/03855/FS.
OBJECTIVE:Insomnia is a risk factor related to the onset and course of other mental disorders and is prevalent among adolescents admitted to psychiatric services. While evidence supports the efficacy of cognitive behavioural therapy for insomnia (CBT-I), uptake of evidence-based interventions in mental health care for children and adolescents is low. Internet delivery can improve access, but research on implementing internet-based CBT (iCBT) in routine care is limited. The aim of this study was to investigate if iCBT for insomnia (iCBT-I) could be successfully implemented at two child and adolescent psychiatry (CAP) clinics. METHODS:The implementation followed Aaron, Hurlburt & Horwitz' stage model (2011) encompassing four phases: exploration, preparation, implementation and sustainment. It engaged ninety percent of the outpatient units across the clinics and involved seventeen therapists who completed a three-day training. Patients aged 13-17 years with insomnia alongside other psychiatric conditions were recruited for the intervention. RESULTS:Results showed a high degree of acceptability of iCBT-I among managers and staff, and a moderate to high degree of acceptability among patients. The fifteen patients treated showed significant reductions in insomnia and depression symptoms. However, there were important threats to feasibility including low prioritisation of iCBT-I, difficulties in recruiting patient and getting them to start the treatment, technical problems, and staff turnover, all of which led to failed implementation in these settings. CONCLUSION:iCBT-I could not be successfully implemented at either of the two CAP clinics investigated in this study due to problems with feasibility and sustainability.
Background:An increased use of the internet and digital health care for patients with long-term conditions implies a need for assuring digital health literacy skills. Patients with restless legs syndrome (RLS) represent a group where digital sources of information are highly valued. This is due to a difficult diagnosis and complex treatment situation that contributes to patients seeking out digital resources themselves to handle the perceived shortcomings in their care. To benefit from these resources, patients need to have the digital skills to explore information to optimize their understanding of the disease and its treatments. The eHealth Literacy Scale (eHEALS), which has been used in both general populations and patients with long-term conditions, could, if proven valid, be used by researchers and clinicians to assess digital health literacy among patients with RLS to inform the development of patient-centered digital health care information and interventions. Objective:The aim of the study is to investigate the psychometric properties of eHEALS in patients with RLS to determine its adequacy and potential utility. Methods:A cross-sectional design including patients with RLS from the Swedish national RLS patient organization was used. Data were collected via a mail-based survey comprising back-and-forth translated Swedish versions of the following instruments: eHEALS, Restless Legs Syndrome-6 Scale (RLS symptoms), Pittsburgh Sleep Quality Inventory (sleep quality), Epworth Sleepiness Scale (daytime sleepiness), Patient Health Questionnaire-9 (depressive symptoms), and CollaboRATE (shared decision-making). Confirmatory factor analysis and Rasch models were used to assess the validity and reliability of the eHEALS. Measurement invariance, unidimensionality, and differential item functioning across age, gender, medication use, sleep quality, level of depressive symptoms, and participation in care decisions were assessed. Results:A total of 788 patients with a mean age of 70.8 (SD 11.3) years participated. Among them, 64.7% (n=510) were women, 73.8% (n=582) were married or living together, and 43.5% (n=343) had attained a university education. A median eHEALS score of 28 (IQR 22-33) was reported. The unidimensionality of the eHEALS was supported by the confirmatory factor analysis and the Rasch model. The reliability of the eHEALS was confirmed using composite reliability and Cronbach α. No differential item functioning was identified for age, gender, medication use, shared decision-making condition, depressive symptoms, or sleep quality, meaning that these groups do not have different probabilities of endorsing a given item after controlling for the overall score. Conclusions:The eHEALS showed good validity and reliability and operated equivalently for men and women of different ages with various clinical and treatment conditions related to RLS. Accordingly, health care professionals can use eHEALS as a psychometrically sound tool to explore the digital health literacy level among patients with RLS.
INTRODUCTION:Sleep is a biological necessity with vital effects on all tissues and organs of the body. Preoperative sleep disturbance is associated with increased postoperative pain intensity and opioid consumption. Given that insomnia is a potentially modifiable risk factor, interventions targeting sleep prior to surgery may improve postoperative pain control and enhance key outcomes of recovery. METHODS AND ANALYSIS:Promoting Sleep to Alleviate Pain-Arthroplasty (PROSAP-A) is a randomised, parallel group, two arm, controlled trial evaluating the effects of preoperative sleep-promotion on postoperative pain control, brain health and physical recovery. The main objective is to investigate whether preoperative insomnia treatment in patients scheduled to undergo total knee arthroplasty (TKA) or total hip arthroplasty (THA) may improve acute postoperative pain control. 100 adults with insomnia disorder (Insomnia Severity Index score >10 and confirmed Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for persistent insomnia disorder), scheduled to undergo primary TKA or THA, will be randomised to preoperative cognitive behavioural therapy for insomnia (CBT-I) or an active comparator control intervention, sleep education therapy (SET). Both interventions will be delivered over 4 weeks in hybrid format through a digital self-guided platform in combination with weekly telehealth video sessions with a psychologist (CBT-I) or research nurse (SET). A video-assisted booster session will be provided 1-2 weeks postoperatively. The primary outcome measure is acute postoperative pain intensity, averaged over the first 7 postoperative days (POD). Secondary outcome measures include long-term postoperative pain control, changes in quantitative sensory testing variables (eg, temporal summation, conditioned pain modulation), sleep, cognition (eg, attention, memory, processing speed, executive function), mental health, health-related function, physical activity, quality of life and blood biomarkers. Participants will undergo on-site evaluation preoperative (preintervention and postintervention) and 6 months postoperative. Additional remote assessments will take place during POD1-7, 3 and 12 months postoperative. ETHICS AND DISSEMINATION:The Swedish Ethical Review Authority has approved the PROSAP-A trial protocol. Results will be published in international peer-reviewed journals and summaries will be provided to funders and participants of the trial. TRIAL REGISTRATION NUMBER:NCT06145516.
Cognitive behavioural therapy for insomnia includes methods to adjust bedtimes and risetimes. The most well-known is sleep restriction therapy, but alternatives like sleep compression therapy and bedtime regularization also exist. Instructions and terminology vary. This scoping review uses "time-in-bed manipulation therapy" to encompass all such interventions, aiming to synthesize information on their implementation in adult populations, focusing on different instructions found in the literature. We searched five electronic databases. Two independent reviewers screened full-text papers, followed by data extraction. Both quantitative (e.g., instruction frequencies) and qualitative (e.g., analysis of content) syntheses were conducted. Of 7474 citations and 500 full-text papers, 52 studies met inclusion criteria, covering 60 therapies. Most interventions were termed sleep restriction therapy, but other names, such as sleep compression and bedtime restriction, were also used. Nine different methods for calculating the initial sleep window were identified, with further variation in other instructions. About half of the studies were randomized controlled trials. This review provides a comprehensive overview of time-in-bed manipulation therapies, aiding researchers and clinicians in selecting appropriate approaches. It highlights the need for clearer reporting, increased direct comparisons, and suggests a new model, The Restriction and Flexibility Model, describing key dimensions of these interventions.
Insomnia Disorder (ID) is a highly debilitating disorder affecting up to 10% of the general population. In recent years, the number of studies in this area has increased rapidly, resulting in a wealth of accumulated knowledge. ID is generally regarded as a hyperarousal disorder affecting cognitive, emotional, cortical and physiological domains. Nevertheless, there is still a significant lack of knowledge about the pathophysiology of ID. For example, the existence of insomnia subtypes is discussed, albeit no uniform definition has yet been found. Significant progress has been made in understanding the neurobiology of insomnia, which points to a dysfunction in emotion regulation. However, neuroimaging studies frequently have small sample sizes and allow only for limited causal conclusions. The assessment of sleep has been significantly influenced by the increasing availability of methods for ambulatory sleep measurement. While these methods enable sleep to be measured more cost-effectively than polysomnography, many devices lack sufficient empirical evidence of validity. In terms of insomnia treatment, cognitive behavioural therapy for insomnia (CBT-I) has been shown to be highly effective. However, the underlying mechanisms of CBT-I remain partially unclear, and the optimal sequence for applying the individual components, as well as the effectiveness of CBT-I in cases of comorbidity, remain open questions. Furthermore, many widely applied pharmacological treatment approaches are used off-label with only a limited empirical evidence base. This narrative review aims to summarise the current state of research on ID and attempts to outline a selection of the important future challenges in insomnia research.
Daytime impairments-such as fatigue, emotional instability, and cognitive difficulties-are increasingly acknowledged as core features of insomnia, yet they remain underrepresented in both research and treatment strategies. While CBT-I remains the gold standard for treating nocturnal symptoms, its effects on daytime functioning, which are often the primary concern for patients, are less robust, inconsistently measured, and poorly understood. This narrative review highlights the need to elevate daytime symptoms from secondary outcomes to central targets in both research and clinical practice. Key gaps include the lack of standardised and conceptually clear outcome measures, limited personalisation of CBT-I protocols, and insufficient understanding of the mechanisms linking improved sleep to daytime recovery. Moreover, the ethical implications of emerging digital assessment tools must be addressed to ensure that technological innovation does not come at the cost of participant trust or autonomy. To move the field forward, future research should prioritise daytime functioning as a primary endpoint, adopt ethically grounded multimodal assessment strategies, and explore adaptive, symptom-specific treatment designs. Finally, insomnia should be recognised not only as a disorder in its own right but also as a transdiagnostic and potentially preventable contributor to broader mental health problems. Addressing these challenges may lead to more effective, personalised, and patient-centred care for individuals living with insomnia.
Background: Comorbid sleep disturbances are common among individuals with chronic pain, and Cognitive Behavioural Therapy for Insomnia (CBT-i) has proven effective for such individuals. Nonetheless, research on web-based CBT-i tailored for patients with both chronic pain and insomnia is limited. This study aimed to evaluate the feasibility and efficacy of internet-based CBT-i and to explore potential mechanisms underlying treatment outcomes. Methods: In this study, 85 participants suffering from comorbid insomnia and chronic pain were randomized into two groups: Internet-based CBT for Insomnia (ICBT-i) and Internet-based Applied Relaxation (IAR). Both interventions spanned eight weeks, supported by therapeutic guidance throughout. Results: Participation was modest, with an average module completion of 2.0 out of 8 for ICBT-i and 2.4 for IAR. Both interventions significantly alleviated insomnia symptoms on one of the insomnia measures post-treatment, without notable differences between them. Directly after treatment, IAR outperformed ICBT-i in reducing pain interference, anxiety, and in enhancing self-rated health, though these differences lessened at the 6-month follow-up. Potential therapeutic mechanisms may involve attenuating maladaptive sleep beliefs and augmenting sleep-related willingness. Conclusions: The study encountered low engagement rates, with approximately one-third of participants not completing any module. The limited efficacy of ICBT-i may be due to low treatment involvement, with few patients completing key techniques like sleep compression and stimulus control. Despite the low adherence, both interventions yielded post-treatment improvements in insomnia symptoms, but to establish internet-based treatments for insomnia as a viable option in chronic pain management, patient engagement must be improved.
Objective: The primary aim was to estimate the pooled mean score of quality of life (QoL) (total, mental and physical health components) among patients with Restless Legs Syndrome (RLS). Secondary aims were to assess: (I) QoL differences for RLS vs. control groups, (II) heterogeneity and possible sources; and (III) moderating variables. Methods: Studies identified in PubMed, Scopus, Web of Science, and ProQuest between January 2000 and December 2022 were included. Methodological quality was assessed with Newcastle Ottawa Scale. The protocol was pre -registered (PROSPERO, CRD42023387318). Results: Twenty-seven studies (20121 participants, 12 countries) were included. The corrected pooled estimated mean score of QoL was 47.92 (27 studies, CI 95 %: 43.11 to 52.72, range 0 -100, i.e., low -high QoL) and was marginally affected by publication year (increased 0.89 by each year, p = 0.12). The corrected pooled estimated mean score of the mental health component was 47.32 (17 studies, 95 % CI: 43.12 to 51.51, range 0 -100) and influenced by RLS instrument (decreased with recent versions, p = 0.05). The corrected pooled estimated mean score of the physical health component was 39.08 (17 studies, 95 % CI: 33.05 to 45.10, range 0 -100), with no statistically significant moderator. The pooled estimated QoL scores were statistically significantly lower in RLS patients compared to control groups with standardized mean difference (SMD) of -0.78, -0.57 and -0.50 respectively for overall QoL (24 studies), physical and mental health components (14 studies). Total QoL SMD was affected by proportion of women. Conclusion: Low QoL was revealed among RLS patients, which was statistically significantly reduced compared to control groups.
BACKGROUND:Insomnia is common in adolescents. This study evaluated feasibility and preliminary efficacy of a six-week internet-delivered cognitive-behavioral therapy for insomnia (ICBT-I) in adolescents.METHODS:In this uncontrolled pilot study, participants (n = 27, 78% female) completed assessments pre- and post intervention. Data on recruitment, adherence to treatment, treatment activity, satisfaction and credibility was collected to assess feasibility. Self-reported insomnia symptoms, sleep parameters as well as depression, anxiety and daytime function were also assessed.RESULTS:Participants showed good adherence to treatment and found the intervention overall credible and satisfactory. From pre- to post-assessment, statistically significant improvements were found for insomnia symptoms (p < .001; d = 1.02), sleep onset latency (p < .001; d = .39), wake after sleep onset (p = .001; d = .34), sleep efficiency (p < .001; d = .5) and depression (p = .01, d = .37). Changes in scores of total sleep time, generalized anxiety, daytime sleepiness and functional disability were not significant.CONCLUSIONS:The present study indicates that ICBT-I is well accepted by adolescents, that insomnia symptoms and sleep parameters can improve following the intervention, and that co-morbid symptoms of depression can be reduced. Due to the limited sample size and the uncontrolled design, the suggested results need to be replicated in well-powered controlled clinical trials.