Insomnia during pregnancy and the Covid-19 pandemic: A case report

Insomnia is a key risk factor for depression and mental disorders, both in general and during peripartum. Covid-19 pandemic outbreak was associated with an alarming increase of insomnia symptoms. This case report aims to describe a digital Cognitive Behavioral Therapy for Insomnia (CBT-I) intervention adapted for pregnancy during the pandemic situation. This article describes the case of a 38 years old woman with significant problems in initiating and maintaining sleep. The intervention was conducted online. The assessment included a clinical psychological interview, semi-structured interview about sleep, sleep diaries and validated questionnaires. Adapted CBT-I protocol was performed including 5 sections lasting 45 minutes each. The case-report description follows CAse REport (CARE) guidelines. The intervention was effective in reducing insomnia symptoms as highlighted by questionnaires and sleep diaries. Furthermore, results showed positive findings with regard to depression symptomatology, stress levels and difficulties in emotion regulation. These positive results were confirmed at post-partum follow ups. Evidence-based CBT-I protocol was applied with relevant benefits for the patient. Furthermore, it was stressed the importance of considering emotions during psychotherapy. High-quality clinical trials evaluating the efficacy of adapted CBT-I in large samples of expecting mothers are suggested to guide changes in gynecological primary care for pregnancy, especially for the post-pandemic time. (PsycInfo Database Record (c) 2022 APA, all rights reserved) (Italian) L'insonnia e un fattore di rischio per la depressione e i disturbi mentali. La pandemia dovuta al Covid-19 e stata associata a un allarmante aumento dell'insonnia. Questo caso clinico ha lo scopo di descrivere un intervento digitale di terapia cognitivo comportamentale per l'insonnia (CBT-I) adattato per la gravidanza durante la pandemia. Viene descritto il caso di una donna di 38 anni con insonnia. La valutazione ha previsto un colloquio clinico psicologico, un'intervista semi-strutturata sul sonno, diari del sonno e questionari. E stato eseguito un protocollo CBT-I comprendente 5 sessioni di 45 minuti ciascuna. L'intervento eseguito e stato efficace nel ridurre i sintomi dell'insonnia e ha mostrato risultati positivi per quanto riguarda la sintomatologia depressiva, i livelli di stress e le difficolta nella regolazione delle emozioni. Questi risultati sono stati confermati anche ai follow-up. I risultati a favore dell'efficacia della CBT-I per l'insonnia in gravidanza sono stati confermati, evidenziando inoltre, l'importanza di considerare le emozioni durante il trattamento. Si suggeriscono futuri studi clinici di alta qualita che valutino l'efficacia della CBT-I adattata in grandi campioni di madri in gravidanza per guidare i cambiamenti nell'assistenza ginecologica primaria per la gravidanza, specialmente nel periodo post-pandemico. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

Internet delivered, non-inferiority, two-arm, assessor-blinded intervention comparing mindfulness-based stress reduction and cognitive-behavioral treatment for insomnia: a protocol study for a randomized controlled trial for nursing staff with insomnia.

BACKGROUND: Insomnia and poor sleep quality are highly prevalent conditions related to coronavirus disease 2019 (COVID-19) complications among clinical nurses. Although cognitive behavioral therapy for insomnia (CBT-I) is a first-line treatment, CBT-I suffers from several major drawbacks. This study investigates whether the application of the internet-delivered mindfulness-based stress reduction (iMBSR) intervention will produce effects that are non-inferior to the internet-delivered CBT-I (iCBT-I) intervention in reducing the severity of insomnia in clinical nurses with insomnia at the end of the study. METHODS: This study protocol presents an internet-delivered, parallel-groups, assessor-blinded, two-arm, non-inferiority randomized controlled trial. The primary outcome is sleep quality, assessed by the Insomnia Severity Index. Secondary outcomes include depression, dysfunctional beliefs, five facets of mindfulness, and client satisfaction. CONCLUSION: It is expected that this study may address several gaps in the literature. The non-inferiority study design is a novel approach to evaluating whether a standardized, complementary treatment (i.e., MBSR) is as practical as a gold standard treatment rather than its potential benefits. This approach may lead to expanded evidence-based practice and improve patient access to effective treatments. TRIAL REGISTRATION: Trial registration number: ISRCTN36198096 . Registered on 24th May 2022.

Insomnia during pregnancy and the Covid-19 pandemic: A case report

(Italian) L'insonnia e un fattore di rischio per la depressione e i disturbi mentali. La pandemia dovuta al Covid-19 e stata associata a un allarmante aumento dell'insonnia. Questo caso clinico ha lo scopo di descrivere un intervento digitale di terapia cognitivo comportamentale per l'insonnia (CBT-I) adattato per la gravidanza durante la pandemia. Viene descritto il caso di una donna di 38 anni con insonnia. La valutazione ha previsto un colloquio clinico psicologico, un'intervista semi-strutturata sul sonno, diari del sonno e questionari. E stato eseguito un protocollo CBT-I comprendente 5 sessioni di 45 minuti ciascuna. L'intervento eseguito e stato efficace nel ridurre i sintomi dell'insonnia e ha mostrato risultati positivi per quanto riguarda la sintomatologia depressiva, i livelli di stress e le difficolta nella regolazione delle emozioni. Questi risultati sono stati confermati anche ai follow-up. I risultati a favore dell'efficacia della CBT-I per l'insonnia in gravidanza sono stati confermati, evidenziando inoltre, l'importanza di considerare le emozioni durante il trattamento. Si suggeriscono futuri studi clinici di alta qualita che valutino l'efficacia della CBT-I adattata in grandi campioni di madri in gravidanza per guidare i cambiamenti nell'assistenza ginecologica primaria per la gravidanza, specialmente nel periodo post-pandemico. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

Real-World Evaluation of Clinical Response and Long-Term Healthcare Resource Utilization Patterns Following Treatment with a Digital Therapeutic for Chronic Insomnia.

Background and Objectives: This analysis evaluated insomnia severity and long-term impact on healthcare resource utilization (HCRU) and costs after treatment with Somryst® (previously called SHUTi), a digital therapeutic delivering cognitive behavioral therapy for insomnia (CBT-I). Methods: Change from baseline in insomnia severity index (ISI) score was assessed using last observed ISI score. A pre/post analysis of claims data was conducted, comparing HCRU in patients with self-identified sleep problems who successfully initiated the therapeutic (index date) between June 1, 2016 and December 31, 2018. Results: A total of 248 patients were analyzed (median age 56.5 years, 57.3% female, mean ISI score 19.13, 52.4% treated with sleep aid medications pre-index). After 9 weeks, mean ISI score declined by 37.2% from baseline (19.1 vs 12.0), 58.8% of patients achieved ISI responder status (ISI score improved by =>7; NNT: 1.7), and 26.6% of patients achieved insomnia remission (ISI score <8; NNT for remission: 3.8). After two-year follow-up, post-index events were reduced (compared to 2 years pre-index) for emergency department visits (-53%; IRR: 0.47; 95% CI 0.27, 0.82; P=0.008), hospiatizations (-21%; IRR: 0.79; 95% CI 0.46, 1.35; P=0.389) and hospital outpatient visits (-13%; IRR: 0.87; 95% CI 0.66, 1.14; P=0.315). Slightly increased rates were observed for ambulatory surgical center visits (2%; IRR: 1.02; 95% CI 0.73, 1.44; P=0.903) and office visits (2%; IRR: 1.02; 95% CI 0.92, 1.14; P=0.672). The number of patients treated with sleep aid medications dropped 18.5% (52.4% pre-index vs 42.7% post-index). Average number of prescriptions decreased from 3.98 pre-index to 3.73 post-index (P= 0.552). Total two-year cost reduction post-index vs pre-index was $510,678, or -$2059 per patient. Conclusion: In a real-world cohort of patients with chronic insomnia, treatment with a digital therapeutic delivering CBT-I was associated with reductions in insomnia severity, emergency department visits, and net costs.

Management of Chronic Insomnia Using Cognitive Behavior Therapy for Insomnia (CBT-I) During COVID-19 Pandemic: Does One Shoe Fit All?

Purpose: Insomnia is a highly prevalent disorder that is seen across all age groups causing significant morbidity to the patients. Its prevalence has further risen during COVID-19 pandemic. It is widely acknowledged that untreated insomnia can lead to significant health risks and socio-occupational dysfunction. Methods: A narrative review was conducted following focused search of databases. Results: Available guidelines mention two different approaches for the management of insomnia-pharmacological and non-pharmacological. Non-pharmacological therapies like multicomponent cognitive behavior therapy for insomnia (CBT-I) have been advocated for the management of acute as well as chronic insomnia in the literature as it has been found efficacious and useful. Multiple variants of CBT-I, e.g., digitally delivered CBT-I, brief CBT-I have been tested during pandemic owing to closure of clinics. However, there are certain issues to be considered while choosing CBT-I as therapy. For example, like other forms of psychotherapies, is there a need for assessing the candidature of patient before administering CBT-I; is CBT-I free of adverse effects as commonly thought; is CBT-I more efficacious than hypnotics; and at last, how to manage cases that are not candidate for CBT-I. Conclusion: This narrative review addresses the scientific robustness of evidence for issues related to adherence, efficacy and adverse effects of non-pharmacological therapies. Available literature suggests that data related to adherence and efficacy of CBT-I suffer from methodological shortcomings and careful selection of patient is important for the successful therapy. At the same time, attempts have been made to shed light to the areas where CBT-I can be helpful in the management of insomnia.

Decreased Transition Rate From Situational Insomnia to Chronic Insomnia by One-Week Internet Cognitive Behavioral Treatments for Insomnia During the COVID-19 Pandemic.

Purpose: The purpose of the study was to determine the long-term effects of one-week self-guided internet cognitive behavioral treatments for insomnia (CBTI) on situational insomnia during the COVID-19 pandemic. Patients and Methods: The participants with situational insomnia (n = 194) were recruited from March 2020 to April 2020 in Guangzhou, China. The insomnia severity index (ISI), pre-sleep arousal scale (PSAS), and hospital anxiety and depression scale (HADS) were evaluated at baseline and a one-week internet CBTI program was delivered to all individuals. The participants were divided into the complete treatment group (the participants completed all seven modules of the CBTI course, n = 75), and the incomplete treatment group (the participants completed 0-6 modules of the CBTI course, n = 119). A total of 135 participants completed the post-intervention assessments. At 3 months follow-up, a total of 117 participants (complete treatment group: n = 51; incomplete treatment group: n = 66) completed the assessments of the ISI, PSAS and HADS. The transition rate from situational insomnia to chronic insomnia (duration of insomnia ≥ 3 months and ISI ≥ 8) was calculated in the two groups. Linear mixed effect model was used to investigate the effect of group (between the two groups), time (baseline vs. follow-up), and interaction (group x time) on various questionnaire score. Results: The transition rate from situational insomnia to chronic insomnia was significantly lower in the complete treatment group compared to the incomplete treatment group (27.5%, 14/51 vs. 48.5%, 32/66, p = 0.023). There were significant differences in group effect (p = 0.032), time effect (p = 0.000) and group × time effect (p = 0.048) between the two groups in the ISI total score. The ISI total scores decreased in both groups during follow-up compared to their baseline values, with a greater magnitude of decrease in the complete treatment group. There were no significant group x time effects between the two groups in the PSAS-total score, PSAS-somatic, PSAS-cognitive score, HADS total score, HADS anxiety score or HADS depression score. Conclusion: Our results suggested that one-week self-guided internet CBTI prevented the development of chronic insomnia from situational insomnia during the COVID-19 pandemic.

Viability of an Early Sleep Intervention to Mitigate Poor Sleep and Improve Well-being in the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial.

BACKGROUND: The COVID-19 pandemic has led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remain unknown. OBJECTIVE: Here, we present the framework and protocol for a novel feasibility, pilot study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS: The protocol details a 2-arm randomized controlled feasibility trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic were randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of cognitive behavioral therapy for insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0) and at weeks 1-6, 12, 28, and 56. RESULTS: The trial began enrollment on June 3, 2020 and closed enrollment on June 17, 2021. As of October 2021, 49 participants had been randomized to either immediate treatment or a 28-week waitlist; 23 participants were still active in the protocol. CONCLUSIONS: To our knowledge, this protocol would represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 pandemic. The findings of this feasibility study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. TRIAL REGISTRATION: ClinicalTrials.gov NCT04409743; https://clinicaltrials.gov/ct2/show/NCT04409743. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34409.

Public interest and awareness regarding general health, sleep quality and mental wellbeing during the early COVID-19 pandemic period: An exploration using Google trends.

The internet network continues to be a major source of health-related information. Our research provides insights into the online health-seeking behaviors of the general population, and evaluates the potential relationship between the COVID-19 pandemic and public interest and awareness of general sleep health, mental health and wellbeing. Google Trends' weekly relative search volumes (RSVs) were examined during 2020 for searches specifically related to COVID-19 symptoms, and for searches related to general health, sleep and wellbeing, in the United Kingdom, the United States of America, France, Italy and Japan. To obtain insight into the association between the initiation of public restrictions and online search trends, we assessed a six-week period; the 'early pandemic period' (EPP) (01 March 2020 - 11 April 2020). To provide a meaningful pre-pandemic comparison, a similar period during 2019 (03 March - 13 April 2019) was compared for RSV and median difference analysis. The EPP was associated with increased online searches related to COVID-19 symptoms, as compared with those related to more general sleep health, mental health and wellbeing. The latter search terms frequently showed a decrease or minimal change in RSV during the EPP compared with the equivalent period in 2019. This finding illustrates the potential link between the COVID-19 pandemic and online search behavior and corroborates existing findings regarding internet searches during this period. Proactive communication by healthcare professionals during future pandemics and as an ongoing measure could help prevent public neglect of general health and wellbeing symptoms, and encourage reporting and early intervention.

Pediatric behavioral sleep medicine in the era of telemedicine: psychology trainee perspectives.

The worldwide coronavirus pandemic in 2020 radically changed the landscape of psychology service provision and training, with rapid rollouts of telemedicine to promote safe access to care. In this perspective article, we share the experiences of 4 psychology trainees, all of whom worked as psychology interns or postdoctoral fellows in pediatric behavioral sleep medicine during the pandemic. With restricted in-person visits and upheaval of children's normative sleep and school schedules, we directly observed growth in both need for psychological care and opportunity to provide this care remotely. Here, we summarize the unique challenges and learning opportunities we faced when trying to learn and implement evidence-based assessment and treatment of child and adolescent sleep difficulties during the pandemic. CITATION: McQuillan ME, Anderson A, Russo KD, Truss A, Honaker SM, Walsh KL. Pediatric behavioral sleep medicine in the era of telemedicine: psychology trainee perspectives. J Clin Sleep Med. 2021;17(9):1965-1967.

Efficacy of simplified-cognitive behavioral therapy for insomnia(S-CBTI) among female COVID-19 patients with insomnia symptom in Wuhan mobile cabin hospital.

BACKGROUND: The outbreak of Coronavirus Disease-2019 (COVID-19) caused great psychological distress often with comorbid insomnia. Insomnia is common in patients with COVID-19 admitted to mobile cabin hospitals. Insomnia may lead to immune dysfunction, a condition not conducive to recovery from COVID-19. The use of sedative-hypnotic drugs is limited by their inhibitory effect on the respiratory system. A paucity of research is available regarding psychotherapy interventions to improve insomnia symptoms among  patients with COVID-19. In the general population, sleep problems are more common in women than in men; insomnia in women patients requires special attention. The aim of this study was to develop simplified-cognitive behavioral therapy for insomnia (S-CBTI) for patients with COVID-19 and comorbid insomnia symptoms and to verify its effectiveness through a self-control trial. A second aim was to compare the effectiveness of S-CBTI between acute and chronic insomnia among women with COVID-19 and comorbid insomnia symptoms in Wuhan Jianghan Cabin Hospital. METHODS: S-CBTI consisted of education on COVID-19 and sleep hygiene, stimulus control, sleep restriction, and self-suggestion relaxation training over a period of two consecutive weeks. Of 67 women, 66 completed psychological intervention and baseline and post-intervention assessments. There were 31 women with acute insomnia and 35 with chronic insomnia. The Insomnia Severity Index (ISI) score and self-compiled sleep data were assessed at baseline and post-intervention, and subjective sleep evaluations were assessed at days 4, 7, 12, and 14. RESULTS: The ISI score, sleep latency, night sleep time, and sleep efficiency were statistically significantlly improved from baseline to post-intervention by paired T-test. After the intervention, the mean ISI score of the acute insomnia group was lower than that of the chronic insomnia group. The reduction of the ISI score and the improvement of sleep time from baseline to post-intervention in the acute insomnia group were greater than those in the chronic insomnia group. Utilization of sedative-hypnotic drugs in the acute insomnia group was less than that in the chronic insomnia group, and the difference was statistically significant. CONCLUSIONS: S-CBTI can improve the insomnia symptoms of women with COVID-19 in mobile cabin hospitals, especially for stress-related acute insomnia.

Profile of Somryst Prescription Digital Therapeutic for Chronic Insomnia: Overview of Safety and Efficacy.

Introduction: Prescription digital therapeutics (PDTs) represent a new class of software-based medical devices authorized by the Food and Drug Administration (FDA) to treat disease. Somryst™, the first PDT for treating chronic insomnia, delivers cognitive behavioral therapy for insomnia (CBT-I) via a mobile application. CBT-I is the guideline-recommended, first-line treatment for chronic insomnia, but availability of CBT-I therapists is limited. Somryst addresses this need by providing asynchronous access to CBT-I treatment. As a contactless therapeutic medium, Somryst is also an ideal option when face-to-face therapy is not available or recommended for safety reasons (e.g. because of possible exposure to the SARS-CoV-2 virus). Areas covered: This review summarizes the mechanisms of action and technical features of Somryst, and describes safety and effectiveness data from the randomized trials on which FDA clearance was based. Expert opinion: Somryst demonstrates robust clinical efficacy with a favorable benefit-to-risk profile for treating adults with chronic insomnia. FDA clearance was based on data from 2 clinical trials of the first-generation web-based CBT-I platform Sleep Healthy Using the Internet (SHUTi). Somryst, and PDTs in general, are promising devices to address the need for greater accessibility to effective therapies.

One-Week Self-Guided Internet Cognitive Behavioral Treatments for Insomnia in Adults With Situational Insomnia During the COVID-19 Outbreak.

Objective: In the current global home confinement due to COVID-19, most individuals are facing unprecedented stress which can induce situational insomnia. We explored the efficacy of self-guided online cognitive behavioral treatment for insomnia (CBTI) on situational insomnia during the COVID-19 outbreak. Methods: Participants were recruited from March to April in 2020 in Guangzhou, China. A 1-week Internet CBTI intervention was performed for all individuals with situational insomnia. The Pre-sleep Arousal Scale (PSAS), Insomnia Severity Index (ISI), and Hospital Anxiety and Depression Scale (HADS) were measured before and after the intervention and compared between individuals who completed the intervention and those who did not. Results: One hundred and ninety-four individuals with situational insomnia were included. For PSAS score, significant group effects were found on total score (p = 0.003), somatic score (p = 0.014), and cognitive score (p = 0.009). Time effect was significant on total score (p = 0.004) and cognitive score (p < 0.001). There was a significant group × time effect of the somatic score (p = 0.025). For ISI total score, there were significant time effect (p < 0.001) and group × time effect (p = 0.024). For the HADS score, a significant group effect was found on the anxiety score (p = 0.045). The HADS had significant time effects for anxiety and depressive symptoms (all p < 0.001). Conclusion: Our study suggests good efficacy of CBTI on situational insomnia during COVID-19 for adults in the community, as well as on pre-sleep somatic hyperarousal symptom. The CBTI intervention is not applied to improve pre-sleep cognitive hyperarousal, depression, and anxiety symptoms.

Digital cognitive behavioral therapy for insomnia promotes later health resilience during the coronavirus disease 19 (COVID-19) pandemic.

STUDY OBJECTIVES: Stressful life events contribute to insomnia, psychosocial functioning, and illness. Though individuals with a history of insomnia may be especially vulnerable during stressful life events, risk may be mitigated by prior intervention. This study evaluated the effect of prior digital cognitive-behavioral therapy for insomnia (dCBT-I) versus sleep education on health resilience during the COVID-19 pandemic. METHODS: COVID impact, insomnia, general- and COVID-related stress, depression, and global health were assessed in April 2020 in adults with a history of insomnia who completed a randomized controlled trial of dCBT-I (n = 102) versus sleep education control (n = 106) in 2016-2017. Regression analyses were used to evaluate the effect of intervention conditions on subsequent stress and health during the pandemic. RESULTS: Insomnia symptoms were significantly associated with COVID-19 related disruptions, and those who previously received dCBT-I reported less insomnia symptoms, less general stress and COVID-related cognitive intrusions, less depression, and better global health than those who received sleep education. Moreover, the odds for resurgent insomnia was 51% lower in the dCBT-I versus control condition. Similarly, odds of moderate to severe depression during COVID-19 was 57% lower in the dCBT-I condition. CONCLUSIONS: Those who received dCBT-I had increased health resilience during the COVID-19 pandemic in adults with a history of insomnia and ongoing mild to moderate mental health symptoms. These data provide evidence that dCBT-I is a powerful tool to promote mental and physical health during stressors, including the COVID-19 pandemic. CLINICAL TRIAL REGISTRATION: NCT02988375.

Testing an early online intervention for the treatment of disturbed sleep during the COVID-19 pandemic (Sleep COVID-19): structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: The primary aim of the present study is to examine the efficacy of an online intervention for poor sleep in the context of an ongoing stressful major life event, by assessing if this intervention can reduce insomnia severity at short-term (one week post-intervention) and long-term (one and three months post-intervention) follow-up time points. It is hypothesised that the intervention will: 1) reduce insomnia severity in poor sleepers, compared to wait-list control poor sleepers, and good sleepers; 2) reduce subjective symptoms of anxiety and depression in all groups, and 3) prevent the transition to acute insomnia in good sleepers. TRIAL DESIGN: This study is a cluster randomised controlled trial. PARTICIPANTS: Both healthy good sleepers, who do not report having any current sleep problems, and individuals who report having sleep problems, will be recruited for the present study. This is a single-site study (Northumbria University). This study will be delivered using the internet and there are no geographic restrictions. Individuals who self-report as poor sleepers will meet DSM-5 criteria for acute insomnia, which is where individuals: 1) have difficulties in falling asleep, staying asleep, or awakening too early for at least three nights per week, for a time period of between two weeks and three months; and 2) report experiencing distress or impairment caused by sleep loss. Both 1) and 2) must have occurred despite the individual having had an adequate opportunity for sleep during this time period. Good sleepers will be individuals who do not have current sleep problems. All participants must have a sufficient level of English comprehension to understand and complete study measures. Individuals cannot participate if they report having chronic sleep problems (where they have existed for more than three months immediately prior to providing consent), nor will individuals who are actively seeking treatment for their sleep problems irrespective of how long they have had the sleep problem. Individuals also cannot participate if they have a self-reported history of head injuries, or if they have a self-reported diagnosis of schizophrenia, epilepsy or personality disorder, as the distraction techniques involved in the insomnia intervention may increase rumination in individuals with these conditions, and influence the effectiveness of the intervention. INTERVENTION AND COMPARATOR: Participants who receive the intervention will be provided with an online version of a self-help leaflet. A printed version of this leaflet has been successfully used in previous treatment studies, which have been conducted by our research group. Participants will be encouraged to download, save or print out this leaflet, which will be provided in PDF format. There will be no restrictions on use and participants will be encouraged to refer to this leaflet as often as they wish to. Briefly, this self-help leaflet aims to improve sleep by identifying and addressing sleep-related dysfunctional thinking by providing education about sleep, providing techniques to distract from intrusive worrisome thoughts at night, and providing guidelines for sleep-related stimulus control. The comparator is a wait-list control (i.e. where they will receive the intervention after a one month delay) group. MAIN OUTCOMES: The primary outcome measure will be insomnia severity, as measured using the Insomnia Severity Index (Bastien, Vallières, & Morin, 2001), assessed immediately prior to the intervention and at one week, one month and three months post-intervention, compared to baseline. Secondary outcome measures will include subjective mood, measured using the 7-item Generalised Anxiety Disorder Questionnaire (GAD-7; Spitzer, Kroenke, Williams, & Lowe, 2006)) and 9-item Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001), assessed immediately prior to the intervention, and one week, one month and three months post-intervention, compared to baseline. Additionally, subjective sleep continuity, derived from sleep diaries (Carney et al., 2012), will be compared pre and post-intervention. RANDOMISATION: This study will operate as a cluster randomised controlled trial. Good sleepers will be randomised into an intervention or a no-intervention group, with a 1:1 allocation. Poor sleepers will be randomised into an intervention or wait-list control group, with a 1:1 allocation. Randomisation will be conducted automatically using Qualtrics study software, where block sizes will be equal and randomisation will be computer-generated. BLINDING (MASKING): Participants will not be blinded to group assignment. The outcomes will be assessed by a blinded investigator. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The minimum sample size is 60. A total of 30 poor sleepers will be randomised to the intervention or wait-list control group. A total of 30 good sleepers will be randomised to the intervention or no intervention group. TRIAL STATUS: Recruitment for this study has yet to start. It is anticipated that recruitment will begin in August 2020 and end in April 2022. The current study protocol is version 1.0 (20 July 2020) TRIAL REGISTRATION: This study was prospectively registered in the ISRCTN registry (registration number ISRCTN43900695 , date of registration: 8 April 2020). FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).