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1.
Int J Environ Res Public Health ; 20(7)2023 03 30.
Article in English | MEDLINE | ID: covidwho-2306857

ABSTRACT

A substantial number of survivors of disasters, pandemics, and other severe stressors develop persistent distress that impairs mental health and well-being. However, only a few brief psychological interventions target distress or subclinical symptoms. This systematic review aimed to identify and describe brief psychological interventions to reduce distress or subclinical symptoms in survivors of disasters, pandemics, and other severe stressors. Based on a systematic literature search (MEDLINE, PsycINFO, PSYNDEX, PTSDpubs, and Web of Science), we reviewed published studies and study protocols on self-help, psychosocial support, or brief psychotherapeutic interventions to reduce distress and/or subclinical symptoms following natural hazards and man-made disasters, pandemics, or other traumatic events. We included 27 published studies or study protocols (n = 15 RCTs, n = 3 controlled pre-post studies, and n = 9 uncontrolled pre-post studies) describing 22 interventions. We found evidence for reducing psychological distress and/or subclinical symptoms in 9 out of 15 RCTs, 2 out of 3 controlled pre-post studies, and 9 out of 9 uncontrolled pre-post studies. One RCT provided evidence of increasing well-being. Innovative brief interventions have been developed to reduce distress and/or subclinical symptoms that have an emerging evidence base.


Subject(s)
Disasters , Stress Disorders, Post-Traumatic , Child , Adult , Adolescent , Humans , Stress Disorders, Post-Traumatic/epidemiology , Crisis Intervention , Psychosocial Intervention , Pandemics
2.
Addict Sci Clin Pract ; 18(1): 22, 2023 03 30.
Article in English | MEDLINE | ID: covidwho-2299331

ABSTRACT

BACKGROUND: Attempts to routinely embed brief interventions in health systems have long been challenging, with healthcare professionals concerned about role adequacy, legitimacy, and support. This is the first study to explore clinical pharmacists' experiences of discussing alcohol with patients in their new role in UK primary care, in developing a novel approach to brief intervention. It investigates their confidence with the subject of alcohol in routine practice and explores views on a new approach, integrating alcohol into the medication review as another drug directly linked to the patient's health conditions and medicines, rather than a separated 'healthy living' issue. The study forms part of wider efforts to repurpose and reimagine the potential application of brief interventions and to rework their contents. METHODS: Longitudinal qualitative study of 10 recruits to the new clinical pharmacist role in English primary care, involving three semi-structured interviews over approximately 16 months, supplemented by 10 one-off interviews with pharmacists already established in general practice. RESULTS: When raised at all, enquiring about alcohol in medication reviews was described in terms of calculating dose and level of consumption, leading to crude advice to reduce drinking. The idea was that those who appeared dependent should be referred to specialist services, though few such referrals were recalled. Pharmacists acknowledged that they were not currently considering alcohol as a drug in their practice and were interested in learning more about this concept and the approach it entailed, particularly in relation to polypharmacy. Some recognised a linked need to enhance consultation skills. CONCLUSIONS: Alcohol complicates routine clinical care and adversely impacts patient outcomes, even for those drinking at seemingly unremarkable levels. Changing clinical practice on alcohol requires engaging with, and supportively challenging, routine practices and entrenched ideas of different kinds. Framing alcohol as a drug may help shift the focus from patients with alcohol problems to problems caused for patients by alcohol. This is less stigmatising and provides role legitimacy for pharmacists to address alcohol clinically in medication reviews, thus providing one element in the formation of a new prevention paradigm. This approach invites further innovations tailored to other healthcare professional roles.


Subject(s)
Pharmacists , Professional Role , Humans , Qualitative Research , Polypharmacy , Primary Health Care
3.
Rev Panam Salud Publica ; 47: e22, 2023.
Article in Spanish | MEDLINE | ID: covidwho-2302481

ABSTRACT

Objective: To measure the impact of the COVID-19 pandemic on the implementation of a program for timely detection, brief intervention, and referral for treatment of alcohol consumption in health centers at the first level of care in Mexico City. Methods: The data were collected at 18 health centers in Mexico City between 2019 and 2021, as part of a larger study. A total of 287 participating health professionals measured their patients' alcohol consumption using the AUDIT-C test. The patients' demographic aspects and consumption patterns were analyzed, as well as care actions (detection, brief intervention, provision of leaflets, monitoring, and referral) at three points in time: before the COVID-19 pandemic, during confinement, and after confinement. Parametric and nonparametric tests were performed to identify the relationship and differences between the variables at the three points. Results: A total of 9090 people who consumed alcohol were identified; detection of consumption fluctuated in the three periods studied (26%, 53%, and 37%, respectively). Medium- and high-risk consumption was more frequent among young men with higher schooling during and after confinement. In the post-confinement period, monitoring and referral actions increased. Conclusions: Measuring the impact of the pandemic on the implementation of a program for timely detection of alcohol consumption, brief intervention, and referral for treatment in health centers helps to develop health policies by age, gender, schooling, and type of consumption at the first level of care.


Objetivo: Medir o efeito da pandemia de COVID-19 na implementação de um programa de detecção oportuna, intervenção breve e encaminhamento para tratamento pelo consumo de álcool em centros de saúde no nível da atenção primária na Cidade do México. Métodos: Foram coletados dados em 18 centros de saúde na Cidade do México entre 2019 e 2021, como parte de um estudo mais amplo. Participaram 287 profissionais de saúde, que mediram o consumo de álcool de seus pacientes com o teste AUDIT-C. Foram analisados aspectos demográficos e o padrão de consumo dos pacientes, bem como as medidas em termos de atendimento (triagem, intervenção breve, entrega de folhetos, monitoramento e encaminhamento) em três momentos: antes da pandemia de COVID-19, durante o confinamento e após o confinamento. Foram feitos testes paramétricos e não paramétricos para identificar a relação e as diferenças entre as variáveis nos três períodos. Resultados: Foram identificadas 9.090 pessoas com consumo de álcool, sendo que a porcentagem de consumo detectada flutuou nos três períodos estudados (26%, 53% e 37%, respectivamente). O consumo de médio e alto risco foi mais prevalente entre homens jovens e com nível maior de escolaridade durante e após o confinamento. No período posterior ao confinamento, as medidas de monitoramento e encaminhamento aumentaram. Conclusões: Medir o impacto da pandemia na implementação de um programa de detecção oportuna, intervenção breve e encaminhamento para tratamento do consumo de álcool em centros de saúde ajuda na formulação de políticas de saúde por idade, gênero, escolaridade e tipo de consumo para o primeiro nível de atenção.

4.
International Journal of Care and Caring ; 7(1):165-165–185, 2023.
Article in English | ProQuest Central | ID: covidwho-2247640

ABSTRACT

There is international evidence that informal or unpaid carers have poorer mental health and experience higher levels of isolation and stress than others in the population. Identifying approaches that promote carer well-being is critical to supporting this essential role in the community. This study presents the findings of the evaluation of a brief carer intervention designed to improve carers' well-being delivered by a community service organisation. The manualised programme provided information and psycho-education to adult carers in five regional locations in Victoria, Australia. Positive change was noted in carers' knowledge of good mental health and well-being, supports, and social connectedness.

5.
Soc Sci Med ; 322: 115800, 2023 04.
Article in English | MEDLINE | ID: covidwho-2286716

ABSTRACT

OBJECTIVE: Cervical cancer is the fourth most common cancer to occur in women worldwide. In the UK, the NHS cervical screening programme invites eligible individuals to take part in screening every 3-5 years. At present, around 70% of individuals attend screening when invited. The present study aimed to test the effectiveness of a volitional and a motivational intervention alone and in combination on screening uptake at 16-week follow up. METHODS: 14,536 participants were recruited from the list of eligible participants invited for screening in Yorkshire, Humber and the North East regions of England in December 2021. They were randomised to a social norm-based motivational intervention (SNA); implementation intention-based Volitional Help Sheet (VHS); combined intervention (SNA + VHS); or treatment as usual control. The primary outcome was screening uptake measured via patient screening records at 16 weeks. RESULTS: Of the 14,466 participants with eligible data for analysis, 5793 (40.0%) attended for cervical cancer screening in the 16 weeks after the intervention mailing. Both age and deprivation influenced screening uptake, with lower uptake in the youngest individuals and those from more deprived areas. Compared to control, there was no evidence of any benefit from the VHS implementation intervention alone (Adj.OR = 0.99, 95% CI 0.90 to 1.10), the SNA motivational intervention alone (Adj.OR = 0.89; 95% CI: 0.80 to 0.99), or the combined intervention (Adj.OR = 0.96, 95% CI 0.86 to 1.06). CONCLUSION: The study did not support any benefit of either VHS or SNA interventions alone or in combination on cervical cancer screening uptake. It did demonstrate alarmingly low levels of screening uptake at 16 weeks which were well below the average rate. Future research needs to urgently investigate and understand the barriers to uptake following on from the COVID-19 pandemic.


Subject(s)
COVID-19 , Uterine Cervical Neoplasms , Humans , Female , Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Neoplasms/prevention & control , Early Detection of Cancer , Pandemics , England
6.
Addiction ; 118(7): 1258-1269, 2023 07.
Article in English | MEDLINE | ID: covidwho-2275735

ABSTRACT

BACKGROUND AND AIMS: The increasing trend in alcohol consumption among women, exacerbated by the COVID-19 pandemic, is of growing concern. Screening, brief intervention, and referral to treatment in primary care is an efficacious and cost-effective treatment approach for unhealthy alcohol use. However, disparities exist in delivery of brief interventions by sex, age and race/ethnicity. This study measures brief intervention rates among eligible patients by sex, age and race/ethnicity and their intersectionality, in the context of a program of systematic alcohol screening and brief intervention program in adult primary care in a large, integrated health-care delivery system. DESIGN, SETTING AND PARTICIPANTS: This was a population-based observational study among primary care clinics in an integrated health-care delivery system in Northern California, USA. The participants comprised adult (18+) patients (n = 287 551) screening positive for unhealthy alcohol use between January 2014 and December 2017. MEASUREMENTS: Receipt of brief intervention, patient and provider characteristics from electronic health records. FINDINGS: Multi-level logistic regression showed that women had lower odds of receiving brief intervention than men among all age, racial/ethnic groups and drinking levels. Sex differences were greater among those aged 35-49 years [odds ratio (OR) = 0.67, 95% confidence interval (CI) = 0.64, 0.69]) and 50-65 years (OR = 0.69, 95% CI =0.66, 0.72) than among other age groups. Sex differences in odds of receiving brief intervention were greater for the Latino/Hispanic group for women versus men (OR = 0.69, 95% CI = 0.66, 0.72) and smaller for the Asian/Pacific Islander group (OR = 0.76, 95% CI = 0.72, 0.81). CONCLUSION: In the United States, compared with men, women appear to have lower odds of receiving brief intervention for unhealthy alcohol use across all age groups, particularly during middle age. Black women and Latina/Hispanic women appear to be less likely to receive brief intervention than women in other race/ethnicity groups. Receipt of brief intervention does not appear to differ by drinking levels between men and women.


Subject(s)
COVID-19 , Ethnicity , Adult , Middle Aged , Humans , Female , Male , United States , Crisis Intervention , Intersectional Framework , Pandemics , White
7.
Behav Modif ; 47(1): 128-153, 2023 01.
Article in English | MEDLINE | ID: covidwho-2241504

ABSTRACT

Behavioral problems, such as noncompliance and aggression, are a common referral reason to mental health services for young children. Behavioral parent training (BPT) is the leading intervention for addressing behavioral problems and leads to benefits in a variety of parental factors (e.g., parenting efficacy and parenting stress). While the COVID-19 pandemic dramatically shifted service delivery toward telehealth services, limited work has evaluated the effectiveness of BPT when delivered in a brief, group format through telehealth. The current retrospective chart review study evaluated the engagement to and preliminary effectiveness of a brief version of BPT delivered through telehealth to 64 families of 3- to 7-year-olds referred for behavioral problems. Families attended an average of 4.55 of 6 sessions and most families had two caregivers who engaged in the intervention. Significant reductions in caregivers' report of children's behavioral problems and improvements in parenting self-efficacy resulted. Future research and clinical implications are discussed.


Subject(s)
COVID-19 , Telemedicine , Child , Humans , Child, Preschool , Parenting/psychology , Pandemics , Retrospective Studies , Behavior Therapy/methods , Parents/education
8.
Child Adolesc Psychiatr Clin N Am ; 32(1): 115-126, 2023 01.
Article in English | MEDLINE | ID: covidwho-2228499

ABSTRACT

Adolescent cannabis use is a modifiable health behavior with potential adverse developmental, cognitive, psychological, and health effects. Over the last 2 decades, work to promote implementation of screening, brief intervention, and referral to treatment has improved screening, use of validated screening tools, and preventive messaging. Current intervention strategies for cannabis use are associated with modest, short-term effects, and referral to treatment is limited by availability of resources for adolescent substance use. This article provides an update on the evidence base for screening, brief intervention, referral to treatment, and the current state of implementation focused on management of cannabis use disorder.


Subject(s)
Cannabis , Hallucinogens , Substance-Related Disorders , Adolescent , Child , Humans , Crisis Intervention , Mental Health , Referral and Consultation , Substance-Related Disorders/diagnosis , Substance-Related Disorders/therapy , Primary Health Care
9.
J Contextual Behav Sci ; 27: 26-33, 2023 Jan.
Article in English | MEDLINE | ID: covidwho-2131359

ABSTRACT

Studies of the effects of the COVID-19 pandemic have shown that this health emergency has affected especially young people. Supporting the well-being of children is thus particularly urgent. However, the high prevalence of ill-being among children requires novel approaches to providing help. Health care resources are limited, and many children did not receive support even before the pandemic. The current study presents a novel approach to delivering brief interventions for school-aged children. A mobile game based on acceptance and commitment therapy was used to increase psychological flexibility and well-being among 10 to 12-year-old schoolchildren. A sample of 106 students played the game in four weekly sessions as part of normal teaching practice in school. The effectiveness of the brief game intervention was examined as a universal intervention among the whole sample and among subgroups created on the basis of baseline psychological flexibility (i.e., based on the need for an intervention). The results show that higher psychological flexibility was associated with less emotional and behavioral problems, higher health-related quality of life, mood, and school satisfaction, and less loneliness (r = 0.46-0.63). While a significant effect was not detected in the whole sample, the subsample of children with initially high psychological inflexibility benefitted from participating in the intervention (Cohen's d = 0.35). These preliminary findings suggest that the brief game-based intervention can increase psychological flexibility among children when the need for an intervention is considered. Further research is necessary to examine the stability of improvements in psychological flexibility.

10.
Front Pain Res (Lausanne) ; 3: 856252, 2022.
Article in English | MEDLINE | ID: covidwho-1862638

ABSTRACT

Estimates suggest that 10-40% of lumbar spine surgery patients experience persistent post-surgical pain (PPSP). PPSP is associated with 50% greater healthcare costs, along with risks of emotional distress and impaired quality of life. In 2019, U.S. Health and Human Services identified brief and digital behavioral treatments as important for pain management after surgery. Indeed, brief behavioral pain treatments delivered in the perioperative period may offer patients a low burden opportunity to acquire essential pain coping strategies for enhanced surgical recovery. Additionally, the COVID-19 pandemic has diminished in-person pain treatment access during extended perioperative time frames, thus underscoring the need for on-line options and home based care. This report describes the integration of an online, live-instructor delivered single-session pain self-management intervention (Empowered Relief) into the standard of care for lumbar spine surgery. Here, we apply the RE-AIM framework; describe systems implementation of the Empowered Relief intervention in a large, academic medical center during the COVID-19 pandemic; describe operational challenges and financial considerations; and present patient engagement data. Finally, we discuss the scalable potential of Empowered Relief and other single-session interventions in surgical populations, their importance during extended perioperative periods, practical and scientific limitations, and new directions for future research on this topic.

11.
J Eat Disord ; 10(1): 71, 2022 May 20.
Article in English | MEDLINE | ID: covidwho-1854876

ABSTRACT

Over the course of the COVID-19 pandemic, rates of eating disorders have increased, further straining systems of care that were already overburdened. The current paper describes novel interventions, largely informed by Family-Based Treatment (FBT), that were implemented by a tertiary specialist adolescent eating disorders service. In response to the pandemic, programming was designed to bridge access to care while waiting for availability of evidence-based therapy. The Brief Psychology Consultation Clinic provides several sessions to patients and families, focused on psychoeducation and problem-solving informed by FBT and other evidence-based therapies. Two groups, the FBT Caregiver Workshop Series and FBT Caregiver Support Group, provide psychoeducation and support for caregivers of youth with eating disorders. Perceived strengths and benefits of these services, as well as barriers to implementation and future research directions are discussed.

12.
JMIR Mhealth Uhealth ; 10(1): e31058, 2022 01 10.
Article in English | MEDLINE | ID: covidwho-1662512

ABSTRACT

BACKGROUND: Personalized prevention tools such as mobile apps designed to reduce alcohol consumption are widespread in mobile app stores accessible in Russia. However, the quality and content of these mobile apps have not been systematically evaluated. OBJECTIVE: This study aimed to identify Russian-language mobile apps for reducing alcohol use and to evaluate their quality and potential to change alcohol-related health behavior. It further aimed to identify apps that could facilitate screening and brief interventions in primary health care in Russia. METHODS: A systematic search for mobile apps available in Russia was carried out between April 1 and 15, 2020, December 1 and 15, 2020, and in March 2021 in the iPhone App Store, Google Play Store, and the 4PDA forum. App quality was assessed using the Mobile App Rating Scale (MARS), and structured searches in electronic libraries and bibliographic databases were used to evaluate the apps' evidence base. The number of features facilitating changes in lifestyle behavior was assessed using the App Behavior Change Scale (ABACUS). RESULTS: We identified 63 mobile apps for reducing alcohol use. The mean MARS quality ratings were high for the subscales of functionality (3.92 out of 5, SD 0.58) and aesthetics (2.96, SD 0.76) and low for engagement (2.42, SD 0.76) and information (1.65, SD 0.60). Additional searches in electronic libraries and bibliographic databases (eLibrary, CyberLeninka, Google Scholar) yielded no studies involving the identified apps. ABACUS scores ranged from 1 to 15 out of 25, with a mean of 5 (SD 3.24). Two of the identified apps might be useful for screening and brief interventions in Russian primary health care after improvements in content and scientific testing. CONCLUSIONS: Russian-language mobile apps for reducing alcohol use are accessible in the app stores. Many of them are aesthetically pleasing, functional, and easy to use. However, information about their scientific trialing or testing is lacking. Most apps contain a low number of features that facilitate changes in lifestyle behavior. Further research should examine the context of Russian-language mobile apps for reducing alcohol use. Our findings underline the need to develop evidence-based apps to mitigate alcohol consumption in Russia and elsewhere. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42020167458; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=167458.


Subject(s)
Mobile Applications , Alcohol Drinking/prevention & control , Delivery of Health Care , Humans , Language , Systematic Reviews as Topic
13.
Contemp Clin Trials ; 111: 106601, 2021 12.
Article in English | MEDLINE | ID: covidwho-1474377

ABSTRACT

BACKGROUND: Mild traumatic brain injury (mTBI) is a signature wound of Veterans of operations in Iraq and Afghanistan (i.e., OIF/OEF/OND). Most Veterans with mTBI also experience stress-based psychopathology (e.g., depression, posttraumatic stress disorder) and chronic pain. This combination - referred to as polytrauma - results in detrimental long-term effects on social, occupational, and community reintegration. This study will compare the efficacy of a one-day Acceptance and Commitment Training plus Education, Resources, and Support (ACT+ERS) workshop to a one-day active control group (ERS) on symptoms of distress and social, occupational, and community reintegration. We will also examine mediators and moderators of treatment response. METHODS: This is an ongoing randomized clinical trial. 212 OIF/OEF/OND Veterans with polytrauma are being recruited. Veterans are randomly assigned to a one-day ACT+ERS or a one-day ERS workshop with two individualized booster sessions approximately two- and four-weeks post-workshop. Veterans complete assessments prior to the workshop and again at six weeks, three months, and six months post-workshop. Of note, workshops were converted to a virtual format due to the COVID-19 pandemic. RESULTS: The primary outcomes are symptoms of distress and reintegration; secondary outcomes are post-traumatic stress disorder symptoms and pain interference. Secondary analyses will assess whether changes in avoidance at three months mediate changes in distress and reintegration at six months. CONCLUSION: Facilitating the psychological adjustment and reintegration of Veterans with polytrauma is critical. The results of this study will provide important information about the impact of a brief intervention for Veterans with these concerns.


Subject(s)
COVID-19 , Multiple Trauma , Veterans , Humans , Multiple Trauma/therapy , Pandemics , Randomized Controlled Trials as Topic , SARS-CoV-2
14.
Front Psychiatry ; 12: 655211, 2021.
Article in English | MEDLINE | ID: covidwho-1278458

ABSTRACT

The Coronavirus disease 2019 (COVID-19) posed unexpected global economic and societal challenges. These include a heavy impact on mental health due to fast changing lockdown and quarantine measures, uncertainty about health and safety and the prospect of new waves of infections. To provide crisis mental health support during the pandemic, Eötvös Loránd University in Hungary launched a specialist online counselling programme, consisting of one to three sessions. The programme was available to all university members between 4th March and 25th May 2020. Overall, 47 clients received support. In this paper we discuss challenges reported by clients, key features of providing a brief mental health intervention online, reflect on counsellor experiences and give recommendations on how mental health services could be developed in the time of crisis. Most clients had challenges with developing a daily routine under quarantine; and many had hardship related to finances, housing, and distance learning. Common mental health consequences included fear from the virus and stress, anxiety, and fatigue due to the interruption to everyday life. In some cases, more complex conditions were triggered by the pandemic. Examples include addictive behaviours and symptoms of depression or psychosis. However, referring cases beyond the competency of counselling proved to be a challenge due to the closure of specialist services. Counsellors observed three key features to the online delivery of a brief crisis mental health intervention: [1] an explicit problem-oriented approach to counselling; [2] challenges of building rapport online; and [3] frames of online counselling. Counsellor experiences often overlapped with those of clients and included challenges of working from home and adjusting to online counselling methods. The possibility of online counselling allowed that mental health care could take place at all during the pandemic. Client experiences reflect findings from previous literature. Like other mental health initiatives launched to tackle COVID-19, the intervention's effectiveness was not measured given the unexpected context and short time frame for programme development. We recommend the use of impact measurement tools to develop mental health services in crises. Meanwhile, the pandemic brought to attention the need to better understand online delivery models. Counsellors should have access to training opportunities on online counselling and managing work-life balance in a remote setting. The COVID-19 counselling programme in Eötvös Loránd University, Hungary is an example of providing online mental health counselling in the time of crisis. Clearly, more studies are needed discussing delivery models and effectiveness of mental health interventions during the pandemic. Experience and knowledge sharing across practitioners should be encouraged to improve how the field reacts to unexpected, high risk events and crises.

15.
Am J Drug Alcohol Abuse ; 47(2): 154-159, 2021 03 04.
Article in English | MEDLINE | ID: covidwho-1066068

ABSTRACT

The ongoing pandemic has led to a sudden disruption of routine treatment services. Consequently, the already existing treatment gap for substance use disorders is likely to widen. There is an opportunity to expand the scope of Screening and Brief Intervention (SBI) to meet this unprecedented challenge. Its brevity, flexibility, and generalizability have positioned SBI to deal with additional systemic, structural, and attitudinal barriers that pertain to the pandemic. The standard content of SBI could be modified to adapt to the current context. SBI could also be used as a vehicle to render strategies for infection risk minimization. In this Perspective, we anticipate the challenges of expanding and implementing SBI in the present circumstances and present potential solutions. SBI, with adaptations, could bridge the augmented treatment gap for substance use disorders during COVID-19.


Subject(s)
COVID-19 , Crisis Intervention/methods , Substance-Related Disorders/therapy , Crisis Intervention/organization & administration , Humans , Substance-Related Disorders/diagnosis
16.
Trials ; 21(1): 704, 2020 Aug 08.
Article in English | MEDLINE | ID: covidwho-705118

ABSTRACT

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).


Subject(s)
Betacoronavirus , Coronavirus Infections/epidemiology , Pneumonia, Viral/epidemiology , Randomized Controlled Trials as Topic , Sleep Initiation and Maintenance Disorders/therapy , COVID-19 , Humans , Outcome Assessment, Health Care , Pandemics , SARS-CoV-2 , Self Report
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