[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650990":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":34,"responsibleParty":61,"collaborators":12,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":12,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":12,"enrollmentInfo":72,"targetDuration":12,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":86,"whyStopped":12,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Sheffield","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Wait List Control Group","NO_INTERVENTION","Participants in the wait-list control group will not receive the self-help intervention during the study and will be compared with the intervention group on the study outcome measures. If the self-help intervention is found to be helpful, participants in the wait-list control group will be offered the intervention after the study has been completed.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention Group","EXPERIMENTAL","The intervention will be a series of self-help booklets aiming to improve sleep quality. The content and length of the intervention has been finalised in collaboration with PHA-UK to ensure it is also informed by experts by experience and education and the Medical Research Council framework for developing complex interventions (Skivington et al., 2021) will be adhered to.",[18],"Behavioral: Sleep Hygiene Self-Help Intervention",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BEHAVIORAL","Sleep Hygiene Self-Help Intervention","Participants randomised to the intervention group will be sent a sleep hygiene self-help intervention for PH. The content of the sessions has been informed by pre-existing self-help booklets, sleep hygiene advice and CBT-I interventions and has been created in collaboration with PHA-UK.\n\nThe self-help materials will be provided online and will take 4 weeks for the participant to complete at home, with one booklet for each week:\n\nWEEK ONE: Sleep difficulties and PH WEEK TWO: How to sleep better WEEK THREE: Working on tricky thoughts WEEK FOUR: Maintaining progress",[14],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Isaac Bhatoy, Trainee Clinical Psychologist","CONTACT","(+44) 114 222 6533","ibhatoy1@sheffield.ac.uk",{"name":32,"role":28,"phone":12,"phoneExt":12,"email":33},"Gregg Rawlings, DClinPsy","gregg.rawlings@ac.uk",[35],{"facility":36,"status":12,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Clinical Psychology Unit","Sheffield","South Yorkshire","S1 4DP","United Kingdom","UK",{"type":43,"coordinates":44},"Point",[45,46],-1.4659,53.38297,{"lat":46,"lon":45},[49,50,52,54,57,59],{"name":27,"role":28,"phone":12,"phoneExt":12,"email":30},{"name":32,"role":28,"phone":12,"phoneExt":12,"email":51},"gregg.rawlings@sheffield.ac.uk",{"name":27,"role":53,"phone":12,"phoneExt":12,"email":12},"PRINCIPAL_INVESTIGATOR",{"name":55,"role":56,"phone":12,"phoneExt":12,"email":12},"Nigel Beail, Prof","SUB_INVESTIGATOR",{"name":58,"role":56,"phone":12,"phoneExt":12,"email":12},"Iain Armstrong, Dr",{"name":60,"role":56,"phone":12,"phoneExt":12,"email":12},"Andrew Thompson, Prof",{"type":62,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100650990","self-help-booklets-for-sleep-in-adults-with-pulmonary-hypertension-100650990",false,"NCT07754981","Self-Help Booklets for Sleep in Adults With Pulmonary Hypertension","Development and Pilot Randomised Controlled Trial of a Self-help Sleep Hygiene Intervention to Help Individuals With Pulmonary Hypertension","Inclusion Criteria:\n\nParticipants much be aged 18 years and over.\n\nMust have a diagnosis of PH, which they will be asked to self-report i.e. we will not ask for proof.\n\nMust be able to meet the requirements of the study: give informed consent; complete questionnaires; be literate in English.\n\nMust self-report sleep difficulties. This will be asked as a categorical (yes\u002Fno) question rather than captured through an outcome measure. No sleep measure has been validated for this population. Whilst we can measure sleep, we are unable to quantify difficulties and cannot use a more standardised method of determining a clinical cut off for when a participant may be included or excluded from the study.\n\nExclusion Criteria:\n\nParticipants displaying any significant issues of risk such as self-reported thoughts of harm to self or suicidal thoughts will not be eligible for this study. This is because they are unlikely to benefit from a self-help intervention. this will be asked during a screening questionnaire prior to accessing the consent form. Instead, we will signpost this group to relevant services.","ALL","18 Years",{"count":73,"type":74},60,"ESTIMATED","INTERVENTIONAL",[77],"NA","The researchers have developed a set of self-help booklets for adults with pulmonary hypertension (PH) who are experiencing sleep problems. The booklets include sleep hygiene advice and are based on a psychological treatment called Cognitive Behavioural Therapy for Insomnia (CBT-I).\n\nCBT-I is a structured, evidence-based treatment for ongoing sleep problems. It helps people understand how their thoughts, behaviours, and daily routines can affect their sleep. It aims to improve sleep quality and help people fall asleep more easily and get back to sleep if they wake during the night.\n\nCBT-I is one of the most effective treatments for ongoing sleep problems. The self-help programme consists of four booklets, which participants will work through at home over four weeks, completing one booklet each week in their own time. The aim of the study is to find out whether the self-help booklets improve sleep quality in people with pulmonary hypertension.\n\nParticipants will be asked to complete questionnaires about their sleep and mental wellbeing, including symptoms of anxiety and depression. Participants will then be randomly allocated to one of two groups. The intervention group will receive the self-help booklets during the study. The wait-list group will receive the booklets at a later date if they are found to be helpful. Having two groups allows the researchers to compare the results and determine whether any improvements in sleep are due to the self-help booklets.\n\nParticipants in the intervention group will also be contacted during the programme to ask about their experiences of using the booklets. Both groups will complete the questionnaires again after four weeks and then again one month later. Participants in the intervention group will also be contacted at the end of the study to discuss their experiences of taking part.",[80,81,82],"Pulmonary Hypertension","Insomnia","Sleep Hygiene",[82,84,85,80,81],"Self-Help","CBT-I","NOT_YET_RECRUITING","2026-08-04",{"date":89,"type":90},"2026-08-10","ACTUAL",{"date":92,"type":74},"2026-09",{"date":94,"type":74},"2027-03",{"name":5,"class":6},1]