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Testing Self-Help Booklets for Sleep in People With Pulmonary Hypertension

Tests self-help sleep booklets for adults with pulmonary hypertension who have sleep problems.

Plain-language title generated from the registry record
Registry title: Self-Help Booklets for Sleep in Adults With Pulmonary Hypertension

Key facts

Where
Sheffield, United KingdomSee the site

Where in United Kingdom

  • Clinical Psychology UnitSheffield, United KingdomNo longer taking part

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Trial details

Who runs it
University of Sheffield
Trial code
NCT07754981
Record updated
10 August 2026
Original description
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).Read full original descriptionShow less

Development and Pilot Randomised Controlled Trial of a Self-help Sleep Hygiene Intervention to Help Individuals With Pulmonary Hypertension

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).

CBT-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.

CBT-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.

Participants 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.

Participants 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.

Inclusion: Participants much be aged 18 years and over; Must have a diagnosis of PH, which they will be asked to self-report i.e. we will not ask for proof; Must be able to meet the requirements of the study: give informed consent; complete questionnaires; be literate in English; Must self-report sleep difficulties. This will be asked as a categorical (yes/no) 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.

Exclusion: Participants 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.

ClinicalTrials.gov NCT07754981