Self-Help Booklets for Sleep in Adults With Pulmonary Hypertension

Sponsor
University of Sheffield
Study ID
NCT07754981
Status
Not Yet Recruiting

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Conditions

  • Insomnia
  • Pulmonary Hypertension
  • Sleep Hygiene

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sleep Hygiene Self-Help Intervention — BEHAVIORAL
    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. The 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: WEEK ONE: Sleep difficulties and PH WEEK TWO: How to sleep better WEEK THREE: Working on tricky thoughts WEEK FOUR: Maintaining progress

Study Details

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.

Key Dates

First listed
Aug 10, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • No Intervention: Wait List Control Group
    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.
  • Experimental: Intervention Group
    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.

Primary Outcome Measure

Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Outcome measures will be collected before the intervention (baseline), immediately after the four-week intervention, and at a one-month follow-up (eight weeks from baseline). ]

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