Self-Help Booklets for Sleep in Adults With Pulmonary Hypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sheffield
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Sleep Hygiene Self-Help Intervention
BehavioralParticipants 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
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Wait List Control GroupNo intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pittsburgh Sleep Quality Index (PSQI)
Consists of 19 items that generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, with higher scores indicating greater dysfunction; these are summed to yield a global score ranging from 0 to 21.
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).Secondary outcomes
1
Sleep Hygiene Index (SHI)
Consists of 13 items that measure the frequency of behaviours such as consumption of caffeine or alcohol before bedtime, irregular sleep schedules, and engaging in stimulating activities prior to sleep. Respondents rate each item on a five-point Likert scale ranging from 0 (never) to 4 (always), with higher scores indicating poorer sleep hygiene.
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).2
Generalized Anxiety Disorder 7 (GAD-7)
Assess symptoms of generalized anxiety over the past two weeks. Each of the seven items corresponds to core anxiety symptoms and is rated on a 4-point Likert scale from 0 ("not at all") to 3 ("nearly every day"), yielding a total score ranging from 0 to 21. Scores of 5, 10, and 15 represent cut-off points for mild, moderate, and severe anxiety and it has a reliable change index of 4.
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).3
The Patient Health Questionnaire-8 (PHQ-8)
It contains eight items, each scored from 0 ("not at all") to 3 ("nearly every day"), generating a total score ranging from 0 to 24. Clinical cut-offs of 5, 10, 15, and 20 correspond to mild, moderate, moderately severe, and severe depression, respectively. Scores below 10 suggest mild symptoms or no significant depression.
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).4
emPHasis-10
Assess HRQoL in individuals with PH It contains 10 items covering key domains relevant to the lived experience of PH, including breathlessness, fatigue, emotional wellbeing, and social functioning. Each item is rated on a 0-5 Likert scale, with total scores ranging from 0 to 50. Higher scores indicate a lower HRQoL.
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).Sponsors and contacts
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Source ClinicalTrials.gov
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