Self-Help Booklets for Sleep in Adults With Pulmonary Hypertension

NCT07754981 | Not Yet Recruiting

• 1 other identifier: 072376
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Hypertension; Insomnia; Sleep Hygiene

Keywords

Sleep Hygiene; Self-Help; CBT-I; Pulmonary Hypertension; Insomnia

Outcome Measures

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.

  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 (5)

• Sleep Hygiene Index (SHI)

  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).

• Generalized Anxiety Disorder 7 (GAD-7)

  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).

• The Patient Health Questionnaire-8 (PHQ-8)

  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).

• emPHasis-10

  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).

• Dyspnoea-12 (D12)

  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).

Study Arms (2)

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.

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.

Behavioral: Sleep Hygiene Self-Help Intervention

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

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sheffield: lead

Study Sites (1)

Clinical Psychology Unit

Sheffield, South Yorkshire, S1 4DP, United Kingdom

Location

Related Publications (7)

• Yorke J, Armstrong I. The assessment of breathlessness in pulmonary arterial hypertension: reliability and validity of the Dyspnoea-12. Eur J Cardiovasc Nurs. 2014 Dec;13(6):506-14. doi: 10.1177/1474515113514891. Epub 2013 Dec 3.

  PMID: 24302457 BACKGROUND

• Yorke J, Deaton C, Campbell M, McGowen L, Sephton P, Kiely DG, Armstrong I. Symptom severity and its effect on health-related quality of life over time in patients with pulmonary hypertension: a multisite longitudinal cohort study. BMJ Open Respir Res. 2018 Mar 1;5(1):e000263. doi: 10.1136/bmjresp-2017-000263. eCollection 2018.

  PMID: 29531745 BACKGROUND

• Rawlings GH, Beail N, Armstrong I, Thompson AR. Self-help cognitive behavioural therapy for anxiety in pulmonary hypertension: pilot randomised controlled trial. ERJ Open Res. 2022 Mar 7;8(1):00526-2021. doi: 10.1183/23120541.00526-2021. eCollection 2022 Jan.

  PMID: 35265707 BACKGROUND

• Matura LA, McDonough A, Hanlon AL, Carroll DL, Riegel B. Sleep disturbance, symptoms, psychological distress, and health-related quality of life in pulmonary arterial hypertension. Eur J Cardiovasc Nurs. 2015 Oct;14(5):423-30. doi: 10.1177/1474515114537951. Epub 2014 May 27.

  PMID: 24867878 BACKGROUND

• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.

  PMID: 27777223 BACKGROUND

• Batal O, Khatib OF, Bair N, Aboussouan LS, Minai OA. Sleep quality, depression, and quality of life in patients with pulmonary hypertension. Lung. 2011 Apr;189(2):141-9. doi: 10.1007/s00408-010-9277-9. Epub 2010 Dec 21.

  PMID: 21174111 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary; Sleep Initiation and Maintenance Disorders; Sleep Hygiene

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Health Behavior; Behavior

Central Study Contacts

Isaac Bhatoy, Trainee Clinical Psychologist

CONTACT

(+44) 114 222 6533; ibhatoy1@sheffield.ac.uk

Gregg Rawlings, DClinPsy

CONTACT

gregg.rawlings@ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Neither participants nor researchers will be blinded to group allocation. This is necessary because participants will be informed before providing consent that they may be randomly allocated to either the intervention group or the wait-list group. In addition, the lead researcher will contact participants in the intervention group halfway through the programme (at two weeks) to collect feedback on the acceptability of the intervention and participants' adherence to the self-help booklets. As a result, the researcher needs to know which participants have been allocated to the intervention group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The project will be a randomised control trial (RCT). Participants will be randomised into one of the two groups using an online random generator (block randomisation will be used to make sure groups are equal). One group will receive the intervention and the other group will be a waiting list condition.

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)