NCT07754981Toborzás még nem indult
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 10.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 60 (tervezett)
- Első benyújtás
- 2026. júl. 27.
- Kezdés
- 2026. szept.
- Elsődleges befejezés
- 2027. márc.
- Fő szponzor
- University of Sheffield
- Betegségek
- Pulmonális artériás hipertónia
- NCT-szám
- NCT07754981
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 60
- 2026. szept. és az elsődleges befejezés (2027. márc.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Clinical Psychology Unit | Sheffield | Egyesült Királyság | Ismeretlen állapot |
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