Development and Pilot Randomised Controlled Trial of a Self-help Sleep Hygiene Intervention to Help Individuals With Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
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.
详细描述
Pulmonary hypertension (PH) is an umbrella term used to describe conditions associated with elevated blood pressure in the pulmonary arteries. Approximately 8,000 people live with PH in the UK severe enough to need specialist care. Without this, the disease can lead to right sided heart failure and early mortality. The range of symptoms include breathlessness, fatigue and chest pain and many have to deal with the high burden of treatment and reduced physical activity.
As treatments PH have advanced, survival rates have improved, drawing attention to the burden the disease places on both healthcare systems and individuals. However, despite increased longevity, symptoms remain significant, and most forms of PH are still incurable. Improving health-related quality of life (HRQoL) is therefore a key priority.
Whilst the research exploring sleep and PH is limited, the prevalence and impact that sleep disturbances can have on HRQoL and the ability to cope with symptoms is becoming more recognised. Research has found an association between increasing levels of sleep disturbances and a worsening of PH symptoms, HRQoL and psychological states. This suggests that psychological distress could be one factor explaining sleep disturbances, or at least is a consequence of sleep difficulties. Further research is needed to identify the relationship between sleep disturbances and psychosocial distress, and to test interventions that target sleep. While there is a growing number of trials exploring the usefulness of psychological therapies targeting distress associated with PH, none have specifically examined the impact on sleep.
Currently there are no National Healthcare Service (NHS) commissioned sleep pathways specifically for individuals with PH and no PH specific sleep interventions are recommended by the National Institute for Health and Care Excellent (NICE). Individuals would receive non-disease specific interventions and this is likely to pose a barrier to accessing care. NICE guidelines recommend advice (self-help) about sleep hygiene as a usual treatment, with face-to-face CBT-I recommended as best practice if insomnia symptoms persist.
The primary aim of this study is to develop a self-help sleep hygiene intervention specifically tailored for individuals who have been diagnosed with PH, in order to improve their self-reported sleep quality. This intervention will be created in collaboration with PHA UK, so that both experts by education and experts by experience can contribute to its structure and content. PHA UK, is the leading charity in the UK for people impacted by PH with over 4,500 service users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: Sleep Hygiene Self-Help Intervention (Behavioral)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: 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).
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.
次要结局
- 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).)