Insomnia, Pulmonary Hypertension, Sleep Hygiene
Conditions
Keywords
Sleep Hygiene, Self-Help, CBT-I, Pulmonary Hypertension, Insomnia
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.
Detailed description
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. The secondary aim of the study is to conduct a pilot randomised controlled trial to explore the acceptability and feasibility of this tailored intervention, through the collection of both quantitative and qualitative data. This will focus on: recruitment; adherence; retention; outcome measure data; participant feedback and any adverse effects and will guide decisions on the feasibility of progressing to a full RCT. Participants will be into one of two groups at random. One group will receive the self-help intervention within a few days. The other group will receive the intervention once the study is complete, but only if the intervention was found to be helpful. Participants in the intervention group, will be asked to work through the intervention in their own time at home. The intervention includes information about pulmonary hypertension and sleep and how the two can interact. It will also provide them with range of techniques and skills to practice, to help them to get a better night sleep and reduce the worry, low mood and physical symptoms associated with poor sleep and insomnia. All participants will be required to complete series of measures before and after the intervention and at a one month follow up. This study is a 2 (intervention or control group) x 3 (pre, post, 1-month follow up) mixed factorial design. Due to the nature of the intervention, this study will not involve any blinding of participants to group allocation. Quantitative Data: * As a pilot study, the primary aim is to explore the feasibility and potential effects of the intervention to inform a definitive trial, rather than to definitively test hypotheses. * Descriptive statistics of demographic variables and baseline measures will be provided for each group to show comparability and indicate effectiveness of randomisation. * To explore the preliminary effectiveness of the intervention a mixed ANOVA will be conducted to examine between subject factors (intervention vs control) as well as within subject factors (pre, post, one-month follow up) and will determine whether changes in sleep quality over time differ between the two groups. * Statistical significance will be set at α = .05 for all statistical analysis. * In addition to testing for statistical significance, effect sizes will be calculated using Cohen's d and may guide power analysis for a future trial. * Both intention-to-treat and per-protocol analyses may be explored to assess the consistency of results. Findings may inform the design and methodology of a full RCT in the future. * Descriptive statistics for attrition rates will be reported and baseline characteristics between those who dropped out vs those who completed the study will be compared to identify possible causes of attrition and issues with acceptability. Chi square tests will be used to compare categorical variables and t-tests used for continuous variables. * All analysis will be conducted using IBM SPSS Statistics. * Descriptive statistics of participant feedback will be reported. Qualitative Data: The data gathered from the feedback questionnaires will be analysed using content analysis: * The objective of the analysis is to explore the acceptability of the intervention. * A coding scheme will be developed, including categories relevant to the objective. * Responses will be coded and then categorised. * The data will be analysed to explore any patterns or trends that arise. * Conclusions will be drawn and these will be coherently reported.
Interventions
BEHAVIORALSleep Hygiene Self-Help Intervention
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
Sponsors
University of Sheffield
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
| 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). | 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. |
| 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). | 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. |
| 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). | 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. |
| 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). | Assesses the severity and impact of breathlessness, which is a common symptom of PH. The D12 is a validated, 12-item measure that captures both physical and affective components of dyspnoea, with total scores ranging from 0 to 36; higher scores indicate greater symptom burden. |
Countries
United Kingdom
Contacts
CONTACTIsaac Bhatoy, Trainee Clinical Psychologist
CONTACTGregg Rawlings, DClinPsy
Outcome results
None listed