Self-Help Booklets for Sleep in Adults With Pulmonary Hypertension

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.

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.