Sleep Well At Night

Condition(s) studied

Investigational drug(s) / intervention(s)

Online cognitive behavioural therapy for insomnia, bright light therapy, activity: Multimodal intervention

Study summary

Research has shown that the incidence of sleep disturbances in people with cancer is much higher than in the general population. Sleep problems can lead to worse symptoms, quality of life, and potentially impact outcomes. The most common treatment of sleep disturbances is medication which often comes with unwanted side-effects and risk. This study aims to test whether a non-drug intervention can be given to people with cancer to help with sleep disturbances.

The study will take place over 8-weeks. The first and final week of the study involves assessments (further described below) while the intervention will take place over weeks 2-7. The intervention involves an online cognitive behavioural therapy course, daily bright light therapy and engaging with an activity plan.

The initial review aims to identify any reversible causes of the sleep disturbance, including reviewing uncontrolled symptoms and medications.

Cognitive behavioural therapy for insomnia (CBT-I) has been shown to be effective at improving the time it takes for people to fall asleep and reducing the amount of time you wake up in the night.

Light therapy mimics our natural exposure to sunlight. Light exposure may help to improve sleep during the night, mood, and activity or attention levels during the day.

Physical activity levels will also be reviewed. Interests and barriers to activity will be discussed and goals will be set for activity. This will be reviewed weekly.

Questionnaires will be completed in the first and final week of the study to assess sleep, symptoms and quality of life. Wrist actigraphy, thigh accelerometry and a sleep diary will also be used on the first and final week of the study to assess sleep, activity and subjective sleep patterns.

Eligibility

Primary outcome measure(s)

• Retention rate — through study completion - 8 weeks
  considering the number of patients who entered the study and completed the study.
• Recruitment — one year
  considering the number of patients approached to take part in the study who then entered the study
• Completion of the intervention — 8 weeks
  Considering engagement with various interventions. The case report form will capture engagement with online cognitive behavioural therapy for insomnia where progress can be viewed online and the sleep diary will be reviewed. The participant will report on use of the bright light therapy box and activity levels throughout the study.
• Acceptability — 8 weeks
  A patient acceptability questionnaire of various aspects of the study, including interventions and study protocol, will be completed at the end of the study.

Trial sites (1)

More Our Lady's Hospice and Care Services trials in Ireland