Extrait

Background and study aims Sleep problems and mental health complaints go hand-in-hand, with sleeping problems associated with many, if not all, mental health problems. This association is particularly apparent between insomnia (problems falling to sleep and staying asleep) and feelings of paranoia (when a person believes that harm is occurring, or is going to occur, to him or her, and that the persecutor has the intention to cause harm). Indeed, both sleeping problems and paranoid thinking are relatively common in both those with a clinical diagnosis and in the general population. This association raises an intriguing possibility that the present study aims to explore: can interventions for insomnia lead to improvements in paranoia? To answer this question, the aim of this study is to test the impact of a self-help intervention designed to improve insomnia on paranoia and associated experiences such as depression, stress and anxiety. The prediction is that by improving insomnia and helping people sleep better, they will also experience less paranoia alongside reduced feelings of depression, stress and anxiety. Who can participate? Anyone over the age of 18 What does the study involve? Participants are randomly allocated to one of three groups: the intervention group, a sleep diary group, and a waiting list group. Participants in the intervention group are asked to log into the intervention website and follow the instructions presented to them. They complete six modules over 6 weeks, each offering information and practical exercises to help them to sleep better. These participants are also asked to complete a daily sleep diary to record the times that they go to bed and get up each day, the number of times that they wake each night, how they feel in the morning (ranging from 1 – ‘very tired’ to 5 – ‘very refreshed’), and their caffeine consumption. Participants who complete the daily sleep diary can access their responses on the intervention website in a section called ‘Sleep Stats’. Here their responses are displayed using graphs, tables and charts so that participants can track their progress throughout the study. Participants in the sleep diary group complete the same sleep dairy for 6 weeks, but do not have access to any other aspect of the intervention. Participants in the waiting list group receive no intervention in the first instance so that we can compare the effects of the intervention to doing nothing at all. However, after the study has finished, participants in the waiting list group are offered access to the full intervention. Levels of insomnia, paranoia, depression, stress and anxiety are measured before the intervention started, immediately after the intervention, and 4- and 18-weeks after the intervention. What are the possible benefits and risks of participating? Participants benefit from receiving an online insomnia intervention for free, which may help them to improve their sleep and access information about their sleep. Participants also benefit from contributing to research that may help patients in the future. There are no risks involved in this study. Where is the study run from? University of Sheffield (UK) When is the study starting and how long is it expected to run for? April 2014 to August 2015 Who is funding the study? Investigator funded Who is the main contact? Dr Alexander Scott

Critère d'inclusion

• Insomnia, paranoia, negative affect

Liens

• isrctn
• ictrp