Sleeping Better
Research type
Research Study
Full title
Sleeping Better: A Randomised Controlled Trial Testing the Effects of Treating Sleep Difficulties in Patients at Ultra-High Risk of Psychosis and Patients Diagnosed with Non-Affective Psychosis
IRAS ID
330747
Contact name
Daniel Freeman
Contact email
Sponsor organisation
University of Oxford Research Governance, Ethics & Assurance
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
“I have now got the motivation to go out and start showing people what I can do. I have signed up to go back to college to go back into education and learn again.” Toby (after our sleep therapy)
Most people with psychosis report sleep problems that are troubling for them, that exacerbate affective and psychotic symptoms, and that make thinking and everyday functioning more difficult. We want to follow through on the implications of what patients are telling us: that sleep problems are a problem in their own right and that successful treatment will bring numerous additional benefits. We aim therefore to conduct the first definitive test of the idea that psychological therapy can help people with psychosis to enjoy greatly improved sleep and that this will lead to gains in many other aspects of people’s lives.
Our team has pioneered the treatment of sleep problems in psychosis, conducting feasibility trials with patients at ultra-high risk of psychosis, with patients diagnosed with psychosis, and with people admitted to psychiatric hospital. In each trial our eight-session intervention has achieved large effect size improvements in sleep.
We will conduct a randomised controlled trial with two cohorts: 554 patients at ultra-high risk of psychosis and 554 patients with diagnosed psychosis (e.g. schizophrenia). Each cohort (ultra-high risk, diagnosed psychosis) will be reported separately. The primary outcome is improvement in sleep but the trial is powered in each cohort to detect change in three important secondary outcomes (mood, psychotic experiences, and cognitive functioning). We will test in each cohort how and for whom the treatment works, and gain further insights from patients in a peer-led qualitative investigation.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
24/YH/0018
Date of REC Opinion
1 Feb 2024
REC opinion
Favourable Opinion