Plain English Summary
Background and study aims
Sleep is a common problem: around a third of the general population experience symptoms of insomnia. There is increasing recognition that poor sleep impacts on emotional wellbeing. This study investigates the role of sleep in emotional wellbeing. Students with sleep problems receive access to an evidence-based digital Cognitive Behaviour Therapy (CBT) sleep improvement programme for insomnia. CBT is a talking therapy that can help people manage their problems by changing the way they think and behave. This CBT treatment for insomnia should improve the sleep in the students. This study also tests the impact this has on mistrust of others, unusual perceptual experiences, anxiety, depression, elevated mood, nightmares and psychological well-being. The prediction is that treating sleep problems will improve these measures.
Who can participate?
Students aged 18 and over who experience symptoms of insomnia
What does the study involve?
Participants are randomly allocated to receive either an evidence-based sleep improvement programme (online CBT therapy for insomnia) or continue as usual. Participants complete a range of online assessments to measure insomnia, mistrust of others, unusual perceptual experiences, mood, nightmares, day to day functioning, and emotional wellbeing. At the end of the study, the group who did not receive the sleep help are also offered the full sleep improvement programme.
What are the possible benefits and risks of participating?
All participants are offered the sleep improvement programme, whether immediately or delayed.
No risks are expected for participants. The sleep improvement programme has already been shown to have a positive effect on sleep, and similar benefits are likely for participants.
Where is the study run from?
The running of the study is automated (delivered entirely online), allowing a large number of students to take part. The study is run by the University of Oxford, but students are recruited from several universities throughout the UK.
When is the study starting and how long is it expected to run for?
December 2013 to March 2017
Who is funding the study?
Wellcome Trust strategic grant awarded to the Sleep and Circadian Neuroscience Institute (SCNi), University of Oxford (UK)
Who is the main contact?
Prof. Daniel Freeman
daniel.freeman@psych.ox.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Daniel Freeman
ORCID ID
Contact details
Department of Psychiatry
University of Oxford
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
+44 (0)1865 226490
daniel.freeman@psych.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled trial testing the effects of cognitive behavioural therapy for insomnia on the mental health of university students
Acronym
OASIS
Study hypothesis
The primary hypotheses for the trial are:
1. Cognitive Behavioural Therapy for insomnia (CBTi) will reduce insomnia by the end of treatment.
2. CBTi will reduce psychotic-like experiences (paranoia and hallucinations) by the end of treatment.
3. Changes in insomnia will mediate the changes in psychotic-like experiences.
The secondary hypotheses are:
1. CBTi will reduce levels of depression, anxiety, nightmares, and mania by the end of treatment.
2. CBTi will improve psychological well-being by the end of treatment.
3. The effects of CBTi will be maintained at follow-up.
4. CBTi will lead to the occurrence of fewer mental health disorders (ultra-high risk for psychosis, bipolar affective disorder, depression, anxiety, treatment by mental health services) during the period of the trial.
Ethics approval
Medical Sciences Division Interdisciplinary Research Ethics committee (MSD-IDREC), 29/10/2014, Reference: MSD-IDREC-C2-2014-034
Study design
Multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Insomnia in university students
Intervention
The treatment arm will receive digital Cognitive Behavioural Therapy for insomnia (in addition to treatment as usual). The control arm will continue with treatment as usual. Participants will not be recruited from clinical services, therefore most people will not be receiving any help for their sleep difficulties. The control group will be offered the full intervention at the end of the trial (22 weeks) as an ethical consideration.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. The Sleep Condition Indicator (SCI) will be used as the primary sleep outcome measure. It will be administered at weeks 0, 3, 10 and 22. Week 10 will be the primary endpoint
2. The Green Paranoid Thoughts Scale (GPTS) and the hallucinations subscale of the Specific Psychotic Experiences Questionnaire (SPEQ) will be administered at weeks 0, 3, 10 and 22. Both of these measures will be primary measures to assess sub-clinical levels of mistrust of others (paranoia) and abnormal perceptual experiences (hallucinatory experiences) which are common in the general population. Week 10 will be the primary endpoint
Secondary outcome measures
1. Depression, measured using the Patient Health Questionnaire 9-item version at weeks 0, 10, and 22 and 2-item version at week 3
2. Anxiety, measured using the Generalised Anxiety Disorder Questionnaire 7-item version at weeks 0, 10, and 22 and 2-item version at week 3
3. Mania, measured using the Altman mania scale at weeks 0, 3, 10 and 22
4. Nightmare severity, measured using the Disturbing Dream and Nightmare Severity Index at weeks 0, 10 and 22
5. Emotional wellbeing, measured using the Warwick-Edinburgh Mental Wellbeing scale at weeks 0, 10 and 22
6. Ultra high risk for psychosis, measured using the Prodromal Questionnaire at weeks 0, 10 and 22
7. Use of services for mental health problems
Overall trial start date
01/12/2013
Overall trial end date
01/03/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Students (undergraduate, post-graduate or other) screening positive for probable insomnia disorder, using the sleep condition indicator questionnaire (Espie et al., 2014)
2. All participants must be aged 18 or older
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2614
Participant exclusion criteria
Under age 18
Recruitment start date
01/03/2015
Recruitment end date
01/03/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Oxford
OX1 2JD
Trial participating centre
Other UK universities - to be confirmed
-
Sponsor information
Organisation
Medical Sciences Inter-Divisional Research Ethics Committee, University of Oxford
Sponsor details
Research Services
University of Oxford
University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 616575
ethics@medsci.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
This study is supported by a Wellcome Trust Strategic Award (098461/Z/12/Z) to the Oxford Sleep and Circadian Neuroscience Institute (SCNi)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The trialists intend to submit an outcome paper to a peer reviewed journal within six months of data collection being complete (estimated 01/09/2017).
Intention to publish date
31/12/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26016697
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28888927