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. The current study will investigate the role of sleep in emotional wellbeing. For students with sleep problems we will provide 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. We will also test 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?
The study will recruit a sample of students (aged 18+) who experience symptoms of insomnia.
What does the study involve?
Participants will receive either an evidence-based sleep improvement programme (online CBT therapy for insomnia) or will continue as usual. This will be decided entirely at random. Participants will 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 will also be offered the full sleep improvement programme.
What are the possible benefits and risks of participating?
All participants will be offered the sleep improvement programme, whether immediately or delayed.
We do not expect any risks to participants taking part in the trial. Rather, the sleep improvement programme has already been shown to have a positive effect on sleep (see previous research Espie et al., 2012). Given that the population invited to take part in the current study are similarly presenting with sleep difficulties, similar benefits are likely for participants.
Where is the study run from?
The running of the study will be automated (delivered entirely online), allowing a large number of students to take part. The study will be run by the University of Oxford, but students will be recruited from several universities throughout the UK.
When is the study starting and how long is it expected to run for?
We will begin recruitment of participants in March 2015. It is expected that the study will run until September 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?
Professor Daniel Freeman
daniel.freeman@psych.ox.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Professor 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 of cognitive behavioural therapy (in addition to treatment as usual) for insomnia compared to treatment as usual.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Treatment
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 measures
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 end point.
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 end point.
Secondary outcome measures
Depression - Patient Health Questionnaire (9 item version at weeks 0,10, and 22 and 2 item version at week 3).
Anxiety - Generalised Anxiety Disorder Questionnaire (7 item version at weeks 0,10, and 22 and 2 item version at week 3).
Mania - Altman mania scale at weeks 0,3,10 and 22.
Nightmare severity - Disturbing Dream and Nightmare Severity Index at weeks 0,10 and 22.
Emotional wellbeing - Warwick-Edinburgh Mental Wellbeing scale at weeks 0,10 and 22.
Ultra high risk for psychosis - The Prodromal Questionnaire at weeks 0,10 and 22.
Use of services for mental health problems.
Overall trial start date
01/12/2013
Overall trial end date
01/03/2017
Reason abandoned
Eligibility
Participant inclusion criteria
Students (undergraduate, post-graduate or other) screening positive for probable insomnia disorder, using the Sleep condition indicator questionnaire (Espie et al., 2014). All participants must be age 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 01865 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
We 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
Results - basic reporting
Publication summary
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26016697