The Oxford Access for Students Improving Sleep (OASIS) study

ISRCTN	ISRCTN61272251
DOI	https://doi.org/10.1186/ISRCTN61272251
Secondary identifying numbers	N/A

Submission date: 15/01/2015
Registration date: 29/01/2015
Last edited: 12/09/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Daniel Freeman
Scientific

Department of Psychiatry
University of Oxford
Warneford Hospital
Oxford
OX3 7JX
United Kingdom

Phone	+44 (0)1865 226490
Email	daniel.freeman@psych.ox.ac.uk

Study information

Study design	Multicentre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Internet/virtual
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A randomised controlled trial testing the effects of cognitive behavioural therapy for insomnia on the mental health of university students
Study acronym	OASIS
Study objectives	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(s)	Medical Sciences Division Interdisciplinary Research Ethics committee (MSD-IDREC), 29/10/2014, Reference: MSD-IDREC-C2-2014-034
Health condition(s) or problem(s) studied	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
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 study start date	01/12/2013
Completion date	01/03/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	2614
Key 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
Key exclusion criteria	Under age 18
Date of first enrolment	01/03/2015
Date of final enrolment	01/03/2017

Locations

Countries of recruitment

United Kingdom

Study participating centres

University of Oxford

OX1 2JD

Other UK universities - to be confirmed

Sponsor information

Medical Sciences Inter-Divisional Research Ethics Committee, University of Oxford
University/education

Research Services
University of Oxford
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom

Phone	+44 (0)1865 616575
Email	ethics@medsci.ox.ac.uk
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Charity

This study is supported by a Wellcome Trust Strategic Award (098461/Z/12/Z) to the Oxford Sleep and Circadian Neuroscience Institute (SCNi)

No information available

Results and Publications

Intention to publish date	31/12/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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).
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	28/05/2015		Yes	No
Results article	results	01/10/2017		Yes	No

Editorial Notes

12/09/2017: Publication reference added.