Condition category
Mental and Behavioural Disorders
Date applied
15/01/2015
Date assigned
29/01/2015
Last edited
29/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Publication citations

Additional files

Editorial Notes