Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

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

Trial website

Contact information



Primary contact

Professor Daniel Freeman


Contact details

Department of Psychiatry
University of Oxford
Warneford Hospital
United Kingdom
+44 (0)1865 226490

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A randomised controlled trial testing the effects of cognitive behavioural therapy for insomnia on the mental health of university students



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Insomnia in university students


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



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


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


Participant exclusion criteria

Under age 18

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford

Trial participating centre

Other UK universities - to be confirmed

Sponsor information


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

Sponsor details

Research Services
University of Oxford
University Offices
Wellington Square
United Kingdom
+44 01865 616575

Sponsor type




Funder type


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


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


Participant level data

Available on request

Results - basic reporting

Publication summary

2015 protocol in:

Publication citations

Additional files

Editorial Notes