Condition category
Nervous System Diseases
Date applied
03/12/2015
Date assigned
04/12/2015
Last edited
25/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We want to find out if digital Cognitive Behavioural Therapy (dCBT) can improve health and well-being and whether any changes are the result of changes in sleep. In particular we are interested in the impact that sleep has on quality of life, psychological well-being, mood, energy, relationships, concentration, productivity and sleepiness. To find out whether better sleep improves people’s health, quality of life and well-being, we are offering participants an online/mobile phone delivered course, proven (through previous research) to improve sleep. We want to see whether those people who receive this course immediately see any changes in their health, quality of life and well-being in comparison to those people who receive sleep hygiene education (i.e., habits and practices to promote better quality sleep).

Who can participate?
Men and women above 18 years of age with complaints of insomnia (difficulty getting to sleep or staying asleep).

What does the study involve?
Participants are randomly allocated to one of two groups. One group receives dCBT straight away, delivered using the web and/or mobile phones. dCBT consists of 6 weekly, tailored sessions with a virtual animated therapist, and access to a range of digital tools (such as an online sleep diary and audio help) and an online community of people who are also working through the programme. The second group receives sleep hygiene education, which consists of advice on habits and routines that will help them to sleep better, provided via a website and a downloadable booklet. Both groups complete online surveys at weeks 0 (start of treatment), 4 (mid-treatment), 8 (after treatment), and 24 weeks (follow-up). At week 25 all participants allocated to sleep hygiene education are offered dCBT as well. Participants are invited to complete two more surveys at weeks 36 and 48. The online survey measures health and wellbeing, sleep, mood, fatigue, sleepiness, concentration, productivity and social functioning.

What are the possible benefits and risks of participating?
dCBT and sleep hygiene education are likely to be both interesting and helpful. They are not considered to involve significant risk to participants.

Where is the study run from?
The study will be coordinated at the University of Oxford, UK, but participants can be from anywhere around the world as the study will be completely online.

When is the study starting and how long is it expected to run for?
April 2015 to July 2017

Who is funding the study?
BigHealth Ltd (UK)

Who is the main contact?
Prof. Colin Espie or Dr Annemarie Luik
insomnia@ndcn.ox.ac.uk

Trial website

www.sleepio.com/research/dials

Contact information

Type

Scientific

Primary contact

Prof Colin Espie

ORCID ID

http://orcid.org/0000-0002-1294-8734

Contact details

Sleep & Circadian Neuroscience Institute
Nuffield Department of Clinical Neurosciences
University of Oxford
Sir William Dunn School of Pathology
South Parks Road
Oxford
OX3 1RE
United Kingdom

Type

Public

Additional contact

Dr Annemarie Luik

ORCID ID

Contact details

Sleep & Circadian Neuroscience Institute
Nuffield Department of Clinical Neurosciences
University of Oxford
Sir William Dunn School of Pathology
South Parks Road
Oxford
OX1 3RE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial of fully automated digital cognitive behavioural therapy for Insomnia versus sleep hygiene education: the impact of improved sleep on functional health and wellbeing

Acronym

DIALS

Study hypothesis

The primary hypotheses for the trial are that, compared to SHE:
1. The dCBT intervention will improve functional health status by the end of treatment (8 weeks)
2. The dCBT intervention will improve positive psychological wellbeing by the end of treatment (8 weeks)
3. The dCBT intervention will reduce patient-generated sleep-related quality of life impairment (8 weeks)
4. The effect of dCBT on outcomes (8 weeks) will be mediated by sleep status during the treatment phase (4 weeks)

The secondary hypotheses are that, compared to SHE:
1. The dCBT intervention will reduce symptoms of negative mood, fatigue and relationship/social dysfunction by the end of treatment (8 weeks)
2. The dCBT intervention will reduce problems with sleepiness, concentration and productivity by the end of treatment (8 weeks)
3. Improvements will be maintained at follow up (24, 36, 48 weeks)
4. The effect of dCBT on longer-term outcomes (24, 36, 48 weeks) will be mediated by sleep status during and upon completion of the treatment phase (4, 8 weeks)

Ethics approval

Medical Sciences Inter-divisional Research Ethics Committee, University of Oxford, 15/10/2015, ref: MS-IDREC-C2-2015-024

Study design

Parallel-group superiority randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Internet

Trial type

Quality of life

Patient information sheet

www.sleepio.com/research/dials

Condition

Insomnia disorder

Intervention

All recruitment and study contact will be online, participants will be actively recruited in the UK, USA and Australia but participation is not limited to inhabitants of these countries.

Intervention: Digital Cognitive Behavioural Therapy for Insomnia + Treatment As Usual
Control: Sleep Hygiene Education + Treatment As Usual, after 24 weeks participants will receive access to the digital Cognitive Behavioural Therapy for Insomnia

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Functional health and wellbeing: Global Health scale (PROMIS-10, Hays et al, 2009)
2. Psychological wellbeing: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS, Tennant et al, 2007)
3. Sleep-related quality of life: Glasgow Sleep Impact Index (GSII, Kyle et al 2013)
All these measures will be taken at baseline, 4 weeks, 8 weeks, 24 weeks, 36 weeks and 48 weeks.

Secondary outcome measures

1. Mood: Patient Health Questionnaire (PHQ9, Kroenke, Spitzer & Williams, 2010) and Generalised Anxiety Disorder (GAD, Spitzer, Kroenke & Williams, 2006)
2. Energy: Flinders Fatigue Scale (FSS, Gradisar et al., 2007)
3. Relation satisfaction: Relation Assessment Scale (RAS, Hendrick et al., 1988)
4. Cognitive status: Cognitive Failures Questionnaire (CFQ, Broadbent, 1982)
5. Work performance and satisfaction: Work and Productivity and Activity Impairment Questionnaire (WPAI, Reilly et al., 1993) and 1 item about job satisfaction (Dolbier et al., 2005)
6. Sleepiness: Epworth Sleepiness Scale (ESS, Johns, 1991)
7. Life satisfaction (1 item, Cheung et al, 2014)
8. Sleep improvement: Sleep Condition Indicator (SCI, Espie et al, 2014)
All these measures will be taken at baseline, 4 weeks, 8 weeks, 24 weeks, 36 weeks and 48 weeks.

Overall trial start date

01/04/2015

Overall trial end date

01/07/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. A positive screen for probable DSM-5 insomnia disorder
2. A test score of ≤16 on the Sleep Condition Indicator
3. Being aged 18 or older (no upper age limit)
4. Having reliable internet access at home or at work
5. Being able to read and understand English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000

Participant exclusion criteria

We will screen for comorbid conditions and medication use at baseline but exclude only those people whose health may be considered to be unstable such as significant current symptoms of:
1. An additional sleep disorder (e.g., excessively sleepy and possible obstructive sleep apnea)
2. Psychosis or mania
3. Serious physical health concerns necessitating surgery or with prognosis <6 months
4. Those undergoing a psychological treatment programme for insomnia with a health professional
5. Habitual night shift, evening, or rotating shift-workers.
We will not omit participants who take medication for sleep problems, or for any other physical or mental health problems providing they report their health to be stable.

Recruitment start date

01/12/2015

Recruitment end date

01/08/2016

Locations

Countries of recruitment

Australia, United Kingdom, United States of America

Trial participating centre

University of Oxford
OX1 3RE
United Kingdom

Trial participating centre

BigHealth Ltd
E1 6LT
United Kingdom

Trial participating centre

University of Sydney
NSW 2006
Australia

Trial participating centre

Henry Ford Health Systems
MI 48202
United States of America

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Research Services
University Offices
Wellington Square
Oxford
OX2 2JD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

BigHealth Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results of the study will be presented at national and international scientific meetings and will be published in leading peer-reviewed scientific journals.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27216112

Publication citations

Additional files

Editorial Notes

25/05/2016: Publication reference added.