Digital insomnia therapy to assist your life as well as your sleep

ISRCTN ISRCTN60530898
DOI https://doi.org/10.1186/ISRCTN60530898
Secondary identifying numbers N/A
Submission date
03/12/2015
Registration date
04/12/2015
Last edited
19/12/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Study website

Contact information

Prof Colin Espie
Scientific

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

ORCiD logoORCID ID 0000-0002-1294-8734
Dr Annemarie Luik
Public

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

Study information

Study designParallel-group superiority randomised controlled trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Internet/virtual
Study typeQuality of life
Participant information sheet www.sleepio.com/research/dials
Scientific titleA 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
Study acronymDIALS
Study objectivesThe 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(s)Medical Sciences Inter-divisional Research Ethics Committee, University of Oxford, 15/10/2015, ref: MS-IDREC-C2-2015-024
Health condition(s) or problem(s) studiedInsomnia disorder
InterventionAll 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 typeBehavioural
Primary outcome measure1. 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 measures1. 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 study start date01/04/2015
Completion date01/07/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1000
Total final enrolment1711
Key inclusion criteria1. 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
Key exclusion criteriaWe 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.
Date of first enrolment01/12/2015
Date of final enrolment01/08/2016

Locations

Countries of recruitment

  • Australia
  • England
  • United Kingdom
  • United States of America

Study participating centres

University of Oxford
OX1 3RE
United Kingdom
BigHealth Ltd
E1 6LT
United Kingdom
University of Sydney
NSW 2006
Australia
Henry Ford Health Systems
MI 48202
United States of America

Sponsor information

University of Oxford (UK)
University/education

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

ROR logo "ROR" https://ror.org/052gg0110

Funders

Funder type

Industry

BigHealth Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planResults of the study will be presented at national and international scientific meetings and will be published in leading peer-reviewed scientific journals.
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 23/05/2016 Yes No
Results article results 01/01/2019 Yes No
Results article results 01/08/2020 02/03/2020 Yes No
Other publications Secondary analysis of effects on QALYs 10/10/2022 11/10/2022 Yes No
Other publications Interaction between symptopms and impairment 08/12/2022 19/12/2022 Yes No

Editorial Notes

19/12/2022: Publication reference added.
11/10/2022: Publication reference added.
02/03/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
01/10/2018: Publication reference added.
25/05/2016: Publication reference added.