Evaluation of internet cognitive behavioural therapy for insomnia disorder
| ISRCTN | ISRCTN44615689 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44615689 |
| Secondary identifying numbers | FM06509 |
- Submission date
- 18/01/2011
- Registration date
- 18/05/2011
- Last edited
- 17/12/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims:
This study was carried our to investigate if online cognitive behaviour therapy (CBT) given via the internet would be effective in the treatment of persistent insomnia. Insomnia is a very common problem, so providing treatment in this way could potentially reach many people who have problems sleeping. CBT is a non-drug treatment where people are helped to overcome the problem of the racing mind, and to establish a new healthy sleep pattern.
Who can participate?
Adults with persistent sleep problems, identified from their participation in the online Great British Sleep Survey.
What does the study involve?
People were randomly allocated to receive CBT, the standard treatment, or to a group that had to wait to receive treatment. In all groups information on sleep, mood and daytime functions (like energy and concentration) were gathered regularly so that we could evaluate the outcomes across the 6 weeks. They were then followed up 8 weeks later to see if benefits lasted. The online CBT was delivered by a virtual sleep expert (a cartoon character).
What are the possible benefits and risks of participating?
Benefits of participating included improvement in daytime wellbeing and in quality of sleep. There were no known risks associated with participating in the trial.
Where is the study run from?
The study was run online and there was no contact with participants except by email and through the web-based programme.
When is study starting and how long is it expected to run for?
The study ran from February to June 2011.
Who is funding the study?
Sleepio Ltd, London, UK
Who is the main contact?
Professor Colin Espie
colin@sleepio.com
Contact information
Scientific
University of Glasgow Sleep Centre
Sackler Institute of Psychobiological Research
Southern General Hospital
Glasgow
G51 4TF
United Kingdom
Study information
| Study design | Placebo controlled randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The comparative efficacy of online cognitive behavioural therapy (CBT) versus online imagery relief therapy (IRT) as treatments for insomnia disorder: a randomised placebo controlled trial |
| Study acronym | Sleepio |
| Study objectives | Online cognitive behavioural therapy (CBT) for adults with insomnia disorder will be associated with increased sleep efficiency at post treatment relative to a to a credible placebo intervention and a waiting list control condition |
| Ethics approval(s) | University of Glasgow Faculty of Medicine Research Ethics Committee approved on the 20th August 2010 |
| Health condition(s) or problem(s) studied | Insomnia disorder |
| Intervention | This is a pragmatic, randomised controlled trial comprising three treatment arms: 1. Online cognitive behavioural therapy (CBT) 2. Online IRT (placebo) 3. Waiting list comprising usual care (treatment as usual [TAU]) 2. Major assessments will be at baseline, post-treatment, and follow-up 6 weeks and 12 weeks later 3. All data will be analysed on an intention to treat basis 4. Participants randomised to the IRT placebo or TAU care arm will be offered CBT upon completion of the study. 5. CBT: is a 6 session treatment course guided by an animated personal therapist. It is both engaging and interactive and uses email, SMS technologies, and other motivational tools to prompt and support the user to progressively and systematically implement behavioural and cognitive strategies 6. The rationale given is that thoughts and behaviour influence engagement with sleep, sleep pattern and sleep quality, and subsequent daytime functioning 7. The programme provides effective strategies to deal with sleeplessness, to reduce dysfunctional sleep behaviour, attitudes and beliefs, and to help restore normal sleep patterns 8. The content of the therapy is based entirely upon proven methods, such as sleep hygiene education, relaxation, imagery, stimulus control, sleep restriction, cognitive restructuring and other cognitive techniques 9. Social networking methods will also be used to afford support to people undertaking the CBT programme 10. IRT: is also is a 6 session treatment, designed to mimic the structure and ethos of CBT but without any known therapeutic ingredient or advice on dealing with sleeplessness. 11. Thus non-specific factors such as credibility, expectation, regular sessions and support will be controlled 12. The rationale and instructions are based on a quasi-desensitisation model 13. The participant constructs a list of chronologically ordered typical evening/bedtime activities and a list of 6 mental images 14. These are then paired with the hierarchy items in a pseudo-deconditioning paradigm 15. They are told that by using early evening regular practice they will become desensitised to their insomnia 16. The IRT placebo has been validated and found credible in numerous RCTs of face to face individual and group CBT for insomnia over the past 25 years 17. TAU: is essentially a wait list control condition, where people complete all measures at the required times, and are entirely free to continue with whatever their usual care for insomnia is 18. Indeed, this much is true for all 3 conditions. So for example; GPs are free to prescribe/or not, unaffected by participation in the study |
| Intervention type | Other |
| Primary outcome measure | 1. Sleep efficiency: this is the percentage of the time spend in bed that the person is asleep 2. Sleep Condition Indicator (SCI), a valid and reliable patient-reported outcome measure which is brief (8-item; range 0 - 32), valid (based on DSM-V) and reliable (a = 0.83). The SCI profiles daytime consequences of poor sleep and classifies clinical sleep status. Total 3. Derived sleep status category (very good, good, average, poor, very poor) 4. Measured at baseline, post-treatment evaluation and the 14 and 20 week follow-up evaluations |
| Secondary outcome measures | 1. Standard daily sleep diary data (e.g. sleep onset latency, wakeful time after sleep-onset) 2. Depression Anxiety and Stress Scales (DASS) 3. Sleep Disturbance Questionnaire (SDQ) 4. Content of Thoughts Inventory (CTI) 5. Sleep Effort Scale (SES) 6. Descriptive information on demographics and general physical and mental health, including alcohol use and lifestyle 7. CBT user experience and satisfaction 8. Adherence with treatment advice 9. Measured at baseline, post-treatment evaluation and the 14 and 20 week follow-up evaluations |
| Overall study start date | 01/03/2011 |
| Completion date | 01/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 156 (52 per condition) |
| Key inclusion criteria | 1. Healthy participants from the community at large (18+ years, either sex) 2. Completed the on-line Great British Sleep Survey (www.sleepio.com) 3. Meet proposed Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for insomnia disorder: complaint of poor sleep (difficulty initiating and/or maintaining sleep, early morning wakening, or non-restorative sleep), with daytime consequences for greater than or equal to 3 months |
| Key exclusion criteria | 1. Possible significant mental (e.g. depression) or physical health problems (e.g. cardiovascular disease) 2. Disorders of sleep other than insomnia (e.g. sleep apnoea) 3. Dementia 4. Heavy alcohol use, excluded conservatively 5. Using online screening tools |
| Date of first enrolment | 01/03/2011 |
| Date of final enrolment | 01/01/2012 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
G51 4TF
United Kingdom
Sponsor information
University/education
College of Medicine
Veterinary Medicine and Life Sciences
Glasgow
G12 8QQ
Scotland
United Kingdom
| Sarah.Torbet@glasgow.ac.uk | |
| Website | http://www.gla.ac.uk/ |
"ROR" |
https://ror.org/00vtgdb53 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2012 | Yes | No |
