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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN60530898
Enrollment
1000
Registered
2015-12-04
Start date
2015-12-01
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia disorder Nervous System Diseases Disorders of initiating and maintaining sleep [insomnias]

Interventions

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.

Sponsors

University of Oxford (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Australia, England, United Kingdom, United States of America

Contacts

Public ContactAnnemarie Luik

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026