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Defining the impact of improved sleep on cognitive function

Defining the Impact of improved Sleep on COgnitive function: a randomised-controlled trial of digital Cognitive Behavioural Therapy for insomnia versus wait-list control

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN89237370
Enrollment
404
Registered
2016-10-17
Start date
2016-10-18
Completion date
Unknown
Last updated
2020-06-15

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

Conditions

Insomnia disorder Mental and Behavioural Disorders Insomnia disorder

Interventions

Participants are randomised to one of two study groups in a 1:1 ratio using an in-built randomisation feature in the survey software. Treatment group: Participants recieve digital Cog

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Positive screen for probable DSM-5 insomnia disorder using items from the Sleep Condition Indicator (SCI) 2. Endorsement of difficulties with concentration or memory 3. Being aged 25 and above 4. Reliable internet access at home or work 5. Being able to read and understand English 6. Currently living in the UK

Exclusion criteria

Exclusion criteria: 1. Additional sleep disorder (e.g. possible obstructive sleep apnoea, restless legs syndrome) 2. Diagnosis of mild cognitive impairment or dementia 3. Psychosis or mania 4. Serious physical health concerns necessitating surgery or with prognosis of <6 months 5. Those undergoing a psychological treatment programme for insomnia with a health professional 6. Habitual night, evening, or rotating shift-workers 7. Those taking prescribed sleeping pills on study entry 8. Those with suicidal ideation Participants will not be omitted for any other physical or mental health problems providing they report their health to be stable.

Design outcomes

Primary

MeasureTime frame
Self-reported cognitive impairment is measured using the British Columbia Cognitive Complaints Inventory (BC-CCI) at baseline, post-treatment (10 weeks) and follow-up (24 weeks)

Secondary

MeasureTime frame
1. Objective cognitive performance is measured using an online battery of tasks developed by UK Biobank Cognitive Psychology Sub-Group for Cognitive Assessments, including measures of simple attention, episodic memory, working memory, visual attention and complex processing speed at baseline, 10 and 24 weeks 2. Insomnia severity is measued using the Insomnia Severity Index (ISI) and four items from Pittsburgh Sleep Quality Index (PSQI) at baseline, 10 and 24 weeks 3. Fatigue is measured using the Multidimensional Fatigue Inventory (MFI) at baseline, 10 and 24 weeks 4. Sleepiness is measured using the Epworth Sleepiness Scale (ESS) at baseline, 10 and 24 weeks 5. Cognitive failures is measured using the Cognitive Failures Questionnaire (CFQ) at baseline, 10 and 24 weeks 6. Emotional distress (depression and anxiety) will be measured using the Patient Health Questionnaire 9 (PHQ-9) and two items from the Generalised Anxiety Disorder 7 questionnaire (GAD-7) at baseline, 10 and 24 weeks 7. Information on the use of sleep medication will be collected by asking how many nights the participant has used prescribed or non-prescribed medication to aid sleep over the past two weeks at baseline, 10 and 24 weeks In addition: 8. Additional sleep treatment usage is assessed through asking participants during treatment and follow-up phase 9. Profiling of self-reported chronotype is done using one item from the Morningness-Eveningness Questionnaire (MEQ) at baseline

Countries

United Kingdom

Contacts

Public ContactMadeleine Hurry
disco@fmrib.ox.ac.uk+44 (0)1865 618668

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 9, 2026