Insomnia disorder Nervous System Diseases Disorders of initiating and maintaining sleep [insomnias]
Conditions
Interventions
Participants are randomly assigned to the treatment group, SRT, or a specific factors component control group, BCT (bedtime consistency therapy) (1:1) over a 14-week measurement period using a compute
the study team is therefore blind to future allocations. Randomisation is stratified by age (25-40:41-55) and gender (Male: Female). Treatment for both groups is delivered in a one hour session by the
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Adults aged 25-55 years 3. Screening positive for persistent insomnia (chronicity >3 months) as indicated on the Sleep Condition Indicator 4. Access to the internet with a tablet, laptop or desktop computer 5. Regular use of a personal mobile phone
Exclusion criteria
Exclusion criteria: 1. Psychiatric diagnoses other than insomnia 2. Anxiety (anxiety items of the HADS >10) 3. Depression (PHQ > 10) 4. Current substance misuse 5. Additional sleep disorders other than insomnia (e.g. narcolepsy, circadian rhythm disorder) 6. Sleep-disruptive medical comorbidity or conditions contraindicated for SRT (e.g. epilepsy) 7. Current prescription of medication or psychotherapy for sleep 8. Overnight shift work, evening, or rotating shift work 9. Pregnancy 10. Not living in the area of Oxford (participants’ homes had to be accessible by the researcher for ambulatory PSG)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported insomnia severity is measured by the insomnia severity index (ISI) at baseline, post-treatment (4 weeks) and follow-up (12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary clinical outcomes: 2. Wake time after sleep onset (WASO) and sleep onset latency (SOL) are derived from continuous daily sleep diary (consensus sleep diary) 3. Quality of life is measured by the Glasgow sleep impact index (GSII) baseline, post-treatment (4 weeks) and follow-up (12 weeks) 4. Self-reported symptoms of depression and anxiety are measured by the hospital anxiety and depression scale (HADS) at baseline, post-treatment (4 weeks) and follow-up (12 weeks) 5. Self-reported cognitive complaints are measured with the British Columbia Cognitive Complaints Inventory (BC-CCI) at baseline, post-treatment (4 weeks) and follow-up (12 weeks) Primary mechanistic outcome: 1. Objective sleep continuity will be obtained by polysomnography at baseline, during the acute treatment (1 week) and at the end of treatment (4 weeks) Secondary mechanistic outcomes: 1. Objective sleep continuity (SOL and WASO) will be obtained by continuous actigraphy (2 weeks baseline and 4 weeks treatment) 2. Homeostatic sleep drive will be obtained by slow wave activity derived from polysomnography (PSG) at the end of week of treatment 1 and 4 3. Subjective sleepiness is measured by: 3.1. Daily self-reported sleep diary (2 weeks baseline, 4 weeks treatment) 3.2. The Epworth sleepiness scale (ESS) measured at baseline, weekly during treatment phase weeks 1-4 and at follow-up (12 weeks) 4. Objective sleepiness is measured by the psychomotor vigilance task (PVT) at baseline and at the end of treatment week 1 and 4 5. Objective-subjective discrepancy of sleep estimates are derived from continuous sleep diary and actigraphy estimates over a 6-week period (2 weeks baseline, 4 weeks treatment) and polysomnography measurements at baseline and at the end of treatment week | — |
Countries
England, United Kingdom
Outcome results
None listed