Insomnia disorder Mental and Behavioural Disorders Insomnia disorder
Conditions
Interventions
Participants are block randomized (1:1) to one of two study arms. The sequence is generated using the website, www.sealedenvelope.com, and is stratified by sex (male/female) and age (25-44/45-65).
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. Male or Female, aged 25-65 years 3. Screening positive for persistent insomnia disorder as indicated on the Sleep Condition Indicator 4. Average (over 7 nights) sleep onset latency of >30min and/or wake after sleep onset >30min (determined by actigraphy) 5. Typical sleep period takes place within the hours of 10pm – 9am 6. Can read and understand English 7. Regular access to the internet with a tablet, laptop or desktop computer 8. Normal or corrected to normal vision
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 10/03/2020: 1. Unstable physical or mental health problems that may explain sleep disturbance 2. Additional sleep disorders (e.g. sleep disordered breathing or periodic leg movements during sleep) 3. Habitual night shift, evening, or rotating shift-workers 4. Undergoing a psychological treatment programme for insomnia with a health professional 5. Central nervous system medications (including hypnotics) 6. Substance misuse 7. Pregnancy 8. Psychosis or epilepsies 9. A score within the clinical range for depression (>14) or anxiety (>14) on the Hospital Anxiety and Depression Questionnaire (HADS) 10. Learning disability 11. Skin allergies or very sensitive skin 12. Diagnosis of a neurological condition (e.g. epilepsy, stroke, multiple sclerosis) 13. Previously accessing a digital CBT sleep improvement programme _____ Previous exclusion criteria as of 09/12/2019: 1. Unstable physical or mental health problems that may explain sleep disturbance 2. Additional sleep disorders (e.g. sleep disordered breathing or periodic leg movements during sleep) 3. Habitual night shift, evening, or rotating shift-workers 4. Undergoing a psychological treatment programme for insomnia with a health professional 5. Central nervous system medications (including hypnotics) 6. Substance misuse 7. Pregnancy 8. Psychosis or epilepsies 9. A score within the clinical range for depression (>10) or anxiety (>10) on the Hospital Anxiety and Depression Questionnaire (HADS) 10. Learning disability 11. Skin allergies or very sensitive skin 12. Diagnosis of a neurological condition (e.g. epilepsy, stroke, multiple sclerosis) 13. Previously accessing a digital CBT sleep improvement programme _____ Previous exclusion criteria: 1. Unstable physical or mental health problems that may explain sleep disturbance 2. Additional sleep disorders (e.g. sleep disordered breathing or periodic leg movements during sleep) 3. Habitual night shift, evening, or rotating shift-workers 4. Undergoing a psychological treatment programme for insomnia with a health professional 5. Central nervous system medications (including hypnotics) 6. Substance misuse 7. Pregnancy 8. Psychosis or epilepsies 9. A score within the clinical range for depression (>7) or anxiety (>10) on the Hospital Anxiety and Depression Questionnaire (HADS) 10. Learning disability 11. Skin allergies or very sensitive skin 12. Diagnosis of a neurological condition (e.g. epilepsy, stroke, multiple sclerosis) Added 21/08/2019: 13. Previously accessing a digital CBT sleep improvement programme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Insomnia severity will be measured through the Sleep Condition Indicator 2. Objective sleep efficiency will be measured with polysomnography (PSG) at baseline and post-treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective sleep latency and sleep continuity will be measured through PSG and actigraphy (sleep onset latency, wake-time after sleep onset, and number of awakenings) at baseline and post-treatment. 2. Objective sleep architecture will be measured through PSG [duration in each sleep stage and sleep fragmentation (stage change index)] at baseline and post-treatment. 3. Subjective sleep continuity will be measured through a sleep diary (sleep onset latency, wake-time after sleep onset, number of awakenings, and sleep efficiency) at baseline and post-treatment. 4. Changes in EEG delta power and slow wave activity will be measured through whole night EEG spectral analysis (power in the delta frequency band and slow wave oscillation evaluations) at baseline and post-treatment. 5. Subjective and objective arousal will be measured through 1) questionnaires (Glasgow Content of Thoughts Inventory, the Sleep Interference Rating Scale and the Pre-Sleep Arousal Scale) and 2) pre/post sleep resting state EEG (assessed by EEG spectral power in the high frequency range) at baseline and post-treatment. 6. Global sleep quality (Pittsburgh Sleep Quality Index), cognitive impairment (British Columbia Cognitive Complaints Inventory), fatigue (Flinders Fatigue Scale), worry (Penn State Worry Questionnaire), rumination (Ruminative Responses Scale), emotion regulation (Difficulties in Emotion Regulation), and sleep-related quality of life (Glasgow Sleep Impact Index) will be measured at baseline and post-treatment. 7. Cognitive and emotional functioning will be measured using the Emotional Test Battery, word-pair memory task, and attention task at baseline and post treatment. 8. Inter-daily stability and relative amplitude of rest-activity rhythms (non-parametric circadian rhythm analysis) will be measured with actigraphy during treatment phase. 9. Objective-su | — |
Countries
England, United Kingdom
Outcome results
None listed