Chronic insomnia Mental and Behavioural Disorders Chronic insomnia
Conditions
Interventions
Participants are randomised into 2 groups, either the cognitive-behavioural therapy (CBT) group or a waiting list control group, in a 1:1 allocation ratio.
Randomisation is conducted w
Sponsors
Concordia University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Meeting diagnostic criteria for chronic insomnia for at least 6 months 2. Aged 18 years or older
Exclusion criteria
Exclusion criteria: 1. Current neurological disorder 2. Past history of brain lesion 3. Major surgery requiring general anaesthesia in the past 3 months 4. Untreated thyroid disorder 5. Chronic pain syndrome self-reported as interfering with sleep 6. Recent and severe infection in the past 3 months (e.g. pneumonia, kidney infection) 7. Active cancer or treated cancer with post-cancer treatment for less than 2 years 8. Stroke 9. Myocardial infarction 10. Arterial bypass or angioplasty (e.g. coronary, carotid, femoral) 11. Pacemaker 12. Heart failure causing limitation of ordinary physical activity 13. Renal insufficiency 14. Sleep apnea with an apnea-hypopnea index greater than 15/h 15. Restless legs syndrome with symptoms occurring on 3 or more days per week (based on Restless Legs Syndrome Rating Scale) 16. Periodic limb movements during sleep with index greater than 15/h during polysomnography 17. REM sleep behaviour disorder with more than 1 episode per month (based on polysomnography) 18. Narcolepsy with cataplexy (based on Ullanlinna Narcolepsy Scale) 19. Sleepwalking more than once per month 20. Having worked on night shifts or rotating shifts for more than 2 weeks in the last 3 months, or expecting to do so during the study period 21. Poor cognitive function (diagnosed with dementia and/or Montreal Cognitive Assessment (MoCA) less than 26) 22. Severe mental disorders: 22.1. Type I bipolar disorder 22.2. Schizophrenia 22.3. Anxiety disorders other than generalised anxiety disorder, except if associated with major depressive disorder (MDD) 22.4. Current substance use disorder 22.5. Current post-traumatic stress disorder 23. Current suicidality 24. Frequency alcohol consumption (more than 10 glasses per week) 25. Use of illicit drugs (more than once per month) 26. Pregnant or breastfeeding 27. Current psychotherapy or past cognitive behavioural therapy for insomnia 28. Unable to stop hypnosedative medications for at least 2 weeks prior to the first assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following are assessed at the baseline, post-treatment/post-waiting period and 12 month follow up: 1. Self-reported insomnia symptoms, assessed using the following, both of which are completed using online questionnaires: 1.1. Insomnia Severity Index (ISI) 1.2. 14-day sleep diary (sleep efficacy measure) based on the Consensus Sleep Diary 2. Physiological hyperarousal, assessed using the following: 2.1. Heart rate variability, measured using electrocardiogram leads 2.2. Sleep spindles, measured using electroencephalography leads during polysomnography 3. Emotional hyperarousal, assessed using the UCLA Life Stress Interview and a daily stress diary, completed conjointly with the sleep diary (1.2.) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total sleep time, assessed using the Consensus Sleep Diary and actigraphy with an accelerometer over 14 consecutive days at the baseline, post-treatment/post-waiting period and 12 month follow up 2. Sleep latency, assessed using the Consensus Sleep Diary and actigraphy with an accelerometer over 14 consecutive days at the baseline, post-treatment/post-waiting period and 12 month follow up 3. Duration of wake-after-sleep-onset (WASO), assessed using the Consensus Sleep Diary and actigraphy with an accelerometer over 14 consecutive days at the baseline, post-treatment/post-waiting period and 12 month follow up 4. Sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI) at the baseline, post-treatment/post-waiting period and 12 month follow up 5. Fatigue severity, assessed using the Fatigue Symptoms Inventory at the baseline, post-treatment/post-waiting period and 12 month follow up 6. Health-related quality of life, assessed using the 36-Item Short Form Survey (SF-36) at the baseline, post-treatment/post-waiting period and 12 month follow up 7. Presence of an insomnia disorder, assessed through a diagnostic interview with a trained interviewer using the Structured Clinical Interview for DSM-5 (SCID-V) at the baseline, post-treatment/post-waiting period and 12 month follow up 8. Polysomnography (PSG) measures, assessed at the baseline, post-treatment/post-waiting period and 12 month follow up: 8.1. PSG-derived sleep efficacy 8.2. Total sleep time 8.3. WASO 8.4. Sleep latency 8.5. Durations of sleep stages N1, N2, N3 and REM 9. Markers of physiological arousal: 9.1. Blood pressure, assessed using oscillometer measurements of systolic and diastolic blood pressure in the morning following overnight polysomnography 9.2. | — |
Countries
Canada
Outcome results
None listed