Chronic insomnia Mental and Behavioural Disorders
Conditions
Interventions
Participants will be randomized into 2 groups: the CBTi group and a wait-list control group, in a 1:1 allocation ratio. Randomization will be conducted with block sizes of 4 participants.
Participant
at first spaced one week apart (first 4 sessions) and then every two weeks (last 4 sessions)
meetings involving psychoeducation about sleep and circadian rhythms, stimulus control, sleep restriction, relaxation and cognitive therapy.
Participants assigned to the waiting list control group wil
Sponsors
Institut Universitaire De Gériatrie De Montréal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Meeting DSM-V diagnostic criteria for insomnia disorder: 1.1. sleep initiation difficulties (sleep latency > 30min after switching off the lights) 1.2. and/or sleep maintenance difficulties (waking up > 30min during the night) 1.3. negative diurnal repercussions • for more than 3 months, at least 3 times per week 2. Aged 60 years or older 3. Ability to speak and understand French (as CBTi sessions are conducted in French) 4. Chronic BZD or BZRA use: more than 3 times per week, for more than 3 months
Exclusion criteria
Exclusion criteria: 1. Cognitive deficits with MMSE score equal to or less than 23/30 2. Dementia 3. Parkinson's disease 4. Severe sensorimotor deficit (including severe visual or hearing impairment) 5. Epilepsy, anti-epileptic medication 6. Major depression 7. Psychotic disorder, anti-psychotic medication 8. Other psychotropic drugs prescribed for sleep 9. Recent history of alcoholism or drug abuse 10. Moderate to severe sleep apnea syndrome 11. Palliative care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following are assessed at the baseline, post-treatment/post-waiting period: 1. Questionnaire: Insomnia Severity Index (ISI) 2. Sleep efficiency from polysomnographic recordings and sleep diary 3. N3 sleep stage duration from polysomnographic recordings 4. Sleep spindle density from polysomnographic recordings | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Questionnaires, assessed at the baseline, post-treatment/post-waiting period, and at the 3- and 12-months follow-up: 1.1. Pittsburgh Sleep Quality Index (PSQI) 1.2. Geriatric Anxiety Inventory 1.3. Geriatric Depression Scale 1.4. Epworth Sleepiness Scale 2. Sleep diary measures, assessed at the baseline, post-treatment/post-waiting period, and at the 3- and 12-months follow up: 2.1. Total Sleep Time 2.2. Sleep latency 2.3. Duration of wake-after-sleep-onset (WASO) 3. Actigraphy measures, assessed at the baseline, post-treatment/post-waiting period, and at the 3- and 12-months follow up: 3.1. Total Sleep Time and Time in Bed 3.2. Sleep latency 3.3. Duration of wake-after-sleep-onset (WASO) 3.4. Sleep Efficiency 4. Polysomnography (PSG) measures, assessed at the baseline, post-treatment/post-waiting period: 4.1. Total sleep time 4.2. WASO 4.3. Sleep latency 4.4. Durations of sleep stages N1, N2 and REM 4.5 Other sleep spindle variables: amplitude, frequency, spectral power and number 5. Neuropsychological assessment, assessed at the baseline, post-treatment/post-waiting period: 5.1 Global cognitive function using the Mini Mental State Examination (MMSE) 5.2 Verbal Memory using the Free and Cued Selective Reminding Test (FCSRT) 5.3 Executive Function using the Color Word Interference Test – a subtest of Delis–Kaplan Executive Function Scale, as well as the Trail Making Test 5.4 Attention and Concentration using the Digit Symbol Substitution Test 5.5 Visuospatial Abilities using the Modified Taylor Complex Figure (MTCF) 5.6 Psychomotor Performance and Manual Dexterity using the Purdue Pegboard test 6. Withdrawal success: 6.1 Percentage decrease of self-reported BZD or BZRA consumption from baseline to the completion of the 16-week weaning program for each participant, the proportion of participants achieving complete withdrawal in each group. | — |
Countries
Canada
Outcome results
None listed