Overview

The goal of this randomized controlled clinical trial is to assess a novel cognitive-behavioral program for sleep and mental health using a multidomain web platform (eCBTi+) in participants with insomnia and subjective cognitive complaint. The main questions it aims to answer are:

• Whether the eCBTi+ intervention improves sleep (subjective: Insomnia severity index [ISI], objective: EEG-based sleep efficiency) sleep and mental health (Geriatric Anxiety Index [GAI] and Geriatric Depression Scale [GDS]) compared to the control intervention
• Whether the eCBTi+ intervention improves cognitive abilities (subjective: Cognitive Failure Questionnaire [CFQ], objective: CANTAB executive functions composite score) compared to the control intervention

Eligibility

Inclusion

• age 60 years or older at the time of enrolment
• Sleep Condition Indicator, SCI ≤ 16 and meeting DSM-V criteria based on the symptoms assessed by the SCI
• subjective cognitive complaints (self-report version of Everyday Cognition scale (ECog), score ≥ 3 on any item)
• ability to read and understand French or English
• ability to use a smartphone or tablet, and access to home internet connection
• If on hypnotic or psychotropic medication (including cannabis), being on stable dosage for at least 2 months prior to study entry

Exclusion

• located outside of Québec or Ontario
• current hospitalization or planned major surgery
• uncorrected severe hearing or vision impairment
• reported diagnosis of major neurocognitive disorder or mild cognitive impairment (MCI)
• performance suggestive of major neurocognitive disorder or MCI on T-MoCA < 17
• reported diagnosis of schizophrenia or bipolar disorder
• reported diagnosis or positive screen on the MINI for psychotic or bipolar disorders
• high suicidal risk, as assessed by the modified Columbia-Suicide Severity Rating Scale
• reported diagnosis or positive screening for another untreated sleep disorder (e.g., sleep disordered breathing (OSA), REM sleep behavior disorder (RBD), restless legs syndrome (RLS); individuals with treated and controlled OSA or RLS will not be excluded)
• apnea-hypopnea index >10 on a level 3 home sleep apnea test or residual AHI >10 for individuals on CPAP
• current shift work
• currently receiving CBT
• frequent alcohol consumption (>10 glasses/week or 3 times/week), or use of alcohol 3x/week for sleep, or illicit drugs (more than once a month)
• smoking more than 10 cigarettes/day

Additional exclusion criteria for neuroimaging

• psychotropic (including hypnotic) medication in the past 2 weeks
• contraindications for MRI (e.g., pacemaker, metallic implant, claustrophobia)
• unable or unwilling to come to one of the participating MRI centers (Montreal, Ottawa)
• medical conditions likely to affect sleep; in particular:
• current neurological disorder (e.g., epilepsy with any seizure in the past year, concussion in the past 3 months, multiple sclerosis, Parkinson's disease)
• past history of brain lesion (e.g., brain hemorrhage, brain tumor, any condition having required brain surgery)
• major surgery (i.e., requiring general anesthesia) in the past 3 months
• untreated thyroid disorder
• chronic pain syndrome self-reported as interfering with sleep (e.g., migraine, fibromyalgia, rheumatoid arthritis)
• recent and severe infection in the past 3 months (e.g., pneumonia, kidney infection)
• active cancer or treated cancer with post-cancer treatment for less than 2 years

        Inclusion/exclusion criteria for good sleepers Twenty-five good sleepers without cognitive
        complaint will be recruited as controls for the MRI session following the same criteria
        described above, except that SCI ≥ 17, not meeting the diagnostic criteria for chronic
        insomnia as assessed by the insomnia module of the SCID and no subjective cognitive
        complaint.