Status:
RECRUITING
Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints
Lead Sponsor:
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Conditions:
Insomnia
Eligibility:
All Genders
60-99 years
Phase:
NA
Brief Summary
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 insom...
Detailed Description
Participants with insomnia disorder will complete: * A phone interview * Two video conferences (assessment of eligibility and tutorial to set up sleep monitoring devices) * 9 nights of at-home polyso...
Eligibility Criteria
Inclusion
- Inclusion
- age 60 years or older at the time of enrolment
- Sleep Condition Indicator, SCI ≤ 16 and/or meeting DSM-V criteria based on the symptoms assessed by the SCI
- subjective cognitive complaints (self-report version of Everyday Cognition scale (ECog), score ≥ 2 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
- Score on the STOP-BANG questionnaire \< 3 corresponding to participants with low risk of obstructive sleep apnea
- 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 (apnea-hypopnea index \>30 on a level 3 home sleep apnea test) 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 (residual apnea-hypopnea index \<30 and good therapeutic compliance) or RLS will not be excluded
- current shift work
- currently receiving CBT, having received CBTi in the past
- frequent alcohol consumption having an impact on functionning (\>10 glasses/week and having a significant impact on functionning)
- illicit drugs use (more than once a month)
- 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.
Exclusion
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT06032377
Start Date
November 15 2023
End Date
December 1 2025
Last Update
June 10 2025
Active Locations (2)
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1
The Royal's Institute of Mental Health Research (IMHR)
Ottawa, Ontario, Canada, K1Z7K4
2
Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de l'Île-de-Montréal. CCSMTL - IUGM
Montreal, Quebec, Canada, H3W 1W5