Recruiting

Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints

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 \[GDS\])…

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ClinicalTrials.gov IDNCT06032377
PhaseNA
Enrollment275
SponsorCentre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Age60 Years – 99 Years
SexALL
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Conditions studied

Insomnia

About this study

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

Interventions

Primary outcomes

Eligibility information

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.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-06.