Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints
Recruiting now NCT06032377
Run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal · for 60 to 99 · All sexes · accepts healthy volunteers
What this study is about
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
Who can join (things the study team will check)
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 Seve…
Where this trial is running
- The Royal's Institute of Mental Health Research (IMHR), Ottawa, Ontario, Canada
- Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de l'Île-de-Montréal. CCSMTL - IUGM, Montreal, Quebec, Canada
Who to contact
Thien Thanh Dang-Vu, MD PhD · +1 (514) 340-3540 · tt.dangvu@concordia.ca
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06032377.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.