Online cognitive behavioral therapy for sleep and mental health in older adults with insomnia
Improving Sleep to Protect Brain Health in Older Adults: Assessing a Novel Cognitive-behavioral Program for Insomnia Using a Multidomain Web Platform
This study is testing an online therapy program to see if it can help older adults with insomnia improve their sleep and mental health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 275 (estimated) |
| Ages | 60 Years to 99 Years |
| Sex | All |
| Sponsor | Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal Academic / other |
| Locations | 2 sites (Ottawa, Ontario and 1 other locations) |
| Trial ID | NCT06032377 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a novel online cognitive-behavioral therapy program designed to improve sleep and mental health in older adults suffering from insomnia and subjective cognitive complaints. Participants will undergo a series of assessments, including phone interviews, video conferences, at-home sleep monitoring, and cognitive testing over a 10-week period. The study aims to compare the effectiveness of the eCBTi+ intervention against a control group, measuring improvements in sleep quality, mental health, and cognitive abilities. Additionally, it will gather normative data by comparing outcomes with good sleepers.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 60 and above who experience insomnia and subjective cognitive complaints.
Not a fit: Patients with major neurocognitive disorders, severe hearing or vision impairments, or those currently hospitalized may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance sleep quality and mental health in older adults, leading to improved cognitive function.
How similar studies have performed: Previous studies have shown promise in using cognitive-behavioral therapy for insomnia, suggesting that this approach may be effective, though the specific online format is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ottawa, Ontario and 1 other locations
- The Royal's Institute of Mental Health Research (IMHR) — Ottawa, Ontario, Canada (Recruiting)
- Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de l'Île-de-Montréal. CCSMTL - IUGM — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Thien Thanh Dang-Vu, MD PhD
- Email: tt.dangvu@concordia.ca
- Phone: +1 (514) 340-3540
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.