Online cognitive behavioral therapy for sleep and mental health in older adults with insomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.