Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints
NCT ID: NCT06032377
Last Updated: 2025-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
275 participants
INTERVENTIONAL
2023-11-15
2025-12-31
Brief Summary
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* 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
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Detailed Description
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* A phone interview
* Two video conferences (assessment of eligibility and tutorial to set up sleep monitoring devices)
* 9 nights of at-home polysomnography with an EEG headband (3 times x 3 nights)
* 42 sleep diaries (3 times x 14 days)
* 42 days wearing an actigraphy device (3 times x 14 days)
* Online questionnaires
* Phone call for a check-in with a psychologist
* 3 cognitive testing sessions
* 10 modules of online information on health, over the course of 10 weeks
* In MRI subgroup: 2 in-person testing
Good sleeper participants will complete:
* A phone interview
* Two video conferences (assessment of eligibility and tutorial to set up sleep monitoring devices)
* 3 nights of at-home polysomnography with an EEG headband
* 14 sleep diaries
* 14 days wearing an actigraphy device
* Online questionnaires
* 1 cognitive testing session
* 1 in person session for MRI.
In addition, researchers will compare outcomes from participants with insomnia and subjective cognitive complaint to a group of good sleepers to have normative values for imaging data.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
One group will receive the online CBT for sleep and mental health after the baseline assessment and the other group will receive the control intervention. The group receiving the control intervention will access the CBT intervention after completion of the study.
A good sleepers group, matched on age and gender, will also be recruited and assessed at baseline only to provide a normative reference group.
A subgroup of participants from the insomnia group and the good sleepers group will undergo MRI and classical neuropsychological testing at baseline and 24 weeks after the start of the intervention.
TREATMENT
NONE
Study Groups
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online cognitive behavioral therapy for insomnia, anxiety and depression
10 self-directed modules of cognitive behavioral therapy for insomnia, anxiety and depression, delivered online, once a week
cognitive behavioral therapy for sleep, anxiety, and depression
This intervention addresses insomnia, anxiety and depression via modules covering all the core CBTi components: psychoeducation about insomnia, relaxation, cognitive restructuring, stimulus control, sleep restriction and stress management; as well as psychoeducation about anxiety and low mood, behavioral activation strategies, and strategies to better manage ruminations. The modules are adapted to older adults and include short texts, pictures, quizzes with feedback, interactive exercises, logbooks, audio and video recordings.
online intervention on nutrition and communication in older age
10 self-directed modules on healthy nutrition habits and communication strategies, delivered online, once a week
education about healthy nutrition habits and communication in older age
This intervention addresses healthy nutrition habits as well as communication and aging. The modules are adapted to older adults and include short texts, pictures, quizzes with feedback, interactive exercises, logbooks, audio and video recordings
Interventions
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cognitive behavioral therapy for sleep, anxiety, and depression
This intervention addresses insomnia, anxiety and depression via modules covering all the core CBTi components: psychoeducation about insomnia, relaxation, cognitive restructuring, stimulus control, sleep restriction and stress management; as well as psychoeducation about anxiety and low mood, behavioral activation strategies, and strategies to better manage ruminations. The modules are adapted to older adults and include short texts, pictures, quizzes with feedback, interactive exercises, logbooks, audio and video recordings.
education about healthy nutrition habits and communication in older age
This intervention addresses healthy nutrition habits as well as communication and aging. The modules are adapted to older adults and include short texts, pictures, quizzes with feedback, interactive exercises, logbooks, audio and video recordings
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
60 Years
99 Years
ALL
Yes
Sponsors
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Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
OTHER
Responsible Party
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Thien Thanh Dang-Vu
Professor, Neurologist; Director, Sleep, Cognition & Neuroimaging Laboratory (SCNLab)
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BH210177
Identifier Type: -
Identifier Source: org_study_id
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