Clinical trial NCT06032377: Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints
Official title: Improving Sleep to Protect Brain Health in Older Adults: Assessing a Novel Cognitive-behavioral Program for Insomnia Using a Multidomain Web Platform
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: insomnia
cognition
mental health
subjective cognitive complaint
sleep
online CBT
older adults
anxiety
depression
executive functions
electroencephalography
magnetic resonance imaging
Lead sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 275
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants with insomnia and subjective cognitive complaint are randomized into 2 groups with a 1:1 allocation ratio, after the pre-treatment assessment. Allocation will be stratified based on a composite mental health score and hypnotic medication intake. Follow-up assessments will occur 10 weeks and 24 weeks after the start of the intervention.

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.
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: Participants with insomnia disorder will complete:

* 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.

Eligibility 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.

Primary outcomes:
measure: Insomnia severity index
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Subjective cognitive impairment based on cognitive failure questionnaire
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Objective cognitive performance based on a composite score for executive functions from the CANTAB
timeFrame: At baseline and at 24 weeks after the start of the intervention
measure: Geriatric anxiety index
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Geriatric depression scale
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary outcomes:
measure: Sleep quality based on the Pittsburgh sleep quality index
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Objective sleep measures based on actigraphy: Sleep Efficiency
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Objective sleep measures based on actigraphy: Sleep Latency
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Objective sleep measures based on actigraphy: Total Sleep Time
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Objective sleep measures based on actigraphy: Wake After Sleep Onset
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Objective sleep measures based on EEG: Sleep Efficiency
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Objective sleep measures based on EEG: Sleep Latency
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Objective sleep measures based on EEG: Total Sleep Time
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Objective sleep measures based on EEG: Wake After Sleep Onset
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Objective sleep measures based on EEG: Slow Wave Activity
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Objective sleep measures based on EEG: Slow Wave Sleep
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Subjective sleep measures based on sleep diaries: Sleep Efficiency
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Subjective sleep measures based on sleep diaries: Sleep Latency
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Subjective sleep measures based on sleep diaries: Total Sleep Time
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Subjective sleep measures based on sleep diaries: Wake After Sleep Onset
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Cognitive performances from the CANTAB: Rapid Visual Information Processing (RVP)
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Cognitive performances from the CANTAB: Spatial Span (SSP)
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Cognitive performances from the CANTAB: Spatial Working Memory (SWM)
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Cognitive performances from the CANTAB: Paired Associates Learning (PAL)
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Cognitive performances from the CANTAB: Pattern Recognition Memory (PRM)
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Cognitive performances from the CANTAB: Intra-Extra Dimensional Set Shift (IED)
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Cognitive performances from the CANTAB: Stocking of Cambridge (SOC)
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Negative emotional bias measured on the Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
measure: Memory encoding fMRI activations
timeFrame: At baseline, at 24 weeks after the start of the intervention
measure: Cognitive performance (classical neuropsychological tests)
timeFrame: At baseline, at 24 weeks after the start of the intervention
measure: Cortical thickness measures
timeFrame: At baseline, at 24 weeks after the start of the intervention
measure: Fractional anisotropy
timeFrame: At baseline, at 24 weeks after the start of the intervention
measure: Resting-state measures
timeFrame: At baseline, at 24 weeks after the start of the intervention
measure: GABA/glutamate ratio from magnetic resonance spectroscopy
timeFrame: At baseline, at 24 weeks after the start of the intervention
measure: Treatment-mediated association between changes in sleep and cognition
timeFrame: At 10-12 weeks and at 24 weeks after the start of the intervention
measure: Satisfaction from System Usability Scale
timeFrame: At 10-12 weeks after the start of the intervention
measure: Technology acceptance
timeFrame: At 10-12 weeks after the start of the intervention
measure: Adherence to treatment
timeFrame: At 10-12 weeks after the start of the intervention
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Royal's Institute of Mental Health Research (IMHR)
state: Ontario
city: Montréal
country: Canada
facility: Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de l'Île-de-Montréal. CCSMTL - IUGM
state: Quebec
Study officials:
References: