Insomniae-COSMOSNCT06032377
Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints
A study testing cognitive behavioral therapy for sleep, anxiety, and depression and education about healthy nutrition habits and communication in older age in people with Insomnia, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- cognitive behavioral therapy for sleep, anxiety, and depression and education about healthy nutrition habits and communication in older age
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 2 sitesCanada
- Study dates
- 15 Nov 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de l'Île-de-Montréal. CCSMTL - IUGM
Montreal, Quebec, H3W 1W5
Florence Pomares, PhD, +1 514-340-3540 ext. 4790, e-cosmos@criugm.qc.ca
Thien Thanh Dang-Vu, MD, PhD
- Recruiting
The Royal's Institute of Mental Health Research (IMHR)
Ottawa, Ontario, K1Z7K4
Rébecca Robillard, PhD, +1 613-722-6521 ext. 6095, e-cosmos@uottawa.ca
Rébecca Robillard, PhD
About this study
Official title: Improving Sleep to Protect Brain Health in Older Adults: Assessing a Novel Cognitive-behavioral Program for Insomnia Using a Multidomain Web Platform
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
Read the 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.
- Conditions
- Insomnia
- Being tested
- cognitive behavioral therapy for sleep, anxiety, and depression, education about healthy nutrition habits and communication in older age
- Keywords
- insomnia, cognition, mental health, subjective cognitive complaint, sleep, online CBT, older adults, anxiety, depression, executive functions, electroencephalography, magnetic resonance imaging
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Psychological Well-Being, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapy for sleep, anxiety, and depressionBehavioural
Also called eCBTi+
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 ageBehavioural
Also called active control
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
| Study group | Role | What they receive |
|---|---|---|
| online cognitive behavioral therapy for insomnia, anxiety and depression | Experimental | 10 self-directed modules of cognitive behavioral therapy for insomnia, anxiety and depression, delivered online, once a week Receives: Behavioral: cognitive behavioral therapy for sleep, anxiety, and depression |
| online intervention on nutrition and communication in older age | Active comparator | 10 self-directed modules on healthy nutrition habits and communication strategies, delivered online, once a week Receives: Behavioral: education about healthy nutrition habits and communication in older age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia severity index
Change in Insomnia Severity Index. ISI range from 0 to 28, higher score means more severe insomnia symptoms.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Subjective cognitive impairment based on cognitive failure questionnaire
Change in Cognitive Failure Questionnaire (CFQ) total score as well as number of items with a score ≥ 3. The CFQ comprises 25 items and total score corresponds to the sum of all completed items, total score range from 0 to 100.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective cognitive performance based on a composite score for executive functions from the CANTAB
Change in the Cambridge Neuropsychological Test Automated Battery (CANTAB) executive functions composite score (Intra-Extra Dimensional Set Shift [IED] and Stocking of Cambridge [SOC], ranging from 0 to 100 with higher scores reflecting poorer executive functions.
Measured: At baseline and at 24 weeks after the start of the intervention
Geriatric anxiety index
Change in Geriatric anxiety index. GAI scores range from 0 to 20 and higher scores mean more severe anxiety symptoms.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Geriatric depression scale
Change in Geriatric depression scale. GDS scores range from 0 to 15, higher scores mean more severe depression symptoms.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary outcomes (33)
Sleep quality based on the Pittsburgh sleep quality index
Change in Pittsburgh sleep quality index. PSQI scores range from 0 to 21, higher scores mean worse sleep quality.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on actigraphy: Sleep Efficiency
Change in Sleep Efficiency (SE) from actigraphs. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on actigraphy: Sleep Latency
Change in Sleep Latency (SL) from actigraphs. Sleep latency in minutes, greater values mean longer time to fall asleep.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on actigraphy: Total Sleep Time
Change in Total Sleep Time (TST) from actigraphs. Total Sleep Time in minutes, greater values mean longer time spent asleep.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on actigraphy: Wake After Sleep Onset
Change in Wake After Sleep Onset (WASO) from actigraphs. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on EEG: Sleep Efficiency
Change in Sleep Efficiency (SE) from EEG. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on EEG: Sleep Latency
Change in Sleep Latency (SL) from EEG. Sleep latency in minutes, greater values mean longer time to fall asleep
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on EEG: Total Sleep Time
Change in Total Sleep Time (TST) from EEG. Total Sleep Time in minutes, greater values mean longer time spent asleep.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on EEG: Wake After Sleep Onset
Change in Wake After Sleep Onset (WASO) from EEG. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on EEG: Slow Wave Activity
Change in Slow Wave Activity (SWA) power density from EEG.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on EEG: Slow Wave Sleep
Change in Slow Wave Sleep (SWS) from EEG. Slow Wave Sleep in minutes, greater values mean longer time spent in Slow Wave Sleep.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Subjective sleep measures based on sleep diaries: Sleep Efficiency
Change in Sleep Efficiency (SE) from sleep diaries. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Subjective sleep measures based on sleep diaries: Sleep Latency
Change in Sleep Latency (SL) from sleep diaries. Sleep latency in minutes, greater values mean longer time to fall asleep.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Subjective sleep measures based on sleep diaries: Total Sleep Time
Change in Total Sleep Time (TST) from sleep diaries. Total Sleep Time in minutes, greater values mean longer time spent asleep.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Subjective sleep measures based on sleep diaries: Wake After Sleep Onset
Change in Wake After Sleep Onset (WASO) from sleep diaries. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Cognitive performances from the CANTAB: Rapid Visual Information Processing (RVP)
Change in Rapid Visual Information Processing RVP - A' (sensitivity to the target sequence) and probability of false alarm (range: 0.00 - 1.00; bad to good)].
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Cognitive performances from the CANTAB: Spatial Span (SSP)
Change in Spatial Span [SSP - Forward/Reverse Span Lengths (range: 2-9; bad to good]
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Cognitive performances from the CANTAB: Spatial Working Memory (SWM)
Change in Spatial Working Memory [SWM - Number of times the subject incorrectly revisits a box in which a token has previously been found (range: 0 - ∞; good to bad)].
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Cognitive performances from the CANTAB: Paired Associates Learning (PAL)
Change in Paired Associates Learning [PAL - Total errors adjusted (range: 0 - 70; good to bad; First attempt memory score (range: 0-20; bad to good)]
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Cognitive performances from the CANTAB: Pattern Recognition Memory (PRM)
Change in Pattern Recognition Memory [PRM - Percent correct immediate/delayed (range: 0-100; bad to good)].
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Cognitive performances from the CANTAB: Intra-Extra Dimensional Set Shift (IED)
Intra-Extra Dimensional Set Shift, IED - number of times that the subject failed to select the stimulus compatible with the current rule on the stage where the extra-dimensional shift occurs (range: 0-50; good to bad); Total errors adjusted (range: 0-402; good to bad)
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Cognitive performances from the CANTAB: Stocking of Cambridge (SOC)
Stocking of Cambridge, SOC - Number of problems successfully completed in the minimum possible number of moves (range: 0 - 12; bad to good); Mean number of moves required to complete problems (range: 5 - 12; good to bad); Initial thinking time median (range: 0 ms to ∞; longer times may indicate better planning efforts
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Negative emotional bias measured on the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Change in Emotional Bias Task (EBT) subscales from the CANTAB [EBT - proportion of trials rated as 'Happy' (range: 0-15, bad to good)].
Measured: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Memory encoding fMRI activations
Change in fMRI activation level (arbitrary units) in the hippocampus, temporal lobe and prefrontal cortex during the memory encoding task.
Measured: At baseline, at 24 weeks after the start of the intervention
Cognitive performance (classical neuropsychological tests)
all subscales from classical neuropsychological test battery (Trail Making Test A [TMT-A], Digit Symbol Substitution test (WAIS), Boston Naming Test, Digit Span - forward and backward (WAIS), Rey Auditory Verbal Learning test, Logical Memory I and II (Wechsler Memory Scale), Brief Visuospatial Memory Test Revised (BVMT-R), Trail Making Test B [TMT-B], Verbal Fluency Test (from D-KEFS), Color-Word Interference Test [Stroop test, from D-KEFS]).
Measured: At baseline, at 24 weeks after the start of the intervention
Cortical thickness measures
Change in cortical thickness (mm) in the prefrontal cortex and precuneus.
Measured: At baseline, at 24 weeks after the start of the intervention
Fractional anisotropy
Change in fractional anisotropy of the superior longitudinal fasciculus and internal capsule.
Measured: At baseline, at 24 weeks after the start of the intervention
Resting-state measures
Change in the ratio between segregation and integration within and between the default-mode network and the limbic network during resting-state as measured with functional connectivity.
Measured: At baseline, at 24 weeks after the start of the intervention
GABA/glutamate ratio from magnetic resonance spectroscopy
Change in the GABA/glutamate ratio in the anterior cingulate cortex.
Measured: At baseline, at 24 weeks after the start of the intervention
Treatment-mediated association between changes in sleep and cognition
Mediation estimate of the extent to which exposure to eCBTi+ explains the association between improved sleep and improved cognition
Measured: At 10-12 weeks and at 24 weeks after the start of the intervention
Satisfaction from System Usability Scale
Score on the System Usability Scale, reflecting the degree to which participants were satisfied with the eCBTi+ and the control intervention. Percentage ranging between 0 and 100%.
Measured: At 10-12 weeks after the start of the intervention
Technology acceptance
Score on the extended version of the Technology Acceptance Model-2 reflecting th degree to which participants use and intend to use the eCBTi+ (and control intervention) as implemented on e-SPACE. Each process influencing technology acceptance is scored on a 7-point Likert scale.
Measured: At 10-12 weeks after the start of the intervention
Adherence to treatment
Number of modules completed as a measure of treatment adherence
Measured: At 10-12 weeks after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start15 Nov 2023
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thien Thanh Dang-Vu, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032377
- Sponsor's protocol ID
- BH210177
- Acronym
- e-COSMOS
- Status last verified
- Mar 2026
- First submitted
- 24 Aug 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep to Protect Brain Health in Older Adults: Assessing a Novel Cognitive-behavioral Program for Insomnia Using a Multidomain Web Platform
- ClinicalTrials.gov ID
- NCT06032377
- Acronym / sponsor ID
- e-COSMOS / BH210177
- Conditions
- Insomnia
- Keywords
- insomnia, cognition, mental health, subjective cognitive complaint, sleep, online CBT, older adults, anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de MontrealUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| online cognitive behavioral therapy for insomnia, anxiety and depression | Experimental | Behavioral: cognitive behavioral therapy for sleep, anxiety, and depression10 self-directed modules of cognitive behavioral therapy for insomnia, anxiety and depression, delivered online, once a week |
| online intervention on nutrition and communication in older age | Active comparator | Behavioral: education about healthy nutrition habits and communication in older age10 self-directed modules on healthy nutrition habits and communication strategies, delivered online, once a week |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behavioral therapy for sleep, anxiety, and depressionAlso: eCBTi+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. | Behavioural | online cognitive behavioral therapy for insomnia, anxiety and depression |
| education about healthy nutrition habits and communication in older ageAlso: active controlThis 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 | Behavioural | online intervention on nutrition and communication in older age |
Primary outcome
Insomnia severity index
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Change in Insomnia Severity Index. ISI range from 0 to 28, higher score means more severe insomnia symptoms.
Subjective cognitive impairment based on cognitive failure questionnaire
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Change in Cognitive Failure Questionnaire (CFQ) total score as well as number of items with a score ≥ 3. The CFQ comprises 25 items and total score corresponds to the sum of all completed items, total score range from 0 to 100.
Objective cognitive performance based on a composite score for executive functions from the CANTAB
Time frame: At baseline and at 24 weeks after the start of the intervention
Change in the Cambridge Neuropsychological Test Automated Battery (CANTAB) executive functions composite score (Intra-Extra Dimensional Set Shift [IED] and Stocking of Cambridge [SOC], ranging from 0 to 100 with higher scores reflecting poorer executive functions.
Geriatric anxiety index
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Change in Geriatric anxiety index. GAI scores range from 0 to 20 and higher scores mean more severe anxiety symptoms.
Geriatric depression scale
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Change in Geriatric depression scale. GDS scores range from 0 to 15, higher scores mean more severe depression symptoms.
33 secondary outcomes
Sleep quality based on the Pittsburgh sleep quality index
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on actigraphy: Sleep Efficiency
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on actigraphy: Sleep Latency
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on actigraphy: Total Sleep Time
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on actigraphy: Wake After Sleep Onset
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on EEG: Sleep Efficiency
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on EEG: Sleep Latency
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on EEG: Total Sleep Time
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on EEG: Wake After Sleep Onset
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on EEG: Slow Wave Activity
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Objective sleep measures based on EEG: Slow Wave Sleep
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Subjective sleep measures based on sleep diaries: Sleep Efficiency
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Subjective sleep measures based on sleep diaries: Sleep Latency
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Subjective sleep measures based on sleep diaries: Total Sleep Time
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Subjective sleep measures based on sleep diaries: Wake After Sleep Onset
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Cognitive performances from the CANTAB: Rapid Visual Information Processing (RVP)
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Cognitive performances from the CANTAB: Spatial Span (SSP)
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Cognitive performances from the CANTAB: Spatial Working Memory (SWM)
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Cognitive performances from the CANTAB: Paired Associates Learning (PAL)
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Cognitive performances from the CANTAB: Pattern Recognition Memory (PRM)
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Cognitive performances from the CANTAB: Intra-Extra Dimensional Set Shift (IED)
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Cognitive performances from the CANTAB: Stocking of Cambridge (SOC)
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Negative emotional bias measured on the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Memory encoding fMRI activations
Time frame: At baseline, at 24 weeks after the start of the intervention
Cognitive performance (classical neuropsychological tests)
Time frame: At baseline, at 24 weeks after the start of the intervention
Cortical thickness measures
Time frame: At baseline, at 24 weeks after the start of the intervention
Fractional anisotropy
Time frame: At baseline, at 24 weeks after the start of the intervention
Resting-state measures
Time frame: At baseline, at 24 weeks after the start of the intervention
GABA/glutamate ratio from magnetic resonance spectroscopy
Time frame: At baseline, at 24 weeks after the start of the intervention
Treatment-mediated association between changes in sleep and cognition
Time frame: At 10-12 weeks and at 24 weeks after the start of the intervention
Satisfaction from System Usability Scale
Time frame: At 10-12 weeks after the start of the intervention
Technology acceptance
Time frame: At 10-12 weeks after the start of the intervention
Adherence to treatment
Time frame: At 10-12 weeks after the start of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy for sleep, anxiety, and depression and education about healthy nutrition habits and communication in older age in people with Insomnia, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thien Thanh Dang-Vu, MD PhD (+1 (514) 340-3540 ext. 3540, tt.dangvu@concordia.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity index (time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.