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RecruitingNCT06032377e-COSMOSUpdated Mar 18, 2026

Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints

An interventional study of cognitive behavioral therapy for sleep, anxiety, and depression and education about healthy nutrition habits and communication in older age in Insomnia, sponsored by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal. Recruiting at 2 sites in Canada. Open to participants aged 60 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
275
Allocation
Randomized
Ages
60 Years to 99 Years
Sex
All
01

Study 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
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.

02

Conditions studied

  • Insomnia

Keywords

  • insomnia
  • cognition
  • mental health
  • subjective cognitive complaint
  • sleep
  • online CBT
  • older adults
  • anxiety
  • depression
  • executive functions
  • electroencephalography
  • magnetic resonance imaging
03

In context

Sleep Initiation and Maintenance Disorders

2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.

This study's planned enrollment of 275 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal is the lead sponsor of 18 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age 60 years or older at the time of enrolment
  • Sleep Condition Indicator, SCI ≤ 16 and/or meeting 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 criteria

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- \< 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
  • 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.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
275 participants (estimated)

Study arms

  • Experimental
    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

    Behavioral: cognitive behavioral therapy for sleep, anxiety, and depression

  • Active comparator
    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

    Behavioral: education about healthy nutrition habits and communication in older age

Interventions

  • Behavioralcognitive 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.

    Also known as: eCBTi+

  • Behavioraleducation 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

    Also known as: active control

06

What researchers measure

Primary outcomes

  1. Insomnia severity index

    Change in Insomnia Severity Index. ISI range from 0 to 28, higher score means more severe insomnia symptoms.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  2. 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.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  3. 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.

    Time frame: At baseline and at 24 weeks after the start of the intervention

  4. Geriatric anxiety index

    Change in Geriatric anxiety index. GAI scores range from 0 to 20 and higher scores mean more severe anxiety symptoms.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  5. Geriatric depression scale

    Change in Geriatric depression scale. GDS scores range from 0 to 15, higher scores mean more severe depression symptoms.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

Secondary outcomes

  1. 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.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  2. 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.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  3. 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.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  4. 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.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  5. 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.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  6. 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.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  7. 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

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  8. 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.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  9. 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.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  10. Objective sleep measures based on EEG: Slow Wave Activity

    Change in Slow Wave Activity (SWA) power density from EEG.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  11. 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.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  12. 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.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  13. 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.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  14. 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.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  15. 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.

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  16. 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)\].

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  17. Cognitive performances from the CANTAB: Spatial Span (SSP)

    Change in Spatial Span \[SSP - Forward/Reverse Span Lengths (range: 2-9; bad to good\]

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  18. Cognitive performances from the CANTAB: Spatial Working Memory (SWM)

    Change in Spatial Working Memory \[SWM - Number of times the subject incorrectly revisits a box in which a token has previously been found (range: 0 - ∞; good to bad)\].

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  19. Cognitive performances from the CANTAB: Paired Associates Learning (PAL)

    Change in Paired Associates Learning \[PAL - Total errors adjusted (range: 0 - 70; good to bad; First attempt memory score (range: 0-20; bad to good)\]

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  20. Cognitive performances from the CANTAB: Pattern Recognition Memory (PRM)

    Change in Pattern Recognition Memory \[PRM - Percent correct immediate/delayed (range: 0-100; bad to good)\].

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  21. 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)

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  22. 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

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  23. Negative emotional bias measured on the Cambridge Neuropsychological Test Automated Battery (CANTAB)

    Change in Emotional Bias Task (EBT) subscales from the CANTAB \[EBT - proportion of trials rated as 'Happy' (range: 0-15, bad to good)\].

    Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

  24. Memory encoding fMRI activations

    Change in fMRI activation level (arbitrary units) in the hippocampus, temporal lobe and prefrontal cortex during the memory encoding task.

    Time frame: At baseline, at 24 weeks after the start of the intervention

  25. 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 \[Stroop test, from D-KEFS\]).

    Time frame: At baseline, at 24 weeks after the start of the intervention

  26. Cortical thickness measures

    Change in cortical thickness (mm) in the prefrontal cortex and precuneus.

    Time frame: At baseline, at 24 weeks after the start of the intervention

  27. Fractional anisotropy

    Change in fractional anisotropy of the superior longitudinal fasciculus and internal capsule.

    Time frame: At baseline, at 24 weeks after the start of the intervention

  28. 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.

    Time frame: At baseline, at 24 weeks after the start of the intervention

  29. GABA/glutamate ratio from magnetic resonance spectroscopy

    Change in the GABA/glutamate ratio in the anterior cingulate cortex.

    Time frame: At baseline, at 24 weeks after the start of the intervention

  30. 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

    Time frame: At 10-12 weeks and at 24 weeks after the start of the intervention

  31. 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%.

    Time frame: At 10-12 weeks after the start of the intervention

  32. 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.

    Time frame: At 10-12 weeks after the start of the intervention

  33. Adherence to treatment

    Number of modules completed as a measure of treatment adherence

    Time frame: At 10-12 weeks after the start of the intervention

07

Study locations

2 of 2 sites recruiting
  • The Royal's Institute of Mental Health Research (IMHR)
    Ottawa, Ontario K1Z7K4, Canada
    Recruiting
    • Rébecca Robillard, PhD · Contacte-cosmos@uottawa.ca · +1 613-722-6521
    • Rébecca Robillard, PhD · Principal investigator
  • Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de l'Île-de-Montréal. CCSMTL - IUGM
    Montreal, Quebec H3W 1W5, Canada
    Recruiting
    • Florence Pomares, PhD · Contacte-cosmos@criugm.qc.ca · +1 514-340-3540
    • Thien Thanh Dang-Vu, MD, PhD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for May 2026, 30 months after the start.

Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 30 months is above that.

Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2023
First posted
Sep 13, 2023
StartActual
Nov 15, 2023
Primary completionEst.
May 2026
CompletionEst.
Dec 2026
Last update
Mar 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06032377
Lead sponsor
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Responsible party
Thien Thanh Dang-Vu (Professor, Neurologist; Director, Sleep, Cognition & Neuroimaging Laboratory (SCNLab), Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal) — Principal investigator
First posted
Sep 13, 2023
Start date
Nov 15, 2023
Primary completion
May 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Mar 18, 2026

Study contacts

Thien Thanh Dang-Vu, MD PhD
Contact
tt.dangvu@concordia.ca
+1 (514) 340-3540 ext. 3540
Rebecca Robillard, PhD
Contact
rebecca.robillard@uottawa.ca
+1 (613) 722-6521 ext. 6279

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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