Recruiting

eCBTi+

Sponsor:

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Code:

NCT06032377

Conditions

Insomnia

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Interventions

cognitive behavioral therapy for sleep, anxiety, and depression

education about healthy nutrition habits and communication in older age

Study Details

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

Conditions

Insomnia

Study ID

NCT06032377

Start date

Nov 15, 2023

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

275 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

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

Interventions

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

Primary outcome measure

  • Insomnia severity index [ Time Frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention ]
  • 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 ]
  • 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 ]
  • Geriatric anxiety index [ Time Frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention ]
  • Geriatric depression scale [ Time Frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention ]

Central Contacts and Locations

Central contacts

Thien Thanh Dang-Vu, MD PhD

+1 (514) 340-3540tt.dangvu@concordia.ca

Rebecca Robillard, PhD

+1 (613) 722-6521rebecca.robillard@uottawa.ca

Locations

The Royal's Institute of Mental Health Research (IMHR)

Recruiting

Ottawa, Ontario, Canada, K1Z7K4

Contacts

Rébecca Robillard, PhD

+1 613-722-6521e-cosmos@uottawa.ca

Principal Investigator:

Rébecca Robillard, PhD

Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de l'Île-de-Montréal. CCSMTL - IUGM

Recruiting

Montreal, Quebec, Canada, H3W 1W5

Contacts

Florence Pomares, PhD

+1 514-340-3540e-cosmos@criugm.qc.ca

Principal Investigator:

Thien Thanh Dang-Vu, MD, PhD

More Information

Sponsor

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal on 2026-03-18.