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

NCT06032377 | Recruiting

• 1 other identifier: BH210177
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Insomnia severity index

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

  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.

  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.

  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.

  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.

  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

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

• Objective sleep measures based on actigraphy: Sleep Efficiency

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

• Objective sleep measures based on actigraphy: Sleep Latency

  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

  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

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

Study Arms (2)

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

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

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

Interventions

cognitive behavioral therapy for sleep, anxiety, and depression BEHAVIORAL

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+

online cognitive behavioral therapy for insomnia, anxiety and depression

education about healthy nutrition habits and communication in older age BEHAVIORAL

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

online intervention on nutrition and communication in older age

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• psychotropic (including hypnotic) medication in the past 2 weeks
• contraindications for MRI (e.g., pacemaker, metallic implant, claustrophobia)

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal: lead

Study Sites (2)

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

Ottawa, Ontario, K1Z7K4, Canada

RECRUITING

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

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Psychological Well-Being; Anxiety Disorders; Depression

Interventions

Cognitive Behavioral Therapy; Sleep

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Personal Satisfaction; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Thien Thanh Dang-Vu, MD PhD

CONTACT

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

Rebecca Robillard, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Neurologist; Director, Sleep, Cognition & Neuroimaging Laboratory (SCNLab)

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 13, 2023
• Study Start: November 15, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

CA (2)