NCT06032377

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

Improving Sleep to Protect Brain Health in Older Adults: Assessing a Novel Cognitive-behavioral Program for Insomnia Using a Multidomain Web Platform

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 275 (estimated)
• Sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal · Academic / Other
• Sex: All
• Age: 60 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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

Timeline

• Start date: 2023-11-15
• Primary completion: 2026-05-01
• Completion: 2026-12-01
• First posted: 2023-09-13
• Last updated: 2026-03-18

Locations

2 sites across 1 country: Canada