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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 99
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Canada
Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de l'Île-de-Montréal. CCSMTL - IUGM
RECRUITING
Montreal
The Royal's Institute of Mental Health Research (IMHR)
RECRUITING
Ottawa
Contact Information
Primary
Thien Thanh Dang-Vu, MD PhD
tt.dangvu@concordia.ca
+1 (514) 340-3540
Backup
Rebecca Robillard, PhD
rebecca.robillard@uottawa.ca
+1 (613) 722-6521
Time Frame
Start Date: 2023-11-15
Estimated Completion Date: 2025-12
Participants
Target number of participants: 275
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

This content was sourced from clinicaltrials.gov