Online COgnitive Behavioural Therapy for Sleep & Mental Health for Older

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Insomnia
Sleep Initiation and Maintenance Disorders

Clinical Trial Details

NCT number	NCT06032377
Study type	Interventional
Source	Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Contact	Thien Thanh Dang-Vu, MD PhD
Phone	+1 (514) 340-3540
Email	tt.dangvu@concordia.ca
Status	Recruiting
Phase	N/A
Start date	November 15, 2023
Completion date	December 2025

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms