RecruitingNAINTERVENTIONAL

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

This study is for older adults (60-99 years old) who have difficulty sleeping (insomnia) and are noticing some memory or thinking issues. Researchers are testing a new online program called eCBTi+ that uses special techniques to improve sleep and overall mental health. The program also includes tips on healthy eating and communication. The main goal is to see if this online tool can significantly improve sleep quality, reduce anxiety and depression, and help with memory and thinking abilities compared to standard care. The study aims to understand if an accessible online approach can make a real difference for older people struggling with these common concerns.

At a glance

Status

Recruiting

Phase

Sponsor

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

Enrolment target

275

Start

15 Nov 2023

Estimated completion

01 Dec 2026

Insomnia

What is this study about?

This research study is looking for older adults, aged 60 to 99, who are experiencing two main things: trouble sleeping (insomnia) and concerns about their memory or thinking skills. Many older people find it harder to sleep as they get older, and sometimes they worry that their memory isn't as sharp as it used to be. This study wants to help with both of these issues by testing a new online program.

The program is a type of 'cognitive behavioural therapy' (CBT), which is a common and effective way to help people change unhelpful thoughts and behaviours. This particular program, called eCBTi+, is designed specifically for sleep and mental well-being, and it's delivered completely online. It also includes general health information on things like healthy eating and talking with others. The researchers want to find out if this online tool can make a real difference in how well people sleep, how they feel emotionally (whether they're anxious or down), and if it can even help with their thinking and memory.

The study is important because it’s looking for an easy-to-access way to support older adults who are struggling with sleep and memory worries. If this online program works well, it could become a helpful tool for many people, allowing them to get support from the comfort of their own homes. The study also compares how people with insomnia do to a group of people who sleep well, to get a better understanding of the findings.

Key takeaways

Online program for older adults with insomnia and memory concerns.
Tests if online CBT helps sleep, mood, and thinking.
Participation involves online modules, diaries, and at-home sleep tracking.
Requires internet and a smartphone/tablet.
You can withdraw from the study at any time.
Compares participants with sleep issues to good sleepers.

Who may be eligible?

To be part of this study, you need to be 60 years old or older. You should be experiencing sleep problems that fit the definition of insomnia, and also have noticed some worries about your memory or thinking. It's important that you can read and understand either French or English, and you'll need to know how to use a smartphone or tablet and have access to the internet at home.

There are also some health conditions that would mean you couldn't join. For example, if you've been diagnosed with a severe memory condition like dementia, or if you have certain serious mental health conditions like schizophrenia or bipolar disorder. If you have severe hearing or sight problems that can't be corrected, or if you regularly drink a lot of alcohol or use illegal drugs, you wouldn't be able to take part. Also, if you're already having CBT for sleep, or have had it recently, you won't be able to join this study.

If you take certain medications for sleep or mental health, you might still be able to join as long as your dose has been steady for at least two months. The researchers will also check for other sleep problems like severe sleep apnoea. If you're currently doing shift work or planning major surgery, this study wouldn't be right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 60 years old or older?
Do you have trouble sleeping (insomnia) and concerns about your memory?
Can you read and understand English or French?
Do you have a smartphone/tablet and home internet?
Do you have a stable dose of any sleep or mood medication for at least 2 months?
Do you NOT have a diagnosis of severe memory loss (dementia) or serious mental health conditions?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll first have a phone chat and two video calls to check if you're eligible and to learn how to use some sleep tracking devices. For people with insomnia, taking part involves several things over about 10 weeks: you'll wear an EEG headband at home for 9 nights (3 periods of 3 nights each) to measure your sleep, and wear a small actigraphy device on your wrist for 42 days (3 periods of 14 days) to track your activity. You'll also fill out 42 daily sleep diaries and complete online questionnaires.

You'll participate in 10 weekly online health modules and have a phone call check-in with a psychologist. There will also be three sessions for cognitive (thinking and memory) tests. If you're in a special subgroup, you'll also have two in-person visits, including an MRI scan. Good sleepers in the study will have a shorter commitment, including 3 nights with an EEG headband, 14 days of sleep diaries and actigraphy, online questionnaires, one cognitive testing session, and one in-person MRI scan. You can stop taking part at any time.

Potential risks and benefits

Participating in this study might offer several benefits, such as potentially improving your sleep, reducing anxiety and depression, and helping with your memory and thinking skills through the online program. You’ll also receive regular check-ins with a psychologist. However, there are some potential risks. You might find the assessments, like wearing the sleep tracking devices or completing daily diaries, time-consuming or a little inconvenient. Although every effort is made to keep your information private, there's always a minimal risk with online activities. It's important to remember that you are free to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

The Royal's Institute of Mental Health Research (IMHR)
Verified postcode
Ottawa, Canada· Recruiting
Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de l'Île-de-Montréal. CCSMTL - IUGM
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is 'cognitive behavioural therapy'?

It's a type of talking therapy that helps you change unhelpful ways of thinking and behaving, and it's often used to help with sleep problems, anxiety, and low mood.

Do I need special equipment to join?

Yes, you'll need a smartphone or tablet and a working internet connection at home to access the online program and materials. The study will provide other devices like the EEG headband.

How long will the study take?

If you have insomnia, the main part of the study will involve activities spread over about 10 weeks, with some assessments lasting a bit longer, like wearing devices for a total of 42 days. Good sleepers have a shorter involvement.

Will I have to go to a clinic?

Most of the study, including the program and many assessments, will be done online or at home. However, some participants, especially those in the MRI group, will have a small number of in-person appointments.

What if I'm already taking sleep medication?

You might still be able to join if your dose of sleep or mental health medication has been stable (unchanged) for at least two months before you start the study.

How to find out more

Thien Thanh Dang-Vu, MD PhD

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

Always speak to your GP or specialist before deciding to take part in a study.