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Behavioral Intervention

Online Cognitive Behavioural Therapy for Insomnia (e-COSMOS Trial)

N/A
Recruiting
Research Sponsored by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 60 years or older at the time of enrollment
Be older than 18 years old
Must not have
Medical conditions likely to affect sleep; in particular: current neurological disorder (e.g., epilepsy with any seizure in the past year, concussion in the past 3 months, multiple sclerosis, Parkinson's disease), past history of brain lesion (e.g., brain hemorrhage, brain tumor, any condition having required brain surgery), major surgery (i.e., requiring general anesthesia) in the past 3 months, untreated thyroid disorder, chronic pain syndrome self-reported as interfering with sleep (e.g., migraine, fibromyalgia, rheumatoid arthritis), recent and severe infection in the past 3 months (e.g., pneumonia, kidney infection), active cancer or treated cancer with post-cancer treatment for less than 2 years
Uncorrected severe hearing or vision impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Awards & highlights

Summary

This trial is testing a new online program to help people with insomnia and memory problems. The study wants to know if this program can improve sleep quality, mental health, and cognitive abilities compared to a control

Who is the study for?
This trial is for adults aged 60 or older who have trouble sleeping (insomnia) and feel their memory isn't as good as it used to be. They should be able to read French or English, use a smartphone or tablet, and have internet at home. If they're taking sleep or mood medications, the dose must have been the same for at least two months.
What is being tested?
The study tests an online program that combines cognitive-behavioral therapy with education on nutrition and communication aimed at improving sleep, anxiety, depression, and cognitive abilities in older adults with insomnia and self-perceived memory issues.
What are the potential side effects?
Since this intervention involves therapy and education without medication changes, significant side effects are not expected. However, participants may experience discomfort discussing personal issues during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any medical conditions that could affect my sleep.
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I have severe hearing or vision problems that haven't been corrected.
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I have been diagnosed with a significant memory or thinking problem.
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I am currently undergoing cognitive behavioral therapy.
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I am currently in the hospital or have major surgery planned.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, at 10-12 weeks and at 24 weeks after the start of the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Geriatric anxiety index
Geriatric depression scale
Insomnia severity index
+2 more
Secondary study objectives
Adherence to treatment
Cognitive performance (classical neuropsychological tests)
Cognitive performances from the CANTAB: Intra-Extra Dimensional Set Shift (IED)
+30 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: online cognitive behavioral therapy for insomnia, anxiety and depressionExperimental Treatment1 Intervention
10 self-directed modules of cognitive behavioral therapy for insomnia, anxiety and depression, delivered online, once a week
Group II: online intervention on nutrition and communication in older ageActive Control1 Intervention
10 self-directed modules on healthy nutrition habits and communication strategies, delivered online, once a week

Find a Location

Who is running the clinical trial?

Centre de Recherche de l'Institut Universitaire de Geriatrie de MontrealLead Sponsor
23 Previous Clinical Trials
8,645 Total Patients Enrolled
1 Trials studying Insomnia
300 Patients Enrolled for Insomnia
~155 spots leftby Nov 2025
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