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Behavioral Intervention

online cognitive behavioral therapy for insomnia, anxiety and depression 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

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

e-COSMOS Trial 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.Check my eligibility

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.See study design

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.

e-COSMOS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 60 years old or older.

e-COSMOS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, at 10-12 weeks and at 24 weeks after the start of the intervention

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Geriatric anxiety index

Geriatric depression scale

Insomnia severity index

+2 more

Secondary outcome measures

Adherence to treatment

Cognitive performance (classical neuropsychological tests)

Cognitive performances from the CANTAB: Intra-Extra Dimensional Set Shift (IED)

+30 more

e-COSMOS 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre de Recherche de l'Institut Universitaire de Geriatrie de MontrealLead Sponsor

22 Previous Clinical Trials

8,614 Total Patients Enrolled

1 Trials studying Insomnia

300 Patients Enrolled for Insomnia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals able to enroll in this study at the present time?

"As per clinicaltrials.gov, this investigation is actively seeking participants. The trial was first listed on 11/15/2023 and last modified on 2/5/2024."

Answered by AI

What is the primary objective that this medical study aims to achieve?

"The primary objective of this trial, to be evaluated at baseline, 10-12 weeks, and 24 weeks post-intervention, is the assessment of cognitive performance using a composite score for executive functions derived from CANTAB. Secondary endpoints consist of measuring negative emotional bias utilizing the Emotional Bias Task (EBT) subscales within CANTAB [EBT - proportion of trials rated as 'Happy' (range: 0-15; lower scores indicate more negative bias)], fractional anisotropy alterations in the superior longitudinal fasciculus and internal capsule, and spatial span cognitive abilities assessed through Spatial Span task on CANTAB ["

Answered by AI

Are individuals who are older than 75 years being enrolled in this medical research study?

"Participants aged 60 years or older but under 99 are eligible for enrollment in this trial."

Answered by AI

What is the overall count of individuals actively participating in this medical study?

"Yes, information available on clinicaltrials.gov confirms that this trial is actively pursuing participants. Initially shared on November 15th, 2023 and last revised on February 5th, 2024, the study aims to recruit a total of 275 patients from two distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Thien Thanh Dang-Vu 2023. "Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06032377.

All > Anxiety > Insomnia