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Behavioral Intervention

Cognitive Behavioural Therapy for Chronic Insomnia

N/A
Recruiting
Led By Thanh Dang-Vu, MD PhD
Research Sponsored by Concordia University, Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
80 participants with chronic primary insomnia (40 per group)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months and 1 year
Awards & highlights

Study Summary

This trial will assess whether a psychological treatment for insomnia can help improve daytime functioning by normalizing brain responses to certain tasks.

Who is the study for?
This trial is for adults aged 25-65 with chronic insomnia, experiencing persistent trouble sleeping and daytime issues. It's open to both those suffering from insomnia and good sleepers as controls. Exclusions include serious health conditions like heart failure, untreated thyroid disorders, severe mental disorders, recent major surgery or infections, substance abuse, and certain sleep-related disorders.Check my eligibility
What is being tested?
The study tests if Cognitive-Behavioural therapy for insomnia (CBT-I) can normalize brain responses during cognitive tasks and rest in people with chronic insomnia. It aims to improve attentional processing by altering activation in specific brain regions related to memory and emotions.See study design
What are the potential side effects?
Since CBT-I is a psychological treatment involving no medication or invasive procedures, it typically does not have physical side effects. However, participants may experience temporary increases in anxiety or distress while addressing their sleep habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with chronic primary insomnia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months and 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Functional magnetic resonance imaging (fMRI) to examine brain responses to declarative memory encoding
Functional magnetic resonance imaging (fMRI) to examine brain responses to insomnia-related stimuli
Functional magnetic resonance imaging (fMRI) to examine brain responses to working memory with increasing task difficulty
+1 more
Secondary outcome measures
Arousal index
Attention
Beck Depression Inventory (BDI)
+37 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate interventionExperimental Treatment1 Intervention
Group II: WaitlistActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Concordia University, MontrealLead Sponsor
22 Previous Clinical Trials
4,547 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,336 Previous Clinical Trials
25,750,988 Total Patients Enrolled
Thanh Dang-Vu, MD PhDPrincipal InvestigatorConcordia University, Montreal

Media Library

Cognitive-Behavioural therapy for insomnia (CBT-I) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04024787 — N/A
Chronic Insomnia Research Study Groups: Immediate intervention, Waitlist
Chronic Insomnia Clinical Trial 2023: Cognitive-Behavioural therapy for insomnia (CBT-I) Highlights & Side Effects. Trial Name: NCT04024787 — N/A
Cognitive-Behavioural therapy for insomnia (CBT-I) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04024787 — N/A

Frequently Asked Questions

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

Does the protocol for this research encompass participants of a young age?

"This particular medical trial has a limited age range for participants, being between 25 and 65. However, other trials are available that accept younger minors (19) or older adults (160)."

Answered by AI

Are any enrolment slots still available in this research protocol?

"Affirmative, the clinicaltrials.gov page displays that this trial is presently enrolling patients. This medical experiment was first posted on July 30th 2019 and has recently been updated in March 2022. At present, 120 individuals need to be recruited at 1 location."

Answered by AI

What is the aggregate patient population participating in this clinical trial?

"Affirmative. Per the information published on clinicaltrials.gov, this trial is actively searching for volunteers to join. The study was initially posted on July 30th 2019 and most recently updated in March 7th 2022; with a goal of recruiting 120 participants from 1 location."

Answered by AI

To whom would this clinical trial be most beneficial?

"Interested individuals should be aged between 25 and 65, demonstrate symptoms of insomnia, and no more than 120 people will be accepted into the trial."

Answered by AI

Who else is applying?

What site did they apply to?
Perform Center, Concordia University
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have been diagnosed with idiopathic insomnia since 2005. I have been on many different medications that either have bad side effects or don't work. Currently, I take medication to sleep and wake up every 2 to 3 hours during the night and medication to keep me awake during the day. At this point, I want to try Cognitive Behavior Therapy rather than medication.
PatientReceived 1 prior treatment
~8 spots leftby Jul 2024