Cognitive Behavioral Therapy (CBT) for Insomnia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Miami, Miami, FLInsomniaCognitive Behavioral Therapy (CBT) - Behavioral
Eligibility
55 - 70
Female
What conditions do you have?
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Study Summary

This trial is testing whether improving sleep quality can help slow down brain aging.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Year 2

Year 2
Cognitive Performance
Rate of brain tissue volume loss in specific brain regions

Trial Safety

Safety Progress

1 of 3

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Side Effects for

Citalopram
18%Weight increase
10%Tachycardia
6%Hypertension
6%Loss of libido
6%Psychiatric Hospitalization
4%Appetite increase
4%Amenorrhea
4%Restlessness
4%Memory impaired
4%Rash
4%Concentration impaired
2%Drooling
2%Hurt when riding a bike
2%Anorgasmia
2%Cellulitis
2%Akathisia
2%Appetite decrease
2%Pneumonia
2%Drug-related hospitalization
2%Mental activity decreased
2%Dizziness upon standing
2%Sleeplessness
2%Fatigue
2%Blurred vision
2%Hot flashes
2%Medical Hospitalization
2%Apathy
2%Hit by a motorcycle
2%Sensory hallucinations
2%Nightmares
2%Sleep disturbed
2%Incarceration
2%Muscle twitch
2%Hiccup
2%Drug abuse
2%Teeth grating
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT01041274) in the Citalopram ARM group. Side effects include: Weight increase with 18%, Tachycardia with 10%, Hypertension with 6%, Loss of libido with 6%, Psychiatric Hospitalization with 6%.

Trial Design

2 Treatment Groups

Control Group
1 of 2
Cognitive Behavioral Therapy (CBT) Group
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Cognitive Behavioral Therapy (CBT) · No Placebo Group · N/A

Cognitive Behavioral Therapy (CBT) Group
Behavioral
Experimental Group · 1 Intervention: Cognitive Behavioral Therapy (CBT) · Intervention Types: Behavioral
Control GroupNoIntervention Group · 1 Intervention: Control Group · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy (CBT)
2008
Completed Phase 4
~3620

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: year 2

Who is running the clinical trial?

University of MiamiLead Sponsor
806 Previous Clinical Trials
387,016 Total Patients Enrolled
2 Trials studying Insomnia
90 Patients Enrolled for Insomnia
Florida Department of HealthOTHER_GOV
24 Previous Clinical Trials
12,241 Total Patients Enrolled
Noam AlperinPrincipal Investigator - University of Miami
University of Miami

Eligibility Criteria

Age 55 - 70 · Female Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have trouble sleeping and have reported it yourself. You do not have any cognitive issues.
References

Frequently Asked Questions

Does the protocol for this research study permit individuals aged 40 and above to partake?

"According to the study's eligibility requirements, patients must be between 55 and 70 years old in order to participate." - Anonymous Online Contributor

Unverified Answer

Is there availability for participants in this investigation?

"Affirmative. The information found on clinicaltrials.gov shows that this experiment is still recruiting participants, with the initial posting being made September 28th 2021 and last updated on September 28th 2022. 100 research subjects are needed at a single medical centre for participation in the study." - Anonymous Online Contributor

Unverified Answer

What is the total number of participants being recruited for this experiment?

"Affirmative. Clinicaltrials.gov details that this research study, posted on September 28th 2021, is still recruiting participants from a single site with the goal of enrolling 100 patients." - Anonymous Online Contributor

Unverified Answer

Is there a way I can join this clinical experiment?

"This research seeks a hundred participants aged 55 to 70 who suffer from impaired slumber. Eligible subjects must possess the capacity and willingness to consent, while being fluent in English. Additionally, they should be of sound cognition with demonstrable issues that lead to poor sleep quality as evaluated by self-reporting methods." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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