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Combined Behavioral and Pharmacologic Therapy for Insomnia (PRECEPT-D Trial)
Phase 4
Waitlist Available
Led By Ali A El-Solh, MD MPH
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of PTSD as determined by the intake conducted through the PTSD Clinic or the Mental Health Clinic
Age >18 years and <65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up repeated measures between baseline and 6 months post randomization
Awards & highlights
PRECEPT-D Trial Summary
This trial is testing whether adding a sleep medication to cognitive behavioral therapy for insomnia will help improve sleep quality, PTSD severity, and CPAP adherence in veterans with both PTSD and obstructive sleep apnea.
Who is the study for?
This trial is for Veterans with PTSD, aged 18-65, who have both obstructive sleep apnea and chronic insomnia. They must be stable on psychotherapeutic treatments and not adherent to CPAP therapy. Exclusions include significant liver issues, eszopiclone sensitivity, pain-related insomnia, alcohol overuse, certain psychiatric or substance abuse disorders.Check my eligibility
What is being tested?
The study tests if combining cognitive behavioral therapy (CBT) for insomnia with a sleeping pill called eszopiclone improves sleep quality, PTSD severity, and adherence to CPAP treatment in Veterans compared to CBT alone.See study design
What are the potential side effects?
Eszopiclone may cause drowsiness during the day, headaches, dizziness; rare side effects include complex nocturnal behaviors like sleepwalking. Behavioral therapy typically has no direct physical side effects.
PRECEPT-D Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with PTSD by a specialized clinic.
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I am between 18 and 65 years old.
Select...
I understand the study and can agree to participate.
Select...
I have been experiencing insomnia for more than 3 months.
PRECEPT-D Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ repeated measures between baseline and 6 months post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~repeated measures between baseline and 6 months post randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Pittsburgh Sleep Quality Index (PSQI) (32)
Secondary outcome measures
Change in Beck Depression Inventory-II (BDI-II)
Change in Insomnia Severity Index (ISI)
Change in PTSD checklist-5 (PCL-5)
Other outcome measures
CPAP adherence
PRECEPT-D Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BBTI plus eszopicloneExperimental Treatment2 Interventions
participants randomized to the combination therapy will receive eszopiclone 2 mg orally at bedtime or placebo starting with the BBTI sessions for a period of 2 weeks in combination with 4 sessions of BBTI over 4 weeks.
Group II: BBTIActive Control1 Intervention
participants randomized to BBTI will receive 4 sessions of BBTI over 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
eszopiclone
2006
Completed Phase 4
~1630
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,381 Total Patients Enrolled
27 Trials studying Insomnia
4,197 Patients Enrolled for Insomnia
Ali A El-Solh, MD MPHPrincipal InvestigatorVA Western New York Healthcare System, Buffalo, NY
1 Previous Clinical Trials
42 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am receiving treatment for seizures.I have a history of serious liver problems.My mental health treatment has been stable for over a month.My insomnia is caused by pain.I have been diagnosed with schizophrenia or schizoaffective disorder.You have been diagnosed with obstructive sleep apnea and don't use a CPAP machine for at least 4 hours every night.I have been diagnosed with bipolar disorder.You drink more than two alcoholic beverages every night.You have been diagnosed with a substance addiction or abuse disorder in the last year.You have a history of narcolepsy or cataplexy.I have been diagnosed with PTSD by a specialized clinic.You have severe mental health issues, like being actively suicidal or a danger to yourself or others.I am between 18 and 65 years old.You have had a bad reaction to eszopiclone before, or you are not supposed to take it for medical reasons.I understand the study and can agree to participate.I am taking strong medications that I cannot or should not stop.I have had complex behaviors at night while on eszopiclone.I am not willing to use CPAP.I have been experiencing insomnia for more than 3 months.My insomnia has improved with treatment.
Research Study Groups:
This trial has the following groups:- Group 1: BBTI plus eszopiclone
- Group 2: BBTI
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Insomnia Patient Testimony for trial: Trial Name: NCT03937713 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial accept participants who are under the age of 65?
"To be a viable candidate for this clinical trial, individuals must possess an age ranging from 18 to 65 years."
Answered by AI
Are new participants being recruited for this medical experiment?
"This is correct. According to the data available on clinicaltrials.gov, this medical study has been open for recruitment since December 1st 2019 and was recently updated on February 22nd 2022. This trial needs to enroll 52 participants from a single centre."
Answered by AI
Has Brief behavioral therapy for insomnia been studied in other contexts?
"Presently, there are 4 ongoing studies researching Brief Behavioral Therapy (BBT) for insomnia with 1 trial in Phase 3. Trials of BBT have been initiated from 39 different locations, primarily situated around Salt Lake City in Utah."
Answered by AI
Has the FDA sanctioned Brief behavioral therapy as a treatment for sleeplessness?
"There is abundant clinical data in support of brief behavioral therapy for insomnia, so it was awarded a score of 3."
Answered by AI
How many individuals can potentially benefit from this clinical trial?
"Affirmative. Clinicaltrials.gov's repository of information indicates that this trial, which officially began on December 1st 2019, is still recruiting participants. The study requires the enlistment of 52 individuals from a single medical centre."
Answered by AI
Would I be eligible to participate in this research initiative?
"Potential participants for this trial must suffer from complex insomnia and be between the ages of majority and retirement age. We are currently looking to recruit 52 people in total."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
VA Western New York Healthcare System, Buffalo, NY
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have tried prescription sleep medication without success and am willing to try just about anything to be able to sleep for more than 2 hours every other day.
PatientReceived 1 prior treatment
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