Combined Behavioral and Pharmacologic Therapy for Insomnia

(PRECEPT-D Trial)

Overseen By Ali A El-Solh, MD MPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: VA Office of Research and Development

Must not be taking: Cytochrome inhibitors

Disqualifiers: Narcolepsy, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to assist Veterans with PTSD who have sleep apnea and insomnia. One group receives therapy for insomnia, while the other receives the same therapy plus a sleep aid called eszopiclone (Lunesta). The goal is to determine which treatment improves sleep quality, PTSD symptoms, and regular CPAP machine use. Veterans diagnosed with PTSD, chronic insomnia, and sleep apnea who struggle with CPAP use might be suitable candidates. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, providing an opportunity to assess its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain medications like potent cytochrome p450 3A4 inhibitors and are unwilling or unable to stop them.

What is the safety track record for Brief Behavioral Therapy for Insomnia and Eszopiclone?

Research has shown that Brief Behavioral Therapy for Insomnia (BBTI) is generally manageable for participants. Studies indicate that BBTI effectively alleviates insomnia symptoms, such as difficulty falling asleep and poor sleep quality, without major adverse effects. However, some individuals may experience mild side effects like tiredness or reduced motivation after therapy.

Eszopiclone, marketed as Lunesta, aids in falling asleep faster and staying asleep longer. While safe for many, the FDA warns that it can cause next-day drowsiness, potentially affecting activities like driving. Some users may also experience temporary sleep difficulties after discontinuing the medication.

Both BBTI and eszopiclone have been shown to improve sleep, though some side effects are possible. Considering these potential effects is important when deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the combination of Brief Behavioral Therapy for Insomnia (BBTI) with eszopiclone because it merges two different approaches to tackle insomnia. Unlike standard treatments that often rely solely on medication like benzodiazepines or non-benzodiazepine sleep aids, this combined approach uses a cognitive-behavioral strategy alongside a hypnotic drug. BBTI focuses on changing sleep habits and thought patterns over a short time, while eszopiclone helps initiate sleep. This dual approach could potentially offer quicker and more sustainable improvements in sleep quality by addressing both the behavioral and physiological aspects of insomnia.

What evidence suggests that this trial's treatments could be effective for insomnia in Veterans with PTSD?

This trial will compare Brief Behavioral Therapy for Insomnia (BBTI) alone with a combination of BBTI and eszopiclone. Studies have shown that BBTI can significantly reduce insomnia severity, helping individuals fall asleep faster and improving overall sleep quality. Research indicates that BBTI effectively increases the time spent sleeping while in bed.

Regarding eszopiclone, studies confirm that it helps individuals fall asleep more quickly and reduces nighttime awakenings. It also enhances perceptions of sleep quality and is considered safe for treating insomnia. The combination of BBTI and eszopiclone, as tested in this trial, may improve sleep quality and assist veterans with PTSD and obstructive sleep apnea in adhering to their CPAP (continuous positive airway pressure) treatment. ^{1 2 6 7 8}

Who Is on the Research Team?

Ali A El-Solh, MD MPH

Principal Investigator

VA Western New York Healthcare System, Buffalo, NY

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My mental health treatment has been stable for over a month.

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 PTSD by a specialized clinic.

Exclusion Criteria

I am receiving treatment for seizures.

I have a history of serious liver problems.

My insomnia is caused by pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either BBTI plus eszopiclone or BBTI alone over a period of 4 weeks

4 weeks

4 sessions of BBTI

Follow-up

Participants are monitored for changes in sleep quality, PTSD symptoms, and CPAP adherence

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Brief Behavioral Therapy for Insomnia
• Eszopiclone

Trial Overview 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.

How Is the Trial Designed?

Group I: BBTI plus eszopiclone Experimental Treatment 2 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: Brief Behavioral Therapy for Insomnia Active Control 1 Intervention

participants randomized to BBTI will receive 4 sessions of BBTI over 4 weeks.

Brief Behavioral Therapy for Insomnia is already approved in United States for the following indications:

Approved in United States as BBT-I for:

• Insomnia
• Postconcussive symptoms in Mild Traumatic Brain Injury

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8994790/

Brief Behavioral Treatment for Insomnia: A Meta-Analysis Overall, BBTI was associated with improved insomnia symptoms of medium to large magnitude and can be considered preliminarily efficacious. Despite the ...

2. sigmapubs.onlinelibrary.wiley.com sigmapubs.onlinelibrary.wiley.com/doi/10.1111/wvn.70075?af=R

Comparative Efficacy of Brief Behavioral Therapy for Insomnia ... Compared with usual care, BBTI significantly reduced insomnia severity (mean difference [MD] = −4.79; 95% confidence interval [CI = −6.05, −3.53]; ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32586428/

Brief Behavioral Treatment for Insomnia vs. Cognitive ... The goal of this study was to compare a brief behavioral treatment for insomnia (BBTI), which has fewer sessions (4), shorter duration (<30-45 minutes), and ...

4. med.upenn.edu med.upenn.edu/cbti/assets/user-content/documents/Germain_BBTofInsomnia.pdf

Brief Behavioral Treatment of Insomnia | BBTI Specifically, stimulus control and sleep restriction are associated with significant improvements in sleep latency, sleep duration, and sleep efficiency (ratio ...

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.11256

Effects of nurse-led brief behavioral treatment for insomnia in ... Study Impact: Nurse-led brief behavioral treatment for insomnia effectively improved insomnia severity, sleep onset latency, sleep efficiency, sleep quality, ...

6. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/227356

Efficacy of Brief Behavioral Treatment for Chronic Insomnia ... Older adults with chronic insomnia treated with BBTI showed clinically and statistically significant improvement in sleep outcomes at 4 weeks ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06073990?term=AREA%5BBasicSearch%5D(Behavioral%20Intervention%20for%20Insomnia%20in%20Older)&rank=3

Brief Behavioral Therapy for Insomnia(BBTi) in Middle ... Study Overview. This study aims to investigate whether a four-week BBTi program can effectively improve chronic insomnia and reduce overall stress in middle- ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1389945725001133

Negative effects of cognitive behavioral therapy for insomnia Evidence exists that cognitive behavioral therapy for insomnia (CBT-I) can lead to negative effects (e.g., exhaustion, reduced motivation). Psychometrically ...