Combined Behavioral and Pharmacologic Therapy for Insomnia
(PRECEPT-D Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAli A El-Solh, MD MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?Obstructive sleep apnea (OSA) is commonly reported in Veterans with post-traumatic stress disorder, which can potentiate symptoms of anxiety and depression, daytime symptoms and worsen nightmares. Continuous positive airway pressure (CPAP) is the most effective therapy but adherence to treatment is suboptimal. Insomnia is considered a barrier to long-term adherence. The overarching theme of the proposal is to compare the effectiveness of cognitive behavioral therapy for insomnia (CBT) plus eszopiclone, a nonbenzodiazepine hypnotic, versus CBT alone in Veterans with PTSD who are diagnosed with both OSA and insomnia, using a randomized, clinical trial, on sleep quality of life, PTSD severity, and CPAP adherence.

Eligibility Criteria

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.

+3 more

Exclusion Criteria

I am receiving treatment for seizures.

I have a history of serious liver problems.

My insomnia is caused by pain.

+12 more

Participant Groups

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.

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.

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

🇺🇸 Approved in United States as BBT-I for: