NCT05516277 Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder
| NCT ID | NCT05516277 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Posttraumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 167 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 167 participants in total. It began in 2023-04-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This pilot pre-post trial will address a gap in knowledge related to addressing modifiable risk factors for cardiometabolic disease through treating residual insomnia, sleep difficulties that remain after successful treatment of another condition, in the context of PTSD in understudied older adults. This study provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT) followed by a non-medication sleep education and treatment program (Cognitive Behavioral Therapy for Insomnia, CBT-I) for sleep problems that remain after completing PTSD treatment in older adults with PTSD. The aims of this project are to evaluate 1) the added benefits of treating residual insomnia on sleep and PTSD symptoms; 2) the added benefits of treating residual insomnia following CPT on cardiometabolic risk biomarkers and quality of life; and 3) the durability of the sleep, PTSD, cardiometabolic and quality of life benefits of treating residual insomnia following CPT at 6-month follow-up in older adults with PTSD.
Eligibility Criteria
Inclusion Criteria: * Community-dwelling Veterans aged 50 years and older * Received care from a Veterans Health Administration (VHA) facility in the prior year * Diagnosis of PTSD * Diagnosis of insomnia disorder * Lives within a 50-mile radius of the research offices at the VA Sepulveda Ambulatory Care Center Exclusion Criteria: * Active substance use or in recovery with less than 90 days of sobriety * Too ill to engage in the study procedures (e.g., unable to attend the in-person meetings) * Unable to self-consent to participate * Unstable housing (as this will impact the research team's ability to retrieve costly and difficult to replace monitoring equipment) * Severe cardiovascular or respiratory disease (e.g., ventilatory failure, CHF) * Unstable medical or psychiatric disorders (which are a contraindication for behavioral treatment of insomnia) * Comorbid sleep disorders (i.e., central sleep apnea syndrome, diagnosed narcolepsy or circadian rhythm sleep-wake phase disorders) based on medical record review and baseline assessment data, or untreated, severe sleep disordered breathing (SDB) as assessed via WatchPAT or previous clinical evaluation (apnea-hypopnea index \[AHI\] ≥ 30; or AHI ≥ 15 plus Epworth Sleepiness Scale \[ESS\] score ≥ 10) that better explain sleep difficulties
Contact & Investigator
Monica Kelly, PhD
PRINCIPAL INVESTIGATOR
UCLA / VA Greater Los Angeles
Frequently Asked Questions
Who can join the NCT05516277 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Posttraumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05516277 currently recruiting?
Yes, NCT05516277 is actively recruiting participants. Contact the research team at monica.kelly2@va.gov for enrollment information.
Where is the NCT05516277 trial being conducted?
This trial is being conducted at North Hills, United States.
Who is sponsoring the NCT05516277 clinical trial?
NCT05516277 is sponsored by University of California, Los Angeles. The principal investigator is Monica Kelly, PhD at UCLA / VA Greater Los Angeles. The trial plans to enroll 167 participants.