Treating insomnia to improve heart and metabolic health in older adults with PTSD
Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder
This study is testing if treating insomnia with therapy can help older adults with PTSD improve their heart health and overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 167 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (North Hills, California) |
| Trial ID | NCT05516277 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to explore the effects of treating insomnia in older adults with Posttraumatic Stress Disorder (PTSD) on their cardiometabolic health. Participants will undergo Cognitive Processing Therapy (CPT) for PTSD followed by Cognitive Behavioral Therapy for Insomnia (CBT-I) to address residual sleep difficulties. The study will evaluate the impact of these interventions on sleep quality, PTSD symptoms, cardiometabolic risk factors, and overall quality of life. Participants will be monitored through various assessments, including wearable devices for sleep patterns and continuous glucose monitoring.
Who should consider this trial
Good fit: Ideal candidates are community-dwelling veterans aged 50 and older with a diagnosis of PTSD and insomnia who have received care from a Veterans Health Administration facility.
Not a fit: Patients with severe cardiovascular or respiratory diseases, unstable medical or psychiatric disorders, or other comorbid sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and reduce cardiometabolic risks for older adults suffering from PTSD and insomnia.
How similar studies have performed: While the specific combination of treatments in this study is novel, previous studies have shown that addressing insomnia can lead to improvements in PTSD symptoms and overall health outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
North Hills, California
- VA Greater Los Angeles Healthcare System — North Hills, California, United States (Recruiting)
Study contacts
- Principal investigator: Monica Kelly, PhD — UCLA / VA Greater Los Angeles
- Study coordinator: Monica Kelly, PhD
- Email: monica.kelly2@va.gov
- Phone: 818-891-7711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.