Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder
Recruiting now · Not applicable
Conditions studied: Posttraumatic Stress Disorder, Insomnia, Cardiovascular Diseases, Metabolic Disease
In brief
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.
Key facts
- Study ID
- NCT05516277
- Run by
- University of California, Los Angeles
- People needed
- 167
- Starts
- 2023-04-01
- Expected to finish
- 2028-03-31
- Last updated by the study team
- 2026-04-15
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- VA Greater Los Angeles Healthcare System — North Hills, California, United States (enrolling)
Full record on ClinicalTrials.gov
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