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Insomnia Treatment and Cardiometabolic Health in Older Adults With PTSD

This study is looking at how treating insomnia (trouble sleeping) in older adults with Posttraumatic Stress Disorder (PTSD) might improve their heart and metabolic health. You might be able to join if you are a Veteran aged 50 or older, have PTSD and insomnia, and live near the VA Sepulveda Ambulatory Care Center. The study first provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT), followed by a non-medication sleep education program called Cognitive Behavioral Therapy for Insomnia (CBT-I). Researchers will measure changes in your sleep, PTSD symptoms, and blood pressure to see if these treatments are helpful. The study plans to enroll 167 participants, but its current status is unclear.

Study design
This is an interventional pilot pre-post trial, meaning participants receive treatments and are measured before and after. It plans to enroll 167 participants.
What's involved
You would complete a baseline evaluation, which includes answering questions about your health, wearing a blood pressure monitor for 24 hours, and wearing a continuous glucose monitor. You would then receive 5 weekly, 60-minute individual sessions of a behavioral sleep education program.
Compensation
Not stated in the trial record.
Follow-up
Your sleep, PTSD symptoms, and blood pressure will be measured again one week after completing the sleep intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05516277

Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder

Recruiting
NAAges 50+InterventionalTreatment
University of California, Los Angeles
~167 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Behavioral Sleep Education Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Consensus sleep diary questionnaire
Measured over Change from baseline to 1 week after completion of sleep intervention
+5 more outcomes measured

Conditions

Posttraumatic Stress Disorder
Insomnia
Cardiovascular Diseases
Metabolic Disease

Explore related trials

Cardiovascular DisorderInsomniaMetabolic DisorderPost-Traumatic Stress Disorder

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Monica Kelly, PhD · PRINCIPAL_INVESTIGATOR · UCLA / VA Greater Los Angeles

Who to contact

Monica Kelly, PhD
[email protected]
818-891-7711 · ext. 36066
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Consensus sleep diary questionnaireChange from baseline to 1 week after completion of sleep intervention

    Self-reported sleep quality assessed with the Consensus sleep diary, a brief patient questionnaire evaluating multiple aspects of sleep quality including sleep onset latency (time to fall asleep in minutes) and sleep efficiency percentage (time asleep in minutes/time in bed in minutes x 100).

  • PTSD Checklist for DSM-5 (PCL-5)Change from baseline to 1 week after completion of sleep intervention

    The PCL-5 is a self-report PTSD severity questionnaire evaluating multiple aspects of PTSD symptoms. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. A higher score indicates more severe PTSD symptoms.

  • 24-hr ambulatory blood pressure monitoring (ABPM) blood pressure variabilityChange from baseline to 1 week after completion of sleep intervention

    ABPM is an assessment of hypertension, a cardiometabolic disease, and blood pressure patterns across the 24-hour period. We will assess within-subject blood pressure variability via standard deviation across 24-hours.

  • 24-hr ambulatory blood pressure monitoring (ABPM) systolic/diastolic loadsChange from baseline to 1 week after completion of sleep intervention

    ABPM is an assessment of hypertension, a cardiometabolic disease, and blood pressure patterns across the 24-hour period. We will assess systolic/diastolic loads via percentage of elevated values across 24-hours.

  • 24-hr ambulatory blood pressure monitoring (ABPM) change in blood pressure day to nightChange from baseline to 1 week after completion of sleep intervention

    ABPM is an assessment of hypertension, a cardiometabolic disease, and blood pressure patterns across the 24-hour period. We will assess change in blood pressure from day to night (day-night).

  • WHOQOL-BREF questionnaireChange from baseline to 1 week after completion of sleep intervention

    Self-reported quality of life assessed with a brief patient questionnaire evaluating aspects of quality of life across four domains: 1) Physical health, 2) Psychological, 3) Social relations, and 4) Environment. Mean scores for each domain range from 4-20, which are multiplied by 4 to transform the domain score into a scaled score that is comparable to the full WHOQOL-100 measure. A higher score indicated higher quality of life.