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

University of California, Los Angeles · with VA Office of Research and Development · NCT05516277

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 50+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
167
US sites recruiting
1
Study start
April 1, 2023
Record last updated
April 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Behavioral Sleep Education Intervention

Conditions: Posttraumatic Stress Disorder; Insomnia; Cardiovascular Diseases; Metabolic Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • VA Greater Los Angeles Healthcare System

    North Hills, CA 91343

    Site contact: Monica Kelly, PhD · 818-891-7711 · monica.kelly2@va.gov

Study contacts (from the official record)

  • Monica Kelly, PhD · 818-891-7711 · monica.kelly2@va.gov
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Insomnia Treatment and Cardiometabolic Health in Older Adults With… (NCT05516277) | Bored Studies