Recruiting

CPT & CBT-I

Sponsor:

UCLA

Code:

NCT05516277

Conditions

Posttraumatic Stress Disorder

Insomnia

Cardiovascular Diseases

Metabolic Disease

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Behavioral Sleep Education Intervention

Study Details

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.

Conditions

Posttraumatic Stress Disorder

Insomnia

Cardiovascular Diseases

Metabolic Disease

Study ID

NCT05516277

Start date

Apr 1, 2023

Status verified date

Apr, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

167 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Behavioral Sleep Education Intervention

Manual-based education program focusing on behavioral sleep techniques provided in individual 60-minute sessions for 5 weekly sessions.

Interventions

Behavioral Sleep Education Intervention

Manual-based education program focusing on behavioral sleep techniques provided in individual 60-minute sessions for 5 weekly sessions.

Primary outcome measure

  • Consensus sleep diary questionnaire [ Time Frame: Change from baseline to 1 week after completion of sleep intervention ]
  • PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Change from baseline to 1 week after completion of sleep intervention ]
  • 24-hr ambulatory blood pressure monitoring (ABPM) blood pressure variability [ Time Frame: Change from baseline to 1 week after completion of sleep intervention ]
  • 24-hr ambulatory blood pressure monitoring (ABPM) systolic/diastolic loads [ Time Frame: Change from baseline to 1 week after completion of sleep intervention ]
  • 24-hr ambulatory blood pressure monitoring (ABPM) change in blood pressure day to night [ Time Frame: Change from baseline to 1 week after completion of sleep intervention ]
  • WHOQOL-BREF questionnaire [ Time Frame: Change from baseline to 1 week after completion of sleep intervention ]

Central Contacts and Locations

Central contacts

Monica Kelly, PhD

818-891-7711monica.kelly2@va.gov

Locations

VA Greater Los Angeles Healthcare System

Recruiting

North Hills, California, United States, 91343

Contacts

Monica Kelly, PhD

818-891-7711monica.kelly2@va.gov

Principal Investigator:

Monica Kelly, PhD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • Quality of Life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-04-15.