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

NCT05516277 | Recruiting

• 1 other identifier: 1K23HL157754-01A1
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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

Keywords

Quality of Life

Outcome Measures

Primary Outcomes (6)

• Consensus sleep diary questionnaire

  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).

  Change from baseline to 1 week after completion of sleep intervention

• PTSD Checklist for DSM-5 (PCL-5)

  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.

  Change from baseline to 1 week after completion of sleep intervention

• 24-hr ambulatory blood pressure monitoring (ABPM) blood pressure variability

  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.

  Change from baseline to 1 week after completion of sleep intervention

• 24-hr ambulatory blood pressure monitoring (ABPM) systolic/diastolic loads

  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.

  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

  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).

  Change from baseline to 1 week after completion of sleep intervention

• WHOQOL-BREF questionnaire

  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.

  Change from baseline to 1 week after completion of sleep intervention

Secondary Outcomes (6)

• Homeostatic Model Assessment of Insulin Resistance (HOMA)

  Change from baseline to 1 week after completion of sleep intervention

• Hemoglobin A1c (HbA1c)

  Change from baseline to 6 months after completion of sleep intervention

• Body Mass Index (BMI)

  Change from baseline to 1 week after completion of sleep intervention

• Central adiposity

  Change from baseline to 1 week after completion of sleep intervention

• Actigraphy

  Change from baseline to 1 week after completion of sleep intervention

Study Arms (1)

Behavioral Sleep Education Intervention

EXPERIMENTAL

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

Behavioral: Behavioral Sleep Education Intervention

Interventions

Behavioral Sleep Education Intervention BEHAVIORAL

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

Also known as: Cognitive Behavioral Therapy for Insomnia

Behavioral Sleep Education Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• VA Office of Research and Development: collaborator

Study Sites (1)

VA Greater Los Angeles Healthcare System

North Hills, California, 91343, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Sleep Initiation and Maintenance Disorders; Cardiovascular Diseases; Metabolic Diseases

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Monica Kelly, PhD

  UCLA / VA Greater Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Kelly, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All eligible participants will receive the same treatments for PTSD and insomnia.

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 25, 2022
• Study Start: April 1, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)