RECRUITING

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

Conditions

Posttraumatic Stress Disorder Insomnia Cardiovascular Diseases Metabolic Disease Quality of Life

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-01

Study Completion:2027-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05516277

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Monica Kelly, PhD

CONTACT

818-891-7711

monica.kelly2@va.gov

Principal Investigator

Monica Kelly, PhD

PRINCIPAL_INVESTIGATOR

UCLA / VA Greater Los Angeles

Study Locations (Sites)

VA Greater Los Angeles Healthcare System

North Hills, California, 91343

United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-01

Study Completion Date2027-03-31

Study Record Updates

Study Start Date2023-04-01

Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

Quality of Life

Additional Relevant MeSH Terms

Posttraumatic Stress Disorder
Insomnia
Cardiovascular Diseases
Metabolic Disease