Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of California, Los Angeles
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Behavioral Sleep Education Intervention
BehavioralManual-based education program focusing on behavioral sleep techniques provided in individual 60-minute sessions for 5 weekly sessions.
Treatment groups
167 Participants
are divided into 1 treatment groupGroup A: Behavioral Sleep Education InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Change from baseline to 1 week after completion of sleep intervention2
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.
Time frame
Change from baseline to 1 week after completion of sleep intervention3
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.
Time frame
Change from baseline to 1 week after completion of sleep intervention4
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.
Time frame
Change from baseline to 1 week after completion of sleep interventionSecondary outcomes
1
Homeostatic Model Assessment of Insulin Resistance (HOMA)
HOMA is an assessment of insulin resistance, a cardiometabolic disease risk factor
Time frame
Change from baseline to 1 week after completion of sleep intervention2
Hemoglobin A1c (HbA1c)
HbA1c is an assessment of hyperglycemia, a cardiometabolic disease.
Time frame
Change from baseline to 6 months after completion of sleep intervention3
Body Mass Index (BMI)
BMI is a measure body composition, a cardiometabolic disease risk factor.
Time frame
Change from baseline to 1 week after completion of sleep intervention4
Central adiposity
Hip-to-waist ratio is a measure of central adiposity, a cardiometabolic disease risk factor.
Time frame
Change from baseline to 1 week after completion of sleep interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
VA Office of Research and Development
Collaborator
Source ClinicalTrials.gov