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Sleep Education for Insomnia in PTSD
N/A
Recruiting
Led By Monica Kelly, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 1 week after completion of sleep intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of treating residual insomnia in older adults with PTSD on sleep, PTSD symptoms, cardiometabolic risk biomarkers, and quality of life.
Who is the study for?
This trial is for Veterans aged 55+ with PTSD and insomnia, living within 50 miles of the VA Sepulveda Ambulatory Care Center. Participants must have used VHA services in the past year and be able to attend meetings. Those with severe diseases, unstable conditions, other sleep disorders or recent substance use recovery are excluded.
What is being tested?
The study tests non-medication treatments for insomnia after Cognitive Processing Therapy (CPT) for PTSD in older adults. It compares Behavioral Sleep Education against General Sleep Education to see if they improve sleep, PTSD symptoms, cardiometabolic health, and quality of life.
What are the potential side effects?
Since this trial involves educational interventions rather than medications, typical drug side effects are not expected. However, participants may experience changes in sleeping patterns or stress levels due to new sleep routines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 1 week after completion of sleep intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 1 week after completion of sleep intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
24-hr ambulatory blood pressure monitoring (ABPM) blood pressure variability
Body Weight Changes
24-hr ambulatory blood pressure monitoring (ABPM) systolic/diastolic loads
+3 moreSecondary study objectives
Actigraphy
Body Mass Index (BMI)
Central adiposity
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: General Sleep Education InterventionExperimental Treatment1 Intervention
Manual-based education program focusing on general sleep provided in individual 60-minute sessions for 5 weekly sessions.
Group II: Behavioral Sleep Education InterventionExperimental Treatment1 Intervention
Manual-based education program focusing on behavioral sleep provided in individual 60-minute sessions for 5 weekly sessions.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentFED
1,668 Previous Clinical Trials
3,765,699 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,569 Previous Clinical Trials
10,314,128 Total Patients Enrolled
Monica Kelly, PhDPrincipal InvestigatorUCLA / VA Greater Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe heart or lung disease.I have been diagnosed with PTSD.I am unable to give consent for myself.I am a Veteran over 50 years old living in the community.I am too sick to participate in study activities or attend meetings.I have been diagnosed with insomnia.I have a diagnosed sleep disorder or severe untreated sleep issues.I do not have any unstable medical or mental health conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Behavioral Sleep Education Intervention
- Group 2: General Sleep Education Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05516277 — N/A