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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 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 1 week after completion of sleep intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 1 week after completion of sleep intervention for reporting.

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 more
Secondary study objectives
Actigraphy
Body Mass Index (BMI)
Central adiposity
+3 more

Awards & 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
1,664 Previous Clinical Trials
3,765,616 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,565 Previous Clinical Trials
10,263,022 Total Patients Enrolled
Monica Kelly, PhDPrincipal InvestigatorUCLA / VA Greater Los Angeles

Media Library

General Sleep Education Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05516277 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Behavioral Sleep Education Intervention, General Sleep Education Intervention
Post-Traumatic Stress Disorder Clinical Trial 2023: General Sleep Education Intervention Highlights & Side Effects. Trial Name: NCT05516277 — N/A
General Sleep Education Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05516277 — N/A
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05516277 — N/A
~76 spots leftby Mar 2026
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