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Trauma-Informed CBT-I for PTSD-Related Insomnia

N/A
Recruiting
Led By Gwendolyn C Carlson, PhD
Research Sponsored by VA Office of Research and Development
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 3-month follow-up (approximately 90 days after last intervention session)
Awards & highlights
No Placebo-Only Group

Summary

This trial compares treatments to help women Veterans with insomnia and PTSD improve their PTSD treatment readiness & engagement.

Who is the study for?
This trial is for women Veterans over 18 who have PTSD and insomnia, received care from VAGLAHS in the past year, and can consent to participate. It's not for those with severe health/emotional issues, drug/alcohol problems, prior CBT-I therapy or extensive PTSD treatment, recent pregnancy, untreated sleep apnea, unstable housing or medical conditions, or remission of symptoms.
What is being tested?
The study compares trauma-informed Cognitive Behavioral Therapy for Insomnia (CBT-I) with a psychoeducational intervention in treating insomnia and improving PTSD treatment readiness among women Veterans. Participants will be randomly assigned to one of the two treatments which consist of five sessions each.
What are the potential side effects?
As this trial involves psychological therapies rather than medications, typical side effects associated with drugs are not expected. However participants may experience emotional discomfort when discussing traumatic experiences during sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-month follow-up (approximately 90 days after last intervention session)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-month follow-up (approximately 90 days after last intervention session) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency of PTSD Treatment Appointments
Readiness for Psychotherapy Index (RPI)
University of Rhode Island Change Assessment Scale (URICA)

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
Active Control
Group I: Trauma-Informed CBT-IExperimental Treatment1 Intervention
This intervention includes trauma-informed adaptations to standard treatment for insomnia, CBT-I
Group II: PTSD PsychoeducationActive Control1 Intervention
This intervention includes psychoeducation about PTSD symptoms modeled after usual care in a VA Women's Health Clinic.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,766 Total Patients Enrolled
Gwendolyn C Carlson, PhDPrincipal InvestigatorVA Greater Los Angeles Healthcare System, West Los Angeles, CA

Media Library

PTSD Psychoeducation Clinical Trial Eligibility Overview. Trial Name: NCT05683132 — N/A
Post-Traumatic Stress Disorder Research Study Groups: PTSD Psychoeducation, Trauma-Informed CBT-I
Post-Traumatic Stress Disorder Clinical Trial 2023: PTSD Psychoeducation Highlights & Side Effects. Trial Name: NCT05683132 — N/A
PTSD Psychoeducation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05683132 — N/A
~57 spots leftby Dec 2026
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