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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-month follow-up (approximately 90 days after last intervention session)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-month follow-up (approximately 90 days after last intervention session)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of PTSD Treatment Appointments
Readiness for Psychotherapy Index (RPI)
University of Rhode Island Change Assessment Scale (URICA)
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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,184 Total Patients Enrolled
26 Trials studying Insomnia
4,097 Patients Enrolled for Insomnia
Gwendolyn C Carlson, PhDPrincipal InvestigatorVA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman veteran over 18 and live in the community.I cannot read, write, or communicate in English.My PTSD or insomnia symptoms are currently in remission.I have undergone Cognitive Behavioral Therapy for Insomnia.I am too sick to participate in study activities.I am unable to give consent for myself.I do not have unstable medical or mental health conditions.I have trouble sleeping.I have completed more than 3 sessions of PTSD treatment.I have been diagnosed with moderate to severe sleep apnea.I experience symptoms of PTSD.
Research Study Groups:
This trial has the following groups:- Group 1: PTSD Psychoeducation
- Group 2: Trauma-Informed CBT-I
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there free opportunities for individuals to take part in this scientific experiment?
"As per the information on clinicaltrials.gov, this clinical trial is not recruiting participants at present. Initially posted on June 1st 2023 and last updated January 5th 2021, this study has no current openings; however, there are currently 517 other trials that need volunteers."
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