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New treatment option for Insomnia
Official title Treatments in Women Veterans With Insomnia and PTSD
ClinicalTrials.gov ID: NCT05683132
What this study is testing
- What it's testing
- This pilot trial will compare trauma-informed Cognitive Behavioral Therapy for Insomnia (CBT-I) to a psychoeducational intervention in women Veterans with comorbid insomnia and posttraumatic stress disorder (PTSD). The CBT-I intervention includes trauma-informed adaptations to an insomnia treatment and the psychoeducational intervention is modeled after usual care in a VA Women's Mental Health Clinic.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Community-dwelling women Veterans aged 18 years and older
- Received care from VAGLAHS
- Have symptoms of PTSD
- Have symptoms of insomnia
You likely can't join if
- Reported health or emotional problems, or use of drugs or alcohol that would make it difficult for them to participate in this study
- Too ill to engage in the study procedures
- Unable to self-consent to participate
- Previously engaged in \>1 session of Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment
- Previously engaged in \>1 session of PTSD psychoeducational group offered in VAGLAHS Women's Health Clinic
- Previously completed \>3 sessions of PTSD treatment (e.g., Cognitive Processing Therapy, Prolonged Exposure, and/or Eye Movement Desensitization and...
See the full eligibility criteria
- Community-dwelling women Veterans aged 18 years and older
- Received care from VAGLAHS
- Have symptoms of PTSD
- Have symptoms of insomnia
- Reported health or emotional problems, or use of drugs or alcohol that would make it difficult for them to participate in this study
- Too ill to engage in the study procedures
- Unable to self-consent to participate
- Previously engaged in \>1 session of Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment
- Previously engaged in \>1 session of PTSD psychoeducational group offered in VAGLAHS Women's Health Clinic
- Previously completed \>3 sessions of PTSD treatment (e.g., Cognitive Processing Therapy, Prolonged Exposure, and/or Eye Movement Desensitization and Reprocessing )
- Pregnant or pregnant within 6 months of study
- Untreated moderate to severe obstructive sleep apnea diagnosis as evidenced by Apnea Hypopnea Index (AHI) in chart and/or screens that indicate high risk
- Unstable housing
- Inability to read, write, and communicate in English
- Unstable medical or psychiatric disorders (which is a contraindication for behavioral treatment of insomnia)
- Remission of PTSD or insomnia symptoms
The study team makes the final eligibility decision.
Where it's taking place
- West Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.