Comparing therapies for insomnia and PTSD in women veterans
Increasing PTSD Treatment Engagement in Women Veterans: Role of CBT for Insomnia (CDA 20-227)
This study is testing a special therapy for insomnia designed for women veterans with PTSD to see if it helps them feel more ready and engaged in their treatment compared to a standard education program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (West Los Angeles, California) |
| Trial ID | NCT05683132 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to compare trauma-informed Cognitive Behavioral Therapy for Insomnia (CBT-I) with a psychoeducational intervention for women Veterans suffering from both insomnia and posttraumatic stress disorder (PTSD). The CBT-I intervention is specifically adapted to address trauma, while the psychoeducational intervention reflects standard care practices in a VA Women's Mental Health Clinic. The study will refine the CBT-I approach and assess its impact on PTSD treatment readiness and engagement among participants. Additionally, it will explore the mechanisms that influence variations in treatment readiness and engagement over time.
Who should consider this trial
Good fit: Ideal candidates are community-dwelling women Veterans aged 18 and older who have symptoms of both PTSD and insomnia.
Not a fit: Patients with severe health issues, unstable housing, or those who have previously engaged in specific PTSD treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve sleep quality and PTSD symptoms in women veterans, enhancing their overall mental health and treatment engagement.
How similar studies have performed: This approach is novel, as no previous studies have specifically examined the impact of trauma-informed CBT-I on women Veterans with comorbid insomnia and PTSD.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Community-dwelling women Veterans aged 18 years and older * Received care from VAGLAHS * Have symptoms of PTSD * Have symptoms of insomnia Exclusion Criteria: * 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
Where this trial is running
West Los Angeles, California
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Gwendolyn C Carlson, PhD — VA Greater Los Angeles Healthcare System, West Los Angeles, CA
- Study coordinator: Gwendolyn C Carlson, PhD
- Email: Gwendolyn.Carlson@va.gov
- Phone: (818) 891-7711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.