NCT05683132 · VA Office of Research and Development
Treatments in Women Veterans With Insomnia and PTSD
What this study is about
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).
View original scientific description
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. The study objectives are to: 1) Iteratively refine the structure and materials of trauma-informed CBT-I in preparation for a pilot trial, 2) Pilot test the effects of trauma-informed CBT-I on PTSD treatment readiness and engagement in a sample of women Veterans, and 3) Examine potential mechanisms underlying variations in PTSD treatment readiness and engagement over time among women Veterans. Women Veterans with insomnia and comorbid PTSD who receive care at Sepulveda and West Los Angeles facilities will be recruited for the study. Those who pass an initial eligibility screen will be enrolled and written informed consent will be obtained. A baseline assessment will be completed that includes measures of PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms. Then Veterans who meet all eligibility criteria will be randomly assigned to trauma-informed CBT-I (n=25) or the psychoeducational intervention (n=25). Both treatments will be provided in 5 one-on-one sessions by a trained instructor who is supervised by a behavioral sleep medicine specialist. All randomized participants (n=50) will have 2 follow-up assessments (post-treatment and 3-months). The follow-up assessments will collect information on PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms. Chart reviews will be conducted 6-months post-treatment to assess number of PTSD treatment appointments attended (treatment engagement measure). Qualitative interviews will be conducted to identify mechanisms underlying PTSD treatment engagement.
Interventions
BEHAVIORAL
Trauma-Informed CBT-I
5 individual sessions incorporating behavioral and cognitive therapy components and trauma-informed adaptations with a trained instructor.
BEHAVIORAL
PTSD Psychoeducation
5 individual sessions incorporating psychoeducation about PTSD symptoms with a trained instructor.
Primary outcome measures
University of Rhode Island Change Assessment Scale (URICA)
Time frame: Post-Treatment (approximately 1 week after last intervention session)
The problem-specific URICA (psychotherapy version) is a 32-item questionnaire that assesses respondent's readiness to change at entrance to treatment. The URICA includes 4 subscales measuring the stages of change: Precontemplation (P), Contemplation (C), Action (A), and Maintenance (M). To obtain a readiness to change score, first sum items from each subscale and divide by 7 to get the mean for each subscale. One item from each subscale is omitted for the subscale mean calculations for the 32-item version of the URICA (items 4, 9, 20, and 31). Then sum the means from the Contemplation, Action, and Maintenance subscales and subtract the Precontemplation mean (C + A + M - PC = Readiness). Scores range from -2 to 14. Higher scores will indicate greater readiness.
Readiness for Psychotherapy Index (RPI)
Time frame: Post-Treatment (approximately 1 week after last intervention session)
The RPI is a 20-item questionnaire that assesses respondent's readiness to engage in psychotherapy. The RPI consists of 4 subscales including: disinterest, perseverance, openness, and distress. To obtain a readiness score, sum items from each subscale. Then sum the scores from the perseverance, openness, and distress subscales and subtract the disinterest subscale score (Perseverance + Openness + Distress - Disinterest = Readiness). Scores range from -10 to 70. Higher scores will indicate greater readiness.
University of Rhode Island Change Assessment Scale (URICA)
Time frame: 3-month Follow-up (approximately 90 days after last intervention session)
The problem-specific URICA (psychotherapy version) is a 32-item questionnaire that assesses respondent's readiness to change at entrance to treatment. The URICA includes 4 subscales measuring the stages of change: Precontemplation (P), Contemplation (C), Action (A), and Maintenance (M). To obtain a readiness to change score, first sum items from each subscale and divide by 7 to get the mean for each subscale. One item from each subscale is omitted for the subscale mean calculations for the 32-item version of the URICA (items 4, 9, 20, and 31). Then sum the means from the Contemplation, Action, and Maintenance subscales and subtract the Precontemplation mean (C + A + M - PC = Readiness). Scores range from -2 to 14. Higher scores will indicate greater readiness.
Readiness for Psychotherapy Index (RPI)
Time frame: 3-month Follow-up (approximately 90 days after last intervention session)
The RPI is a 20-item questionnaire that assesses respondent's readiness to engage in psychotherapy. The RPI consists of 4 subscales including: disinterest, perseverance, openness, and distress. To obtain a readiness score, sum items from each subscale. Then sum the scores from the perseverance, openness, and distress subscales and subtract the disinterest subscale score (Perseverance + Openness + Distress - Disinterest = Readiness). Scores range from -10 to 70. Higher scores will indicate greater readiness.
Frequency of PTSD Treatment Appointments
Time frame: 6-month Follow-up (180 days after last intervention session)
A structured medical record review will be performed 6 months post-treatment to obtain information on utilization of VA healthcare services during the time period between the last intervention session and 180 days after the last intervention session. Reviews will identify the presence and frequency of mental health appointments with evidence-based practice (EBP) health codes and/or Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) note templates, which are psychotherapies to treat PTSD. Attendance will be measured as a count, ranging from 0 to an unlimited value. Higher counts will indicate greater engagement in PTSD treatment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- West Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 21, 2026 · Source of record for eligibility and locations