Treatments in Women Veterans With Insomnia and PTSD

Official title

Increasing PTSD Treatment Engagement in Women Veterans: Role of CBT for Insomnia (CDA 20-227)

Overview

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.

Detailed description

Posttraumatic stress disorder (PTSD) is the most common psychiatric service-connected condition among women Veterans, yet many women Veterans do not receive evidence-based psychotherapies for PTSD. PTSD and insomnia disorder are highly comorbid in women Veterans and research suggests that insomnia is a risk factor for PTSD development and severity, while healthy sleep is associated with improved mood, daytime functioning, enhanced learning, and increased emotion regulation. Addressing insomnia symptoms in women Veterans may offer an early point of intervention to reduce insomnia and some PTSD symptoms, while also providing a novel approach to improve patient engagement in PTSD treatments. No previous studies have examined the impact of trauma-informed Cognitive Behavioral Therapy for insomnia (CBT-I) on sleep and psychiatric symptoms among women Veterans with comorbid insomnia disorder and PTSD.

This pilot trial will compare trauma-informed CBT-I to a psychoeducational intervention in women Veterans with comorbid insomnia and 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. The first 5 eligible participants will receive trauma-informed CBT-I and provide feedback to guide intervention refinement. 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. A chart review will be conducted 6-months post-treatment to assess number of PTSD treatment appointments attended (i.e., treatment engagement measure). Qualitative interviews (n=20) will be conducted with pilot completers and non-completers to identifying other facilitators of and barriers to 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)]
• Readiness for Psychotherapy Index (RPI) [Time frame: Post-Treatment (approximately 1 week after last intervention session)]
• University of Rhode Island Change Assessment Scale (URICA) [Time frame: 3-month Follow-up (approximately 90 days after last intervention session)]
• Readiness for Psychotherapy Index (RPI) [Time frame: 3-month Follow-up (approximately 90 days after last intervention session)]
• Frequency of PTSD Treatment Appointments [Time frame: 6-month Follow-up (180 days after last intervention session)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles

Identifiers

NCT: NCT05683132 · CDX 22-009

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗