Clinical trial NCT05683132: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
PTSD
Women Veterans
Keywords: Insomnia Disorder
Posttraumatic Stress Disorder
Women's Health
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-01-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment
* Previously engaged in PTSD psychoeducational group offered in VAGLAHS Women's Health Clinic
* Previously completed \>3 sessions of PTSD treatment (Cognitive Processing Therapy and/or Prolonged Exposure)
* 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

Primary outcomes:
measure: University of Rhode Island Change Assessment Scale (URICA)
timeFrame: Post-Treatment (approximately 1 week after last intervention session)
measure: Readiness for Psychotherapy Index (RPI)
timeFrame: Post-Treatment (approximately 1 week after last intervention session)
measure: University of Rhode Island Change Assessment Scale (URICA)
timeFrame: 3-month Follow-up (approximately 90 days after last intervention session)
measure: Readiness for Psychotherapy Index (RPI)
timeFrame: 3-month Follow-up (approximately 90 days after last intervention session)
measure: Frequency of PTSD Treatment Appointments
timeFrame: 6-month Follow-up (180 days after last intervention session)
Secondary outcomes:
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Gwendolyn C Carlson, PhD
role: PRINCIPAL_INVESTIGATOR
References: