Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-06-01
2028-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Trauma-Informed CBT-I
This intervention includes trauma-informed adaptations to standard treatment for insomnia, CBT-I
Trauma-Informed CBT-I
5 individual sessions incorporating behavioral and cognitive therapy components and trauma-informed adaptations with a trained instructor.
PTSD Psychoeducation
This intervention includes psychoeducation about PTSD symptoms modeled after usual care in a VA Women's Health Clinic.
PTSD Psychoeducation
5 individual sessions incorporating psychoeducation about PTSD symptoms with a trained instructor.
Interventions
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Trauma-Informed CBT-I
5 individual sessions incorporating behavioral and cognitive therapy components and trauma-informed adaptations with a trained instructor.
PTSD Psychoeducation
5 individual sessions incorporating psychoeducation about PTSD symptoms with a trained instructor.
Eligibility Criteria
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Inclusion Criteria
* Received care from VAGLAHS
* Have symptoms of PTSD
* Have symptoms of insomnia
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Gwendolyn C Carlson, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Locations
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VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CDX 22-009
Identifier Type: -
Identifier Source: org_study_id
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