Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05683132
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2022-12-21
Brief Title:
Treatments in Women Veterans With Insomnia and PTSD
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Increasing PTSD Treatment Engagement in Women Veterans Role of CBT for Insomnia CDA 20-227
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Womens 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 n25 or the psychoeducational intervention n25 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 n50 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
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 n25 or the psychoeducational intervention n25 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 n50 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 Womens 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 n25 or the psychoeducational intervention n25 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 n50 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 ie treatment engagement measure Qualitative interviews n20 will be conducted with pilot completers and non-completers to identifying other facilitators of and barriers to PTSD treatment engagement
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 Womens 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 n25 or the psychoeducational intervention n25 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 n50 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 ie treatment engagement measure Qualitative interviews n20 will be conducted with pilot completers and non-completers to identifying other facilitators of and barriers to PTSD treatment engagement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None