Increasing PTSD Treatment Engagement in Women Veterans: Role of CBT for Insomnia (CDA 20-227)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- University of Rhode Island Change Assessment Scale (URICA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Outcome assessors will be blinded from group assignment and the treatment content. Participants will be blinded to the content of the treatment arm to which they are not assigned.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Community-dwelling women Veterans
- •Received care from VA Greater Los Angeles Healthcare System (VAGLAHS)
- •Have symptoms of post-traumatic stress disorder (PTSD)
- •Have symptoms of insomnia
排除标准
- •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 VA Greater Los Angeles Healthcare System (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
研究组 & 干预措施
PTSD Psychoeducation
This intervention includes psychoeducation about PTSD symptoms modeled after usual care in a VA Women's Health Clinic.
干预措施: PTSD Psychoeducation (Behavioral)
Trauma-Informed CBT-I
This intervention includes trauma-informed adaptations to standard treatment for insomnia, CBT-I
干预措施: Trauma-Informed CBT-I (Behavioral)
结局指标
主要结局
University of Rhode Island Change Assessment Scale (URICA)
时间窗: 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)
时间窗: 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
时间窗: 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.
University of Rhode Island Change Assessment Scale (URICA)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点