Trauma-Informed CBT-I for PTSD-Related Insomnia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Substance abuse, Pregnancy, Sleep apnea, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your healthcare provider.
What data supports the effectiveness of the treatment Trauma-Informed CBT-I for PTSD-Related Insomnia?
Research shows that using cognitive-behavioral therapy for insomnia (CBT-I) can help improve sleep and reduce PTSD symptoms, making it easier for patients to engage in further PTSD treatments. Studies also indicate that treating insomnia alongside PTSD can lead to better overall outcomes than treating PTSD alone.
12345Is Trauma-Informed CBT-I safe for treating PTSD-related insomnia?
Research suggests that Cognitive Behavioral Therapy for Insomnia (CBT-I), including its trauma-informed versions, is generally safe for individuals with PTSD and insomnia. Studies have shown that it can improve sleep and PTSD symptoms without significant safety concerns.
12367How is the Trauma-Informed CBT-I treatment for PTSD-related insomnia different from other treatments?
Trauma-Informed CBT-I is unique because it combines cognitive behavioral therapy for insomnia (CBT-I) with trauma-focused psychoeducation, specifically addressing both sleep disturbances and PTSD symptoms. This approach prepares patients for further PTSD treatments by improving sleep and reducing PTSD symptoms, unlike standard treatments that may not address both issues simultaneously.
128910Eligibility Criteria
This trial is for women Veterans over 18 who have PTSD and insomnia, received care from VAGLAHS in the past year, and can consent to participate. It's not for those with severe health/emotional issues, drug/alcohol problems, prior CBT-I therapy or extensive PTSD treatment, recent pregnancy, untreated sleep apnea, unstable housing or medical conditions, or remission of symptoms.Inclusion Criteria
I am a woman veteran over 18 and live in the community.
Received care from VAGLAHS
I have trouble sleeping.
+1 more
Exclusion Criteria
Pregnant or pregnant within 6 months of study
I cannot read, write, or communicate in English.
Reported health or emotional problems, or use of drugs or alcohol that would make it difficult for them to participate in this study
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Baseline assessment includes measures of PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms
1 week
1 visit (in-person)
Treatment
Participants receive either trauma-informed CBT-I or a psychoeducational intervention in 5 one-on-one sessions
5 weeks
5 visits (in-person)
Follow-up
Participants are monitored for PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms
3 months
2 visits (in-person)
Extended Follow-up
Chart reviews and qualitative interviews conducted to assess PTSD treatment engagement and identify facilitators and barriers
6 months post-treatment
Participant Groups
The study compares trauma-informed Cognitive Behavioral Therapy for Insomnia (CBT-I) with a psychoeducational intervention in treating insomnia and improving PTSD treatment readiness among women Veterans. Participants will be randomly assigned to one of the two treatments which consist of five sessions each.
2Treatment groups
Experimental Treatment
Active Control
Group I: Trauma-Informed CBT-IExperimental Treatment1 Intervention
This intervention includes trauma-informed adaptations to standard treatment for insomnia, CBT-I
Group II: PTSD PsychoeducationActive Control1 Intervention
This intervention includes psychoeducation about PTSD symptoms modeled after usual care in a VA Women's Health Clinic.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los Angeles, CA
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Cognitive behavioral therapy for insomnia as a preparatory treatment for exposure therapy for posttraumatic stress disorder. [2022]Insomnia is present in a majority of individuals with posttraumatic stress disorder (PTSD). However, when both disorders are present, disagreements exist about whether to provide exposure therapy for PTSD before insomnia treatment, or vice versa. The current case study describes the psychological treatment of a psychotherapy-naive veteran with comorbid insomnia and PTSD. The patient initially refused exposure therapy for PTSD; thus, cognitive-behavioral therapy for insomnia (CBTi) was a first-step treatment. Cognitive Behavior Therapy for Insomnia provided insomnia symptom relief psychoeducation and self-monitoring of PTSD symptoms prepared the patient to enter exposure therapy. After six CBTi sessions, the patient completed seven sessions of trauma-specific exposure therapy. At the conclusion of treatment and at 90-day follow up, the patient demonstrated significant reductions in insomnia and PTSD symptoms. Findings support the safe and effective use of CBTi in patients with comorbid insomnia and PTSD to improve sleep and facilitate entry into exposure therapy for PTSD.
Treatment of comorbid sleep disorders and posttraumatic stress disorder in active duty military: Design and methodology of a randomized clinical trial. [2021]Many individuals with posttraumatic stress disorder (PTSD) also suffer from insomnia and nightmares, which may be symptoms of PTSD or constitute partially independent comorbid disorders. Sleep disturbances are resistant to current treatments for PTSD, and those suffering from PTSD, insomnia, and nightmares have worse PTSD treatment outcomes. In addition, insomnia and nightmares are risk factors for depression, substance abuse, anxiety, and suicide. Cognitive-Behavioral Therapy for Insomnia and Nightmares (CBT-I&N) and Cognitive Processing Therapy (CPT) for PTSD are first line treatments of these conditions. CPT does not typically address insomnia or nightmares, and CBT-I&N does not typically address other symptoms of PTSD. There are limited scientific data on how best to provide these therapies to individuals suffering with all three disorders. This project aims to inform the most effective way to treat individuals suffering from PTSD, insomnia, and nightmares, potentially changing the standard of care. U.S. military personnel and recently discharged Veterans who served in support of combat operations following 9/11 aged 18-65 with PTSD, insomnia, and nightmares (N = 222) will be randomly assigned to one of the following 18-session individual treatment conditions delivered over 12-weeks: (1) 6 sessions of CBT-I&N followed by 12 sessions of CPT; (2) 12 sessions of CPT followed by 6 sessions of CBT-I&N; or (3) 12 sessions of CPT followed by an additional 6 sessions of CPT. All participants will be assessed at baseline, during treatment, and at 1-week, 1-month, 3-months, and 6-months posttreatment. The primary outcome will be PTSD symptom severity.
Treatment of comorbid sleep disorders and posttraumatic stress disorder in U.S. active duty military personnel: A pilot randomized clinical trial. [2023]Insomnia and nightmares are common in patients with posttraumatic stress disorder (PTSD). They are associated with worse psychological and physical health and worse PTSD treatment outcomes. In addition, they are resistant to PTSD treatments, which do not typically address sleep disorders. Cognitive behavioral therapy for insomnia and nightmares (CBT-I&N) and cognitive processing therapy (CPT) for PTSD are first-line treatments, but limited evidence exists guiding the treatment of individuals with all three disorders. The current study randomized U.S. military personnel (N = 93) to one of three conditions: CBT-I&N delivered before CPT, CBT-I&N delivered after CPT, or CPT alone; all groups received 18 sessions. Across groups, participants demonstrated significantly improved PTSD symptoms. Because the study was terminated prematurely due to challenges with recruitment and retention, it was underpowered to answer the initially intended research questions. Nonetheless, statistical findings and relevant clinically meaningful changes were observed. Compared to participants who received CPT alone, those who received CBT-I&N and CPT, regardless of sequencing, demonstrated larger improvements in PTSD symptoms, d = -0.36; insomnia, d = -0.77; sleep efficiency, d = 0.62; and nightmares, d = -.53. Compared to participants who received CBT-I&N delivered before CPT, those who received CBT-I&N delivered after CPT demonstrated larger improvements in PTSD symptoms, d = 0.48, and sleep efficiency, d = -0.44. This pilot study suggests that treating comorbid insomnia, nightmares, and PTSD symptoms results in clinically meaningful advantages in improvement for all three concerns compared to treating PTSD alone.
Treatment of residual insomnia after CBT for PTSD: case studies. [2022]Insomnia is one of the most common symptoms of posttraumatic stress disorder (PTSD). Evidence suggests that insomnia may persist for many PTSD patients after other symptoms have responded to cognitive-behavioral therapy (CBT). The present article reports the effects of administering a five-session cognitive-behavioral insomnia treatment to 5 patients who responded to CBT for PTSD yet continued to report insomnia. Insomnia treatment was associated with improvements on subjective sleep measures (Pittsburgh Sleep Quality Index, Insomnia Severity Index, and Beliefs and Attitudes about Sleep Scale) and self-monitored sleep efficiency and related measures in 4 of 5 cases. Results highlight issues specific to treating insomnia in trauma populations and future directions for examining treatment of insomnia associated with PTSD.
Piloting cognitive-behavioral therapy for insomnia integrated with prolonged exposure. [2023]Approximately 35-61% of individuals with posttraumatic stress disorder (PTSD) report insomnia. Further, upward of 70% report clinically significant insomnia following PTSD treatment. There are converging lines of evidence suggesting that insomnia not only independently affects daytime functioning and worsens PTSD symptoms but also may compromise response to PTSD treatment, such as prolonged exposure (PE). Taken together, integrated insomnia and PTSD treatment may increase client-centered care and treatment outcomes.
A combined group treatment for nightmares and insomnia in combat veterans: a pilot study. [2022]Insomnia and nightmares are hallmarks of posttraumatic stress disorder (PTSD). Sleep disturbances in PTSD negatively impact clinical course and functioning. In this open clinical trial, the preliminary effects of a combined treatment for insomnia and nightmares in combat veterans with PTSD were assessed. Ten combat veterans participated in a 10-session group treatment combining cognitive-behavioral therapy for insomnia with exposure, rescripting, and relaxation therapy. Participants maintained daily sleep and dream diaries and completed self-report measures of sleep quality and PTSD symptoms pre- and posttreatment. Participants reported improvements in sleep and nightmares following treatment. Future research using controlled designs to evaluate this treatment is warranted.
Recent Advancements in Treating Sleep Disorders in Co-Occurring PTSD. [2023]Comorbidity of posttraumatic stress disorder (PTSD) and insomnia, nightmares, and obstructive sleep apnea (OSA) is high. We review recent research on psychotherapeutic and pharmacological interventions for sleep disorders in PTSD.
Posttraumatic sleep disturbances in veterans: A pilot randomized controlled trial of cognitive behavioral therapy for insomnia and imagery rehearsal therapy. [2023]Posttraumatic stress disorder (PTSD) is associated with sleep disturbances including insomnia and nightmares. This study compared cognitive behavioral therapy for insomnia (CBT-I) with CBT-I combined with imagery rehearsal therapy (IRT) for nightmares to evaluate if the combined treatment led to greater reductions in trauma-related sleep disturbances in Australian veterans.
Cognitive Behavioral Therapy for Insomnia and Imagery Rehearsal in Combat Veterans with Comorbid Posttraumatic Stress: A Case Series. [2020]Disrupted sleep is common among combat veterans and can negatively impact response to mental health treatments. A trial of cognitive behavioral therapy for insomnia (CBT-I) and imagery rehearsal therapy (IRT) for nightmares was conducted with 14 combat veterans diagnosed with insomnia, and who were experiencing posttraumatic stress and/or depression. In the case-series that follows veterans experienced clinically significant changes in sleep, and statistically significant reductions in insomnia, nightmare, depression and posttraumatic stress severity following treatment. Combined CBT-I and IRT is a promising treatment for patients with combat-related trauma and psychiatric morbidity.
Efficacy of a cognitive-behavioral treatment for insomnia and nightmares in Afghanistan and Iraq veterans with PTSD. [2022]Sleep disturbances are a core and salient feature of posttraumatic stress disorder (PTSD). Pilot studies have indicated that combined cognitive-behavioral therapy for insomnia (CBT-I) and imagery rehearsal therapy (IRT) for nightmares improves sleep as well as PTSD symptoms.