Cognitive Behavioral Therapy for PTSD
Recruiting in Palo Alto (17 mi)
Overseen byJean C Beckham, PhD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Duke University
Must be taking: Benzodiazepines
Must not be taking: Psychoactive, Cardiovascular
Disqualifiers: CVD history, Substance use, Bipolar, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Posttraumatic stress disorder (PTSD) is a chronic, debilitating psychiatric disorder that is associated with an increased risk of death due to cardiovascular disease (CVD). Most individuals with PTSD also have Insomnia Disorder. Sleep quality is also associated with risk factors for CVD. The objective of this study is to examine how insomnia contributes to CVD risk among people with PTSD. The investigators will also examine whether this risk can be decreased with treatment for Insomnia Disorder.
Will I have to stop taking my current medications?
The trial requires that participants have stable medications and doses for at least one month before and during the study. If your medications are not stable, you may need to adjust them before participating.
What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia for PTSD?
Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve sleep, reduce nightmares, and enhance overall PTSD symptoms in individuals with PTSD. Studies have found that combining CBT-I with other PTSD treatments leads to better outcomes than treating PTSD alone.
12345Is Cognitive Behavioral Therapy for PTSD safe for humans?
Cognitive Behavioral Therapy (CBT) for PTSD, including its variations like CBT for insomnia and nightmares, has been studied in military personnel and veterans. These studies suggest that CBT is generally safe and can lead to improvements in PTSD symptoms, sleep quality, and nightmares without significant safety concerns.
14678How does Cognitive Behavioral Therapy for Insomnia differ from other treatments for PTSD?
Cognitive Behavioral Therapy for Insomnia (CBT-I) is unique because it specifically targets sleep disturbances like insomnia, which are common in PTSD patients, and can be used as a preparatory step before exposure therapy. This approach not only improves sleep but also helps patients better engage in trauma-specific therapies, potentially leading to greater overall improvements in PTSD symptoms.
14589Eligibility Criteria
This trial is for adults aged 40-59 with chronic PTSD and insomnia, without a history of cardiovascular events or severe mental health conditions like psychosis. Participants must not be pregnant, have restless leg syndrome, sleep apnea, or other major health issues that could interfere with the study.Inclusion Criteria
I am between 40 and 59 years old.
I have been diagnosed with chronic PTSD for at least 3 months.
I am between 40 and 59 years old.
+2 more
Exclusion Criteria
I experience seizures.
You work overnight.
Meets criteria for a psychotic spectrum disorder or bipolar disorder
+20 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive cognitive behavioral therapy for insomnia (CBT-I) or are monitored in a minimal contact control condition for 8 weeks
8 weeks
8 visits (in-person or virtual)
Follow-up
Participants are monitored for changes in sleep efficiency, blood pressure, and cardiovascular risk biomarkers
6 months
2 visits (in-person)
Participant Groups
The study tests if Cognitive Behavior Therapy for Insomnia can reduce cardiovascular risk in PTSD patients. It involves weekly phone check-ins to monitor progress and adherence to the therapy.
2Treatment groups
Experimental Treatment
Group I: Minimal Contact Control ConditionExperimental Treatment1 Intervention
Participants assigned to this condition will be contacted every week for eight weeks and monitored regarding their insomnia symptoms.
Group II: Cognitive Behavior Therapy for Insomnia (CBT-I)Experimental Treatment1 Intervention
Participants assigned to this arm will receive eight sessions of a well-established, evidence-based therapy called cognitive behavior therapy for insomnia (CBT-I).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke University Medical CenterDurham, NC
Loading ...
Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
References
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.
Benefits of Cognitive Behavioral Therapy for Insomnia for Women Veterans with and without Probable Post-Traumatic Stress Disorder. [2022]This study compared the benefits of cognitive-behavioral therapy for insomnia for sleep, mental health symptoms, and quality of life (QoL) in a sample of women veterans with and without probable post-traumatic stress disorder (PTSD) comorbid with insomnia disorder.
Cognitive behavioral therapy for insomnia in posttraumatic stress disorder: a randomized controlled trial. [2022]Examine whether cognitive behavioral therapy for insomnia (CBT-I) improves sleep in posttraumatic stress disorder (PTSD) as well as nightmares, nonsleep PTSD symptoms, depression symptoms, and psychosocial functioning.
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.
Predictors of cognitive behavioral therapy outcomes for insomnia in veterans with post-traumatic stress disorder. [2020]Insomnia is a well-recognized co-morbid condition in veterans with post-traumatic stress disorder (PTSD) with negative personal and social consequences. Cognitive behavioral therapy (CBT) is considered an efficacious treatment, yet little attention has been devoted to treatment response in this population. The aim of this study was to identify factors that may predict clinical response to CBT for insomnia (CBT-I) in veterans with PTSD.
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.
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.
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 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.