Sleep Education for Insomnia in PTSD
Recruiting in Palo Alto (17 mi)
Overseen byMonica Kelly, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Los Angeles
Disqualifiers: Substance use, Severe cardiovascular, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This pilot randomized controlled trial will address a gap in knowledge related to addressing modifiable risk factors for cardiometabolic disease through treating residual insomnia, sleep difficulties that remain after successful treatment of another condition, in the context of PTSD in understudied older adults. This study provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT) followed by one of two non-medication sleep education and treatment programs for sleep problems that remain after completing PTSD treatment in older adults with PTSD. The aims of this project are to evaluate 1) the added benefits of treating residual insomnia on sleep and PTSD symptoms; 2) the added benefits of treating residual insomnia following CPT on cardiometabolic risk biomarkers and quality of life; and 3) the durability of the sleep, PTSD, cardiometabolic and quality of life benefits of treating residual insomnia following CPT at 6-month follow-up in older adults with PTSD.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Since the study focuses on non-medication treatments, it's likely you can continue your current medications, but you should confirm with the study team.
What data supports the effectiveness of the treatment for insomnia in PTSD?
Research shows that cognitive behavioral therapy for insomnia (CBT-I) is effective in reducing insomnia severity and improving sleep quality. It has been successfully used in various formats, such as workshops and self-help programs, and is beneficial for people with PTSD who often experience sleep problems.
12345Is sleep education for insomnia in PTSD safe for humans?
Cognitive Behavioral Therapy for Insomnia (CBT-I), which includes sleep education, is generally considered safe for humans. It is widely recommended as a first-line treatment for insomnia and has been used in various settings without significant safety concerns.
13467How does the Sleep Education for Insomnia in PTSD treatment differ from other treatments for this condition?
This treatment is unique because it focuses on sleep education specifically tailored for individuals with PTSD, addressing both insomnia and trauma-related sleep disturbances. Unlike standard cognitive behavioral therapy for insomnia (CBT-I), it may incorporate elements like imagery rehearsal therapy (IRT) for nightmares, making it more comprehensive for PTSD-related sleep issues.
24789Eligibility Criteria
This trial is for Veterans aged 55+ with PTSD and insomnia, living within 50 miles of the VA Sepulveda Ambulatory Care Center. Participants must have used VHA services in the past year and be able to attend meetings. Those with severe diseases, unstable conditions, other sleep disorders or recent substance use recovery are excluded.Inclusion Criteria
I have been diagnosed with PTSD.
Received care from a Veterans Health Administration (VHA) facility in the prior year
I am a Veteran over 50 years old living in the community.
+2 more
Exclusion Criteria
I do not have severe heart or lung disease.
Active substance use or in recovery with less than 90 days of sobriety
I am unable to give consent for myself.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Baseline Evaluation
Participants complete baseline evaluations including health questionnaires, blood pressure monitoring, glucose monitoring, and sleep pattern assessments
1 week
1 visit (in-person), home monitoring
PTSD Treatment
Participants receive Cognitive Processing Therapy (CPT) for PTSD
12 weeks
12 sessions (in-person)
Sleep Education Program
Participants are randomly assigned to one of two sleep education programs to address residual insomnia
5 weeks
5 sessions (in-person)
Follow-up
Participants are monitored for sleep, PTSD symptoms, cardiometabolic health, and quality of life
6 months
3 assessments (in-person)
Participant Groups
The study tests non-medication treatments for insomnia after Cognitive Processing Therapy (CPT) for PTSD in older adults. It compares Behavioral Sleep Education against General Sleep Education to see if they improve sleep, PTSD symptoms, cardiometabolic health, and quality of life.
2Treatment groups
Experimental Treatment
Group I: General Sleep Education InterventionExperimental Treatment1 Intervention
Manual-based education program focusing on general sleep provided in individual 60-minute sessions for 5 weekly sessions.
Group II: Behavioral Sleep Education InterventionExperimental Treatment1 Intervention
Manual-based education program focusing on behavioral sleep provided in individual 60-minute sessions for 5 weekly sessions.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Greater Los Angeles Healthcare SystemNorth Hills, CA
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
VA Office of Research and DevelopmentCollaborator
References
Low-Intensity Cognitive Behavioral Therapy for Insomnia as the Entry of the Stepped-Care Model in the Community: A Randomized Controlled Trial. [2021]Background/Objectives: Diverse low-intensity interventions are available as the entry points in the stepped-care model for insomnia. The study aims to compare a single-session cognitive behavioral therapy for insomnia (CBTI) workshop, self-help CBTI and sleep hygiene education (SHE) workshop among adults with insomnia in the community, in terms of insomnia severity, anxiety and depressive symptoms, the quality of life, treatment adherence and credibility.Participants: Two-hundred-and-ten Hong Kong adults with DSM-5 defined insomnia disorder for at least one month were recruited in the community.Methods: A three-arm-parallel, active-treatment-controlled and assessor-blinded randomized controlled trial was performed. Participants were block-randomized to the half-day CBTI workshop, self-help Internet-delivered CBTI and half-day SHE workshop groups evenly. Eight-week and 16-week post-baseline follow-ups were conducted. The primary outcome measure was the Insomnia Severity Index whereas the secondary measures included the Hospital Anxiety and Depression Scale, the Short-Form Six-Dimension Health Survey, treatment adherence and credibility.Results: All arms demonstrated a significant treatment effect on insomnia severity, anxiety and depressive symptoms and the quality of life. However, there was no difference between arms. Treatment adherence did not vary among the three groups, but treatment credibility of the self-help group dropped whereas that of the CBTI workshop group rose after interventions (p = .037).Conclusions: Despite the lack of between-group differences, self-help CBTI can be considered as the preferred entry point of the stepped-care model for insomnia. It demonstrates comparable efficacy and adherence rate to the workshop-based interventions, and is highly accessible and convenient with few resources required.
Evaluation of sleep and therapeutic education needs of military with PTSD. [2023]Sleep disorders in post-traumatic stress disorder (PTSD) are both diagnostic (nocturnal reliving) and prognostic. Poor sleep worsens the daytime symptomatology of PTSD and makes it resistant to treatment. However, no specific treatment is codified in France to treat these sleep disorders although sleep therapies (cognitive behavioural therapy for insomnia, psychoeducation and relaxation) have proven for years to be effective in treating insomnia. Therapeutic sessions can be part of a therapeutic patient education program, which is a model for the management of chronic pathologies. It allows for an improvement in a patient's quality of life and enhanced medication compliance. We therefore carried out an inventory of sleep disorders of patients with PTSD. First, we collected data by means of sleep diaries concerning the population's sleep disorders at home. Then we assessed the population's expectations and needs regarding its management of sleep, thanks to a semi-qualitative interview. The data from sleep diaries, which was consistent with the literature, showed that our patients suffered from severe sleep disorders that strongly impact their daily lives, with 87% of patients having an increased sleep onset latency, and 88% having nightmares. We observed a strong demand from patients for specific support for these symptoms, 91% expressing an interest in a TPE program targeting sleep disorders. Thanks to the data collected, the emerging themes for a future therapeutic patient education program targeting sleep disorders of soldiers with PTSD are: sleep hygiene; management of nocturnal awakenings, including nightmares; and psychotropic drugs.
Dissemination of CBTI to the non-sleep specialist: protocol development and training issues. [2022]Strong evidence supports the efficacy of cognitive behavioral therapy for insomnia (CBTI). A significant barrier to wide dissemination of CBTI is the lack of qualified practitioners. We describe challenges and decisions made when developing a CBTI dissemination program in the Veterans Health Administration (VHA). The program targets mental health clinicians from different disciplines (psychiatry, psychology, social work, and nursing) with varying familiarity and experience with general principles of cognitive behavioral therapies (CBT). We explain the scope of training (how much to teach about the science of sleep, comorbid sleep disorders, other medical and mental health comorbidities, and hypnotic-dependent insomnia), discuss adaptation of CBTI to address the unique challenges posed by comorbid insomnia, and describe decisions made about the strategy of training (principles, structure and materials developed/recommended). Among these decisions is the question of how to balance the structure and flexibility of the treatment protocol. We developed a case conceptualization-driven approach and provide a general session-by-session outline. Training licensed therapists who already have many professional obligations required that the training be completed in a relatively short time with minimal disruptions to training participants' routine work responsibilities. These "real-life" constraints shaped the development of this competency-based, yet pragmatic training program. We conclude with a description of preliminary lessons learned from the initial wave of training and propose future directions for research and dissemination.
Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. [2023]: Cognitive behavioral treatment for insomnia (CBT-I) is the first line of treatment for insomnia. However, the expanded use of CBT-I is limited by the number of specialty-trained clinicians in addition to the duration and cost of individual treatment sessions. One viable option is a single-session educational group format delivered by a trained health educator.
Cognitive-behavioral therapy of insomnia: a clinical case series study of patients with co-morbid disorders and using hypnotic medications. [2018]Cognitive-behavioral therapy for insomnia (CBTi) has demonstrated considerable efficacy within randomized clinical trials and case-series designs. This case-series study in a community sleep medicine clinic assessed the effectiveness of an eight-session CBTi protocol chronic insomnia patients who were allowed to continue their use of hypnotics (intent-to-treat n = 48), administered by a clinical psychology doctoral student receiving training and supervision in CBTi by a behavioral sleep medicine certified clinician. Outcome measures included daily sleep diaries, self-report measures on insomnia severity, dysfunctional beliefs and attitudes about sleep, daytime sleepiness, as well as medication usage. Patients showed significant improvements in sleep onset latency, wake time after sleep onset, sleep efficiency, insomnia severity, and dysfunctional sleep beliefs from pre- to post-treatment. No changes were seen in daytime sleepiness - patients were not excessively sleepy either before or after treatment. Use of sleep medication declined significantly from 87.5% pre-treatment to 54% post-treatment, despite no active efforts to encourage patients to withdraw. Results demonstrate that a CBTi conducted in a community sleep medicine clinic with patients not required to discontinue sleep-related medications can have similar effects as therapy delivered among those not on medication.
The European Academy for Cognitive Behavioural Therapy for Insomnia: An initiative of the European Insomnia Network to promote implementation and dissemination of treatment. [2020]Insomnia, the most prevalent sleep disorder worldwide, confers marked risks for both physical and mental health. Furthermore, insomnia is associated with considerable direct and indirect healthcare costs. Recent guidelines in the US and Europe unequivocally conclude that cognitive behavioural therapy for insomnia (CBT-I) should be the first-line treatment for the disorder. Current treatment approaches are in stark contrast to these clear recommendations, not least across Europe, where, if any treatment at all is delivered, hypnotic medication still is the dominant therapeutic modality. To address this situation, a Task Force of the European Sleep Research Society and the European Insomnia Network met in May 2018. The Task Force proposed establishing a European CBT-I Academy that would enable a Europe-wide system of standardized CBT-I training and training centre accreditation. This article summarizes the deliberations of the Task Force concerning definition and ingredients of CBT-I, preconditions for health professionals to teach CBT-I, the way in which CBT-I should be taught, who should be taught CBT-I and to whom CBT-I should be administered. Furthermore, diverse aspects of CBT-I care and delivery were discussed and incorporated into a stepped-care model for insomnia.
Modularized iCBT‑I self-learn training for university staff-prevention and early intervention in the SARS-CoV-2 crisis: A pilot study. [2022]Insomnia is a widespread disease in adults and has a high prevalence rate. As sleep disturbances are a risk factor concerning mental and physical health, prevention and early intervention are necessary. Thus, the aim of this study was to implement a self-learning prevention and early intervention training for university staff members. We adapted an established cognitive behavioral therapy for insomnia (CBT-I) intervention as an online version for use during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) crisis.
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.