CBT for Insomnia in Veterans with Psychosis
(CBT-I Merit Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Currently in CBT-I, moving
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this project is to examine the efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) for improving sleep and related functional outcomes in Veterans with psychosis and insomnia.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It would be best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I) in veterans with psychosis?
Research shows that CBT-I can significantly reduce insomnia symptoms in patients with psychosis, and in some cases, it also lessens psychotic symptoms like delusions and hallucinations. Studies have found that CBT-I improves sleep quality and duration, and some patients experience better daytime functioning and mood.
12345Is Cognitive Behavioral Therapy for Insomnia (CBT-I) safe for humans?
Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered a safe treatment for insomnia, with no associated risks like those found with sleeping medications.
678910How is the treatment CBT-I unique for veterans with insomnia and psychosis?
CBT-I is unique because it not only targets insomnia but also helps reduce psychotic symptoms like delusions and hallucinations, which are often worsened by poor sleep. Unlike medications, CBT-I is a structured therapy that focuses on changing sleep habits and thoughts about sleep, making it a non-drug option that can be effective for veterans with both insomnia and psychosis.
12111213Eligibility Criteria
This trial is for Veterans aged 18-80 with serious mental illnesses like schizophrenia, various psychosis disorders, major depression with psychotic features, and schizotypal personality disorder. They must be receiving outpatient mental health services but not currently in CBT-I treatment or planning to move during the study.Inclusion Criteria
I have been diagnosed with a specific type of mental health disorder, such as schizophrenia or major depression with psychosis.
Be actively participating in outpatient mental health services at designated site
I am between 18 and 80 years old.
Exclusion Criteria
Planning to move out of the area during the study period
I am currently undergoing cognitive behavioral therapy for insomnia.
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) to address sleep difficulties, including sessions on assessment, psychoeducation, and behavioral strategies
12 weeks
Weekly sessions
Follow-up
Participants are monitored for changes in insomnia severity and health functioning after treatment
6 months
Assessment at 6 months post-treatment
Participant Groups
The trial is testing Cognitive Behavioral Therapy for Insomnia (CBT-I) to see if it can improve sleep and day-to-day functioning in Veterans who have both insomnia and psychosis.
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Behavioral Therapy-InsomniaExperimental Treatment1 Intervention
CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime.
Group II: Health and WellnessActive Control1 Intervention
Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating).
Cognitive Behavioral Therapy-Insomnia is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as CBT-I for:
- Chronic insomnia
- Insomnia in veterans with psychosis
- Insomnia in patients with post-traumatic stress disorder (PTSD)
- Insomnia in patients with chronic pain disorders
- Insomnia in patients with cancer
- Insomnia in patients with HIV
- Insomnia in patients with depression
- Insomnia in patients with alcohol dependency
🇪🇺 Approved in European Union as CBT-I for:
- Chronic insomnia
- Insomnia in patients with psychiatric comorbidities
- Insomnia in patients with medical comorbidities
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDBaltimore, MD
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PAPhiladelphia, PA
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
The effects of using cognitive behavioural therapy to improve sleep for patients with delusions and hallucinations (the BEST study): study protocol for a randomized controlled trial. [2022]Patients with psychosis frequently report difficulties getting or staying asleep (insomnia). Dissatisfaction with sleep is high. Insomnia should be treated in this group, but typically it is not even assessed. Importantly, recent evidence indicates that insomnia triggers and exacerbates delusions and hallucinations. The clinical implication is that if the insomnia is treated then the psychotic symptoms will significantly lessen. In a case series with 15 patients with persecutory delusions resistant to previous treatment this is exactly what we found: cognitive behavioural therapy for insomnia (CBT-I) led to large reductions in both the insomnia and delusions. The clear next step is a pilot randomized controlled test. The clinical aim is to test whether CBT-I can reduce both insomnia and psychotic symptoms. The trial will inform decisions for a definitive large-scale evaluation.
The effect of cognitive behavioral therapy for insomnia in schizophrenia patients with sleep Disturbance: A non-randomized, assessor-blind trial. [2019]This non-randomized, assessor blind study evaluated the effects of cognitive behavioral therapy for insomnia (CBT-I) delivered in a group format on insomnia symptoms as well as psychotic, depressive, and anxiety symptoms in schizophrenia patients (n = 63) recruited from residential or rehabilitative facilities in Seoul, South Korea. Thirty-one patients received four sessions of CBT-I in groups of 2-9 patients in addition to usual care, while the control group (n = 32) received no additional intervention. The Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI), Psychotic Symptoms Rating Scale (PSYRATS), Anxiety Sensitivity Index (ASI), and Beck Depression Inventory (BDI) were administered at baseline, week 4, and week 8. Both groups showed significant time-group interactions on the ISI and PSQI. Post hoc testing showed that, compared to the control group, the CBT-I group showed significant reductions in ISI and PSQI at both week 4 and week 8. For the PSYRATS, ASI, and BDI scores, the CBT-I and control groups showed significant time-group interactions, but post hoc testing revealed no significant group differences at either week 4 or week 8. Therefore, CBT-I was effective for reducing insomnia symptoms in patients with schizophrenia and the effect lasted for 4 weeks after the intervention.
Different patterns of treatment response to Cognitive-Behavioural Therapy for Insomnia (CBT-I) in psychosis. [2021]People with psychosis benefit enormously from Cognitive Behavioural Therapy for Insomnia (CBTI), although some variability exists in treatment outcomes. While recent efforts have focused on profiling sleep at treatment initiation, an alternative methodological approach involves using treatment response as a starting point to better understand what constitutes an effective treatment. This study used Grade of Membership analysis (GoM) to estimate the occurrence of unique treatment outcomes and associated patient characteristics. Outcome measures included changes in sleep (self-reported latency, efficiency, duration, quality), functional outcomes (daytime dysfunction, negative mood, need for sleep medication) and treatment goal, collected in 50 individuals with a psychotic disorder and insomnia who underwent CBT-I treatment. Three distinct profiles were identified: (1) Strong responders, who met their treatment goals and showed broad improvements in both sleep and functional domains; (2) Partial responders, who showed sleep improvements (particularly in total sleep time), without noticeable gains in function, and who were predominantly female; and (3) Non-responders who showed little treatment response and failed to meet their treatment goals. This group was also more likely to have greater psychopathology (high levels of negative mood and psychotic symptoms, and antipsychotic medication dosage). These findings suggest that (i) CBT-I can serve to improve sleep and daytime function (although sleep can improve independently from function), (ii) client-elicited treatment goals are a key predictor of CBT-I response, (iii) other important variables associated with treatment response include sleep profile, clinical acuity, and sex.
An algorithmic approach to the management of insomnia in patients with schizophrenia. [2018]Insomnia is an important problem in patients with schizophrenia and is an emerging area of interest for researchers. We propose a treatment algorithm that synthesizes the various psychological and pharmacological interventions for insomnia in this population.
Cognitive behavioural therapy for insomnia in inpatient psychiatric care: a systematic review. [2023]Insomnia is highly prevalent among patients with psychiatric disorders. According to current guidelines, cognitive behavioural therapy for insomnia (CBT-I) represents the first-line treatment for chronic insomnia, also for patients with psychiatric comorbidity. While recent studies have demonstrated that CBT-I not only improves insomnia but also other health outcomes in patients with psychiatric disorders and comorbid insomnia in outpatient settings, the level of implementation and treatment potential of CBT-I in inpatient psychiatry is less clear. The objective of this systematic review is to present and discuss studies that have adapted CBT-I for inpatient psychiatric care. PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and PsycINFO, were searched until June 2023. A total of 10 studies were identified, with the majority being non-randomised trials without comparison groups and small sample sizes. With preliminary character, studies report feasibility and potential efficacy in inpatient settings. Together, this review identifies a paucity of studies on CBT-I or derivates in inpatient psychiatry. Despite challenging in this setting, studies adapting CBT-I to the needs of severely ill patients and hospital settings might have the potential to improve mental health care.
"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). [2021]Cognitive behavioral therapy for insomnia (CBT-I) provides safe and effective insomnia care without the risk of harm associated with sleeping medications. Unfortunately, few patients with insomnia engage with CBT-I, with most using sedative hypnotics instead. This study conducted focus groups with patients with insomnia who were treated with sleeping medication, including older adults, women, and patients with chronic pain. The goal was to explore the perspectives of high-risk, CBT-I naïve patients on increasing access and engagement with CBT-I.
Cognitive Behavioral Therapy in the Treatment of Insomnia. [2018]Insomnia disorder is present in as much as 30% of the general adult population. Given the significant adverse effects of pharmacotherapy, cognitive behavioral therapy (CBT) has been found to be an effective alternative in individuals with insomnia. CBT for insomnia (CBTi) encompasses sleep hygiene, stimulus control, sleep restriction, cognitive therapy, and relaxation training. In this article we review evidence that establishes CBTi as a useful treatment affecting remission, sleep onset latency, wakefulness after sleep, sleep efficiency, and sleep quality in adults with insomnia to include older adults and adolescents. In addition, we briefly highlight various CBTi delivery methods as well as barriers to accessing this safe and effective therapy.
New developments in cognitive behavioral therapy as the first-line treatment of insomnia. [2022]Insomnia is the most common sleep disorder. Psychological, behavioral, and biological factors are implicated in the development and maintenance of insomnia as a disorder, although the etiology of insomnia remains under investigation, as it is still not fully understood. Cognitive behavioral therapy for insomnia (CBTI) is a treatment for insomnia that is grounded in the science of behavior change, psychological theories, and the science of sleep. There is strong empirical evidence that CBTI is effective. Recognition of CBTI as the first-line treatment for chronic insomnia (National Institutes of Health consensus, British Medical Association) was based largely on evidence of its efficacy in primary insomnia. The aim of this article is to provide background information and review recent developments in CBTI, focusing on three domains: promising data on the use of CBTI when insomnia is experienced in the presence of comorbid conditions, new data on the use of CBTI as maintenance therapy, and emerging data on the delivery of CBTI through the use of technology and in primary care settings.
Insomnia and its effective non-pharmacologic treatment. [2018]Emerging data underscores the public health and economic burden of insomnia evidenced by increased health risks; increased health care utilization; and work domain deficits (absenteeism and reduced productivity). Cognitive behavioral therapy for insomnia (CBTi) is a brief and effective non-pharmacologic treatment for insomnia that is grounded in the science of sleep medicine and the science of behavior change and psychological theory, and in direct comparisons with sleep medication in randomized control trials that demonstrate that CBTi has comparable efficacy with more durable long-term maintenance of gains after treatment discontinuation. The high level of empirical support for CBTi has led the National Institutes of Health Consensus and the American Academy of Sleep Medicine Practice Parameters to make the recommendation that CBTi be considered standard treatment. The aim of this report is to increase awareness and understanding of health care providers of this effective treatment option.
Insomnia overview: epidemiology, pathophysiology, diagnosis and monitoring, and nonpharmacologic therapy. [2021]Insomnia, whether short-term or chronic, is a common condition. It has a negative impact on vulnerable patient groups, including active military personnel and veterans, patients with coexisting psychiatric and medical disorders, those in life transitions such as menopause, and elderly persons. Although cognitive behavioral therapy for insomnia (CBTI) is first-line treatment for insomnia, its high cost and a lack of trained providers has prevented widespread uptake. Now, digital CBTI (dCBTI) is emerging as a scalable option with the potential to overcome these barriers in managed care. The first part of this article reviews the epidemiology and pathophysiology of insomnia with a focus on vulnerable patient groups. The second part explores the rapidly evolving landscape of nondrug therapy for insomnia. The underlying concepts and supporting evidence for CBTI and dCBTI are presented, including their utility in vulnerable patient groups.
Cognitive Behavioural Therapy for Insomnia in Psychiatric Disorders. [2020]Insomnia means difficulties in initiating or maintaining sleep and is commonly comorbid with psychiatric disorders. From being considered secondary to primary psychiatric disorders, comorbid insomnia is now considered an independent health issue that warrants treatment in its own right. Cognitive behavioural therapy for insomnia (CBT-I) is an evidence-based treatment for insomnia. The effects from CBT-I on comorbid psychiatric conditions have received increasing interest as insomnia comorbid with psychiatric disorders has been associated with more severe psychiatric symptomologies, and there are studies that indicate effects from CBT-I on both insomnia and psychiatric symptomology. During recent years, the literature on CBT-I for comorbid psychiatric groups has expanded and has advanced methodologically. This article reviews recent studies on the effects from CBT-I on sleep, daytime symptoms and function and psychiatric comorbidities for people with anxiety, depression, bipolar disorder, psychotic disorders and post-traumatic stress disorder. Future strategies for research are suggested.
In-person and telehealth treatment of veterans with insomnia disorder using cognitive behavioral therapy for insomnia during the COVID-19 pandemic. [2023]Cognitive behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for insomnia disorder. The goal of this study was to evaluate clinical benefits of CBT-I to veterans with insomnia disorder during the early months of the COVID-19 pandemic using an uncontrolled observational design.
Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]Insomnia is a pervasive problem for many patients suffering from medical and psychiatric conditions. Even when the comorbid disorders are successfully treated, insomnia often fails to remit. In addition to compromising quality of life, untreated insomnia may also aggravate and complicate recovery from the comorbid disease. Cognitive behavior therapy for insomnia (CBT-I) has an established efficacy for primary insomnia, but less is known about its efficacy for insomnia occurring in the context of medical and psychiatric conditions. The purpose of this article is to present a rationale for using CBT-I in medical and psychiatric disorders, review the extant outcome literature, highlight considerations for adapting CBT-I procedures in specific populations, and suggest directions for future research. Outcome studies were identified for CBT-I in mixed medical and psychiatric conditions, cancer, chronic pain, HIV, depression, posttraumatic stress disorder, and alcoholism. Other disorders discussed include: bipolar disorder, eating disorders, generalized anxiety, and obsessive compulsive disorder. The available data demonstrate moderate to large treatment effects (Cohen's d, range=0.35-2.2) and indicate that CBT-I is a promising treatment for individuals with medical and psychiatric comorbidity. Although the literature reviewed here is limited by a paucity of randomized, controlled studies, the available data suggest that by improving sleep, CBT-I might also indirectly improve medical and psychological endpoints. This review underscores the need for future research to test the efficacy of adaptations of CBT-I to disease specific conditions and symptoms.