CBT for Insomnia in Veterans with Psychosis

(CBT-I Merit Trial)

Recruiting at 1 trial location

Overseen By Elizabeth A Klingaman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Currently in CBT-I, moving

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

156 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of Cognitive Behavioral Therapy for Insomnia (CBT-I) for veterans experiencing both psychosis and sleep difficulties. The researchers aim to determine if CBT-I can enhance sleep and overall daily functioning. Participants will either receive CBT-I, which includes strategies such as sleep habit changes and relaxation techniques, or engage in general health and wellness sessions. Veterans diagnosed with a serious mental illness, such as schizophrenia or major depression with psychotic features, and currently receiving outpatient mental health care, might be suitable candidates. As an unphased trial, this study provides veterans the chance to contribute to research that could improve therapeutic options for individuals with similar conditions.

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 prior data suggests that Cognitive Behavioral Therapy for Insomnia is safe for Veterans with psychosis?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally safe and well-tolerated. Studies have found that CBT-I helps people with sleep problems without causing major side effects. As a talking therapy rather than a medication, CBT-I presents fewer risks compared to drugs. People who try CBT-I usually experience improvements in their sleep with minimal risks. Additionally, CBT-I is widely used to treat insomnia, so its safety is well established. Overall, this therapy is considered a safe option for addressing sleep issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy for Insomnia (CBT-I) for veterans with psychosis because it offers a tailored approach that addresses the unique sleep challenges this group faces. Unlike standard sleep medications that primarily focus on inducing sleep chemically, CBT-I targets the root causes of insomnia by modifying behaviors and thoughts related to sleep. It incorporates techniques like stimulus control and relaxation methods, aiming to break the cycle of conditioned arousal that often disrupts sleep. By focusing on behavioral adjustments rather than medication, CBT-I provides a non-drug alternative that may reduce the risk of side effects and dependency, which is particularly beneficial for individuals managing psychosis.

What evidence suggests that CBT-I might be an effective treatment for insomnia in veterans with psychosis?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I), one of the treatments in this trial, can significantly alleviate sleep problems. Studies have found that CBT-I improves insomnia symptoms, sleep quality, tiredness, and daytime sleepiness in veterans with long-term insomnia. Specifically, veterans who received CBT-I experienced substantial improvements in their sleep issues. The therapy works by changing habits and thoughts that affect sleep, using methods like managing bedtime routines and relaxation techniques. These findings suggest that CBT-I effectively treats insomnia, especially for veterans. Another treatment arm in this trial involves Health and Wellness, which focuses on providing education and support for managing physical and emotional well-being. ^{5 6 7 8 9}

Who Is on the Research Team?

Elizabeth A. Klingaman, PhD

Principal Investigator

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Are You a Good Fit for This Trial?

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

Be actively participating in outpatient mental health services at designated site

I have been diagnosed with a specific type of mental health disorder, such as schizophrenia or major depression with psychosis.

Exclusion Criteria

Planning to move out of the area during the study period

I am currently undergoing cognitive behavioral therapy for insomnia.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy-Insomnia
• Health and Wellness

Trial Overview 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.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy-Insomnia Experimental Treatment 1 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 Wellness Active Control 1 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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Cognitive behavioral therapy for insomnia (CBT-I) is a safe and effective alternative to sleeping medications, but many patients are unaware or reluctant to engage with it, preferring sedative hypnotics instead.

Focus groups with 29 Veterans revealed that patients prefer a stepped-care approach to CBT-I, starting with self-management tools and progressing to provider-delivered therapy if necessary, highlighting the need for multiple outreach efforts and delivery options to increase engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). Koffel, E., Branson, M., Amundson, E., et al.[2021]

Cognitive Behavioural Therapy for Insomnia (CBTI) significantly improves sleep and daytime functioning in individuals with psychosis, but treatment outcomes can vary widely among patients, as identified in a study of 50 individuals.

Three distinct treatment response profiles were found: Strong responders showed broad improvements, Partial responders had sleep improvements without functional gains (predominantly female), and Non-responders exhibited minimal changes and higher levels of psychopathology, indicating that individual characteristics and treatment goals are crucial for predicting CBTI effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different patterns of treatment response to Cognitive-Behavioural Therapy for Insomnia (CBT-I) in psychosis. Waters, F., Chiu, VW., Dragovic, M., et al.[2021]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is recognized as the first-line treatment for chronic insomnia, even in patients with psychiatric disorders, but its implementation in inpatient settings is not well established.

A systematic review of 10 studies suggests that while there is limited research on adapting CBT-I for inpatient psychiatric care, preliminary findings indicate it may be feasible and potentially effective for improving insomnia and overall mental health in severely ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for insomnia in inpatient psychiatric care: a systematic review. Schneider, CL., Hertenstein, E., Nissen, C.[2023]

Cognitive behavior therapy for insomnia (CBT-I) shows moderate to large treatment effects (Cohen's d range of 0.35-2.2) for patients with insomnia related to various medical and psychiatric conditions, indicating its efficacy beyond primary insomnia.

Improving sleep through CBT-I may also lead to better outcomes in managing comorbid medical and psychological conditions, highlighting the need for further research on adapting CBT-I for specific disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. Smith, MT., Huang, MI., Manber, R.[2022]

Cognitive behavioral therapy for insomnia (CBTi) is a highly effective non-drug treatment for insomnia, showing comparable efficacy to sleep medications in randomized control trials, with better long-term maintenance of benefits after treatment ends.

Due to its strong empirical support, both the National Institutes of Health and the American Academy of Sleep Medicine recommend CBTi as the standard treatment for insomnia, highlighting its importance in addressing the public health burden of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia and its effective non-pharmacologic treatment. Siebern, AT., Manber, R.[2018]

Cognitive behavioral therapy for insomnia (CBTI) is the recommended first-line treatment for insomnia, but its high cost and limited availability of trained providers hinder access, especially for vulnerable groups like military personnel and the elderly.

Digital CBTI (dCBTI) is emerging as a promising and scalable alternative that could improve access to effective insomnia treatment, particularly for those who face barriers to traditional CBTI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia overview: epidemiology, pathophysiology, diagnosis and monitoring, and nonpharmacologic therapy. Dopheide, JA.[2021]

Cognitive Behavioral Therapy for Insomnia (CBTI) is recognized as the first-line treatment for chronic insomnia, supported by strong empirical evidence of its effectiveness, particularly in cases of primary insomnia.

Recent developments in CBTI show promising results for treating insomnia alongside other health conditions, its use as a maintenance therapy, and the potential for delivering CBTI through technology and in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in cognitive behavioral therapy as the first-line treatment of insomnia. Siebern, AT., Manber, R.[2022]

A case series with 15 patients showed that cognitive behavioral therapy for insomnia (CBT-I) significantly reduced both insomnia and resistant persecutory delusions, suggesting that treating sleep issues can alleviate psychotic symptoms.

The upcoming pilot randomized controlled trial (the Better Sleep Trial) will involve 60 patients and aims to test whether adding CBT-I to standard treatment improves sleep and reduces delusions and hallucinations, potentially providing a new effective intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Freeman, D., Startup, H., Myers, E., et al.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly reduced insomnia symptoms in patients with schizophrenia, as evidenced by improvements in the Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) over 8 weeks in a study of 63 participants.

The benefits of CBT-I for insomnia persisted for at least 4 weeks after the intervention, although it did not significantly impact psychotic, depressive, or anxiety symptoms compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of cognitive behavioral therapy for insomnia in schizophrenia patients with sleep Disturbance: A non-randomized, assessor-blind trial. Hwang, DK., Nam, M., Lee, YG.[2019]

Cognitive-behavioral therapy (CBT) for insomnia has shown promising effectiveness in treating sleep issues in patients with schizophrenia, highlighting a psychological approach to managing insomnia in this population.

Pharmacological treatments, such as eszopiclone and melatonin, have demonstrated significant short-term benefits for insomnia symptoms, suggesting that a combination of psychological and medication strategies may be effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An algorithmic approach to the management of insomnia in patients with schizophrenia. Joober, R., Cole, K., Tabbane, K., et al.[2018]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is an effective, evidence-based treatment for insomnia that is increasingly recognized as a standalone health issue, especially when it coexists with psychiatric disorders.

Recent studies indicate that CBT-I not only improves sleep quality but also positively impacts psychiatric symptoms in individuals with conditions like anxiety, depression, and PTSD, highlighting its dual benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioural Therapy for Insomnia in Psychiatric Disorders. Jansson-Fröjmark, M., Norell-Clarke, A.[2020]

Cognitive behavioral therapy for insomnia (CBT-I) was effective for veterans during the early months of the COVID-19 pandemic, with an average decrease of 9.9 points in Insomnia Severity Index scores and a 66% response rate among participants.

The effectiveness of CBT-I was similar whether delivered in-person or entirely via telehealth, demonstrating its adaptability and efficacy in challenging circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-person and telehealth treatment of veterans with insomnia disorder using cognitive behavioral therapy for insomnia during the COVID-19 pandemic. Martin, JL., DeViva, J., McCarthy, E., et al.[2023]

Cognitive Behavioral Therapy for insomnia (CBTi) is an effective alternative to medication for treating insomnia, which affects up to 30% of adults, and has been shown to improve various sleep-related outcomes such as sleep onset latency and sleep quality.

CBTi includes techniques like sleep hygiene and cognitive therapy, making it a safe and beneficial option for both adults and adolescents, although access to this therapy can be limited by certain barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy in the Treatment of Insomnia. Haynes, J., Talbert, M., Fox, S., et al.[2018]

Citations

1. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id1649937.pdf

Cognitive Behavioral Therapy for Insomnia With Prolonged ... This study compared the efficacy of integrated cognitive behavioral therapy for insomnia (CBT-I) and prolonged exposure (PE; CBTI-PE) therapy to ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005796713001976

Cognitive Behavioral Therapy for insomnia with veterans CBT-I was associated with large overall improvements in insomnia among Veterans. •. Therapist-rated patient adherence to CBT-I was significantly associated ...

3. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.11756

main outcomes of a randomized dismantling trial National evaluation of the effectiveness of cognitive behavioral therapy for insomnia among older versus younger veterans. Int J Geriatr ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24412462/

Cognitive Behavioral Therapy for insomnia with Veterans This paper examines the effectiveness of Cognitive Behavioral Therapy for insomnia (CBT-I) in Veterans and the effects of two process measures on CBT-I ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38888493/

The effectiveness of cognitive behavioral therapy for ... Results: CBT-I improved insomnia symptoms, perceived sleep quality, fatigue, and daytime sleepiness among older veterans with chronic insomnia.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04646200

CBT-I to Improve Functional Outcomes in Veterans With ... 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 ...

7. reporter.nih.gov reporter.nih.gov/project-details/10854777

Cognitive Behavioral Therapy For Insomnia (CBT ... A larger, fully powered trial is needed to evaluate efficacy of CBT-I delivered with these guidelines on insomnia and functioning of Veterans with psychosis. If ...

8. research.va.gov research.va.gov/about/funded_research/proj-details-FY2025.cfm?pid=700094

Cognitive Behavioral Therapy For Insomnia (CBT-I) to ... Title: Cognitive Behavioral Therapy For Insomnia (CBT-I) to Improve Functional Outcomes in Veterans with Psychosis ; Principal Investigator:.

9. trialx.com trialx.com/clinical-trials/listings/265432/cbt-i-to-improve-functional-outcomes-in-veterans-with-psychosis/

CBT-I to Improve Functional Outcomes in Veterans With ... The goal of this project is to examine the efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) for improving sleep and related ...