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

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{1 2 11 12 13}

Research Team

Elizabeth A. Klingaman, PhD

Principal Investigator

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

Eligibility 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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 (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 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 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 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]

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]

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 (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 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]

References

1. England 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. [2022]

2. Ireland 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. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Different patterns of treatment response to Cognitive-Behavioural Therapy for Insomnia (CBT-I) in psychosis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

An algorithmic approach to the management of insomnia in patients with schizophrenia. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for insomnia in inpatient psychiatric care: a systematic review. [2023]

6. England 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). [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy in the Treatment of Insomnia. [2018]

8. New Zealand pubmed.ncbi.nlm.nih.gov

New developments in cognitive behavioral therapy as the first-line treatment of insomnia. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Insomnia and its effective non-pharmacologic treatment. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Behavioural Therapy for Insomnia in Psychiatric Disorders. [2020]

12. United States 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. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]