Cognitive Behavioral Therapy for Insomnia

Recruiting at 2 trial locations

Overseen By Henry J Orff, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Schizophrenia, Bipolar, Psychotic disorder, others

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

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two versions of Cognitive Behavioral Therapy for Insomnia (CBT-I) to determine if a shorter, 4-session version is as effective as the standard 6-session therapy. The goal is to help Veterans with insomnia improve their sleep and overall quality of life. The trial seeks Veterans who have experienced insomnia for over three months, suffer from it at least three nights a week, and also have a mental health condition. As an unphased trial, it offers Veterans the opportunity to contribute to valuable research that could enhance insomnia treatments.

Will I have to stop taking my current medications?

The trial requires that participants have been on a stable medication regimen for at least 4 weeks before joining, so you will not need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive-Behavioral Therapy for Insomnia (CBT-I) is a safe and well-tolerated treatment. Studies have found that CBT-I works as well as sleep medications but without side effects. People who use CBT-I often continue to sleep better over time, experiencing fewer relapses.

Both the short and full versions of CBT-I are safe. They help people with insomnia by making it easier to fall asleep and increasing overall sleep time. Importantly, this therapy does not use medication, which can sometimes cause unwanted side effects.

Overall, CBT-I is considered the best choice for treating insomnia because it is both safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore different approaches to using Cognitive Behavioral Therapy for Insomnia (CBT-I). Unlike traditional insomnia treatments that often rely on medication, both Brief CBT-I and Standard CBT-I focus on behavioral interventions to improve sleep patterns. Brief CBT-I is designed to deliver effective results in a shorter time frame, making it more accessible for those with busy schedules. Meanwhile, the Standard CBT-I offers a comprehensive six-session program, providing more in-depth support for managing insomnia symptoms. These techniques aim to offer sustainable, drug-free solutions to improve sleep quality and overall well-being.

What evidence suggests that this trial's treatments could be effective for insomnia?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) effectively improves sleep. It works as well as medication but without side effects. In this trial, participants will receive either Standard CBT-I, the top recommended treatment for insomnia that helps many people sleep better, or Brief CBT-I, a shorter version that offers similar benefits in less time. Studies consistently show that CBT-I can reduce insomnia symptoms and improve overall health. Both types of CBT-I are effective options for addressing sleep problems. ^{1 6 7 8 9}

Who Is on the Research Team?

Henry J. Orff, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for Veterans with insomnia who have an Insomnia Severity Index score over 7, meet the criteria for a mental health disorder, haven't had CBT-I therapy in 2 years, and are on stable meds. It's not for those with certain severe mental illnesses, high suicide risk, other sleep disorders, or recent substance abuse.

Inclusion Criteria

I have been diagnosed with insomnia, affecting my daily life for over 3 months.

I haven't had professional CBT for insomnia in the last 2 years.

My medications have not changed in the last 4 weeks.

Exclusion Criteria

Suicidality more than 'medium risk' as determined by the VA Comprehensive Suicide Risk Assessment

I have sleep issues not related to insomnia, like sleep apnea or narcolepsy.

I have been diagnosed with schizophrenia, a psychotic disorder, or bipolar disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessment of sleep, functional, and psychiatric outcome measures

1 week

1 visit (in-person)

Treatment

Randomization and assignment to either 4-session brief CBT-I or 6-session standard CBT-I

6 weeks

4-6 visits (in-person or virtual)

Post-treatment Assessment

Assessment of sleep, functional, and psychiatric outcomes after treatment

1 week

1 visit (in-person)

Follow-up

3-month follow-up assessment to monitor long-term outcomes

12 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Brief CBT-I
• Standard CBT-I

Trial Overview The study compares two types of Cognitive-Behavioral Therapy for Insomnia (CBT-I): a brief version with four sessions and the standard VA version with six sessions. The goal is to see if the shorter treatment works as well as the longer one in improving sleep and overall functioning.

How Is the Trial Designed?

Group I: Cognitive-Behavioral Therapy for Insomnia (CBT-I) Active Control 2 Interventions

Compare two behavioral interventions for insomnia

Group II: Standard Cognitive-Behavioral Therapy for Insomnia (CBT-I) Active Control 2 Interventions

Standard VA 6 session version of CBT-I

Brief CBT-I is already approved in United States, European Union for the following indications:

Approved in United States as CBT-I for:

• Insomnia
• Chronic insomnia

Approved in European Union as CBT-I for:

• Insomnia
• Chronic insomnia

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

VA Finger Lakes Healthcare System

Collaborator

Trials

2

Recruited

350+

Published Research Related to This Trial

Cognitive behavioral therapy for insomnia (CBT-I) significantly improves insomnia symptoms, with 36% of patients achieving remission compared to only 16.9% in control groups, indicating its efficacy for those with comorbid conditions.

CBT-I shows medium to large effect sizes for various sleep parameters, such as sleep efficiency and sleep onset latency, and has a small positive effect on comorbid symptoms, particularly benefiting patients with psychiatric conditions more than those with medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. Wu, JQ., Appleman, ER., Salazar, RD., et al.[2022]

Cognitive-behavioral therapy for insomnia (CBT-I) is the preferred treatment for chronic insomnia, but it faces challenges such as a lack of trained therapists and a low response rate among patients.

Alternative methods to CBT-I, including bibliotherapy, phone psychotherapy, brief behavioral therapy, and online CBT-I, are gaining interest, and hypnotics can be used alongside CBT-I to enhance its effectiveness or as a standalone treatment when CBT-I is not accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. Pchelina, PV., Poluektov, MG.[2019]

A single 4-hour group workshop on cognitive behavioral treatment for insomnia (CBT-I) significantly improved insomnia symptoms in 45 participants, with Insomnia Severity Index scores dropping from an average of 20.09 to 11.89 after one month.

Participants also reported a reduction in sleep aid use, with 80% indicating better sleep quality and 20% achieving remission of insomnia, highlighting the effectiveness of this accessible treatment format.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. Okun, ML., Glidewell, RN.[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 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]

In a study of 92 patients with chronic insomnia who underwent a two-week inpatient cognitive behavioral treatment for insomnia (CBT-I), both those with short sleep duration (< 6 hours) and those with normal sleep duration (≥ 6 hours) showed similar improvements in subjective insomnia symptoms after treatment.

Interestingly, patients with short sleep duration demonstrated a better response in objective sleep measures post-treatment compared to those with normal sleep duration, suggesting that the classification of insomnia based on sleep duration may not significantly impact treatment decisions for CBT-I.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral treatment for insomnia is equally effective in insomnia patients with objective short and normal sleep duration. Crönlein, T., Wetter, TC., Rupprecht, R., et al.[2021]

Cognitive behavioral therapy for insomnia (CBT-I) is recognized as the first-line treatment for both uncomplicated insomnia and insomnia associated with other chronic disorders, demonstrating its broad efficacy.

This review aims to summarize efficacy data across various clinical and demographic factors and to outline future research and implementation strategies for CBT-I, highlighting its importance in treating sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? Muench, A., Vargas, I., Grandner, MA., et al.[2022]

Cognitive-behavioral therapy for insomnia (CBT-I) showed positive effects on sleep quality and depressive symptoms in a study of 30 psychiatric outpatients, with 38% achieving normal sleep after treatment.

While CBT-I led to significant improvements within the treatment group over 4 and 8 weeks, there were no significant differences when compared to the control group, suggesting that while beneficial, the effects may not be strong enough to outperform standard care alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. Wagley, JN., Rybarczyk, B., Nay, WT., et al.[2022]

A study involving 203 adults undergoing Cognitive Behavioral Insomnia Therapy (CBT-I) found that post-treatment insomnia severity scores (measured by the Insomnia Severity Index) were influenced more by pre-treatment perceptions of sleep quality and changes in fatigue and anxiety rather than actual sleep improvements.

The Insomnia Severity Index demonstrated strong reliability post-CBT-I (Cronbach's alpha of .88), but clinicians should be aware that patients' ratings may reflect their overall well-being, suggesting that CBT-I could be enhanced by also addressing fatigue and anxiety symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are patients completing Cognitive Behavioral Insomnia Therapy telling us with their post-treatment Insomnia Severity Index scores? Marway, OS., Lau, PH., Carmona, NE., et al.[2023]

Cognitive behavioral therapy for insomnia (CBT-I) was effective in improving insomnia symptoms over a 24-month follow-up among 59 media workers, with 62% of participants showing moderate improvement.

The study found that working hour arrangements did not impact the effectiveness of CBT-I, indicating that this treatment can benefit both daytime and shift workers with chronic insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. Järnefelt, H., Sallinen, M., Luukkonen, R., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6796223/

Cognitive-Behavioral Therapy for Insomnia: An Effective ... CBT-i produces results that are equivalent to sleep medication, with no side effects, fewer episodes of relapse, and a tendency for sleep to continue to improve ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1087079222000594

Effects of cognitive behavioral therapy for insomnia (CBT-I) ... The effects of cognitive behavioral therapy for insomnia (CBT-I) have consistently been shown to improve insomnia symptoms and other health-related outcomes.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2803668

Digital Cognitive Behavioral Therapy vs Medication ... In this study, clinical evidence suggested that combination therapy was optimal, and dCBT-I was more effective than medication therapy, with long-term benefits ...

4. nature.com nature.com/articles/s41746-025-01847-0

A randomized controlled trial of a digital cognitive ... Results indicate that digital CBT-I provides important benefits for older adults, offering strong potential to expand access to insomnia ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jsr.70058

Effectiveness of Cognitive Behavioural Therapy for ... Overall, based on the outcomes from studies included in this review, CBT-I did not improve mental health or quality of life in people with NDC.

6. sciencedirect.com sciencedirect.com/science/article/pii/S138994572500156X

Effectiveness of group-delivered cognitive behavioural ... Group-delivered CBT-I reduced insomnia severity compared with a waiting list. Group-delivered CBT-I is a suitable low-threshold insomnia treatment in primary ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3899314/

Impact of Brief Cognitive Behavioral Treatment for ... CBTi was equally as effective as hypnotic medication in improving other sleep-related outcomes (e.g., wake time after sleep onset, number of awakenings, sleep ...

8. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1413694/full

The efficacy of cognitive behavioral therapy for insomnia in ... CBT-I was effective in improving insomnia in adolescents and some sleep-related outcomes, including sleep onset latency, total sleep time, and sleep efficiency.

9. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2814164

Components and Delivery Formats of Cognitive Behavioral ... Cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment for chronic insomnia, based on its efficacy and safety profile. CBT-I is a ...