Cognitive Behavioral Therapy for Insomnia

Recruiting at2 trial locations

Overseen by Henry J. Orff, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Schizophrenia, Bipolar, Psychotic disorder, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Insomnia is a common condition in Veterans, with prevalence rates as high as 53% among treatment-seeking Veterans. Chronic untreated insomnia is associated with increased risk for functional impairment, psychiatric illness, suicidal ideation, unhealthy lifestyles, and decreased quality of life. Cognitive-Behavioral Therapy for Insomnia (CBT-I) is recognized as the first-line treatment for insomnia. Despite its proven efficacy, CBT-I is not always readily provided and/or accessible to Veterans. To address these limitations, behavioral sleep medicine specialists have endeavored to streamline CBT-I through development of time-shortened variations of CBT-I. Although these modifications show promise for advancing care and access, studies comparing brief treatments to standard CBT-I have yet to be performed. This investigation will therefore compare a 4-session brief CBT-I to VA standard 6-session CBT-I to evaluate whether a brief intervention can provide comparable benefits to sleep, functional, and psychiatric outcomes in Veterans with insomnia.

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.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective for treating persistent insomnia, even in people with other psychiatric conditions. It is considered the first-choice treatment for both simple insomnia and insomnia that occurs alongside other chronic disorders. ^{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 safe and effective for treating insomnia without the risks associated with sleeping medications. ^{2 4 6 7 8}

How is Cognitive Behavioral Therapy for Insomnia (CBT-I) different from other treatments for insomnia?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is unique because it is a non-drug treatment that focuses on changing sleep habits and misconceptions about sleep, making it the first-line treatment for both simple and complex insomnia cases. Unlike medications, CBT-I can be delivered in various formats, such as brief sessions, online, or even in a single workshop, which helps overcome barriers like cost and access to trained therapists. ^{1 2 6 9 10}

Research Team

Henry J. Orff, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Brief CBT-I (Behavioural Intervention)
• Standard CBT-I (Behavioural Intervention)

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.

Participant Groups

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

VA Finger Lakes Healthcare System

Collaborator

Trials

2

Recruited

350+

Findings from Research

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]

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]

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) 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]

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) 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 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]

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]

References

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

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. [2022]

2. England pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? [2022]

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

Cognitive behavioral treatment for insomnia is equally effective in insomnia patients with objective short and normal sleep duration. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

What are patients completing Cognitive Behavioral Insomnia Therapy telling us with their post-treatment Insomnia Severity Index scores? [2023]

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

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. [2022]

7. 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]

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

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

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. [2023]