32 Participants NeededMy employer runs this trial

Cognitive Behavioral Therapy for Insomnia

(SLEEP-OK Trial)

YS
Overseen ByYeonsu Song, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a culturally adapted sleep program based on cognitive behavioral therapy for insomnia (CBT-I), specifically designed for older Korean immigrants in the U.S. The goal is to evaluate how well this program improves sleep for individuals who struggle with sleep issues and find mainstream treatments less effective due to cultural differences. Participants will either try the new CBT-I-based sleep intervention or receive general sleep information. Korean immigrants who are at least 60 years old and experience sleep problems might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to explore a culturally tailored approach to better sleep.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this CBT-I based sleep intervention is safe?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I) is generally safe and well-tolerated. Studies indicate that it can be as effective as sleep medication but without the side effects often associated with drugs. Most participants in these studies did not report any negative effects. However, a few mentioned feeling tired or less motivated after starting CBT-I, though these feelings are uncommon.

CBT-I is often recommended as the first treatment choice for adults with insomnia. It employs various methods to improve sleep. The therapy has been shown to help with daytime tiredness and mood, and it may even enhance quality of life. While some people report mild negative effects at the beginning of the therapy, these usually resolve quickly.

Overall, CBT-I is considered a safe option for those dealing with sleep problems.12345

Why are researchers excited about this trial?

Researchers are excited about this cognitive behavioral therapy for insomnia (CBT-I) sleep intervention because it offers a culturally adapted approach to treating insomnia. Unlike traditional treatments that often rely on medication, which can have side effects and dependency issues, this program uses a tailored educational method to tackle sleep problems. By focusing on behavioral changes and cognitive strategies, it aims to provide a more sustainable and holistic solution to improving sleep quality without the need for drugs.

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 treats long-term sleep problems. One study found that CBT-I improved insomnia severity scores by more than 8 points, significantly enhancing sleep quality. Approximately 45% of participants who used CBT-I experienced longer sleep durations. This therapy is as effective as sleep medication but without the side effects. Many individuals continue to sleep better even after therapy concludes, demonstrating long-term benefits. Participants in this trial may receive a culturally adapted sleep education program based on CBT-I principles, while others will receive general sleep information as part of the control group.24678

Are You a Good Fit for This Trial?

This trial is for Korean immigrants in the US who are at least 60 years old, can speak, read, and write Korean, have significant insomnia symptoms, can move around on their own (with or without help), and show normal thinking abilities.

Inclusion Criteria

* Score less than 5 on STOP-BANG (or proceed with an additional testing \[Watch Peripheral Arterial Tonometry (WatchPAT) and the Epworth Sleepiness Scale if score is equal to or greater than 5 on STOP-BANG)
* Korean immigrants (i.e., being a resident of the United States with a birthplace in Korea)
* Able to speak, read, and write in Korean
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a culturally adapted sleep education program or general sleep information

6-8 weeks
Weekly sessions

Follow-up

Participants are monitored for sleep health outcomes and intervention adherence

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CBT-I based sleep intervention
  • Sleep Education

Trial Overview

The study compares a culturally adapted cognitive behavioral therapy for insomnia (CBT-I) program with general sleep education to see which helps older Korean immigrants with chronic insomnia improve their sleep.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Sleep Intervention ProgramExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Citations

Cognitive-Behavioral Therapy for Insomnia: An Effective and ...

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 ...

Outcomes from a combined cognitive behavioral therapy ...

Insomnia Severity Index (ISI) scores improved by 8.28 points (95 % CI 7.56, 9.01, d = −1.63) and Pittsburgh Sleep Quality Index (PSQI) scores by 4.96 points (95 ...

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 ...

Cognitive Behavioral Therapy for Insomnia (CBT-I): A Primer

CBT-I is a multi-component treatment for insomnia that targets difficulties with initiating and/or maintaining sleep and is delivered over the course of six to ...

How Effective is CBT-I for Treating Insomnia?

45% of patients treated with CBT-I are able to increase their total nightly sleep time significantly by the end of the treatment period[3]; The ...

Negative effects of cognitive behavioral therapy for insomnia

Evidence exists that cognitive behavioral therapy for insomnia (CBT-I) can lead to negative effects (e.g., exhaustion, reduced motivation). Psychometrically ...

Recording and reporting of adverse events during a ...

CBT-I is a safe treatment that is well-tolerated by cancer survivors. The majority of participants did not experience AEs that could be ...

Few Studies Adequately Report Adverse Events in CBT for ...

Only about 7% of clinical trials that address cognitive behavioral therapy (CBT) for insomnia adequately report adverse events, according to ...