Cognitive Behavioral Therapy for Insomnia

Overseen By Sarah Emert

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Idaho State University

Must not be taking: Sedating medications

Disqualifiers: Brain damage, Pregnancy, Untreated sleep disorders, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve Cognitive Behavioral Therapy for Insomnia (CBTi). Researchers aim to determine if modifications to CBTi can benefit individuals with chronic sleep issues, such as insomnia, which can impact brain health and memory. The trial will test various methods within CBTi, including adjustments to sleep habits and routines, to identify the most effective approach. Individuals with insomnia who are stable on non-sedating medications may be suitable candidates for this trial. As an unphased trial, it presents a unique opportunity to contribute to innovative research that could enhance sleep therapy for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be stable on any prescribed, non-sedating medications for at least one month before participating.

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

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBTi) is generally safe and well-tolerated. Studies have found that CBTi can improve sleep quality and offers long-term benefits compared to sleep medications, which often have side effects. Importantly, CBTi itself usually has no major side effects, though some people might feel a bit tired or less motivated.

The main parts of this therapy include:

1. **Sleep Compression**: This involves gradually spending less time in bed to improve sleep. It is as effective as sleep medication but without the side effects.

2. **Sleep Restriction**: This reduces the time spent awake in bed to enhance sleep. It works well, though initially, it might cause anxiety due to reduced sleep. This usually improves as sleep patterns stabilize.

3. **Stimulus Control**: This technique helps associate the bedroom only with sleep. It is effective, but initially, it might cause increased wakefulness at night until the body adjusts.

Overall, CBTi has shown promising results without the risks of medication. However, experiences can vary, and some people might feel a bit uncomfortable at first as they adjust to new sleep habits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new approaches to treating insomnia with Cognitive Behavioral Therapy for Insomnia (CBTi). Unlike standard options like medication, which often work by targeting sleep chemicals in the brain, these CBTi techniques focus on changing behaviors and thoughts related to sleep. The Stimulus Control Core helps retrain the brain to associate the bedroom only with sleep, while the Sleep Restriction Core works to consolidate sleep by limiting time spent awake in bed. Meanwhile, the Sleep Compression Core gradually reduces time in bed over weeks to improve sleep quality. These methods offer a non-drug alternative that could reduce side effects and dependency associated with traditional sleep medications.

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

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBTi) effectively treats insomnia. This trial will evaluate different components of CBTi, including stimulus control, sleep restriction, and sleep compression, each as separate treatment arms. Studies indicate that CBTi can reduce insomnia symptoms by half and improve both sleep quality and mental sharpness. Stimulus control therapy, one of the trial's arms, helps people fall asleep about 19 minutes faster and improves sleep quality. Sleep restriction therapy, another arm, enhances both sleep duration and quality. Sleep compression, the third arm, gradually reduces time spent in bed to make sleep more efficient, offering results similar to sleep medication but without side effects. Overall, CBTi is considered a safe, reliable, and effective treatment for those struggling with insomnia. ^{1 2 6 7 8}

Who Is on the Research Team?

Sarah Emert

Principal Investigator

Idaho State University

Are You a Good Fit for This Trial?

This trial is for adults with insomnia disorder, aiming to improve their sleep and cognitive functioning. Participants should have a diagnosis of insomnia and be interested in non-medication therapy. Those currently on sedatives or with inconsistent treatment histories may not qualify.

Inclusion Criteria

I am seeking help for my trouble sleeping.

I have been on the same non-sedating medication for at least a month.

Exclusion Criteria

Inability to speak and read English

Moderate to severe brain damage, assessed by the MoCA

I cannot attend weekly therapy sessions, neither in-person nor online.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Waitlist Control

Participants assigned to the waitlist control group will wait 4 weeks before starting treatment, maintaining their regular schedule

4 weeks

1 visit (in-person) for post-waitlist assessment

Treatment

Participants receive modified Cognitive Behavioral Therapy for Insomnia (CBTi) to improve sleep and cognitive function

6 weeks

Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) at 1 month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• CBTi: Sleep Compression Core
• CBTi: Sleep Restriction Core
• CBTi: Stimulus Control Core

Trial Overview The study tests modified Cognitive Behavioral Therapy for Insomnia (CBTi), which includes techniques like stimulus control, sleep restriction, and sleep compression. It's designed to see if these methods can help people sleep better without medication and potentially protect against cognitive decline.

How Is the Trial Designed?

Group I: Waitlist Control Active Control 1 Intervention

Waitlist Control. Those randomly assigned to the WLC group will be told that they must wait 4 weeks for treatment, which is a fraction of the typical wait period in routine clinical care. During this time the participants are asked to maintain their regular schedule. At the end of 4 weeks, they will complete the baseline assessments again, which will serve as the post-waitlist assessment and then scheduled with a clinician to receive CBTi.

Group II: Stimulus Control Active Control 1 Intervention

Stimulus control.45 People with insomnia may fail to associate the bedroom with sleep, and instead may associate it with worrying, planning, or recreation. Stimulus control includes the following instructions: (1) go to bed only when sleepy; (2) only use your bed or bedroom for sleep (or sex); (3) if you do not fall asleep quickly (i.e., 15 minutes), leave the bed, do something in another room, and return to bed only when you feel a strong sleep urge; (4) if you do not fall asleep quickly upon returning to bed, repeat instruction 3; (5) use your alarm to awaken at the same time every morning regardless of duration of sleep obtained; and (6) do not take long naps.

Group III: Sleep Restriction Active Control 1 Intervention

Sleep restriction.46 People with insomnia often spend too much time awake in bed. Sleep restriction modifies the participant's sleep window so total time in bed is no more than 30 minutes beyond their average total sleep time to consolidate sleep, thus improving depth, continuity, and consistency. As the participant's sleep efficiency improves with treatment (i.e., the percentage of total time spent asleep within the sleep window), their sleep window is also increased. However, the shortened sleep window often causes increased anxiety.

Group IV: Sleep Compression Active Control 1 Intervention

Sleep compression.47,48 Sleep compression encourages time-in-bed restrictions. Unlike sleep restriction, sleep compression allows a gradual reduction in time-in-bed over the course of multiple weeks. Typically, average total sleep time and total time in bed values are calculated from one or more weeks of daily sleep diaries. The difference between these two values is then divided by the number of weeks remaining and the allotted time in bed duration is compressed by this calculated value weekly, by delaying bedtime or advancing wake time.

CBTi: Sleep Compression Core is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for Insomnia for:

• Insomnia disorder
• Chronic insomnia

Approved in European Union as Cognitive Behavioural Therapy for Insomnia for:

• Insomnia disorder
• Chronic insomnia

Approved in Canada as Cognitive Behavioral Therapy for Insomnia for:

• Insomnia disorder
• Chronic insomnia

Who Is Running the Clinical Trial?

Idaho State University

Lead Sponsor

Trials

10

Recruited

2,600+

Published Research Related to This Trial

Brief behavioral treatment for insomnia (BBTI) is a 4-session program that can effectively reduce insomnia symptoms, such as difficulty falling asleep and waking up during the night, making it a practical option for non-psychologist health professionals to administer.

BBTI has shown promising results, including cases of full remission from insomnia, and ongoing clinical trials are exploring its efficacy in different treatment settings and delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Behavioral Treatment of Insomnia. Gunn, HE., Tutek, J., Buysse, DJ.[2019]

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]

A web-delivered cognitive behavior therapy for insomnia (CBTI) program significantly reduced anxiety and insomnia symptoms in a study of 22 adults, demonstrating its efficacy as a treatment option.

Participants in the CBTI group experienced greater improvements in sleep onset latency and overall sleep quality compared to those receiving general sleep hygiene information, suggesting that online CBTI can effectively address insomnia and its comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Anxiolytic Effects of Cognitive Behavior Therapy for Insomnia: Preliminary Results from a Web-delivered Protocol. Pillai, V., Anderson, JR., Cheng, P., et al.[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 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 (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]

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]

A randomized controlled trial is evaluating the effectiveness of provider-supported self-help Cognitive Behavioral Therapy for Insomnia (Tele-Self CBTi) in veterans with insomnia, aiming to improve access to treatment for this population with significant sleep difficulties.

If proven effective, Tele-Self CBTi could serve as a crucial entry-level intervention for veterans, potentially addressing the high demand for insomnia treatment and improving overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial. Ulmer, CS., Bosworth, HB., Zervakis, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10002474/

Cognitive Behavioral Therapy for Insomnia (CBT-I): A Primer Finally, one study showed that CBT-I could even be effective in treating insomnia among “real world” patients (i.e., those with comorbid medical and behavioral ...

2. sleepfoundation.org sleepfoundation.org/insomnia/treatment/cognitive-behavioral-therapy-insomnia

Cognitive Behavioral Therapy for Insomnia (CBT-I) Most individuals who try CBT-I experience improvements to their insomnia and better quality sleep. CBT-I is considered effective for both short- ...

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

Cognitive-Behavioral Therapy for Insomnia: Effective Treatment 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1389945725001133

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 ...

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

Effectiveness of Cognitive Behavioural Therapy for ... At post-treatment, 92% of participants who completed treatment and assessment no longer met insomnia criteria. Proportion reduced to 83% at FU.

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

Components and Delivery Formats of Cognitive Behavioral ... Meta-analyses have shown that CBT-I as a package is associated with improved sleep quality in chronic insomnia with or without comorbidities. ... However, the ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05226585?cond=%22Sleep%20Initiation%20and%20Maintenance%20Disorders%22&viewType=Table&rank=7

Mechanisms of Change in Cognitive Behavioral Therapy ... The purpose of this study is to investigate the mechanisms of change in Cognitive Behavioral Therapy for insomnia (CBTi) in a sample of adults aged 50-65.

8. nature.com nature.com/articles/s41598-023-28853-0

Comparative efficacy of onsite, digital, and other settings ... The primary aim of the study was to compare the efficacy of available CBT-I settings on insomnia severity.