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

Trial Summary

What is the purpose of this trial?

Sleep is a biological need, crucial for maintaining overall health and resiliency. Sleep disorders disrupt this normal functioning. Insomnia disorder is the most prevalent sleep disorder and yields costs to the U.S. Healthcare System in billions of dollars per year. Chronic insomnia has been linked to numerous physical and psychological health outcomes as well as increased mortality. There is also evidence that insomnia is a risk factor for worse inflammation, worse neurological functioning, cognitive performance, and mild cognitive impairment, including cognitive decline, Alzheimer's disease, and faster genetic and brain aging. Moreover, in patients with Alzheimer's disease those with insomnia showed a faster progression to dementia. Better sleep health provides neuroprotection against this decline. Impairment in objective and subjective cognitive performance, highlights the utility of treating insomnia to potentially improve cognitive outcomes during midlife and insomnia symptoms are a modifiable risk factor for cognitive decline, mild cognitive impairment, and Alzheimer's disease and related dementia. Cognitive Behavioral Therapy for Insomnia (CBTi) is the gold-standard, first line recommended treatment for insomnia, and has considerably better long-term outcomes than medications. CBTi decreases insomnia symptom severity by 50%. CBTi also appears to improve cognitive functioning. However, CBTi is underutilized, training is limited, and medical professionals are implementing treatment approaches inconsistent with empirically supported guidelines. Insomnia symptoms are being inadequately treated while misinformation and misconceptions about insomnia disorder, CBTi, and actual therapeutic effects are being propagated. Moreover, sedating medications are currently the most commonly used treatment for insomnia, which is problematic because the potential side effects can have major implications for the aging population. Additionally, some patients continue to experience insomnia symptoms even when taking sleep medication, which can lead to increase dosages, dependence on, and tolerance to these medications, further emphasizing the importance of CBTi. There is also a need for more readily accessible, short-term, modified treatments for insomnia disorder. A modified format of CBTi may assist in dissemination of effective treatments while also providing the potential for adapting this treatment to specific client characteristics. To address this need, we will modify CBTi and conduct a pilot randomized clinical trial to test these modifications. The proposed project will include two primary aims in establishing a foundation needed to examine individual benefits of the components of CBTi. These aims will aid in the continuation of investigation to better assess treatment outcomes, create transdiagnostic treatment plans, and provide individualized health care through accessible psychotherapy. Obtaining a better understanding of the predictors of successful treatment may improve our understanding of the underlying mechanisms of successful treatment. Ultimately, this improved understanding may help to improve treatment for insomnia disorder, improve cognitive functioning, and potentially reduced risk for cognitive decline associated with mild cognitive impairment, Alzheimer's disease, and related dementias. Improved treatment outcomes utilizing specific core components of CBTi may result in improvements of insomnia disorder and cognitive functioning and would provide a major step forward in understanding the mechanisms underlying the etiology and maintenance of insomnia as well as how risks associated with mild cognitive impairment and cognitive decline might be mitigated. Lastly, this proposed project allows for proof of concept and for collaborations to be made within the medical and mental health communities in Pocatello, ID and surrounding areas, decreasing barriers to treatment and improving treatment dissemination.

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.

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

Research shows that Cognitive Behavioral Therapy for Insomnia (CBTi) is an effective treatment for insomnia, with strong evidence supporting its use as a first-line treatment. It has been shown to improve sleep onset, reduce wakefulness after sleep, and enhance overall sleep quality, with benefits that last longer than those from sleep medications. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Insomnia (CBTi) safe for humans?

Cognitive Behavioral Therapy for Insomnia (CBTi) is considered a safe treatment for insomnia, with strong empirical support and recognition as a standard treatment by health organizations. It is a non-drug approach that avoids the adverse effects associated with medication. ^{1 2 3 4 6}

How is the treatment Cognitive Behavioral Therapy for Insomnia (CBTi) unique compared to other treatments for insomnia?

Cognitive Behavioral Therapy for Insomnia (CBTi) is unique because it focuses on changing sleep-related behaviors and thoughts, rather than using medication. It is recognized as the first-line treatment for chronic insomnia and can be delivered in various ways, including online, making it more accessible to people who may not have access to trained therapists. ^{2 3 6 7 8}

Research Team

Sarah Emert

Principal Investigator

Idaho State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 (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]

References

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

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

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

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

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

Brief Behavioral Treatment of Insomnia. [2019]

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

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

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

Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial. [2023]

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

The Anxiolytic Effects of Cognitive Behavior Therapy for Insomnia: Preliminary Results from a Web-delivered Protocol. [2022]

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

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

8. 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]