Behavioral Interventions for Chronic Insomnia

(IBI Trial)

Overseen By Alex J Mathew

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: Sleeping pills

Disqualifiers: Major depression, Bipolar, Psychosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two different behavioral approaches to assist people with chronic insomnia who regularly use sleeping pills. The aim is to improve sleep habits and potentially reduce or stabilize the need for these medications. Participants will be divided into two groups, each receiving a different but clinically proven behavioral treatment. This trial suits individuals aged 55 to 85 who take sleeping pills at least three times a week and have a diagnosis of chronic insomnia. As an unphased trial, it offers an opportunity to explore innovative treatments that could enhance quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it aims to monitor and decrease sleeping pill usage. It might be possible that you will be asked to reduce your sleeping pill intake during the study.

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

Research shows that both methods being tested are safe for treating insomnia. Studies have found that Cognitive Behavioral Therapy for Insomnia (CBT-I), included in both methods, is very effective and safe. It often works as well as sleep medications but without side effects.

CBT-I improves sleep by changing poor sleep habits and correcting misconceptions about sleep. It has been shown to enhance sleep over time. Participants using CBT-I report fewer sleep problems and better sleep quality. Therefore, those considering joining this study can be assured that the treatments involved are well-tolerated and safe according to previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these behavioral interventions for chronic insomnia because they focus on non-pharmacological approaches, which can reduce reliance on medications. Unlike standard treatments that often involve prescription sleep aids, these approaches emphasize sleep hygiene and cognitive strategies to improve sleep quality naturally. By potentially reducing the side effects associated with medication use, these methods offer a promising alternative for individuals seeking long-term, sustainable solutions to insomnia.

What evidence suggests that this trial's behavioral interventions could be effective for chronic insomnia?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I), included in both behavioral approaches in this trial, effectively treats long-term insomnia. Participants will receive either Behavioral Approach 1 or Behavioral Approach 2, both incorporating CBT-I. Studies have found that CBT-I can be as effective as sleep medications, but without side effects. Those who undergo CBT-I often experience better sleep and fewer recurrences of insomnia. This therapy aids in falling asleep and staying asleep, leading to improved overall sleep. Additionally, online versions of CBT-I have greatly improved sleep patterns and quality. Overall, strong evidence supports CBT-I as a successful treatment for insomnia. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 55-85 who have been diagnosed with chronic insomnia and regularly use sleeping pills at least three nights a week. Participants must be able to speak English, use a smartphone or tablet, and have internet access. Those with acute medical conditions or severe mental health issues like major depression or psychosis are excluded.

Inclusion Criteria

Has access to a smartphone and/or smart tablet and can use it

I am between 55 and 85 years old.

Speaks English above a 6th-grade level

Exclusion Criteria

Presence of major depression or other severe psychopathology (e.g., bipolar disorder, psychosis, alcohol/substance abuse, etc.)

Presence of an acute or severe medical condition which, in the opinion of the research team, would interfere with the study participant's ability to participate in the research study, such as an acute heart attack, recent severe trauma, etc.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a behavioral intervention including sleep hygiene improvements and coaching support

4 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for changes in sleep pill dosage and sleep efficiency

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral approach 1
• Behavioral approach 2

Trial Overview The study compares two behavioral approaches to treat chronic insomnia in long-term users of sleeping pills. It includes sleep hygiene improvements and uses an optional smartphone app to track adherence. The goal is to reduce symptoms of insomnia and decrease reliance on medication.

How Is the Trial Designed?

Group I: Behavioral approach 1 Experimental Treatment 1 Intervention

This includes sleep hygiene and other elements to serve as an experimental arm; subjects will receive a clinically proven therapeutic intervention.

Group II: Behavioral approach 2 Active Control 1 Intervention

This includes sleep hygiene and other elements to serve as an active comparator; subjects will receive a clinically proven therapeutic intervention.

Behavioral approach 1 is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for Insomnia (CBT-I) for:

• Chronic Insomnia Disorder

Approved in European Union as Cognitive Behavioral Therapy for Insomnia (CBT-I) for:

• Insomnia
• Sleep Disorders

Approved in Canada as Behavioral Therapy for Insomnia for:

• Insomnia
• Sleep Disturbances

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Cognitive-behavioral therapy (CBT) is a safe and effective treatment for insomnia, showing positive results in 70% to 80% of patients, and can be used alone or alongside medication.

CBT addresses insomnia through behavioral, cognitive, and educational strategies, significantly reducing sleep-onset latency and wake-after-sleep onset, while also helping patients regain control over their sleep and reduce emotional distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral approaches to the treatment of insomnia. Morin, CM.[2022]

Cognitive behavior therapy (CBT) for insomnia is an effective nonpharmacologic intervention that can lead to reliable and sustained improvements in sleep patterns for patients suffering from chronic insomnia, which affects 10 to 30 percent of the population.

CBT includes various components such as cognitive psychotherapy, sleep hygiene, and relaxation techniques, typically delivered over four to eight weekly sessions, making it a recommended first-line treatment for chronic insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacologic management of chronic insomnia. Harsora, P., Kessmann, J.[2022]

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-behavior therapy for insomnia (CBT-I) is effective for 60-80% of patients, but its efficacy is limited by a significant attrition rate of 10-39%.

To improve the effectiveness of CBT-I, the authors suggest using a comprehensive approach that includes personalized techniques, patient motivation, and potentially combining CBT-I with sleep medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Options to enhance the efficacy of cognitive-behavior therapy of insomnia]. Zavalko, IM.[2021]

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]

In a study of 188 adults with persistent insomnia, full cognitive behavior therapy (CBT) showed the greatest overall improvements in sleep, with 67.3% of participants responding positively after treatment, compared to 67.4% for behavior therapy (BT) and 42.4% for cognitive therapy (CT).

While BT provided quicker results, its benefits were not as long-lasting, with a significant drop in response rates at the 6-month follow-up, whereas CT showed slower but sustained improvements over time, highlighting the different effectiveness trajectories of these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of behavior therapy, cognitive therapy, and cognitive behavior therapy for chronic insomnia: a randomized controlled trial. Harvey, AG., Bélanger, L., Talbot, L., et al.[2022]

A web-based training course for Cognitive Behavioral Therapy for Insomnia (CBT-I), called CBTIweb.org, was developed and evaluated, showing high usability and significant knowledge gains among participants, with a knowledge increase from 69% to 92% correct after training.

The effectiveness of CBTIweb.org was found to be equivalent to traditional in-person workshops, suggesting it can effectively train behavioral health providers in CBT-I, thus addressing the shortage of trained professionals and allowing for broader access to insomnia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and Testing a Web-Based Provider Training for Cognitive Behavioral Therapy of Insomnia. Taylor, DJ., Dietch, JR., Pruiksma, K., et al.[2021]

Cognitive Behavioral Therapy for insomnia (CBT-i) is an effective first-line treatment for chronic insomnia, showing significant improvements in sleep onset latency (SOL) by about 19 minutes and wake after sleep onset (WASO) by about 26 minutes based on a review of 20 studies involving 1162 participants.

The benefits of CBT-i, which includes techniques like cognitive therapy and sleep hygiene, appear to be sustained over time, and importantly, no adverse effects were reported, making it a safe alternative to pharmacological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Trauer, JM., Qian, MY., Doyle, JS., et al.[2022]

Cognitive-Behavioral Therapy (CBT) for insomnia is a structured approach that effectively changes poor sleep habits and beliefs, making it the first-line treatment for chronic insomnia in adults according to clinical guidelines.

CBT leads to more significant and lasting improvements in sleep quality and insomnia symptoms compared to medication alone, despite requiring more time from both patients and clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral approach to treating insomnia M Morin, C., Beaulieu-Bonneau, S.[2019]

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. 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/PMC10002474/

Cognitive Behavioral Therapy for Insomnia (CBT-I): A Primer There is an overwhelming preponderance of evidence that CBT-I is an efficacious treatment for chronic insomnia [15; 38]. Specifically, the literature supports ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590142725000205

Internet-delivered Cognitive Behavioral Therapy for Insomnia confirmed that eCBT-I significantly improves insomnia severity, sleep efficiency, sleep quality, latency, and total sleep time, achieving ...

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

Effectiveness of Cognitive Behavioural Therapy for ... The present systematic review and narrative synthesis investigates the effectiveness of CBT-I in individuals with neurodevelopmental conditions.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6491304/

Cognitive behavioural therapy for insomnia - PMC To examine the effectiveness and safety of cognitive behavioural therapy for insomnia in adults aged 18 to 59 years.

7. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.8986

Behavioral and psychological treatments for chronic insomnia ... This guideline establishes clinical practice recommendations for the use of behavioral and psychological treatments for chronic insomnia disorder in adults.

8. kosinmedj.org kosinmedj.org/journal/view.php?number=1311

a focus on components of cognitive behavioral therapy for ... A 2021 meta-analysis of eight RCTs showed that SRT effectively improves insomnia severity and sleep continuity in the short term, with post- ...