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

Trial Summary

What is the purpose of this trial?

This randomized pilot study (n=20) explores the effects of a behavioral intervention, that includes sleep hygiene improvements, in long-term users of sleeping pills, aiming to alleviate or stabilize symptoms of insomnia, monitor and decrease sleeping pill usage. Adherence will be monitored by an optional smartphone application.

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.

What data supports the effectiveness of the treatment Behavioral Interventions for Chronic Insomnia?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is widely recognized as the first-line treatment for chronic insomnia, with strong evidence showing it leads to meaningful and lasting improvements in sleep patterns. Non-drug approaches like CBT-I, which include techniques such as sleep hygiene education, stimulus control, and relaxation training, have been shown to reliably improve sleep in people with insomnia. ^{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 a safe treatment for insomnia, as it does not involve medications and focuses on changing sleep habits and behaviors. It is recommended as a first-line treatment because it produces sustained benefits without the risk of side effects associated with medications. ^{1 2 6 7 8}

How is the treatment for chronic insomnia using cognitive-behavioral therapy different from other treatments?

Cognitive-behavioral therapy for insomnia (CBT-I) is unique because it focuses on changing sleep habits and beliefs about sleep through structured sessions, rather than using medication. It includes techniques like sleep hygiene education, stimulus control, and relaxation training, and is recognized as the first-line treatment for chronic insomnia due to its effectiveness and long-lasting results. ^{1 2 4 6 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 (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]

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 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]

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]

References

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

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

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

Nonpharmacologic management of chronic insomnia. [2022]

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

Comparative efficacy of behavior therapy, cognitive therapy, and cognitive behavior therapy for chronic insomnia: a randomized controlled trial. [2022]

4. France pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral approach to treating insomnia [2019]

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

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

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

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

7. England pubmed.ncbi.nlm.nih.gov

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

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

Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Developing and Testing a Web-Based Provider Training for Cognitive Behavioral Therapy of Insomnia. [2021]