Behavioral Interventions for Chronic Insomnia
(IBI Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Pennsylvania
Must be taking: Sleeping pills
Disqualifiers: Major depression, Bipolar, Psychosis, others
No Placebo Group
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.
12345Is 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.
12678How 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.
12469Eligibility 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
+3 more
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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral approach 1Experimental Treatment1 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 2Active Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Pennsylvania School of MedicinePhiladelphia, PA
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Who Is Running the Clinical Trial?
University of PennsylvaniaLead Sponsor
References
[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. [2019]Cognitive-behavioral therapy for insomnia (CBT-I) is the treatment of choice for chronic insomnia. Together with advantages it has such limitations like shortage of trained staff and low response rate. That is why the alternative methods of CBT-I induce high interest: bibliotherapy, phone psychotherapy, brief behavioral therapy and online-CBT-I. Hypnotics administration is recommended as adjuvant to extent the CBT-I effect. It may also be used as monotherapy when CBT-I is unavailable.
Nonpharmacologic management of chronic insomnia. [2022]Chronic insomnia is highly prevalent in our society, with an incidence of 10 to 30 percent. It is a major cost to society in terms of health care expenditure and reduced productivity. Nonpharmacologic interventions have been studied and shown to produce reliable and sustained improvements in sleep patterns of patients with insomnia. Cognitive behavior therapy for insomnia has multiple components, including cognitive psychotherapy, sleep hygiene, stimulus control, sleep restriction, paradoxical intention, and relaxation therapy. Cognitive psychotherapy involves identifying a patient's dysfunctional beliefs about sleep, challenging their validity, and replacing them with more adaptive substitutes. Sleep hygiene education teaches patients about good sleep habits. Stimulus control therapy helps patients to associate the bedroom with sleep and sex only, and not other wakeful activities. Sleep restriction therapy consists of limiting time in bed to maximize sleep efficiency. Paradoxical intention seeks to remove the fear of sleep by advising the patient to remain awake. Relaxation therapies are techniques taught to patients to reduce high levels of arousal that interfere with sleep. Cognitive behavior therapy involves four to eight weekly sessions of 60 to 90 minutes each, and should be used more frequently as initial therapy for chronic insomnia.
Comparative efficacy of behavior therapy, cognitive therapy, and cognitive behavior therapy for chronic insomnia: a randomized controlled trial. [2022]To examine the unique contribution of behavior therapy (BT) and cognitive therapy (CT) relative to the full cognitive behavior therapy (CBT) for persistent insomnia.
Cognitive-behavioral approach to treating insomnia [2019]Cognitive-Behavioral approach to treating insomnia Cognitive behavioral therapy (CBT) for insomnia is a brief and structured therapeutic intervention aimed at changing maladaptive sleep habits and unhelpful sleep-related beliefs and attitudes that perpetuate insomnia. The main therapeutic components include restriction of time spent in bed, stimulus control procedures, cognitive restructuring of beliefs and perceptions related to insomnia and its perceived consequences, and sleep hygiene education. Based upon a solid conceptual framework and supported by strong empirical evidence, CBT is now recognized and endorsed in clinical practice guidelines of medical and sleep societies as the first-line treatment for adults with chronic insomnia. Although it requires more time both from patients and clinicians, CBT produces clinically meaningful and more durable changes in sleep and associated insomnia symptoms than those obtained with medication treatment used singly.
[Options to enhance the efficacy of cognitive-behavior therapy of insomnia]. [2021]Cognitive-behavior therapy of insomnia (CBT-I) is first-line treatment for insomnia, but it produces a clinical significant result only in 60-80% of patients. Addition reason of reduction of CBT-I efficacy is a relatively low adherence: the attrition rate is 10-39%. The authors discuss options to enhance efficacy of the therapy by usage of complex approach, individualized choice of technics, motivating a patient and his relatives, and combination of CBT-I with hypnotics.
Cognitive-behavioral approaches to the treatment of insomnia. [2022]Insomnia is a pervasive condition with various causes, manifestations, and health consequences. Regardless of the initial cause or event that precipitates insomnia, it is perpetuated into a chronic condition through learned behaviors and cognitions that foster sleeplessness. This article reviews the rationale and objectives of cognitive-behavioral therapy (CBT), a safe and effective treatment for insomnia that may be used to augment hypnotic drugs or as a monotherapy. Cognitive-behavioral management of insomnia includes 3 components--behavioral, cognitive, and educational modules--and is usually presented in a group or individual therapy setting. Each treatment procedure is detailed herein, and recommendations for implementation are given. The evidence supporting this behavioral approach shows that CBT is effective for 70% to 80% of patients and that it can significantly reduce several measures of insomnia, including sleep-onset latency and wake-after-sleep onset. Aside from the clinically measurable changes, this therapy system enables many patients to regain a feeling of control over their sleep, thereby reducing the emotional distress that sleep disturbances cause. Some clinical and practical issues that often arise when implementing this therapeutic approach for insomnia are also discussed.
Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. [2023]: Cognitive behavioral treatment for insomnia (CBT-I) is the first line of treatment for insomnia. However, the expanded use of CBT-I is limited by the number of specialty-trained clinicians in addition to the duration and cost of individual treatment sessions. One viable option is a single-session educational group format delivered by a trained health educator.
Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. [2022]Because psychological approaches are likely to produce sustained benefits without the risk for tolerance or adverse effects associated with pharmacologic approaches, cognitive behavioral therapy for insomnia (CBT-i) is now commonly recommended as first-line treatment for chronic insomnia.
Developing and Testing a Web-Based Provider Training for Cognitive Behavioral Therapy of Insomnia. [2021]Chronic insomnia is a common and debilitating disease that increases risk for significant morbidity and workplace difficulties. Cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment, but there is a critical lack of behavioral health providers trained in CBT-I because, in part, of a bottleneck in training availability and costs. The current project developed and evaluated a web-based provider training course for CBT-I: CBTIweb.org.