What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is a common non-pharmacologic treatment for chronic insomnia that focuses on modifying thoughts and behaviors contributing to sleep difficulties. Known side effects of CBT-I are generally minimal but can include temporary increases in anxiety or stress as patients confront and change their sleep habits. Some individuals may experience initial sleep disturbances as they adjust to new routines. Overall, CBT-I is considered safe and effective with fewer side effects compared to pharmacologic treatments.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of chronic insomnia, including benzodiazepine receptor agonists like zolpidem (Ambien) and eszopiclone (Lunesta), as well as melatonin receptor agonists like ramelteon (Rozerem). However, Cognitive Behavioral Therapy for Insomnia (CBT-I) is a non-pharmacologic treatment that has been shown to be highly effective in managing insomnia by modifying the thoughts and behaviors that contribute to the condition. While CBT-I itself does not require FDA approval, it is considered a first-line treatment for chronic insomnia and is often recommended before or alongside pharmacotherapy.

What other types of research exist?

Promising novel alternatives to WebCBT-I for chronic insomnia patients in 2024 include: 1) Digital therapeutics using AI and machine learning to personalize treatment plans, 2) Wearable devices that monitor sleep patterns and provide real-time feedback, 3) Pharmacologic advancements such as dual orexin receptor antagonists (DORAs) which target wakefulness pathways, and 4) Integrative approaches combining mindfulness-based stress reduction (MBSR) with traditional CBT techniques.

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Behavioral Intervention

Web-Based Cognitive Behavioral Therapy for Caregiver Insomnia (NiteCAPP Trial)

N/A

Recruiting

Led By Christina McCrae

Research Sponsored by University of South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test an online therapy called NiteCAPP, which helps family caregivers of dementia patients manage insomnia. The therapy teaches better sleep habits and coping strategies, making it easier for caregivers to use at home. The goal is to improve sleep, mood, and overall health for these caregivers.

Who is the study for?

This trial is for dementia caregivers over 18, living with the person they care for. They must have insomnia lasting 6+ months, affecting their daily life, and understand English. Participants should not be on new sleep meds or have unstable medication use in the past 6 weeks.

What is being tested?

The study tests a web-based Cognitive Behavioral Therapy program (WebCBT-I) called NiteCAPP designed to help dementia caregivers manage insomnia. It aims to improve sleep quality and reduce related health issues like fatigue and mood disorders.

What are the potential side effects?

Since WebCBT-I is a non-medical therapy focusing on behavior changes and coping strategies, it typically doesn't cause physical side effects but may initially increase awareness of sleeping patterns or stress.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Daily Electronic Sleep and Pain Diaries - Medication Consumption

Daily Electronic Sleep and Pain Diaries - Pain Intensity & Unpleasantness

Daily Electronic Sleep and Pain Diaries - Sleep Efficiency

+8 more

Secondary study objectives

Beck Depression Inventory Second Edition (BDI- II)

Caregiver Functional Unit Scale

Cognitive Failures Questionnaire

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NiteCAPP: Online Cognitive Behavioral Therapy for InsomniaExperimental Treatment1 Intervention

This is a pilot trial with one treatment condition (CBT-I).

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive Behavioral Therapy for Insomnia (CBT-I) is a common treatment that works by modifying the thoughts and behaviors contributing to insomnia. Techniques such as stimulus control, sleep restriction, cognitive restructuring, and relaxation training help patients develop healthier sleep habits, reduce sleep-related anxiety, and change negative thought patterns. This approach is crucial for chronic insomnia patients as it addresses both psychological and behavioral aspects, leading to more sustainable and effective treatment outcomes.