What side effects are associated with this type of intervention?

Cognitive-behavioral therapy for insomnia (CBT-I) and its digital variant (dCBTI) are generally well-tolerated with minimal side effects. Common side effects may include temporary increases in anxiety or stress as patients adjust to new sleep patterns and behaviors. Unlike pharmacological treatments, CBT-I and dCBTI do not carry risks of medication side effects such as dependency, daytime drowsiness, or cognitive impairment. Overall, these therapies are considered safe and effective for improving sleep quality and reducing insomnia symptoms.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for insomnia, including benzodiazepines (e.g., temazepam), non-benzodiazepine receptor agonists (e.g., zolpidem, eszopiclone), and melatonin receptor agonists (e.g., ramelteon). These medications primarily target sleep onset and maintenance but come with potential side effects such as dependency and cognitive impairment. In contrast, non-pharmacological treatments like Cognitive Behavioral Therapy for Insomnia (CBT-I) and its digital variant (dCBTI) focus on cognitive and behavioral techniques to improve sleep patterns and reduce insomnia symptoms without the associated risks of medication. While dCBTI is not an FDA-approved treatment, it is supported by evidence for its efficacy in improving sleep quality and reducing insomnia symptoms.

What other types of research exist?

Promising, novel alternatives to Digital Cognitive-Behavioral Therapy for Insomnia (dCBTI) for treating insomnia include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain to improve sleep patterns. 2) Pharmacotherapy advancements, such as new medications targeting specific neurotransmitters involved in sleep regulation. 3) Internet-delivered cognitive-behavioral therapy (iCBT) tailored for specific populations, such as those with comorbid conditions like HIV or ADHD, which can increase accessibility and effectiveness.

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Digital Behavioral Therapy for Insomnia (dBTS Trial)

N/A

Waitlist Available

Research Sponsored by University of California, Los Angeles

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 weeks 0, 4, 8, and 24

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an online program to help HIV-positive patients with insomnia improve their sleep by teaching better sleep habits and relaxation techniques. It compares this program to standard sleep advice to see which works better.

Who is the study for?

This trial is for HIV-positive patients aged 18 or older who have trouble sleeping and can read English. They need reliable internet to participate in digital therapy sessions from home. It's not suitable for those with severe health issues, high risk of sleep apnea, restless legs syndrome, ongoing psychological treatment for insomnia, or current suicidal thoughts.

What is being tested?

The study compares two non-medical treatments for insomnia: digital cognitive-behavioral therapy (dCBTI) and basic sleep hygiene education (SHE). Participants will be HIV-positive individuals experiencing sleep problems. The goal is to see if these online therapies can improve their sleep without the need to visit a clinic.

What are the potential side effects?

Since this trial involves behavioral therapy conducted online rather than medication or invasive procedures, it has minimal side effects. However, participants may experience some discomfort adjusting to new sleep habits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 0, 4, 8, and 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 0, 4, 8, and 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 4, 8, and 24 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Insomnia Severity Index (ISI)

Change in Sleep Efficiency

Secondary study objectives

Blood coagulation tests

Change in Epworth Sleepiness Scale (ESS)

Change in Generalized Anxiety Disorder 7-item scale (GAD-7)

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Digital cognitive-behavioral therapy for insomnia (dCBTI)Experimental Treatment1 Intervention

Internet-based cognitive-behavioral therapy for insomnia (CBT-I) structured into 6 weekly sessions

Group II: Sleep hygiene education (SHE)Active Control1 Intervention

Recognized and commonly prescribed set of sleep hygiene instructions

Do I qualify?Apply below to find out

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) and its digital variant (dCBTI) work by addressing the underlying cognitive and behavioral factors that contribute to insomnia. Key components include sleep restriction, which limits time in bed to increase sleep drive; stimulus control, which strengthens the bed-sleep connection; cognitive restructuring, which challenges and changes unhelpful beliefs about sleep; relaxation training, which reduces pre-sleep arousal; and sleep hygiene education, which promotes habits conducive to good sleep. These mechanisms are crucial for insomnia patients as they offer a non-pharmacological approach that can lead to sustainable improvements in sleep patterns and overall well-being without the side effects associated with medications.

Cognitive behavioral therapy for insomnia in Parkinson's disease: a case series.