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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

dBTS Trial Summary

This trial is testing an internet-based version of cognitive-behavioral therapy for insomnia (CBT-I) against sleep hygiene education (SHE) in 60 HIV-positive patients with insomnia. The goal is to see if dCBTI or SHE improves insomnia in this patient group.

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.Check my eligibility
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.See study design
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.

dBTS Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Insomnia Severity Index (ISI)
Change in Sleep Efficiency
Secondary outcome measures
Blood coagulation tests
Change in Epworth Sleepiness Scale (ESS)
Change in Generalized Anxiety Disorder 7-item scale (GAD-7)
+5 more

dBTS 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

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,528 Previous Clinical Trials
10,276,791 Total Patients Enrolled
6 Trials studying Insomnia
767 Patients Enrolled for Insomnia

Media Library

Digital cognitive-behavioral therapy for insomnia (dCBTI) Clinical Trial Eligibility Overview. Trial Name: NCT04308499 — N/A
Insomnia Research Study Groups: Digital cognitive-behavioral therapy for insomnia (dCBTI), Sleep hygiene education (SHE)
Insomnia Clinical Trial 2023: Digital cognitive-behavioral therapy for insomnia (dCBTI) Highlights & Side Effects. Trial Name: NCT04308499 — N/A
Digital cognitive-behavioral therapy for insomnia (dCBTI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04308499 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for participants to enroll in this research experiment?

"According to the clinicaltrials.gov database, this specific trial is no longer recruiting participants; it was initially posted on March 1st 2020 and last updated on May 17th 2022. However, there are still 228 other trials looking for volunteers at present time."

Answered by AI

What aims are being pursued through the implementation of this clinical experiment?

"The chief goal of this medical trial, which is adjudicated over a period spanning 24 weeks and assessed at various intervals, will be to measure changes in sleep efficiency. Secondary ambitions include observing alterations in total sleep time (TST), transfigurations in depressive symptoms as recorded on the Center for Epidemiologic Studies Depression Scale (CES-D) - scores range from 0 to 60 with higher numbers indicating greater severity - and shifts observed through Snaith-Hamilton Pleasure Scale (SHAPS) measurements; here too, scores generally run between 0 and 14 where higher readings indicate a poorer outcome."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Digital Behavioral Therapy for Sleep Problems
Joshua Hyong-Jin Cho 2020. "Digital Behavioral Therapy for Sleep Problems". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04308499.
~12 spots leftby Apr 2025
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