Digital Behavioral Therapy for Sleep Problems

NCT ID: NCT04308499

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2024-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Insomnia is very common, especially in HIV population (up to 73%), and contributes to the development of other conditions such as depression, dementia, inflammation, obesity, and heart diseases. Cognitive-behavioral therapy for insomnia (CBT-I) is known to improve insomnia. However, it has never been tested in HIV-positive patients. The investigators aim to examine the Internet version of this therapy in HIV-positive patients because the availability of CBT-I is very limited while the cost is high. The investigators will test this internet version, also called digital CBT-I (dCBTI), against sleep hygiene education (SHE), a commonly prescribed set of instructions in clinical practice, in 60 HIV-positive patients with insomnia invited from the Multicenter AIDS Cohort Study (MACS) Los Angeles site. The investigators aim to test if dCBTI or SHE improves insomnia in this patient group. This trial involves a behavioral treatment that can be done from home with minimal side effects and includes neither medications nor invasive interventions. Lastly, this trial will provide important pilot data for a larger trial testing long-term effects of insomnia treatment in HIV-positive patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insomnia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Digital cognitive-behavioral therapy for insomnia (dCBTI)

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

Group Type EXPERIMENTAL

Digital cognitive-behavioral therapy for insomnia (dCBTI)

Intervention Type BEHAVIORAL

Internet-based cognitive-behavioral therapy for insomnia (CBT-I) structured into 6 weekly sessions accessed using either a computer or a smartphone

Sleep hygiene education (SHE)

Recognized and commonly prescribed set of sleep hygiene instructions

Group Type ACTIVE_COMPARATOR

Sleep hygiene education (SHE)

Intervention Type BEHAVIORAL

Recognized and commonly prescribed set of sleep hygiene instructions comprised of comprise a website and a downloadable booklet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Digital cognitive-behavioral therapy for insomnia (dCBTI)

Internet-based cognitive-behavioral therapy for insomnia (CBT-I) structured into 6 weekly sessions accessed using either a computer or a smartphone

Intervention Type BEHAVIORAL

Sleep hygiene education (SHE)

Recognized and commonly prescribed set of sleep hygiene instructions comprised of comprise a website and a downloadable booklet

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* DSM-5 diagnosis of insomnia disorder
* Aged 18 years or older
* Reliable Internet access using either computer or smartphone
* Ability to read and understand English

Exclusion Criteria

* High risk of obstructive sleep apnea
* Diagnosis of restless legs syndrome
* Severe health issues requiring hospital admission
* Currently receiving psychological treatment for insomnia
* Reporting current suicidal ideation
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Joshua Hyong-Jin Cho

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UCLA Cousins Center for Psychoneuroimmunology

Los Angeles, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19-000064

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Internet-CBT for Insomnia
NCT01256099 COMPLETED NA
dCBTi for Adults With ADHD
NCT05133908 UNKNOWN NA
Cognitive-Behavior Therapy for Insomnia
NCT00869934 COMPLETED PHASE4