NCT04308499

Digital Behavioral Therapy for Sleep Problems

Pilot Randomized Controlled Trial of Digital Cognitive-Behavioral Therapy for Insomnia in HIV-Infected Individuals

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	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
BEHAVIORAL	Sleep hygiene education (SHE)	Recognized and commonly prescribed set of sleep hygiene instructions comprised of comprise a website and a downloadable booklet

Timeline

• Start date: 2020-03-01
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2020-03-16
• Last updated: 2024-05-01

Locations

1 site across 1 country: United States