Digital Behavioral Therapy for Sleep Problems (dBTS)

University of California, Los Angeles (UCLA)

Status: Terminated

Conditions: Insomnia

Treatments: Behavioral: Digital cognitive-behavioral therapy for insomnia (dCBTI); Behavioral: Sleep hygiene education (SHE)

Study type: Interventional

Funder types: Other

Identifiers

NCT04308499

19-000064

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Digital cognitive-behavioral therapy for insomnia (dCBTI)

Experimental group

Description:

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

Treatment:

Behavioral: Digital cognitive-behavioral therapy for insomnia (dCBTI)

Sleep hygiene education (SHE)

Active Comparator group

Description:

Recognized and commonly prescribed set of sleep hygiene instructions

Treatment:

Behavioral: Sleep hygiene education (SHE)