Digital Behavioral Therapy for Sleep Problems

NCT04308499 | Terminated

• 1 other identifier: 19-000064
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change in Insomnia Severity Index (ISI)

  Change in insomnia severity assessed by a scale with higher scores indicating worse outcome (range 0-28)

  Weeks 0, 4, 8, and 24

• Change in Sleep Efficiency

  Change in sleep efficiency estimated using sleep diary with higher percentages indicating better outcome (range 0-100%)

  Weeks 0, 4, 8, and 24

Secondary Outcomes (8)

• Change in Total Sleep Time (TST)

  Weeks 0, 4, 8, and 24

• Change in Epworth Sleepiness Scale (ESS)

  Weeks 0, 4, 8, and 24

• Change in Center for Epidemiologic Studies Depression Scale (CES-D)

  Weeks 0, 4, 8, and 24

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

  Weeks 0, 4, 8, and 24

• Change in Snaith-Hamilton Pleasure Scale (SHAPS)

  Weeks 0, 4, 8, and 24

Study Arms (2)

Digital cognitive-behavioral therapy for insomnia (dCBTI)

EXPERIMENTAL

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

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

Sleep hygiene education (SHE)

ACTIVE COMPARATOR

Recognized and commonly prescribed set of sleep hygiene instructions

Behavioral: Sleep hygiene education (SHE)

Interventions

Digital cognitive-behavioral therapy for insomnia (dCBTI) BEHAVIORAL

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

Digital cognitive-behavioral therapy for insomnia (dCBTI)

Sleep hygiene education (SHE) BEHAVIORAL

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

Sleep hygiene education (SHE)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Cousins Center for Psychoneuroimmunology

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 16, 2020
• Study Start: March 1, 2020
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)