Digital Behavioral Therapy for Sleep Problems (dBTS)

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

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.

Study Overview

• Status: Terminated
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Digital cognitive-behavioral therapy for insomnia (dCBTI); Behavioral: Sleep hygiene education (SHE)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Cousins Center for Psychoneuroimmunology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital cognitive-behavioral therapy for insomnia (dCBTI); Internet-based cognitive-behavioral therapy for insomnia (CBT-I) structured into 6 weekly sessions	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
Active Comparator: Sleep hygiene education (SHE); Recognized and commonly prescribed set of sleep hygiene instructions	Behavioral: Sleep hygiene education (SHE); Recognized and commonly prescribed set of sleep hygiene instructions comprised of comprise a website and a downloadable booklet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Sleep Time (TST)	Change in sleep duration	Weeks 0, 4, 8, and 24
Change in Epworth Sleepiness Scale (ESS)	Change in daytime sleepiness assessed by a scale with higher scores indicating worse outcome (range 0-24)	Weeks 0, 4, 8, and 24
Change in Center for Epidemiologic Studies Depression Scale (CES-D)	Change in depressive symptoms assessed by a scale with higher scores indicating worse outcome (range 0-60)	Weeks 0, 4, 8, and 24
Change in Generalized Anxiety Disorder 7-item scale (GAD-7)	Change in anxiety symptoms assessed by a scale with higher scores indicating worse outcome (range 0-21)	Weeks 0, 4, 8, and 24
Change in Snaith-Hamilton Pleasure Scale (SHAPS)	Change in anhedonia assessed by a scale with higher scores indicating worse outcome (range 0-14)	Weeks 0, 4, 8, and 24
Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)	Change in fatigue assessed by a scale with higher scores indicating worse outcome (range 0-120)	Weeks 0, 4, 8, and 24
Change in UCLA Loneliness Scale (ULS)	Change in loneliness assessed by a scale with higher scores indicating worse outcome (range 20-80)	Weeks 0, 4, 8, and 24
Change in Insomnia Caseness	Change in probable diagnosis of insomnia assessed using Sleep Condition Indicator (SCI)	Weeks 0, 4, 8, and 24

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 19-000064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No