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Digital Behavioral Therapy for Sleep Problems (dBTS)

Primary Purpose

Insomnia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital cognitive-behavioral therapy for insomnia (dCBTI)
Sleep hygiene education (SHE)
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • UCLA Cousins Center for Psychoneuroimmunology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digital cognitive-behavioral therapy for insomnia (dCBTI)

Sleep hygiene education (SHE)

Arm Description

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

Recognized and commonly prescribed set of sleep hygiene instructions

Outcomes

Primary Outcome Measures

Change in Insomnia Severity Index (ISI)
Change in insomnia severity assessed by a scale with higher scores indicating worse outcome (range 0-28)
Change in Sleep Efficiency
Change in sleep efficiency estimated using sleep diary with higher percentages indicating better outcome (range 0-100%)

Secondary Outcome Measures

Change in Total Sleep Time (TST)
Change in sleep duration
Change in Epworth Sleepiness Scale (ESS)
Change in daytime sleepiness assessed by a scale with higher scores indicating worse outcome (range 0-24)
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)
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)
Change in Snaith-Hamilton Pleasure Scale (SHAPS)
Change in anhedonia assessed by a scale with higher scores indicating worse outcome (range 0-14)
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)
Change in UCLA Loneliness Scale (ULS)
Change in loneliness assessed by a scale with higher scores indicating worse outcome (range 20-80)
Change in Insomnia Caseness
Change in probable diagnosis of insomnia assessed using Sleep Condition Indicator (SCI)

Full Information

First Posted
March 9, 2020
Last Updated
September 20, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT04308499
Brief Title
Digital Behavioral Therapy for Sleep Problems
Acronym
dBTS
Official Title
Pilot Randomized Controlled Trial of Digital Cognitive-Behavioral Therapy for Insomnia in HIV-Infected Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digital cognitive-behavioral therapy for insomnia (dCBTI)
Arm Type
Experimental
Arm Description
Internet-based cognitive-behavioral therapy for insomnia (CBT-I) structured into 6 weekly sessions
Arm Title
Sleep hygiene education (SHE)
Arm Type
Active Comparator
Arm Description
Recognized and commonly prescribed set of sleep hygiene instructions
Intervention Type
Behavioral
Intervention Name(s)
Digital cognitive-behavioral therapy for insomnia (dCBTI)
Intervention Description
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
Intervention Name(s)
Sleep hygiene education (SHE)
Intervention Description
Recognized and commonly prescribed set of sleep hygiene instructions comprised of comprise a website and a downloadable booklet
Primary Outcome Measure Information:
Title
Change in Insomnia Severity Index (ISI)
Description
Change in insomnia severity assessed by a scale with higher scores indicating worse outcome (range 0-28)
Time Frame
Weeks 0, 4, 8, and 24
Title
Change in Sleep Efficiency
Description
Change in sleep efficiency estimated using sleep diary with higher percentages indicating better outcome (range 0-100%)
Time Frame
Weeks 0, 4, 8, and 24
Secondary Outcome Measure Information:
Title
Change in Total Sleep Time (TST)
Description
Change in sleep duration
Time Frame
Weeks 0, 4, 8, and 24
Title
Change in Epworth Sleepiness Scale (ESS)
Description
Change in daytime sleepiness assessed by a scale with higher scores indicating worse outcome (range 0-24)
Time Frame
Weeks 0, 4, 8, and 24
Title
Change in Center for Epidemiologic Studies Depression Scale (CES-D)
Description
Change in depressive symptoms assessed by a scale with higher scores indicating worse outcome (range 0-60)
Time Frame
Weeks 0, 4, 8, and 24
Title
Change in Generalized Anxiety Disorder 7-item scale (GAD-7)
Description
Change in anxiety symptoms assessed by a scale with higher scores indicating worse outcome (range 0-21)
Time Frame
Weeks 0, 4, 8, and 24
Title
Change in Snaith-Hamilton Pleasure Scale (SHAPS)
Description
Change in anhedonia assessed by a scale with higher scores indicating worse outcome (range 0-14)
Time Frame
Weeks 0, 4, 8, and 24
Title
Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)
Description
Change in fatigue assessed by a scale with higher scores indicating worse outcome (range 0-120)
Time Frame
Weeks 0, 4, 8, and 24
Title
Change in UCLA Loneliness Scale (ULS)
Description
Change in loneliness assessed by a scale with higher scores indicating worse outcome (range 20-80)
Time Frame
Weeks 0, 4, 8, and 24
Title
Change in Insomnia Caseness
Description
Change in probable diagnosis of insomnia assessed using Sleep Condition Indicator (SCI)
Time Frame
Weeks 0, 4, 8, and 24

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UCLA Cousins Center for Psychoneuroimmunology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Digital Behavioral Therapy for Sleep Problems

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