Digital Behavioral Therapy for Sleep Problems

Study Overview
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Brief Summary
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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.

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

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Digital cognitive-behavioral therapy for insomnia (dCBTI)
* Behavioral: Sleep hygiene education (SHE)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |