Digital Behavioral Therapy for Sleep Problems

Not Applicable

Terminated

• Conditions: Insomnia
• Interventions: Behavioral: Digital cognitive-behavioral therapy for insomnia (dCBTI); Behavioral: Sleep hygiene education (SHE)

• Registration Number: NCT04308499
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-11
• Study First Posted: 2020-03-16
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital cognitive-behavioral therapy for insomnia (dCBTI)	Digital cognitive-behavioral therapy for insomnia (dCBTI)	Internet-based cognitive-behavioral therapy for insomnia (CBT-I) structured into 6 weekly sessions
Sleep hygiene education (SHE)	Sleep hygiene education (SHE)	Recognized and commonly prescribed set of sleep hygiene instructions

Primary Outcome Measures

Name	Time	Method
Change in Sleep Efficiency	Weeks 0, 4, 8, and 24	Change in sleep efficiency estimated using sleep diary with higher percentages indicating better outcome (range 0-100%)
Change in Insomnia Severity Index (ISI)	Weeks 0, 4, 8, and 24	Change in insomnia severity assessed by a scale with higher scores indicating worse outcome (range 0-28)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UCLA Cousins Center for Psychoneuroimmunology; 🇺🇸 Los Angeles, California, United States