Pilot Randomized Controlled Trial of Digital Cognitive-Behavioral Therapy for Insomnia in HIV-Infected Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change in Insomnia Severity Index (ISI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Digital cognitive-behavioral therapy for insomnia (dCBTI)
Internet-based cognitive-behavioral therapy for insomnia (CBT-I) structured into 6 weekly sessions
Intervention: Digital cognitive-behavioral therapy for insomnia (dCBTI) (Behavioral)
Sleep hygiene education (SHE)
Recognized and commonly prescribed set of sleep hygiene instructions
Intervention: Sleep hygiene education (SHE) (Behavioral)
Outcomes
Primary Outcomes
Change in Insomnia Severity Index (ISI)
Time Frame: Weeks 0, 4, 8, and 24
Change in insomnia severity assessed by a scale with higher scores indicating worse outcome (range 0-28)
Change in Sleep Efficiency
Time Frame: Weeks 0, 4, 8, and 24
Change in sleep efficiency estimated using sleep diary with higher percentages indicating better outcome (range 0-100%)
Secondary Outcomes
- Change in Epworth Sleepiness Scale (ESS)(Weeks 0, 4, 8, and 24)
- Change in Total Sleep Time (TST)(Weeks 0, 4, 8, and 24)
- Change in Center for Epidemiologic Studies Depression Scale (CES-D)(Weeks 0, 4, 8, and 24)
- Change in Snaith-Hamilton Pleasure Scale (SHAPS)(Weeks 0, 4, 8, and 24)
- Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)(Weeks 0, 4, 8, and 24)
- Change in Generalized Anxiety Disorder 7-item scale (GAD-7)(Weeks 0, 4, 8, and 24)
- Change in Insomnia Caseness(Weeks 0, 4, 8, and 24)
- Change in UCLA Loneliness Scale (ULS)(Weeks 0, 4, 8, and 24)
Investigators
Joshua Hyong-Jin Cho
Associate professor
University of California, Los Angeles