Insomnia
Conditions
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.
Interventions
BEHAVIORALDigital 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
BEHAVIORALSleep hygiene education (SHE)
Recognized and commonly prescribed set of sleep hygiene instructions comprised of comprise a website and a downloadable booklet
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 Total Sleep Time (TST) | Weeks 0, 4, 8, and 24 | Change in sleep duration |
| 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 Insomnia Caseness | Weeks 0, 4, 8, and 24 | Change in probable diagnosis of insomnia assessed using Sleep Condition Indicator (SCI) |
| 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 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) |
Countries
United States
Outcome results
None listed