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Difficulty to recruit HIV patients with insomnia
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital cognitive-behavioral therapy for insomnia (dCBTI) | Experimental | Internet-based cognitive-behavioral therapy for insomnia (CBT-I) structured into 6 weekly sessions |
|
| Sleep hygiene education (SHE) | Active Comparator | Recognized and commonly prescribed set of sleep hygiene instructions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital cognitive-behavioral therapy for insomnia (dCBTI) | Behavioral | Internet-based cognitive-behavioral therapy for insomnia (CBT-I) structured into 6 weekly sessions accessed using either a computer or a smartphone |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Cousins Center for Psychoneuroimmunology | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Sleep hygiene education (SHE) | Behavioral | Recognized and commonly prescribed set of sleep hygiene instructions comprised of comprise a website and a downloadable booklet |
|
| 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 |
| D001523 |
| Mental Disorders |