Clinical trial NCT04308499: Digital Behavioral Therapy for Sleep Problems
Official title: Pilot Randomized Controlled Trial of Digital Cognitive-Behavioral Therapy for Insomnia in HIV-Infected Individuals
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Insomnia
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Weeks 0, 4, 8, and 24
measure: Change in Sleep Efficiency
timeFrame: Weeks 0, 4, 8, and 24
Secondary outcomes:
measure: Change in Total Sleep Time (TST)
timeFrame: Weeks 0, 4, 8, and 24
measure: Change in Epworth Sleepiness Scale (ESS)
timeFrame: Weeks 0, 4, 8, and 24
measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Weeks 0, 4, 8, and 24
measure: Change in Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Weeks 0, 4, 8, and 24
measure: Change in Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: Weeks 0, 4, 8, and 24
measure: Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)
timeFrame: Weeks 0, 4, 8, and 24
measure: Change in UCLA Loneliness Scale (ULS)
timeFrame: Weeks 0, 4, 8, and 24
measure: Change in Insomnia Caseness
timeFrame: Weeks 0, 4, 8, and 24
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Cousins Center for Psychoneuroimmunology
state: California
Study officials:
References: