Digital Behavioral Therapy for Sleep Problems

Insomnia Clinical Trial

— dBTS  

Official title:

Pilot Randomized Controlled Trial of Digital Cognitive-Behavioral Therapy for Insomnia in HIV-Infected Individuals

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04308499
• Other study ID #: 19-000064
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: February 1, 2024

Study information

• Verified date: April 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Digital 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
• Sleep hygiene education (SHE)
Recognized and commonly prescribed set of sleep hygiene instructions comprised of comprise a website and a downloadable booklet

Locations

Country	Name	City	State
United States	UCLA Cousins Center for Psychoneuroimmunology	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Change in Total Sleep Time (TST)	Change in sleep duration	Weeks 0, 4, 8, and 24
Secondary	Change in Epworth Sleepiness Scale (ESS)	Change in daytime sleepiness assessed by a scale with higher scores indicating worse outcome (range 0-24)	Weeks 0, 4, 8, and 24
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Insomnia Caseness	Change in probable diagnosis of insomnia assessed using Sleep Condition Indicator (SCI)	Weeks 0, 4, 8, and 24