Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2013-11-30
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CBT-I Treatment Condition
The CBT-I treatment condition will be delivered in a one-hour per week group format (10 participants) occurring over the course of six-weeks. Four total CBT-I groups occurring over the course of two years will be implemented, with at total of 40 participants enrolled for the CBT-I condition.
CBT-I Treatment Condition
Each group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep. Blood will be drawn twice in order to compare how the body responds to medical illnesses.
SH Comparison Condition
The SH comparison condition will also be delivered in a one-hour per week group format (10 participants) occurring over the course of six-weeks. Four total SH groups over the course of two years will be conducted, with a total of 40 participants enrolled for the SH condition.
SH Comparison Condition
Each group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep. Blood will be drawn twice in order to compare how the body responds to medical illnesses.
Interventions
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CBT-I Treatment Condition
Each group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep. Blood will be drawn twice in order to compare how the body responds to medical illnesses.
SH Comparison Condition
Each group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep. Blood will be drawn twice in order to compare how the body responds to medical illnesses.
Eligibility Criteria
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Inclusion Criteria
* over the age of 18 years old with a diagnosis of HIV or AIDS who is receiving medical care at the Grady Health System's Infectious Disease Program (IDP)
* study subjects must meet the criteria for primary or secondary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision
* must experience difficulty initiating or maintaining non-restorative sleep for at least l month (DSM- IV-TR)
* the sleep disturbance causes clinically significant impairment or distress in important areas of functioning
* sleep efficiency of less than 85%, sleep disturbances that occur three or more days per week, and sleep latency (i.e., time awake after sleep onset greater than 30 minutes)
Exclusion Criteria
* active psychosis
* Bipolar I and II disorders
* neurocognitive impairment and/or a current diagnosis of dementia
* lack of independent housing
* previous participation in a CBT-I program
* employment in a job requiring shift work that impairs the ability to establish a regular sleep schedule
18 Years
ALL
No
Sponsors
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Emory University
OTHER
Responsible Party
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Amit Shahane
Assistant Professor
Principal Investigators
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Amit Shahane, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Grady Memorial Hospital/Infectious Disease Program
Atlanta, Georgia, United States
Countries
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Other Identifiers
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IRB00065796
Identifier Type: -
Identifier Source: org_study_id
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