Status:
COMPLETED
RCT of CBT for Insomnia With PLWHA
Lead Sponsor:
Emory University
Conditions:
Insomnia
HIV
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The proposed study will consist of a randomized controlled trial (RCT) comparing a known efficacious treatment for insomnia (CBT-I) to a sleep hygiene (SH) comparison condition.
Detailed Description
The purpose of this study is to test whether a group cognitive-behavioral treatment program for insomnia (CBT-I) will help adults diagnosed with HIV to improve the quantity (number of hours) and the q...
Eligibility Criteria
Inclusion
- English-speaking individuals
- 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
- current substance dependence (within the past six months)
- 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
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT02259101
Start Date
November 1 2013
End Date
February 1 2016
Last Update
May 6 2016
Active Locations (1)
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1
Grady Memorial Hospital/Infectious Disease Program
Atlanta, Georgia, United States, 30303