A Randomized Controlled Trial of Cognitive Behavior Therapy for Insomnia With Persons Living With HIV/AIDS
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Insomnia
- Sponsor
- Emory University
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Insomnia Symptoms
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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 quality of their sleep. The PI will compare adults who participated in the CBT-I program to adults who participated in a Sleep Hygiene group, a common treatment for insomnia. The PI will look at the overall quality of life, and number of hours and quality of sleep of adults who participated in the CBT-I program versus adults in the Sleep Hygiene group. Also, the PI will draw blood to compare how the body responds to medical illnesses between adults in the CBT-I program to adults in the Sleep Hygiene group.
Investigators
Amit Shahane
Assistant Professor
Emory University
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Insomnia Symptoms
Time Frame: baseline, up to 5 weeks post-intervention
Compare insomnia scores on the Insomnia Severity Index (questionnaire) between the CBT-I treatment condition vs. SH comparison condition.
Secondary Outcomes
- Blood Sample(baseline, up to 5 weeks post-intervention)
- Quality of Life(baseline, up to 5 weeks post-intervention)