RCT of CBT for Insomnia With PLWHA

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial of Cognitive Behavior Therapy for Insomnia With Persons Living With HIV/AIDS

Conditions
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Insomnia, HIV, Aids

Intervention / Treatment
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* Behavioral: CBT-I Treatment Condition
* Behavioral: SH Comparison Condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-I Treatment Condition<br>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. | Behavioral: CBT-I Treatment Condition<br>* 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.<br>|
| Active Comparator: SH Comparison Condition<br>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. | Behavioral: SH Comparison Condition<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Symptoms | Compare insomnia scores on the Insomnia Severity Index (questionnaire) between the CBT-I treatment condition vs. SH comparison condition. | baseline, up to 5 weeks post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Compare quality of life scores on the HIV/AIDS Targeted-Quality of Life (scale) between CBT-I treatment condition vs. SH comparison condition. | baseline, up to 5 weeks post-intervention | 
| Blood Sample | Evaluate and compare markers of inflammation between participants in the CBT-I treatment condition vs. SH comparison condition. | baseline, up to 5 weeks post-intervention |