Feasibility of Non-pharmacological Insomnia Therapy in People Living With HIV

Study Overview
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Brief Summary
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To establish with a prospective randomized placebo-controlled study the feasibility of allied-health personnel-administered cognitive behavioral insomnia therapy (CBTI) as a means of improving HIV/AIDS treatment adherence.

Conditions
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Insomnia, Sleep Efficiency

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy
* Behavioral: Behavioral Modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: provide documentation of HIV seropositivity, and have been on current HAART (Highly Active AntiRetroviral Therapy) or antiretroviral regimen without any foreseeable reason to discontinue the HAART during the course of the study; males or females age 18-75 years of age; ≥3 month history of insomnia meeting standard psychiatric criteria for insomnia based on DSISD; sleep onset latency (SOL) and/or wake after sleep onset (WASO) greater than 30 minutes, with a corresponding sleep time of less than 6.5 hours at least 3 nights per week (as measured by the 7-day sleep diary); be able to read, understand, and sign an informed consent form before entering into the study and must be willing to comply with all study procedures as well as to agree to participate for the entire study period. Exclusion Criteria: use of any medication with a significant effect on sleep/wake function within 5 half-lives of baseline or during the study including hypnotics, over-the-counter sleep aides, sedating antidepressants or sedating anxiolytics; history or DSISD (Duke Insomnia Sleep Diagnostics) suggests sleep disorder other than insomnia (e.g., sleep apnea, narcolepsy, periodic leg movements, etc.), or have insomnia associated with circadian rhythm disturbances, such as night or rotating shift work or travel across more than four time zones in the 14 days before Initial Screening (Visit 1) or during the study; clinically significant unstable medical or psychiatric condition, or have any clinically significant abnormal finding in physical examination, neurological assessment, or vital signs, as determined by the Investigator; self reports typical consumption of more than five alcoholic beverages on a single day or greater than 14 alcoholic beverages weekly at Initial Screening (Visit 1); have used any investigational drug within 30 days or five half-lives (whichever is longer) prior to Initial Screening (Visit 1), or plans to use an investigational drug during the study; unable to give informed consent or comply with study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT<br>Cognitive Behavioral Therapy | Behavioral: Cognitive Behavioral Therapy<br> <br> |
| Sham Comparator: Behavioral Modification<br>Standard sleep hygiene education/desensitization therapy | Behavioral: Behavioral Modification<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Efficiency | Patients evaluated weekly for change in sleep efficiency. | Week 1, 2,3, and 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to HAART | Evaluated once weekly for changes in medication adherence. | Week 1, 2,3, and 4 | 
| Fatigue | Changes in reported fatigue levels measured weekly, via the Paper Fatigue Scale (PFS), and the HIV-Related Fatigue Scale (HRFS). | Week 1, 2,3, and 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HAART adherence, HIV, Fatigue, treatment