Completed
Feasibility of Non-pharmacological Insomnia Therapy in People Living With HIV
What is being tested
Cognitive Behavioral Therapy
+ Behavioral Modification
Behavioral
Who is being recruted
Mental Disorders+6
+ Nervous System Diseases
+ Signs and Symptoms
From 18 to 75 Years
+11 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-Controlled
Interventional
Study Start: March 2012
Summary
Principal SponsorDuke University
Last updated: April 20, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorDuke University
Last updated: April 20, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
36 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Mental DisordersNervous System DiseasesSigns and SymptomsSleep Wake DisordersPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasFatigueSleep Initiation and Maintenance Disorders
Criteria
5 inclusion criteria required to participate
>= 3 month history of insomnia meeting standard psychiatric criteria for insomnia based on DSISD
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
males or females age 18-75 years of age
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
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6 exclusion criteria prevent from participating
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
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
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
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)
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalCognitive Behavioral Therapy
Group II
ShamStandard sleep hygiene education/desensitization therapy
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center