Back to resultsFeasibility of Non-pharmacological Insomnia Therapy in People Living With HIV
Primary Purpose
Insomnia, Sleep Efficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Behavioral Modification
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring HAART adherence, HIV, Fatigue, treatment
Eligibility Criteria
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.
Sites / Locations
- Duke University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
CBT
Behavioral Modification
Arm Description
Cognitive Behavioral Therapy
Standard sleep hygiene education/desensitization therapy
Outcomes
Primary Outcome Measures
Sleep Efficiency
Patients evaluated weekly for change in sleep efficiency.
Secondary Outcome Measures
Adherence to HAART
Evaluated once weekly for changes in medication adherence.
Fatigue
Changes in reported fatigue levels measured weekly, via the Paper Fatigue Scale (PFS), and the HIV-Related Fatigue Scale (HRFS).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01804907
Brief Title
Feasibility of Non-pharmacological Insomnia Therapy in People Living With HIV
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Sleep Efficiency
Keywords
HAART adherence, HIV, Fatigue, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy
Arm Title
Behavioral Modification
Arm Type
Sham Comparator
Arm Description
Standard sleep hygiene education/desensitization therapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Modification
Primary Outcome Measure Information:
Title
Sleep Efficiency
Description
Patients evaluated weekly for change in sleep efficiency.
Time Frame
Week 1, 2,3, and 4
Secondary Outcome Measure Information:
Title
Adherence to HAART
Description
Evaluated once weekly for changes in medication adherence.
Time Frame
Week 1, 2,3, and 4
Title
Fatigue
Description
Changes in reported fatigue levels measured weekly, via the Paper Fatigue Scale (PFS), and the HIV-Related Fatigue Scale (HRFS).
Time Frame
Week 1, 2,3, and 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
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Feasibility of Non-pharmacological Insomnia Therapy in People Living With HIV
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