Feasibility of Non-pharmacological Insomnia Therapy in People Living With HIV
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ClinicalTrials.gov Identifier: NCT01804907 |
Recruitment Status
:
Completed
First Posted
: March 5, 2013
Last Update Posted
: April 20, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Insomnia Sleep Efficiency | Behavioral: Cognitive Behavioral Therapy Behavioral: Behavioral Modification | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: CBT
Cognitive Behavioral Therapy
|
Behavioral: Cognitive Behavioral Therapy |
Sham Comparator: Behavioral Modification
Standard sleep hygiene education/desensitization therapy
|
Behavioral: Behavioral Modification |
- Sleep Efficiency [ Time Frame: Week 1, 2,3, and 4 ]Patients evaluated weekly for change in sleep efficiency.
- Adherence to HAART [ Time Frame: Week 1, 2,3, and 4 ]Evaluated once weekly for changes in medication adherence.
- Fatigue [ Time Frame: Week 1, 2,3, and 4 ]Changes in reported fatigue levels measured weekly, via the Paper Fatigue Scale (PFS), and the HIV-Related Fatigue Scale (HRFS).

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804907
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27710 |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT01804907 History of Changes |
Other Study ID Numbers: |
Pro00032846 |
First Posted: | March 5, 2013 Key Record Dates |
Last Update Posted: | April 20, 2015 |
Last Verified: | April 2015 |
Keywords provided by Duke University:
HAART adherence HIV Fatigue treatment |
Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Wake Disorders Nervous System Diseases Mental Disorders |