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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01804907
First received: March 4, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Insomnia
Sleep Efficiency
Behavioral: Cognitive Behavioral Therapy
Behavioral: Behavioral Modification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Sleep Efficiency [ Time Frame: Week 1, 2,3, and 4 ] [ Designated as safety issue: No ]
    Patients evaluated weekly for change in sleep efficiency.


Secondary Outcome Measures:
  • Adherence to HAART [ Time Frame: Week 1, 2,3, and 4 ] [ Designated as safety issue: No ]
    Evaluated once weekly for changes in medication adherence.

  • Fatigue [ Time Frame: Week 1, 2,3, and 4 ] [ Designated as safety issue: No ]
    Changes in reported fatigue levels measured weekly, via the Paper Fatigue Scale (PFS), and the HIV-Related Fatigue Scale (HRFS).


Enrollment: 36
Study Start Date: March 2012
Estimated Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT
Cognitive Behavioral Therapy
Behavioral: Cognitive Behavioral Therapy
Sham Comparator: Behavioral Modification
Standard sleep hygiene education/desensitization therapy
Behavioral: Behavioral Modification

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01804907

Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01804907     History of Changes
Other Study ID Numbers: Pro00032846
Study First Received: March 4, 2013
Last Updated: March 4, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Duke University:
HAART adherence
HIV
Fatigue
treatment

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014