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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Sleep Efficiency
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy; Behavioral: Behavioral Modification

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 4, 2013
• First Submitted That Met QC Criteria: March 4, 2013
• First Posted (Estimate): March 5, 2013

Study Record Updates

• Last Update Posted (Estimate): April 20, 2015
• Last Update Submitted That Met QC Criteria: April 17, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: treatment; HIV; Fatigue; HAART adherence
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: Pro00032846