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

NCT ID: NCT01804907

Last Updated: 2015-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-12-31

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.

Conditions

Insomnia; Sleep Efficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CBT

Cognitive Behavioral Therapy

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Behavioral Modification

Standard sleep hygiene education/desensitization therapy

Group Type: SHAM_COMPARATOR

Behavioral Modification

Intervention Type: BEHAVIORAL

Interventions

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Behavioral Modification

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00032846

Identifier Type: -

Identifier Source: org_study_id