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

NCT01804907 | Completed

• 1 other identifier: Pro00032846
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

HAART adherence; HIV; Fatigue; treatment

Outcome Measures

Primary Outcomes (1)

• Sleep Efficiency

  Patients evaluated weekly for change in sleep efficiency.

  Week 1, 2,3, and 4

Secondary Outcomes (2)

• Adherence to HAART

  Week 1, 2,3, and 4

• Fatigue

  Week 1, 2,3, and 4

Study Arms (2)

CBT

EXPERIMENTAL

Cognitive Behavioral Therapy

Behavioral: Cognitive Behavioral Therapy

Behavioral Modification

SHAM COMPARATOR

Standard sleep hygiene education/desensitization therapy

Behavioral: Behavioral Modification

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

CBT

Behavioral Modification BEHAVIORAL

Behavioral Modification

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Fatigue

Interventions

Cognitive Behavioral Therapy; Behavior Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: March 5, 2013
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 20, 2015

Record last verified: 2015-04

Locations

US (1)