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OpenTrials
Completed

NCT Number: NCT02259101

RCT of CBT for Insomnia With PLWHA

The proposed study will consist of a randomized controlled trial (RCT) comparing a known efficacious treatment for insomnia (CBT-I) to a sleep hygiene (SH) comparison condition.

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Key information

About this study

The purpose of this study is to test whether a group cognitive-behavioral treatment program for insomnia (CBT-I) will help adults diagnosed with HIV to improve the quantity (number of hours) and the quality of their sleep. The PI will compare adults who participated in the CBT-I program to adults who participated in a Sleep Hygiene group, a common treatment for insomnia. The PI will look at the overall quality of life, and number of hours and quality of sleep of adults who participated in the CBT-I program versus adults in the Sleep Hygiene group. Also, the PI will draw blood to compare how the body responds to medical illnesses between adults in the CBT-I program to adults in the Sleep Hygiene group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English-speaking individuals
  • over the age of 18 years old with a diagnosis of HIV or AIDS who is receiving medical care at the Grady Health System's Infectious Disease Program (IDP)
  • study subjects must meet the criteria for primary or secondary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision
  • must experience difficulty initiating or maintaining non-restorative sleep for at least l month (DSM- IV-TR)
  • the sleep disturbance causes clinically significant impairment or distress in important areas of functioning
  • sleep efficiency of less than 85%, sleep disturbances that occur three or more days per week, and sleep latency (i.e., time awake after sleep onset greater than 30 minutes)

Exclusion criteria

  • current substance dependence (within the past six months)
  • active psychosis
  • Bipolar I and II disorders
  • neurocognitive impairment and/or a current diagnosis of dementia
  • lack of independent housing
  • previous participation in a CBT-I program
  • employment in a job requiring shift work that impairs the ability to establish a regular sleep schedule

Treatment and study plan

CBT-I Treatment Condition

Behavioral

Each group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep. Blood will be drawn twice in order to compare how the body responds to medical illnesses.

SH Comparison Condition

Behavioral

Each group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep. Blood will be drawn twice in order to compare how the body responds to medical illnesses.

Primary outcomes

  1. Insomnia Symptoms

    Time frame: baseline, up to 5 weeks post-intervention

    Compare insomnia scores on the Insomnia Severity Index (questionnaire) between the CBT-I treatment condition vs. SH comparison condition.

Secondary outcomes

  1. Quality of Life

    Time frame: baseline, up to 5 weeks post-intervention

    Compare quality of life scores on the HIV/AIDS Targeted-Quality of Life (scale) between CBT-I treatment condition vs. SH comparison condition.

  2. Blood Sample

    Time frame: baseline, up to 5 weeks post-intervention

    Evaluate and compare markers of inflammation between participants in the CBT-I treatment condition vs. SH comparison condition.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

A Randomized Controlled Trial of Cognitive Behavior Therapy for Insomnia With Persons Living With HIV/AIDS

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 8, 2014
Registry last updated
May 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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