RCT of CBT for Insomnia With PLWHA

Emory University34 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Insomnia HIV Aids

Interventions

CBT-I Treatment ConditionBEHAVIORAL

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 ConditionBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Grady Memorial Hospital/Infectious Disease Program

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Insomnia Symptoms

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

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

Secondary Outcomes

Quality of Life

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

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

Blood Sample

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

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

Data from ClinicalTrials.gov

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