RCT of CBT for Insomnia With PLWHA

Not Applicable

Completed

• Conditions: Insomnia; Aids; HIV
• Interventions: Behavioral: CBT-I Treatment Condition; Behavioral: SH Comparison Condition

• Registration Number: NCT02259101
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-03
• Study First Posted: 2014-10-08
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-05
• Last Update Posted: 2016-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT-I Treatment Condition	CBT-I Treatment Condition	The CBT-I treatment condition will be delivered in a one-hour per week group format (10 participants) occurring over the course of six-weeks. Four total CBT-I groups occurring over the course of two years will be implemented, with at total of 40 participants enrolled for the CBT-I condition.
SH Comparison Condition	SH Comparison Condition	The SH comparison condition will also be delivered in a one-hour per week group format (10 participants) occurring over the course of six-weeks. Four total SH groups over the course of two years will be conducted, with a total of 40 participants enrolled for the SH condition.

Primary Outcome Measures

Name	Time	Method
Insomnia Symptoms	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 Outcome Measures

Name	Time	Method
Blood Sample	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.
Quality of Life	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.

Trial Locations

Locations (1)

Grady Memorial Hospital/Infectious Disease Program; 🇺🇸 Atlanta, Georgia, United States