RCT of CBT for Insomnia With PLWHA

Emory University

Status: Completed

Conditions: HIV; Insomnia; Aids

Treatments: Behavioral: CBT-I Treatment Condition; Behavioral: SH Comparison Condition

Study type: Interventional

Funder types: Other

Identifiers

NCT02259101

IRB00065796

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

CBT-I Treatment Condition

Experimental group

Description:

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.

Treatment:

Behavioral: CBT-I Treatment Condition

SH Comparison Condition

Active Comparator group

Description:

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.

Treatment:

Behavioral: SH Comparison Condition