RCT of CBT for Insomnia With PLWHA

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02259101
• Other study ID #: IRB00065796
• Status: Completed
• Phase: N/A
• First received: October 2, 2014
• Last updated: May 5, 2016
• Start date: November 2013
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aids
• HIV
• Insomnia

Intervention

Behavioral:
• CBT-I Treatment Condition
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
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.

Locations

Country	Name	City	State
United States	Grady Memorial Hospital/Infectious Disease Program	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Symptoms	Compare insomnia scores on the Insomnia Severity Index (questionnaire) between the CBT-I treatment condition vs. SH comparison condition.	baseline, up to 5 weeks post-intervention	No
Secondary	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.	baseline, up to 5 weeks post-intervention	No
Secondary	Blood Sample	Evaluate and compare markers of inflammation between participants in the CBT-I treatment condition vs. SH comparison condition.	baseline, up to 5 weeks post-intervention	No