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RCT of CBT for Insomnia With PLWHA

Primary Purpose

Insomnia, HIV, Aids

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CBT-I Treatment Condition

SH Comparison Condition

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Grady Memorial Hospital/Infectious Disease Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT-I Treatment Condition

SH Comparison Condition

Arm 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.

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.

Outcomes

Primary Outcome Measures

Insomnia Symptoms

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

Secondary Outcome Measures

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.

Blood Sample

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

Full Information

NCT ID

NCT02259101

First Posted

October 2, 2014

Last Updated

May 5, 2016

Sponsor

Emory University

1. Study Identification

Unique Protocol Identification Number

NCT02259101

Brief Title

RCT of CBT for Insomnia With PLWHA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia, HIV, Aids

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBT-I Treatment Condition

Arm Type

Experimental

Arm Description

Arm Title

SH Comparison Condition

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

CBT-I Treatment Condition

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

SH Comparison Condition

Intervention Description

Primary Outcome Measure Information:

Title

Insomnia Symptoms

Description

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 Outcome Measure Information:

Title

Quality of Life

Description

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

Title

Blood Sample

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amit Shahane, Ph.D.

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Grady Memorial Hospital/Infectious Disease Program

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30303

Country

United States

12. IPD Sharing Statement

Learn more about this trial

RCT of CBT for Insomnia With PLWHA

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