NCT02259101

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 8, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

May 6, 2016

Status Verified

May 1, 2016

Enrollment Period

2.3 years

First QC Date

October 2, 2014

Last Update Submit

May 5, 2016

Conditions

InsomniaHIVAids

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Quality of Life

    baseline, up to 5 weeks post-intervention

  • Blood Sample

    baseline, up to 5 weeks post-intervention

Study Arms (2)

CBT-I Treatment Condition

EXPERIMENTAL

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.

Behavioral: CBT-I Treatment Condition

SH Comparison Condition

ACTIVE COMPARATOR

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.

Behavioral: SH Comparison Condition

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.

CBT-I Treatment Condition
SH Comparison 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 Condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grady Memorial Hospital/Infectious Disease Program

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Amit Shahane, Ph.D.

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 8, 2014

Study Start

November 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

May 6, 2016

Record last verified: 2016-05

Locations

US(1)