Back to resultsComputer-Based Intervention in HIV-Positive Young Adults
Primary Purpose
HIV, Depression
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electronic Self-Management Resource Training for Mental Health
Screen-based health education
Sponsored by
About this trial
This is an interventional treatment trial for HIV
Eligibility Criteria
Inclusion Criteria:
- 23-53 years of age
- Fluent in English
- Be able to view images and text on a computer screen and hear audio using a headset
- Have a diagnosis of unipolar depression or have significant depressive symptoms noted in the electronic medical record (EMR) or referred to the study by a provider at the Grady Ponce de Leon Clinic because of their depressive symptoms
- Receive care at Ponce de Leon Center and at least 1 scheduled HIV medical appointment in the last 6 months
- Reside in the Atlanta, Georgia area
- Have a valid telephone number and email address
- Answer all items correctly on consent post-test
Exclusion Criteria:
- Diagnosis of bipolar depression
- Deaf, blind or unable to understand spoken English
- Currently pregnant, history of pregnancy within the last year or plan to become pregnant within the next 4 months
- Plan to move from the Atlanta, Georgia area within four months of study enrollment
- Taking corticosteroids or disease-modifying anti-rheumatic drugs
- If on antidepressant medication, taking it for less than 1 month
- Fail to pass post-consent test after three attempt
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
eSMART-MH
Attention Control
Arm Description
HIV+ young adults will be randomized to receive Electronic Self-Management Resource Training for Mental Health (eSMART-MH)
HIV+ young adults will be randomized to receive screen-based health education
Outcomes
Primary Outcome Measures
Change in the Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a 9-item self-report measure of depressive symptoms which asks participants to rate the frequency of depression symptoms over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 27, with higher scores reflecting greater severity of depressive symptoms.
Change in the General Well-Being Schedule (GWS)
The GWS is an 18-item self-report measure that examines the subjective feelings of psychological well-being and distress which asks participants to rate each question in relationship to their feelings over the past 4 weeks on a 6-grade Likert scale. The last four items ask respondents to supply ratings on a 1-10 scale. Score range will be transformed into a the scale score on a continuum from 0 to 100, with higher scores reflecting a better well being of the participant.
Change in Center for Disease Control Health Related Quality of Life-4 (CDC HRQOL-4)
CDC HRQOL-4 is self-report measures quality of life over the last 30 days in the domains of physical and mental health and asks participants 4 core questions including one health status measure (self-rated health) and three HRQOL measures (recent physical health, recent mental health, and recent activity limitation). The scoring used is with a summary "unhealthy days" index, computed by adding a respondent's physically and mentally unhealthy days, with a maximum of 30 for one person.
Change in the Quality of Life Enjoyment Scale (Q-LES-Q-SF)
Q-LES-Q-SF is a 16 item self-report measure that assesses the quality of life satisfaction in multiple domains of functioning which asks participants to rate how satisfied they have been with various aspects of their life over the last week, rating on a 1-5 Likert-type scale. Scores range from 16 to 80, with higher scores reflecting less enjoyment and satisfaction.
Secondary Outcome Measures
Medication Adherence
Pill counts for antiretroviral therapy (ART) and medication for mood (if ordered) will be measured through examining pills consumed compared to the doses prescribed.
Change in plasma interleukin-6 (IL-6) levels
IL-6 is circulating inflammatory biomarker. The plasma concentrations of IL-6 will be assessed using commercial enzyme-linked immunoassay (ELISA) kits.
Change in cluster of differentiation 4 (CD4) Count
CD4 is a glycoprotein found on the surface of immune cells such as T helper cells, monocytes, macrophages, and dendritic cells and is a measure for how well the immune system is working. CD4 T-cell will be assessed using flow cytometry and healthy adult/adolescent ranges from 500 cells/mm^3 to 1,200 cells/mm^3.
Change in Log HIV Viral Load
Viral load measures the amount of HIV's genetic material in a blood sample. The results of a viral load test are described as the number of copies of HIV RNA in a milliliter of blood. For example, a viral load of 10,000 would be considered low; 100,000 would be considered high. Viral load changes can be very large, so they are sometimes quantified using the powers of ten, or 'log scale'. A 1-log change is the same as a ten-fold change (so 5000 to 50,000 or vice versa).
Change of plasma brain-derived neurotrophic factor (BDNF) levels
BDNF is a protein that acts on certain neurons of the central nervous system and the peripheral nervous system, helping to support the survival of existing neurons, and encourage the growth and differentiation of new neurons and synapses. The plasma concentrations of BDNF will be assessed using commercial enzyme-linked immunoassay (ELISA) kits.
Change in Fibrinogen levels
Fibrinogen is a hepatic-derived factor directly involved in clotting and in the viscosity characteristics of blood flow. It binds to platelets and contributes to their aggregation, promotes fibrin formation and is also an acute phase reactant that is increased in inflammatory states. The plasma concentrations of fibrinogen antigen will be assessed using the immunochemistry.
Change in plasma oxytocin levels
Oxytocin, a chemical composed of a chain of amino acids, is a substance that has multiple physiological functions within the human body. These functions include roles as both a hormone as well as a neurotransmitter. The plasma concentrations of oxytocin will be assessed using commercial enzyme-linked immunoassay (ELISA) kits.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02544126
Brief Title
Computer-Based Intervention in HIV-Positive Young Adults
Official Title
Computer-Based Intervention in HIV-Positive Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Study Start Date
September 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate how working with a computer program may affect mood, feelings, overall health, and markers in blood in young adults with HIV.
Detailed Description
Depression frequently occurs in young adults with HIV infection. When young adults with HIV experience depression, they are less likely to take their prescribed antiretroviral therapy (ART). When HIV occurs simultaneously with depression, individuals are more likely to have indicators in their blood that are linked risk for developing other illnesses in the future. The purpose of this project is to examine the ability of an avatar-based intervention, called eSMART-MH, to decrease depressive symptoms in HIV-positive depressed young adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eSMART-MH
Arm Type
Experimental
Arm Description
HIV+ young adults will be randomized to receive Electronic Self-Management Resource Training for Mental Health (eSMART-MH)
Arm Title
Attention Control
Arm Type
Active Comparator
Arm Description
HIV+ young adults will be randomized to receive screen-based health education
Intervention Type
Device
Intervention Name(s)
Electronic Self-Management Resource Training for Mental Health
Other Intervention Name(s)
eSMART-MH
Intervention Description
eSMART-MH is a software, which is set in a 3-D virtual primary care office environment in which a subject interacts with avatar virtual healthcare staff (medical receptionist, medical assistant, providers, and a virtual healthcare coach). The avatars are programed to behave like humans. The subject moves through the 3-D virtual primary care office and encounters virtual healthcare staff and providers. The subject practices discussing depressive symptoms with avatar healthcare providers and practices self-management skills related to symptoms of depression.The subject also interacts with the health care coach. The health care coach provides the subject with real-time strategies to enhance communication with healthcare providers during their virtual office visit. Overtime, coaching is decreased to build the the subject's self-confidence. eSMART-MH will be used once a month, for three months.
Intervention Type
Behavioral
Intervention Name(s)
Screen-based health education
Intervention Description
Screen-based health education will be used and cover topics like depression, nutrition, physical activity, and sleep hygiene at the same frequency as the eSMART-MH intervention, which is used once a month, for three months.
Primary Outcome Measure Information:
Title
Change in the Patient Health Questionnaire (PHQ-9)
Description
The PHQ-9 is a 9-item self-report measure of depressive symptoms which asks participants to rate the frequency of depression symptoms over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 27, with higher scores reflecting greater severity of depressive symptoms.
Time Frame
Baseline, 3 months
Title
Change in the General Well-Being Schedule (GWS)
Description
The GWS is an 18-item self-report measure that examines the subjective feelings of psychological well-being and distress which asks participants to rate each question in relationship to their feelings over the past 4 weeks on a 6-grade Likert scale. The last four items ask respondents to supply ratings on a 1-10 scale. Score range will be transformed into a the scale score on a continuum from 0 to 100, with higher scores reflecting a better well being of the participant.
Time Frame
Baseline, 3 months
Title
Change in Center for Disease Control Health Related Quality of Life-4 (CDC HRQOL-4)
Description
CDC HRQOL-4 is self-report measures quality of life over the last 30 days in the domains of physical and mental health and asks participants 4 core questions including one health status measure (self-rated health) and three HRQOL measures (recent physical health, recent mental health, and recent activity limitation). The scoring used is with a summary "unhealthy days" index, computed by adding a respondent's physically and mentally unhealthy days, with a maximum of 30 for one person.
Time Frame
Baseline, 3 months
Title
Change in the Quality of Life Enjoyment Scale (Q-LES-Q-SF)
Description
Q-LES-Q-SF is a 16 item self-report measure that assesses the quality of life satisfaction in multiple domains of functioning which asks participants to rate how satisfied they have been with various aspects of their life over the last week, rating on a 1-5 Likert-type scale. Scores range from 16 to 80, with higher scores reflecting less enjoyment and satisfaction.
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Medication Adherence
Description
Pill counts for antiretroviral therapy (ART) and medication for mood (if ordered) will be measured through examining pills consumed compared to the doses prescribed.
Time Frame
Baseline, 3 months
Title
Change in plasma interleukin-6 (IL-6) levels
Description
IL-6 is circulating inflammatory biomarker. The plasma concentrations of IL-6 will be assessed using commercial enzyme-linked immunoassay (ELISA) kits.
Time Frame
Baseline, 3 months
Title
Change in cluster of differentiation 4 (CD4) Count
Description
CD4 is a glycoprotein found on the surface of immune cells such as T helper cells, monocytes, macrophages, and dendritic cells and is a measure for how well the immune system is working. CD4 T-cell will be assessed using flow cytometry and healthy adult/adolescent ranges from 500 cells/mm^3 to 1,200 cells/mm^3.
Time Frame
Baseline, 3 months
Title
Change in Log HIV Viral Load
Description
Viral load measures the amount of HIV's genetic material in a blood sample. The results of a viral load test are described as the number of copies of HIV RNA in a milliliter of blood. For example, a viral load of 10,000 would be considered low; 100,000 would be considered high. Viral load changes can be very large, so they are sometimes quantified using the powers of ten, or 'log scale'. A 1-log change is the same as a ten-fold change (so 5000 to 50,000 or vice versa).
Time Frame
Baseline, 3 months
Title
Change of plasma brain-derived neurotrophic factor (BDNF) levels
Description
BDNF is a protein that acts on certain neurons of the central nervous system and the peripheral nervous system, helping to support the survival of existing neurons, and encourage the growth and differentiation of new neurons and synapses. The plasma concentrations of BDNF will be assessed using commercial enzyme-linked immunoassay (ELISA) kits.
Time Frame
Baseline, 3 months
Title
Change in Fibrinogen levels
Description
Fibrinogen is a hepatic-derived factor directly involved in clotting and in the viscosity characteristics of blood flow. It binds to platelets and contributes to their aggregation, promotes fibrin formation and is also an acute phase reactant that is increased in inflammatory states. The plasma concentrations of fibrinogen antigen will be assessed using the immunochemistry.
Time Frame
Baseline, 3 months
Title
Change in plasma oxytocin levels
Description
Oxytocin, a chemical composed of a chain of amino acids, is a substance that has multiple physiological functions within the human body. These functions include roles as both a hormone as well as a neurotransmitter. The plasma concentrations of oxytocin will be assessed using commercial enzyme-linked immunoassay (ELISA) kits.
Time Frame
Baseline, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
23-53 years of age
Fluent in English
Be able to view images and text on a computer screen and hear audio using a headset
Have a diagnosis of unipolar depression or have significant depressive symptoms noted in the electronic medical record (EMR) or referred to the study by a provider at the Grady Ponce de Leon Clinic because of their depressive symptoms
Receive care at Ponce de Leon Center and at least 1 scheduled HIV medical appointment in the last 6 months
Reside in the Atlanta, Georgia area
Have a valid telephone number and email address
Answer all items correctly on consent post-test
Exclusion Criteria:
Diagnosis of bipolar depression
Deaf, blind or unable to understand spoken English
Currently pregnant, history of pregnancy within the last year or plan to become pregnant within the next 4 months
Plan to move from the Atlanta, Georgia area within four months of study enrollment
Taking corticosteroids or disease-modifying anti-rheumatic drugs
If on antidepressant medication, taking it for less than 1 month
Fail to pass post-consent test after three attempt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa D Pinto, PhD,RN,FAAN
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Computer-Based Intervention in HIV-Positive Young Adults
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