HIVNCT02544126
Computer-Based Intervention in HIV-Positive Young Adults
A study testing Electronic Self-Management Resource Training for Mental Health and Screen-based health education in people with HIV and Depression, run by Emory University.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 35 years
- Conditions the study is for
- HIV, Depression
- What is being tested?
- Electronic Self-Management Resource Training for Mental Health and Screen-based health education
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- HIV, Depression
- Being tested
- Electronic Self-Management Resource Training for Mental Health, Screen-based health education
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Self-Management Resource Training for Mental HealthDevice
Also called eSMART-MH
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.
Screen-based health educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| eSMART-MH | Experimental | HIV+ young adults will be randomized to receive Electronic Self-Management Resource Training for Mental Health (eSMART-MH) Receives: Device: Electronic Self-Management Resource Training for Mental Health |
| Attention Control | Active comparator | HIV+ young adults will be randomized to receive screen-based health education Receives: Behavioral: Screen-based health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months
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.
Measured: Baseline, 3 months
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.
Measured: Baseline, 3 months
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.
Measured: Baseline, 3 months
Secondary outcomes (7)
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.
Measured: Baseline, 3 months
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.
Measured: Baseline, 3 months
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.
Measured: Baseline, 3 months
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).
Measured: Baseline, 3 months
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.
Measured: Baseline, 3 months
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.
Measured: Baseline, 3 months
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.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Pinto, Emory University
- Investigators
- Melissa D Pinto, PhD,RN,FAAN, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544126
- Sponsor's protocol ID
- IRB00080145
- Status last verified
- Jan 2017
- First submitted
- 4 Sep 2015
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Based Intervention in HIV-Positive Young Adults
- ClinicalTrials.gov ID
- NCT02544126
- Acronym / sponsor ID
- IRB00080145
- Conditions
- HIV, Depression
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eSMART-MH | Experimental | Device: Electronic Self-Management Resource Training for Mental HealthHIV+ young adults will be randomized to receive Electronic Self-Management Resource Training for Mental Health (eSMART-MH) |
| Attention Control | Active comparator | Behavioral: Screen-based health educationHIV+ young adults will be randomized to receive screen-based health education |
Who may qualify
- Ages
- 23 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Self-Management Resource Training for Mental HealthAlso: eSMART-MHeSMART-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. | Device | eSMART-MH |
| Screen-based health educationScreen-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. | Behavioural | Attention Control |
Primary outcome
Change in the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 3 months
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)
Time frame: Baseline, 3 months
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)
Time frame: Baseline, 3 months
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)
Time frame: Baseline, 3 months
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.
7 secondary outcomes
Medication Adherence
Time frame: Baseline, 3 months
Change in plasma interleukin-6 (IL-6) levels
Time frame: Baseline, 3 months
Change in cluster of differentiation 4 (CD4) Count
Time frame: Baseline, 3 months
Change in Log HIV Viral Load
Time frame: Baseline, 3 months
Change of plasma brain-derived neurotrophic factor (BDNF) levels
Time frame: Baseline, 3 months
Change in Fibrinogen levels
Time frame: Baseline, 3 months
Change in plasma oxytocin levels
Time frame: Baseline, 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa D Pinto, PhD,RN,FAAN principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Self-Management Resource Training for Mental Health and Screen-based health education in people with HIV and Depression, run by Emory University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Patient Health Questionnaire (PHQ-9) (time frame: Baseline, 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.