Computer-Based Intervention in HIV-Positive Young Adults

NCT ID: NCT02544126

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-08-31

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.

Conditions

HIV; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

eSMART-MH

HIV+ young adults will be randomized to receive Electronic Self-Management Resource Training for Mental Health (eSMART-MH)

Group Type: EXPERIMENTAL

Electronic Self-Management Resource Training for Mental Health

Intervention Type: DEVICE

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.

Attention Control

HIV+ young adults will be randomized to receive screen-based health education

Group Type: ACTIVE_COMPARATOR

Screen-based health education

Intervention Type: BEHAVIORAL

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.

Interventions

Electronic Self-Management Resource Training for Mental Health

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: DEVICE

Screen-based health education

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

eSMART-MH

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

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Melissa Pinto

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melissa D Pinto, PhD,RN,FAAN

Role: PRINCIPAL_INVESTIGATOR

Emory University

Other Identifiers

IRB00080145

Identifier Type: -

Identifier Source: org_study_id