Computer-Based Intervention in HIV-Positive Young Adults

NCT02544126 | Withdrawn DMC

• 1 other identifier: IRB00080145
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV; Depression

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, 3 months

Secondary Outcomes (7)

• Medication Adherence

  Baseline, 3 months

• Change in plasma interleukin-6 (IL-6) levels

  Baseline, 3 months

• Change in cluster of differentiation 4 (CD4) Count

  Baseline, 3 months

• Change in Log HIV Viral Load

  Baseline, 3 months

• Change of plasma brain-derived neurotrophic factor (BDNF) levels

  Baseline, 3 months

Study Arms (2)

eSMART-MH

EXPERIMENTAL

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

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

Behavioral: Screen-based health education

Interventions

Electronic Self-Management Resource Training for Mental Health 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.

Also known as: eSMART-MH

eSMART-MH

Screen-based health education 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.

Attention Control

Eligibility Criteria

• Age: 23 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Melissa D Pinto, PhD,RN,FAAN

  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: September 4, 2015
• First Posted: September 9, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01