Computer-Based Intervention in HIV-Positive Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in Center for Disease Control Health Related Quality of Life-4 (CDC HRQOL-4)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 23 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Center for Disease Control Health Related Quality of Life-4 (CDC HRQOL-4)
时间窗: 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 General Well-Being Schedule (GWS)
时间窗: 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 the Quality of Life Enjoyment Scale (Q-LES-Q-SF)
时间窗: 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.
Change in the Patient Health Questionnaire (PHQ-9)
时间窗: 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.
次要结局
- Change in cluster of differentiation 4 (CD4) Count(Baseline, 3 months)
- Change in plasma oxytocin levels(Baseline, 3 months)
- Medication Adherence(Baseline, 3 months)
- Change in plasma interleukin-6 (IL-6) levels(Baseline, 3 months)
- Change of plasma brain-derived neurotrophic factor (BDNF) levels(Baseline, 3 months)
- Change in Log HIV Viral Load(Baseline, 3 months)
- Change in Fibrinogen levels(Baseline, 3 months)
研究者
Melissa Pinto
Assistant Professor
Emory University