Neuroinflammation and Modulating Factors in Depression and HIV: The Growth Study-Group Therapy in HIV for Depression IN Uganda
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Change in Patient Health Questionnaire (PHQ)-9
研究概览
简要总结
Determine if depression, which persists after depression treatment at 26 weeks, is associated with increased innate inflammation in a prospective cohort of HIV-infected Ugandans receiving SSRIs in which group psychotherapy is initiated.
详细描述
Depression in HIV is a complex co-morbidity with both social factors such as stigma as well as biologic components. Disruptions in neurotransmitters such as serotonin and catecholamines are known to cause depression. Inflammation caused by diseases such as stroke, diabetes, and HIV is associated with higher rates of depression. HIV causes inflammation throughout the body, but since the virus can cross the blood-brain-barrier, HIV can replicate in and target the brain causing neuroinflammation which predisposes depression. However the pathophysiology of the role of inflammation in comorbid depression and HIV is poorly understood.
- Among depressed HIV-infected Ugandans, determine if the resolution of depression at 26 weeks of HIV therapy is improved with group psychotherapy.
- In the same population determine if persistent depression is associated with higher levels of innate inflammation. Also, compare baseline and follow up inflammation among depressed compared to non-depressed control group.
- Evaluate if viral suppression levels at 26 weeks are improved by group psychotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the depressed patient arm,
- •Newly-presenting clinic patients (<3 months)
- •Mild to Moderately-Severe Depressive Symptoms with PHQ-9 score >5 but <20
- •Not suicidal (PHQ-9 question 9 score >2)
- •Not receiving antiretroviral therapy (ART) at screening
- •Outpatient, not requiring hospitalization
- •For the non-depressed patient arm,
- •Newly-presenting clinic patients (<3 months)
- •Not suicidal (PHQ-9 question 9 score >2)
- •Not receiving antiretroviral therapy (ART) at screening
- •Outpatient, not requiring hospitalization
排除标准
- •No additional exclusion criteria
结局指标
主要结局
Change in Patient Health Questionnaire (PHQ)-9
时间窗: 6 months
The Patient Health Questionnaire (PHQ)-9 is a 9-item survey measuring degree of depression severity over the previous 2 weeks. Items assess how often the patient has been bothered by specific symptoms and are rated on a scale of 0 (not at all) to 3 (nearly every day). Total score is an unweighted sum of the 9 item scores, with higher scores indicating greater depression severity. a score of 0-27 is possible. We aren't reporting subscales. A score of 5+ will screen positive for mild depression, and a score of 10+ is considered a positive to screen for moderate-severe depression. change between baseline and 6 months
次要结局
未报告次要终点