Efficacy of an Emotional Disclosure Intervention in HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 283
- 试验地点
- 1
- 主要终点
- Decrease in psychological distress
研究概览
简要总结
The specific objective of this study are to examine whether or not a treatment aimed at emotional disclosure may have beneficial psychological, health and immune effects for HIV infected individuals. The goal of the current study is to test the efficacy of emotional disclosure through writing in patients with HIV infection. We will compare emotional disclosure through writing about traumatic experiences (experimental intervention) to a control intervention (writing about emotionally neutral topics). [Note that HIV RNA viral load, CD4 T cells, urinary cortisol, health related dysfunction, psychological distress, and medication adherence are the 6 primary outcome variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •18-65 years of age inclusive
- •At least 8 years of formal education
- •Fluent in English
- •All of the following three must apply:
- •No active Category C HIV AIDS-defining symptoms
- •CD4 T-lymphocyte count between 150-499
- •Viral load >1000
排除标准
- •Less than 8 years formal education
- •Illiterate or non-English speaking
- •Active systemic diseases that would interfere with participation
- •Current alcohol or substance dependence
- •Planned change in HIV medication in the next 6 months, or recent change in past 2 months
- •Introduction of antidepressant medication within 30 days of study start
- •Current psychological counseling, cognitive behavior therapy, support group or other psychological therapy, or plans to start any of the above
- •Diagnosis of PTSD or major depression
- •Unable to attend at least 4 treatment sessions
研究组 & 干预措施
Trauma writing
Four sessions of writing about traumatic experiences.
干预措施: Trauma writing (Behavioral)
Writing about daily events
Four sessions of writing about their daily experiences.
干预措施: Writing about daily events (Behavioral)
结局指标
主要结局
Decrease in psychological distress
时间窗: 1 year
次要结局
- Increase in CD4 T-lymphocytes(1 year)
- Decrease in the number of HIV symptoms(1 year)
研究者
Gail Ironson
Professor
University of Miami