Clinical Trial Of Cognitive-behavioral Therapy To Reduce Antiretroviral Side Effects In HIV Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Side effect symptoms measured by visual analogue scales
研究概览
简要总结
The hypothesis is that participants in the intervention group will experience fewer/less intense side effects from anti-HIV medications, if they receive training sessions on the use of guided imagery, relaxation, and reframing of the medication-taking experience. Such training is not part of the usual care of HIV patients.
详细描述
HIV patients on antiretroviral medications, who are suffering from pain, nausea, anxiety, or fatigue will be randomly assigned to either the usual care for an HIV patient, which is an educational program about the medications, or an intervention program, which includes both the educational program and three sessions with a psychologist. The sessions will help participants understand their concerns about the medications and will teach relaxation techniques and guided imagery to help participants reduce discomforts associated with the medications. All patients will continue to receive the usual care from their medical providers. The main measures are the measured frequency and intensity of the symptoms under study; secondary measures examine medication adherence, CD4 counts, and virus levels. Control measures include the number of doses of side effect medications taken in each group, and the number of relaxation/imagery sessions practiced privately by participants in the intervention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants currently taking antiretroviral medications for HIV
- •Participants suffer from one or more: nausea, pain, fatigue, anxiety
排除标准
- •Non-English speaking/reading
- •Pregnant or planning to become pregnant within 3 months
- •Any severe health problem that would prevent participation (e.g., opportunistic infection requiring hospitalization)
- •Substance abuse preventing active participation in care
结局指标
主要结局
Side effect symptoms measured by visual analogue scales
时间窗: study start, 30 days, 60 days, 90 days
次要结局
- Health status by SF-36(study start, 30 days, 60 days, 90 days)
- Adherence by visual analogue scale(study start, 30 days, 60 days, 90 days)
- CD4 lymphocyte count(study start, 90 days)
- Serum HIV level(study start, 90 days)