Effectiveness of Yoga therapy as an adjunct on Mental health status, quality of life and medication adherence among People Living with HIV on Antiretroviral therapy: A Randomized Controlled Trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- 1. Psychological assessment -Hospital anxiety and depression scale (HADS)
研究概览
简要总结
People living with HIV (PLHIV) often experience major psychological challenges such as anxiety, depression, and stress, which are worsened by the stigma, social isolation, and chronic nature of the disease (HIV), impacting both their mental health, quality of life (QoL) and medication adherence.While antiretroviral therapy (ART) effectively increases the lifespan of people living with HIV (PLHIV) and controls viral replication, it does not directly focus on the psychological burden or quality of life, emphasizing the need for holistic and comprehensive interventions in addition to ART.Yoga has demonstrated benefits in improving psychological well-being and quality of life in the HIV seronegative population.However, there are several gaps in the current literature on yoga interventions for PLHIV.First, there is significant heterogeneity in the forms of yoga (e.g., Hatha, Integrated, Sudarshan Kriya) and durations (ranging from 6 days to 20 weeks)used in the existing studies, making it difficult to determine which specific practices are most effective for improving psychological outcomes, quality of life (QOL). Second, theseyoga-based studies have been pilot trials or conducted with small sample sizes and short follow-up periods,resulting in inconsistent findings on depression, anxiety, and quality of life. Furthermore, none of the previous studies investigatedthe effect of yoga interventions on medication adherence in people living with HIV.This is the first study aimed at assessing the effectiveness of yoga as an adjunct therapy . on the psychological outcomes, quality of life and medication adherence of people living with HIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Diagnosed with HIVRNA, and on stable Antiretroviral therapy
- •No contradictions to initiating a Yoga regime.
- •Karnofsky performance scale of more than 70.
排除标准
- •Current or past history of hypertension, diabetes, heart failure,stroke and apparent opportunistic infection.
- •Use of antihypertensive drugs and anti-depressant medication.
- •Use of Immunosuppressive or immunomodulatory medications other than ART (within 6 months).
- •Pregnant and lactating women.
- •Known physical disability or mental disorder.
- •Practicing any form of yoga, meditation or exercise.
结局指标
主要结局
1. Psychological assessment -Hospital anxiety and depression scale (HADS)
时间窗: Baseline,3rd, 6th and 12th months
次要结局
- 1. WHO QoL-HIV BREF(2. SF-36 Questionnaire)
研究者
Dr Gautam Sharma
AIIMS New Delhi
