Relaxation, Depressive Symptoms, Quality of Life, Immunological and Virological Status o in People Living With HIV: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change from baseline in depressive symptoms measured with Personal Health Questionnaire (PHQ-9) assessed at 6 months
研究概览
简要总结
Progressive muscle relaxation (PMR) and autogenic training (AT) are effective relaxation techniques to reduce depressive symptoms. However, no studies on their effectiveness have been conducted among people living with HIV and depressive symptoms. The primary aim of this pilot study was to assess the feasibility and acceptability of PMR and AT interventions among people living with HIV who have depressive symptoms. A secondary aim was to assess the potential effectiveness of these interventions on depressive symptoms and quality of life.
详细描述
This study was a three-arm pilot randomized control trial with mixed methods. Participants were randomized to PMR, AT, or control group (CG), with four assessments (baseline, one-, three-, and six-month). The PMR and AT interventions consisted of six one-hour sessions of individual training over 12 weeks and home practice. Recruitment, attrition, and completion rates were calculated. Depressive symptoms and quality of life were assessed at all times. Participants' perceptions of the interventions were collected in semi-structured interviews.
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 (Outcomes Assessor)
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
- •Age > 18 years
- •HIV diagnosis of at least two years
- •Depressive symptoms between 5 and 14 in the PHQ-9 scale
- •Untreated with antidepressants or psychotherapy
- •Able to speak and understand French
排除标准
- •Started antiretroviral treatment within the last 6 months
- •Start or already receiving Interferon
研究组 & 干预措施
Jacobson progressive muscular relaxation
Jacobson progressive muscular relaxation
干预措施: Jacobson progressive muscular relaxation (Behavioral)
Schultz's autogenic training
Schultz's autogenic training
干预措施: Schultz's autogenic training (Behavioral)
control
The CG continued to receive their standard care. After data collection at the six-month follow-up, the CG participants were invited to attend one of two relaxation interventions.
结局指标
主要结局
Change from baseline in depressive symptoms measured with Personal Health Questionnaire (PHQ-9) assessed at 6 months
时间窗: baseline and 6 months
Depressive symptoms at 6 months will be measured with Personal Health Questionnaire (PHQ-9)
Change from baseline in depressive symptoms measured with Personal Health Questionnaire (PHQ-9) assessed at 3 months
时间窗: baseline and 3 months
Depressive symptoms at 3 months will be measured with Personal Health Questionnaire (PHQ-9)
Change from baseline in depressive symptoms measured with Personal Health Questionnaire (PHQ-9)assessed at 1 month
时间窗: baseline and 1 month
Depressive symptoms at 1 month will be measured with Personal Health Questionnaire (PHQ-9)
次要结局
- Change from baseline in quality of life measured with MOS-HIV) Medical Outcome Study-HIV assessed at 3 months(baseline and 3 months)
- Change from baseline in quality of life measured with (MOS-HIV) Medical Outcome Study-HIV assessed at 6 months(baseline and 6 months)
研究者
Pilar Ramirez-Garcia, RN, PhD
Assistant Professor, Faculty of nursing & Researcher at CHUM research centre
Université de Montréal