Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Intrusive Thoughts
研究概览
简要总结
The purpose of this study is to determine the effectiveness of a stress management group intervention for people with HIV. The study will evaluate several outcomes, including perceived stress, quality of life, psychosocial factors, and physiological measures of stress.
详细描述
It is well documented that living with HIV/AIDS can cause a great amount of stress, and evidence suggests that stress may hasten HIV disease progression by increasing viral replication and suppressing the immune response. Stress management intervention studies using more complex combinations of cognitive and relaxation therapies have shown improvements in both psychological and physiological measures in HIV infected persons. However, no studies have focused on only one intervention or have addressed the spiritual component using a comparable control group to determine which of these interventions is most effective.
Participants will be randomly assigned to receive either a spiritually-based cognitive intervention to an educational control group. The intervention will be given over a 10-week period, with 5 weekly classes, 4 weekly automated phone calls, and one final class meeting. Assessments will be conducted at pre-intervention, fifth class midpoint, tenth week post-intervention, and 3-month follow-up. Time commitment can vary from 6 months to 9 months, depending on when participants are screened.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Ect
- 盲法
- Single
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
- •HIV infected for at least 6 months
- •Ability to read and write English
排除标准
- •Drug use within the past 6 months
- •Cognitive impairment or dementia
- •Diagnosis that may affect cortisol levels, such as diabetes, cancer, or asthma
- •Loss of family/loved one in past 3 months
- •Started a relaxation therapy in past 3 months
- •History or current practice of the RISE program, rosary, chanting, or Transcendental Meditation (TM)
- •Acute infection in past month
- •Change of HAART or drug regimen in past month
结局指标
主要结局
Intrusive Thoughts
Perceived Stress
Trait Anxiety
Trait Anger
次要结局
- Spiritual Well-Being (FACIT-SpEx)
- Quality of Life Enjoyment and Satisfaction
- Ways of Coping
- Urinary cortisol levels
- Urinary catecholamines
- Salivary cortisol levels
