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临床试验/NCT00057538
NCT00057538已完成2 期

Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV

National Center for Complementary and Integrative Health (NCCIH)2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2003年5月最近更新:
适应症

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

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

研究者

研究点 (2)

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