CLINICAL TRIALS OF COPING EFFECTIVENESS TRAINING IN HIV INFECTED MEN

HIV 感染男性应对有效性训练的临床试验

• 批准号: 6243000
• 负责人: MARGARET ANN CHESNEY
• 金额: $ 43.64万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-30 至 1998-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6243000
• 关键词: AIDS education /prevention; AIDS therapy; HIV infections; behavior modification; behavioral /social science research tag; clinical research; clinical trials; coping; counseling; health care service utilization; homosexuals; human subject; human therapy evaluation; longitudinal human study; male; psychological stressor; psychological tests; quality of life; stress management; therapy compliance; training

The estimated 1 million people in the U.S. infected with HIV face a chronic and debilitating disease that can create profound psychological distress. Medical guidelines do not address these negative consequences of hIV and are unlikely to do so until there is evidence from controlled clinical trials that psychosocial interventions are effective in helping hIV- infected persons cope with stress over the course of t heir progressive disease. To address this need, we propose a randomized clinical trial of Coping Effectiveness Training (CET), an innovative intervention for HIV- infected persons that is based on recent advances in stress and coping theory. We will; . Evaluate the effect of CET on the ability of HIV-infected men to decrease psychological distress and increase psychological well-being. . Compare the efficacy of two alternative CET maintenance programs to sustain treatment effects over 12 months. Determine the extent to which improvements in distress and well-being are associated with changes in adherence to medical care. . Identify the potential psychological and social mechanisms by which CET affects psychological and adherence outcomes. . Examine the cost effectiveness of CET by evaluating its effect on health care utilization and health care costs. We will randomly assign 300 HIV-infected, distressed men to one of three conditions; (1) CET with an enhanced maintenance program (CET-E), (2) CET with standard maintenance (CET-S), and (3) a waiting list control. The CET groups will receive training during a 3-month Intervention phase and changes in mediating and outcome variables will be compared with the control group. After this initial phase, the control group will receive training and the CET groups will proceed to the maintenance phase. The CET-S group will meet monthly and bimonthly, in a standard series of booster sessions. Immediately after the Intervention Phase and at 6- and 12-month follow-up, we will assess the effect of CET and the two maintenance strategies on psychological distress and well-being, adherence to care, and costs.

据估计，美国有100万艾滋病毒感染者面临着一种慢性疾病， 和使人衰弱的疾病，这些疾病会造成严重的心理痛苦。 医学指南没有提到HIV的这些负面后果， 不太可能这样做，直到有证据表明， 试验表明，心理社会干预是有效的，在帮助艾滋病毒- 受感染者在其进行性过程中科普压力， 疾病 为了满足这一需求，我们提出了一项随机临床试验， 应对有效性培训（CET），一种创新的干预措施， 艾滋病毒- 根据压力和应对方面的最新进展， 理论 我们会的 . 评估CET对HIV感染者的能力的影响， 减少心理困扰，增加心理健康。 . 比较两种替代CET维护计划的有效性， 持续治疗效果超过12个月。 确定在多大程度上改善痛苦和福祉， 与医疗护理依从性的变化相关。 . 确定CET潜在的心理和社会机制 影响心理和依从性结果。 . 通过评估其对健康的影响来检查CET的成本效益 保健利用率和保健费用。 我们将随机将300名感染艾滋病的痛苦男性分配到三个小组之一， 条件;（1）CET与增强维护计划（CET-E），（2）CET 标准维护（CET-S），以及（3）等待列表控制。 大学英语 小组将在为期3个月的干预阶段接受培训， 中介变量和结果变量的变化将与 对照组 在这个初始阶段之后，对照组将接受 培训结束后，CET组将进入维护阶段。 的 CET-S小组将每月和每两个月举行一次会议， 强化训练 干预阶段后即刻和6-和 12-随访1个月，评估CET的效果， 心理困扰和幸福感的维持策略，坚持 关心，和成本。