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临床试验/NCT00113139
NCT00113139已完成不适用

An Investigation to Examine a Telephone Based Stress Management and Coping Skills Intervention for Patients Waiting for Lung Transplant

Duke University0 个研究点目标入组 389 人开始时间: 2000年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
389
主要终点
Survival/all-cause mortality

研究概览

简要总结

The purpose of this study is to examine the effectiveness of a telephone-based cognitive behavioral therapy intervention to alleviate psychological distress among lung transplant patients.

详细描述

BACKGROUND:

Lung transplantation is a relatively new procedure developed to increase life expectancy in selected individuals with irreversible end-stage lung disease. In the brief period since its inception, it appears that lung transplantation has achieved its initial aim of extending life. Despite these successes, lung transplantation remains fraught with difficult challenges for the patient and the medical community. The pre-surgical waiting period is a particularly stressful time. The long, uncertain wait for an organ, the marked decline in functional capacity, the tremendous financial burden, and the prospect of a complicated medical regimen after surgery, combine to exert a profound strain on patients' coping capacities. Not surprisingly, the rate of clinically significant psychological distress during this period is quite high, with rates of clinical depression, panic, anxiety and adjustment disorders far exceeding those observed in the general population. Although it is well established that brief, focused cognitive-behavioral therapy (CBT) can significantly improve psychological function in medically ill persons, the wide geographic distribution of transplant patients, along with their marked debilitation makes face-to-face delivery of such therapy extremely difficult. Recent pilot data have demonstrated the feasibility and short-term efficacy of a telephone-based psychological intervention with patients awaiting transplant.

DESIGN NARRATIVE:

INSPIRE was a collaborative study between Duke University Medical Center and Washington University Medical School. Participants first completed a baseline evaluation, including an interview with a staff member, tests of memory and concentration, and a questionnaire packet. They were then randomly assigned (by chance) to one of 2 groups: Stress Management (by phone) or Usual Care. Stress management participants received a phone call from an INSPIRE interventionist every week for 12 weeks; the phone sessions focused on helping to reduce stress and learning new skills to better cope with lung disease and the upcoming transplant. The INSPIRE staff interventionists were all psychologists who had been trained to work with patients with lung disease. Usual care participants continued their routine and usual treatments and did not receive the 12 telephone training sessions. Participants completed follow-up evaluations three months after the initial (baseline) evaluation, after transplant surgery, and twelve months after the initial evaluation. The primary outcome measures were measures of health-related quality of life, general psychological well-being, and social support.

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

入选标准

  • Potential lung-transplant candidates listed for lung transplantation at Duke University Medical Center or Washington University

排除标准

  • 未提供

结局指标

主要结局

Survival/all-cause mortality

时间窗: 6 months & 18 months post-transplant

次要结局

  • Quality of live(6 months & 18 months post-transplant)

研究者

申办方类型
Other
责任方
Sponsor

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