Investigational Study of Psychological Intervention in Recipients of Lung Transplant (INSPIRE) (INSPIRE)
An Investigation to Examine a Telephone Based Stress Management and Coping Skills Intervention for Patients Waiting for Lung Transplant
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Potential lung-transplant candidates listed for lung transplantation at Duke University Medical Center or Washington University
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Telephone-based coping skills
Telephone-based coping skills intervention
|
Telephone-based coping skills/stress management: 12 weekly sessions.
其他名称:
|
有源比较器:日常护理
|
Usual care participants continued their routine and usual treatments and do not receive the 12 telephone training sessions.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Survival/all-cause mortality
大体时间:6 months & 18 months post-transplant
|
6 months & 18 months post-transplant
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Quality of live
大体时间:6 months & 18 months post-transplant
|
6 months & 18 months post-transplant
|
合作者和调查者
调查人员
- 首席研究员:James A Blumenthal, Ph.D、Duke University Medical Center, Dept of Psychiatry & Behavioral Sciences
出版物和有用的链接
一般刊物
- Napolitano MA, Babyak MA, Palmer S, Tapson V, Davis RD, Blumenthal JA; Investigational Study of Psychological Intervention in Recipients of Lung Transplant (INSPIRE) Investigators. Effects of a telephone-based psychosocial intervention for patients awaiting lung transplantation. Chest. 2002 Oct;122(4):1176-84. doi: 10.1378/chest.122.4.1176.
- Parekh PI, Blumenthal JA, Babyak MA, LaCaille R, Rowe S, Dancel L, Carney RM, Davis RD, Palmer S; INSPIRE Investigators. Gas exchange and exercise capacity affect neurocognitive performance in patients with lung disease. Psychosom Med. 2005 May-Jun;67(3):425-32. doi: 10.1097/01.psy.0000160479.99765.18.
- Parekh PI, Blumenthal JA, Babyak MA, Merrill K, Carney RM, Davis RD, Palmer SM; INSPIRE Investigators. Psychiatric disorder and quality of life in patients awaiting lung transplantation. Chest. 2003 Nov;124(5):1682-8. doi: 10.1378/chest.124.5.1682.
- Smith PJ, Blumenthal JA, Carney RM, Freedland KE, O'Hayer CVF, Trulock EP, Martinu T, Schwartz TA, Hoffman BM, Koch GG, Davis RD, Palmer SM. Neurobehavioral functioning and survival following lung transplantation. Chest. 2014 Mar 1;145(3):604-611. doi: 10.1378/chest.12-2127.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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