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Investigational Study of Psychological Intervention in Recipients of Lung Transplant (INSPIRE) (INSPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00113139
Recruitment Status : Completed
First Posted : June 6, 2005
Last Update Posted : July 14, 2014
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Diseases Depression Behavioral: Telephone-based coping skills/stress management Other: Usual Care Not Applicable

Detailed Description:


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.


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 389 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Investigation to Examine a Telephone Based Stress Management and Coping Skills Intervention for Patients Waiting for Lung Transplant
Study Start Date : September 2000
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Telephone-based coping skills
Telephone-based coping skills intervention
Behavioral: Telephone-based coping skills/stress management
Telephone-based coping skills/stress management: 12 weekly sessions.
Other Name: Coping Skills Training (CST)

Active Comparator: Usual Care Other: Usual Care
Usual care participants continued their routine and usual treatments and do not receive the 12 telephone training sessions.

Primary Outcome Measures :
  1. Survival/all-cause mortality [ Time Frame: 6 months & 18 months post-transplant ]

Secondary Outcome Measures :
  1. Quality of live [ Time Frame: 6 months & 18 months post-transplant ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00113139

Sponsors and Collaborators
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: James A Blumenthal, Ph.D Duke University Medical Center, Dept of Psychiatry & Behavioral Sciences

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Duke University Identifier: NCT00113139     History of Changes
Other Study ID Numbers: Pro00009150
R01HL065503 ( U.S. NIH Grant/Contract )
First Posted: June 6, 2005    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases