Investigational Study of Psychological Intervention in Recipients of Lung Transplant (INSPIRE) (INSPIRE)
Primary Purpose
Lung Diseases, Depression
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telephone-based coping skills/stress management
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Lung Diseases
Eligibility Criteria
Inclusion Criteria: Potential lung-transplant candidates listed for lung transplantation at Duke University Medical Center or Washington University
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telephone-based coping skills
Usual Care
Arm Description
Telephone-based coping skills intervention
Outcomes
Primary Outcome Measures
Survival/all-cause mortality
Secondary Outcome Measures
Quality of live
Full Information
NCT ID
NCT00113139
First Posted
June 3, 2005
Last Updated
July 11, 2014
Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00113139
Brief Title
Investigational Study of Psychological Intervention in Recipients of Lung Transplant (INSPIRE)
Acronym
INSPIRE
Official Title
An Investigation to Examine a Telephone Based Stress Management and Coping Skills Intervention for Patients Waiting for Lung Transplant
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
389 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telephone-based coping skills
Arm Type
Experimental
Arm Description
Telephone-based coping skills intervention
Arm Title
Usual Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Telephone-based coping skills/stress management
Other Intervention Name(s)
Coping Skills Training (CST)
Intervention Description
Telephone-based coping skills/stress management: 12 weekly sessions.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual care participants continued their routine and usual treatments and do not receive the 12 telephone training sessions.
Primary Outcome Measure Information:
Title
Survival/all-cause mortality
Time Frame
6 months & 18 months post-transplant
Secondary Outcome Measure Information:
Title
Quality of live
Time Frame
6 months & 18 months post-transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Potential lung-transplant candidates listed for lung transplantation at Duke University Medical Center or Washington University
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A Blumenthal, Ph.D
Organizational Affiliation
Duke University Medical Center, Dept of Psychiatry & Behavioral Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
12377839
Citation
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.
Results Reference
background
PubMed Identifier
15911906
Citation
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.
Results Reference
background
PubMed Identifier
14605035
Citation
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.
Results Reference
background
PubMed Identifier
24233282
Citation
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.
Results Reference
derived
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Investigational Study of Psychological Intervention in Recipients of Lung Transplant (INSPIRE)
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