Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113139
Status:
COMPLETED
Last Update Posted:
2014-07-14
First Post:
2005-06-03
Brief Title:
Investigational Study of Psychological Intervention in Recipients of Lung Transplant INSPIRE
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
An Investigation to Examine a Telephone Based Stress Management and Coping Skills Intervention for Patients Waiting for Lung Transplant
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSPIRE
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 176 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01HL065503 |
| R01HL065503 | NIH | None | None |