Investigational Study of Psychological Intervention in Recipients of Lung Transplant (INSPIRE) (INSPIRE)
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|ClinicalTrials.gov Identifier: NCT00113139|
Recruitment Status : Completed
First Posted : June 6, 2005
Last Update Posted : July 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Lung Diseases Depression||Behavioral: Telephone-based coping skills/stress management Other: Usual Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||389 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- Survival/all-cause mortality [ Time Frame: 6 months & 18 months post-transplant ]
- Quality of live [ Time Frame: 6 months & 18 months post-transplant ]
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 ClinicalTrials.gov identifier (NCT number): NCT00113139
|Principal Investigator:||James A Blumenthal, Ph.D||Duke University Medical Center, Dept of Psychiatry & Behavioral Sciences|