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


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Lung Diseases & Disorders

Lung disease 




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

This study is no longer recruiting patients.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)

Purpose

To examine the effectiveness of a telephone-based cognitive behavioral therapy intervention to alleviate psychological distress among lung transplant patients.

Condition Treatment or Intervention
Lung Diseases
Depression
 Behavior: Stress Management

MedlinePlus related topics:  Depression;   Respiratory Diseases

Study Type: Interventional
Study Design: Treatment, Randomized

Further Study Details: 

Study start: September 2000;  Study completion: August 2005

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.

Eligibility

Genders Eligible for Study:  Both

Criteria

No eligibility criteria

More Information

Publications

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.

Nathan SD, Barnett SD. Telesupport: just reach out and touch someone. Chest. 2002 Oct;122(4):1114-6. No abstract available.

Study ID Numbers:  176
Record last reviewed:  May 2005
Last Updated:  June 3, 2005
Record first received:  June 3, 2005
ClinicalTrials.gov Identifier:  NCT00113139
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-06-07


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December 6, 2009



Page Updated: September 6, 2005
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