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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Investigation to Examine a Telephone Based Stress Management and Coping Skills Intervention for Patients Waiting for Lung Transplant

Conditions
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Lung Diseases, Depression

Intervention / Treatment
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* Behavioral: Telephone-based coping skills/stress management
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential lung-transplant candidates listed for lung transplantation at Duke University Medical Center or Washington University

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone-based coping skills<br>Telephone-based coping skills intervention | Behavioral: Telephone-based coping skills/stress management<br>* Telephone-based coping skills/stress management: 12 weekly sessions.<br>* Other names: Coping Skills Training (CST);|
| Active Comparator: Usual Care<br> | Other: Usual Care<br>* Usual care participants continued their routine and usual treatments and do not receive the 12 telephone training sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival/all-cause mortality |  | 6 months & 18 months post-transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of live |  | 6 months & 18 months post-transplant |