Depression Clinical Trial
Official title:
An Investigation to Examine a Telephone Based Stress Management and Coping Skills Intervention for Patients Waiting for Lung Transplant
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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