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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00113139
First received: June 3, 2005
Last updated: July 11, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Lung Diseases
Depression
Behavioral: Telephone-based coping skills/stress management
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Investigation to Examine a Telephone Based Stress Management and Coping Skills Intervention for Patients Waiting for Lung Transplant

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Survival/all-cause mortality [ Time Frame: 6 months & 18 months post-transplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of live [ Time Frame: 6 months & 18 months post-transplant ] [ Designated as safety issue: No ]

Enrollment: 389
Study Start Date: September 2000
Study Completion Date: August 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Potential lung-transplant candidates listed for lung transplantation at Duke University Medical Center or Washington University
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113139

Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: James A Blumenthal, Ph.D Duke University Medical Center, Dept of Psychiatry & Behavioral Sciences
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00113139     History of Changes
Other Study ID Numbers: Pro00009150, R01HL065503, 176
Study First Received: June 3, 2005
Last Updated: July 11, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Lung Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 19, 2014