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

NCT ID: NCT00113139

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 389 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2008-08-31

Brief Summary

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

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.

Conditions

Lung Diseases; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Telephone-based coping skills

Telephone-based coping skills intervention

Group Type: EXPERIMENTAL

Telephone-based coping skills/stress management

Intervention Type: BEHAVIORAL

Telephone-based coping skills/stress management: 12 weekly sessions.

Usual Care

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Usual care participants continued their routine and usual treatments and do not receive the 12 telephone training sessions.

Interventions

Telephone-based coping skills/stress management

Telephone-based coping skills/stress management: 12 weekly sessions.

Intervention Type: BEHAVIORAL

Usual Care

Usual care participants continued their routine and usual treatments and do not receive the 12 telephone training sessions.

Intervention Type: OTHER

Other Intervention Names

Coping Skills Training (CST)

Eligibility Criteria

Inclusion Criteria

• Potential lung-transplant candidates listed for lung transplantation at Duke University Medical Center or Washington University

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James A Blumenthal, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Center, Dept of Psychiatry & Behavioral Sciences

References

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. doi: 10.1378/chest.122.4.1176.

Reference Type: BACKGROUND

PMID: 12377839 (View on PubMed)

Parekh PI, Blumenthal JA, Babyak MA, LaCaille R, Rowe S, Dancel L, Carney RM, Davis RD, Palmer S; INSPIRE Investigators. Gas exchange and exercise capacity affect neurocognitive performance in patients with lung disease. Psychosom Med. 2005 May-Jun;67(3):425-32. doi: 10.1097/01.psy.0000160479.99765.18.

Reference Type: BACKGROUND

PMID: 15911906 (View on PubMed)

Parekh PI, Blumenthal JA, Babyak MA, Merrill K, Carney RM, Davis RD, Palmer SM; INSPIRE Investigators. Psychiatric disorder and quality of life in patients awaiting lung transplantation. Chest. 2003 Nov;124(5):1682-8. doi: 10.1378/chest.124.5.1682.

Reference Type: BACKGROUND

PMID: 14605035 (View on PubMed)

Smith PJ, Blumenthal JA, Carney RM, Freedland KE, O'Hayer CVF, Trulock EP, Martinu T, Schwartz TA, Hoffman BM, Koch GG, Davis RD, Palmer SM. Neurobehavioral functioning and survival following lung transplantation. Chest. 2014 Mar 1;145(3):604-611. doi: 10.1378/chest.12-2127.

Reference Type: DERIVED

PMID: 24233282 (View on PubMed)

Other Identifiers

R01HL065503

Identifier Type: NIH

Identifier Source: secondary_id

View Link

176

Identifier Type: -

Identifier Source: secondary_id

Pro00009150

Identifier Type: -

Identifier Source: org_study_id