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Telephone-based coping skills training for patients awaiting lung transplantation. The INSPIRE Investigators Duke University Medical Center, Durham, NC Washington University Hospital, St. Louis, MO. Background. Awaiting lung transplantation is usually highly stressful
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Telephone-based coping skills training for patients awaiting lung transplantation The INSPIRE Investigators Duke University Medical Center, Durham, NC Washington University Hospital, St. Louis, MO
Background • Awaiting lung transplantation is usually highly stressful • Rate of depression and anxiety disorders is ~45% and 50% respectively • Daily function is often compromised • Mortality rate among listed patients is 30%
Barriers to Psychosocial Intervention • Severity of Illness • Geography
Purpose • To evaluate the efficacy of a telephone-based psychosocial intervention for patients awaiting lung transplantation with respect to: • Psychological well-being • Daily function/Quality of life • Survival while awaiting transplant
Methods • Dual-site randomized clinical trial • Coping Skills vs Usual Care • Randomization stratified by cystic fibrosis/non cystic fibrosis and time on waiting list
Eligibility Criteria • Male or female outpatients 18 years of age • A diagnosis of end-stage pulmonary disease and currently on the active list for lung transplantation • Capacity to give informed consent and follow study procedures
Exclusion Criteria • dementia • delirium • psychotic features including delusions or hallucinations • acute suicide or homicide risk
DESIGN CST Assessment Assessment Follow-up Usual Care 12 Weeks 2 years
Coping Skills Training • 12 Weekly sessions of 30-45 minutes • Workbook • Therapy sessions randomly selected for adherence to protocol • Therapists received routine supervision from senior therapist
Usual Care • Monthly monitoring • Maintain usual level of contact with transplant team • Continue usual medications • Referred to psychological treatment if necessary
Analytic Strategy • Similar to General Linear Model • Intent-to-treat • Propensity score approach with ML imputation • Propensity scores adjust for baseline value of response, age, ethnicity, income, education, gender, diagnosis, hx of psychiatric tx • Results similar between CACE and ITT
Patient Flow Patients on candidate list screened from 12/00 to 7/04 (N = 533) Consented (N = 411) Completed baseline assessments (N = 389) CST (n = 200) Usual care control (n = 189)
Final Completion Rate: N = 273 CST UC N = 126 (63/78%) N = 147 (78/98%)
Sample Size for Analysis N = 328 CST UC N = 166 N = 162 Completers (273) + Dropouts (28) + No post-tx Assessment (27) = 328
Adherence: Therapy Sessions Attended Values are N (%)
Mental Health Outcomes • Beck Depression Inventory • General Health Questionnaire • Spielberger State Anxiety Scale • SF-36 Mental Health • SF-36 Vitality • Perceived Stress Scale • Perceived Social Support
State Anxiety p = .040
Depressive Symptoms p = .002
General Health Questionnaire (negative affect) p = .027
SF36 Mental Health p = .0005
SF36 Vitality p = .0005
Perceived Stress p = .008
Perceived Social Support p = .06
Effect Sizes CST Usual Care BDI GHQ Anxiety SF 36MH SF 36Vit Stress
“Depression” (BDI > 10) Values are N (%)
Anxiety Values are N (%)
Therapy-related reduction in depression and anxiety • OR for post-CST depression = 0.395 • p = .004 • OR for post-CST anxiety = 0.537 • p = .031 Based on logistic regression model adjusting for background covariates and status at study entry
Pulmonary Quality of Life Better CST UC p = .003 Poor Pre-Treatment Level
SF36 Emotional Role p = .616
SF36 Pain p = .531
SF36 Physical Role p = .512
SF36 Social Function p = .597
SF36 General Health p = .751
Shortness of Breath p = .738
Survival Until Transplant --- CST, 22 (11%) Deaths --- Usual Care, 21 (11%) Deaths
All Survival --- CST, 38 (19%) Deaths --- Usual Care, 26 (14%) Deaths
Conclusions • Telephone-based therapy is a feasible psychological intervention among pulmonary transplant candidates • Behavioral interventions are associated with reduced depression and general distress relative to usual care • Behavioral interventions are associated with improved pulmonary quality of life among sicker patients • No apparent effect on physical function or survival
Intervention & Session Topics • 1 Introduction to the program • 2 Review of your life story • 3 Progressive relaxation training • 4 Mini-practices (relaxation) • 5 Goal setting I: pleasant activities • 6 Goal setting II: rest-activity cycles • 7 Calming self-statements I • 8 Calming self-statements II • 9 Problem-solving I • 10 Problem-solving II • 11 Preventing and dealing with setbacks • 12 Review and Maintenance
Mental Health Outcomes as a “Factor” Correlation between Before and After = 0.74, P < .0001