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Telephone-based coping skills training for patients awaiting lung transplantation

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

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  1. 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

  2. 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%

  3. Barriers to Psychosocial Intervention • Severity of Illness • Geography

  4. Possible approach?

  5. INSPIRE

  6. 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

  7. Methods • Dual-site randomized clinical trial • Coping Skills vs Usual Care • Randomization stratified by cystic fibrosis/non cystic fibrosis and time on waiting list

  8. 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

  9. Exclusion Criteria • dementia • delirium • psychotic features including delusions or hallucinations • acute suicide or homicide risk

  10. DESIGN CST Assessment Assessment Follow-up Usual Care 12 Weeks 2 years

  11. Interventions

  12. 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

  13. Usual Care • Monthly monitoring • Maintain usual level of contact with transplant team • Continue usual medications • Referred to psychological treatment if necessary

  14. 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

  15. 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)

  16. Attrition Analysis

  17. Final Completion Rate: N = 273 CST UC N = 126 (63/78%) N = 147 (78/98%)

  18. Sample Size for Analysis N = 328 CST UC N = 166 N = 162 Completers (273) + Dropouts (28) + No post-tx Assessment (27) = 328

  19. Results

  20. Background Characteristics

  21. Attrition analysis: Odds of dropout

  22. Pulmonary Diagnoses

  23. Adherence: Therapy Sessions Attended Values are N (%)

  24. 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

  25. State Anxiety p = .040

  26. Depressive Symptoms p = .002

  27. General Health Questionnaire (negative affect) p = .027

  28. SF36 Mental Health p = .0005

  29. SF36 Vitality p = .0005

  30. Perceived Stress p = .008

  31. Perceived Social Support p = .06

  32. Effect Sizes CST Usual Care BDI GHQ Anxiety SF 36MH SF 36Vit Stress

  33. “Depression” (BDI > 10) Values are N (%)

  34. Anxiety Values are N (%)

  35. 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

  36. Quality of Life/Physical Function

  37. Pulmonary Quality of Life Better CST UC p = .003 Poor Pre-Treatment Level

  38. SF36 Emotional Role p = .616

  39. SF36 Pain p = .531

  40. SF36 Physical Role p = .512

  41. SF36 Social Function p = .597

  42. SF36 General Health p = .751

  43. Shortness of Breath p = .738

  44. Survival

  45. Survival Until Transplant --- CST, 22 (11%) Deaths --- Usual Care, 21 (11%) Deaths

  46. All Survival --- CST, 38 (19%) Deaths --- Usual Care, 26 (14%) Deaths

  47. 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

  48. 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

  49. Mental Health Outcomes as a “Factor” Correlation between Before and After = 0.74, P < .0001

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