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. Severity of Illness Geography Barriers to Psychosocial Intervention

4. Possible approach?

6. INSPIRE

7. 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

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

9. 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

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

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

12. Interventions

13. 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

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

15. 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

16. 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) Patient Flow

17. Attrition Analysis Reason for attrition CST N = 200 UC N = 189 Total N = 389 Deceased5 (2.5)8 (4)13 (3.3) Transplanted26 (13)18 (9.5)44 (11) Delisted3 (1.5)1 (0.5)4 (1) Dropped out25 (12.5)3 (1.5)28 (7.2) Completed tx but not post tx assessment 15 (7.5)12 (6.3)27 (6.9)

18. N = 126 (63/78%) N = 147 (78/98%) Final Completion Rate: N = 273 UCCST

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

20. Results

21. Background Characteristics VariableCSTUC Age, yrs, mean (SD) 50 (11)50 (12) Male N (%) 75 (45)69 (43) Caucasian, N (%) 147 (89)140 (86) Education > HS, N (%) 104 (64)103 (63) Annual Income > $50K, N (%) 66 (40)64 (40) Hx of Psychotropic medication, N (%) 44 (27)45 (28) Hx of Psychotherapy, N (%) 9 (5)9 (6) BDI Score, mean (SD) 13 (8)11 (7) PQLS Score, mean (SD) 70 (17)72 (15) GHQ Score, mean (SD) 49 (24)45 (19) Sf-36 Mental Health Score, mean (SD) 23 (5)24 (4)

22. Attrition analysis: Odds of dropout

23. Pulmonary Diagnoses

24. StatusN = 200 All 12 sessions126 (63) At least 8 sessions148 (74) No sessions 17 (8.5) Adherence: Therapy Sessions Attended Values are N (%)

25. 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

26. State Anxiety p =.040

27. Depressive Symptoms p =.002

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

29. SF36 Mental Health p =.0005

30. SF36 Vitality p =.0005

31. Perceived Stress p =.008

32. Perceived Social Support p =.06

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

34. “Depression” (BDI > 10) No ChangeImprovedWorse Usual Care101 (63)49 (30)12 (7) CST 92 (55)70 (42) 4 (2) Values are N (%)

35. Anxiety No ChangeImprovedWorse Usual Care92 (57)53 (33)17 (10) CST89 (53)70 (42)7 (4) Values are N (%)

36. 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

37. Quality of Life/Physical Function

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

39. SF36 Emotional Role p =.616

40. SF36 Pain p =.531

41. SF36 Physical Role p =.512

42. SF36 Social Function p =.597

43. SF36 General Health p =.751

44. Shortness of Breath p =.738

45. Survival

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

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

48. 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 Conclusions

49. Intervention & Session Topics 1Introduction to the program 2Review of your life story 3Progressive relaxation training 4Mini-practices (relaxation) 5Goal setting I: pleasant activities 6Goal setting II: rest-activity cycles 7Calming self-statements I 8Calming self-statements II 9Problem-solving I 10Problem-solving II 11Preventing and dealing with setbacks 12Review and Maintenance

50. VariableBefore TxAfter Tx SH36 Mental Health0.8930.873 BDI0.8390.847 GHQ0.8610.848 State Anxiety0.8210.870 Mental Health Outcomes as a “Factor” Correlation between Before and After = 0.74, P <.0001

51. Treatment Effect on Negative Affect CST associated with Improvement on Negative Affect Factor, p <.001 CST accounted for about 3.5% of the variance in post-treatment negative affect

52. Phone-based CST was associated with –Reduced depression –Reduced anxiety –Improved pulmonary QOL –Improved general well-being Napolitano et al., Chest, 2000 Pilot Study

53. Study sample small, limited power (N= 71) Therapist also performed assessments No assessment of medical outcomes