Telephone-based coping skills training for patients awaiting lung transplantation

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?

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 Assessment Follow-up Usual Care 12 Weeks 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. 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)

17. Attrition Analysis

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

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

20. Results

21. Background Characteristics

22. Attrition analysis: Odds of dropout

23. Pulmonary Diagnoses

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

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

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

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

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

48. 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

49. 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

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