Telephone-based coping skills training for patients awaiting lung transplantation

The INSPIRE Investigators Duke University Medical Center,

Durham, NCWashington 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%

•Severity of Illness•Geography

Barriers to Psychosocial Intervention

Possible approach?

INSPIRE

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

UsualCare

12 Weeks

Follow-up

2 years

Interventions

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

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

Attrition Analysis

Reason for attritionCST N = 200

UCN = 189

TotalN = 389

Deceased 5 (2.5) 8 (4) 13 (3.3)

Transplanted 26 (13) 18 (9.5) 44 (11)

Delisted 3 (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)

N = 126 (63/78%)

N = 147 (78/98%)

Final Completion Rate:N = 273

UCCST

N = 166 N = 162

Sample Size for AnalysisN = 328

UCCST

Completers (273) + Dropouts (28) + No post-tx Assessment (27) = 328

Results

Background CharacteristicsVariable CST UC

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)

Attrition analysis: Odds of dropout

0.50 1.50 2.50 3.50 4.50 5.50

cbt - 1:0

ghqtott1 - 60:30

white - 1:0

female - 1:0

cf - 1:0

copd - 1:0

somecollege - 1:0

incgt50k - 1:0

psymeds - 1:0

psytx - 1:0

sf36menhltht1 - 27:22

bditott1 - 16:6

saitott1 - 45:28

0

5

10

15

20

25

30

35

40

45

% o

f G

roup

Usual CareCST

Pulmonary Diagnoses

Status N = 200All 12 sessions 126 (63)At least 8 sessions

148 (74)

No sessions 17 (8.5)

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

28

32

36

40

44

CST UC

SA

IState Anxiety

p = .040

6

8

10

12

14

16

18

CST UC

BD

IDepressive Symptoms

p = .002

30

35

40

45

50

55

60

CST UC

GH

QGeneral Health Questionnaire

(negative affect)

p = .027

21

22

23

24

25

26

27

CST UC

MH

SF36 Mental Health

p = .0005

9

10

11

12

13

14

15

CST UC

VIT

SF36 Vitality

p = .0005

14

16

18

20

22

24

26

CST UC

PS

SPerceived Stress

p = .008

64

66

68

70

72

74

76

78

80

CST UC

PS

SS

Perceived Social Support

p = .06

-1.00 -0.75 -0.50 -0.25 0.00 0.25 0.50 0.75 1.00

Effect (SD)

CSTUsual CareBDI

GHQ

Anxiety

SF 36MH

Effect Sizes

SF 36Vit

Stress

“Depression” (BDI > 10)

No Change

Improved Worse

Usual Care

101 (63) 49 (30) 12 (7)

CST 92 (55) 70 (42) 4 (2)

Values are N (%)

Anxiety

No Change

Improved Worse

Usual Care

92 (57) 53 (33) 17 (10)

CST 89 (53) 70 (42) 7 (4)

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 forbackground covariates and status at study entry

Quality of Life/Physical Function

50

55

60

65

70

75

80

85

90

PQ

LS

CST

UC

Poor

Better

Pre-Treatment Level

Pulmonary Quality of Life

p = .003

5

5.2

5.4

5.6

5.8

6

CST UC

ER

SF36 Emotional Role

p = .616

7

8

9

10

11

CST UC

Pai

nSF36 Pain

p = .531

4

4.5

5

5.5

6

CST UC

PR

SF36 Physical Role

p = .512

5

5.5

6

6.5

7

CST UC

SF

SF36 Social Function

p = .597

7

8

9

10

11

12

13

CST UC

GH

SF36 General Health

p = .751

48

53

58

63

68

73

78

CST UC

SO

BShortness of Breath

p = .738

Survival

Days

log

(Pro

ba

bili

ty o

f S

urv

iva

l)

0 200 400 600 800 1000 1200

0.8

0.9

1.0

--- CST, 22 (11%) Deaths

--- Usual Care, 21 (11%) Deaths

Survival Until Transplant

Days

log

(Pro

ba

bili

ty o

f S

urv

iva

l)

0 200 400 600 800 1000 1200

0.5

0.6

0.7

0.8

0.9

1.0

--- CST, 38 (19%) Deaths

--- Usual Care, 26 (14%) Deaths

All Survival

• 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

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

Variable Before Tx After Tx

SH36 Mental Health 0.893 0.873

BDI 0.839 0.847

GHQ 0.861 0.848

State Anxiety 0.821 0.870

Mental Health Outcomes as a “Factor”

Correlation between Before and After = 0.74, P < .0001

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

• Phone-based CST was associated with– Reduced depression– Reduced anxiety– Improved pulmonary QOL– Improved general well-being

Napolitano et al., Chest, 2000

Pilot Study

• Study sample small, limited power (N= 71)

• Therapist also performed assessments

• No assessment of medical outcomes