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 attrition CST 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 out 25 (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 UCAge, 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
05
1015202530354045
% o
f Gro
up
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
SAI
State Anxiety
p = .040
6
8
10
12
14
16
18
CST UC
BDI
Depressive Symptoms
p = .002
30
35
40
45
50
55
60
CST UC
GHQ
General 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
PSS
Perceived Stress
p = .008
646668707274767880
CST UC
PSSS
Perceived Social Support
p = .06
-1.00 -0.75 -0.50 -0.25 0.00 0.25 0.50 0.75 1.00Effect (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 (%)
AnxietyNo 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
PQLS
CSTUC
Poor
Better
Pre-Treatment Level
Pulmonary Quality of Life
p = .003
5
5.2
5.4
5.6
5.8
6
CST UC
ERSF36 Emotional Role
p = .616
7
8
9
10
11
CST UC
PainSF36 Pain
p = .531
4
4.5
5
5.5
6
CST UC
PRSF36 Physical Role
p = .512
5
5.5
6
6.5
7
CST UC
SFSF36 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
SOB
Shortness of Breath
p = .738
Survival
Days
log(
Pro
babi
lity
of S
urvi
val)
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
babi
lity
of S
urvi
val)
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