Transcript Document

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
• Rate of depression and anxiety
disorders is ~45% and 50%
respectively
• Daily function is often compromised
• Mortality rate among listed patients is
30%
Barriers to Psychosocial
Intervention
• Severity of Illness
• Geography
Possible approach?
INSPIRE
Purpose
• To evaluate the efficacy of a telephonebased 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
Follow-up
Usual
Care
12 Weeks
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
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)
Attrition Analysis
Reason for attrition
CST
N = 200
UC
N = 189
Total
N = 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)
27 (6.9)
12 (6.3)
Final Completion Rate:
N = 273
CST
UC
N = 126
(63/78%)
N = 147
(78/98%)
Sample Size for Analysis
N = 328
CST
UC
N = 166
N = 162
Completers (273) + Dropouts (28) +
No post-tx Assessment (27) = 328
Results
Background Characteristics
Variable
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
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
1.50
0.
95
0.50
2.50
3.50
4.50
5.50
Pulmonary Diagnoses
45
40
Usual Care
CST
% of Group
35
30
25
20
15
10
5
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Adherence:
Therapy Sessions Attended
Status
N = 200
All 12 sessions
126 (63)
At least 8 sessions 148 (74)
No sessions
17 (8.5)
Values are N (%)
Mental Health Outcomes
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Beck Depression Inventory
General Health Questionnaire
Spielberger State Anxiety Scale
SF-36 Mental Health
SF-36 Vitality
Perceived Stress Scale
Perceived Social Support
State Anxiety
44
SAI
40
36
32
p = .040
28
CST
UC
Depressive Symptoms
18
16
BDI
14
12
10
8
p = .002
6
CST
UC
General Health Questionnaire
60
(negative affect)
55
GHQ
50
45
40
35
p = .027
30
CST
UC
27
SF36 Mental Health
26
MH
25
24
23
22
p = .0005
21
CST
UC
15
SF36 Vitality
14
VIT
13
12
11
10
p = .0005
9
CST
UC
Perceived Stress
26
24
PSS
22
20
18
16
p = .008
14
CST
UC
Perceived Social Support
80
78
76
PSSS
74
72
70
68
66
p = .06
64
CST
UC
Effect Sizes
Usual Care
CST
BDI
GHQ
Anxiety
SF 36MH
SF 36Vit
Stress
-1.00 -0.75 -0.50 -0.25 0.00 0.25 0.50 0.75 1.00
Effect (SD)
“Depression” (BDI > 10)
No Change Improved
Worse
Usual Care 101 (63)
49 (30)
12 (7)
CST
70 (42)
4 (2)
92 (55)
Values are N (%)
Anxiety
No Change Improved
Worse
Usual Care 92 (57)
53 (33)
17 (10)
CST
70 (42)
7 (4)
89 (53)
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 for
background covariates and status at study entry
Quality of Life/Physical Function
Pulmonary Quality of Life
90
85
80
CST
UC
PQLS
75
Better
70
65
60
55
Poor
p = .003
50
Pre-Treatment Level
SF36 Emotional Role
6
5.8
ER
5.6
5.4
5.2
p = .616
5
CST
UC
SF36 Pain
11
Pain
10
9
8
p = .531
7
CST
UC
SF36 Physical Role
6
PR
5.5
5
4.5
p = .512
4
CST
UC
SF36 Social Function
7
SF
6.5
6
5.5
p = .597
5
CST
UC
SF36 General Health
13
12
GH
11
10
9
8
p = .751
7
CST
UC
Shortness of Breath
78
73
SOB
68
63
58
53
p = .738
48
CST
UC
Survival
0.9
--- CST, 22 (11%) Deaths
0.8
log(Probability of Survival)
1.0
Survival Until Transplant
--- Usual Care, 21 (11%) Deaths
0
200
400
600
Days
800
1000
1200
0.8
0.7
--- CST, 38 (19%) Deaths
0.6
--- Usual Care, 26 (14%) Deaths
0.5
log(Probability of Survival)
0.9
1.0
All Survival
0
200
400
600
800
Days
1000
1200
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
Intervention & Session Topics
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Introduction to the program
Review of your life story
Progressive relaxation training
Mini-practices (relaxation)
Goal setting I: pleasant activities
Goal setting II: rest-activity cycles
Calming self-statements I
Calming self-statements II
Problem-solving I
Problem-solving II
Preventing and dealing with setbacks
Review and Maintenance
Mental Health Outcomes as a “Factor”
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
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
Pilot Study
• Phone-based CST was associated with
– Reduced depression
– Reduced anxiety
– Improved pulmonary QOL
– Improved general well-being
Napolitano et al., Chest, 2000
• Study sample small, limited power (N=
71)
• Therapist also performed assessments
• No assessment of medical outcomes