Telephone-based coping skills training for patients awaiting lung transplantation

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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

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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

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Barriers to Psychosocial Intervention

• Severity of Illness
• Geography

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Possible approach?
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(No Transcript)
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INSPIRE
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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

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Methods

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

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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

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Exclusion Criteria

• dementia
• delirium
• psychotic features including delusions or
  hallucinations
• acute suicide or homicide risk

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

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Usual Care

• Monthly monitoring
• Maintain usual level of contact with transplant
  team
• Continue usual medications
• Referred to psychological treatment if necessary

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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

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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)
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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) 12 (6.3) 27 (6.9)
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Final Completion Rate N 273
UC
CST
N 126 (63/78)
N 147 (78/98)
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Sample Size for Analysis N 328
UC
CST
N 166
N 162
Completers (273) Dropouts (28) No post-tx
Assessment (27) 328
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Results
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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 gt HS, N () 104 (64) 103 (63)
Annual Income gt 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)
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Attrition analysis Odds of dropout
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Pulmonary Diagnoses
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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 ()
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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

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State Anxiety
p .040
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Depressive Symptoms
p .002
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General Health Questionnaire (negative affect)
p .027
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SF36 Mental Health
p .0005
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SF36 Vitality
p .0005
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Perceived Stress
p .008
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Perceived Social Support
p .06
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Effect Sizes
CST
Usual Care
BDI
GHQ
Anxiety
SF 36MH
SF 36Vit
Stress
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Depression (BDI gt 10)
No Change Improved Worse
Usual Care 101 (63) 49 (30) 12 (7)
CST 92 (55) 70 (42) 4 (2)
Values are N ()
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Anxiety
No Change Improved Worse
Usual Care 92 (57) 53 (33) 17 (10)
CST 89 (53) 70 (42) 7 (4)
Values are N ()
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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
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Quality of Life/Physical Function
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(No Transcript)
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SF36 Emotional Role
p .616
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SF36 Pain
p .531
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SF36 Physical Role
p .512
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SF36 Social Function
p .597
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SF36 General Health
p .751
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Shortness of Breath
p .738
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Survival
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Survival Until Transplant
--- CST, 22 (11) Deaths
--- Usual Care, 21 (11) Deaths
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All Survival
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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

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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

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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 lt
.0001
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Treatment Effect on Negative Affect

• CST associated with Improvement on Negative
  Affect Factor, p lt .001
• CST accounted for about 3.5 of the variance in
  post-treatment negative affect

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Pilot Study

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

Napolitano et al., Chest, 2000
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• Study sample small, limited power (N 71)
• Therapist also performed assessments
• No assessment of medical outcomes