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Transcript
Comparison of Depression
Interventions after Acute Coronary
Syndrome
Funded by the National Heart Lung and
Blood Institute
RC2-HL-101663
1
Depressive Symptoms are Related
to Acute Coronary Syndromes
•
•
•
•
•
Increased risk of ACS recurrence/mortality
Independent of traditional risk factors
Reduced long-term survival (up to 5-years) post ACS
Dose-dependent
Highly prevalent
•
•
35-45 % of with elevated depressive symptom
Risk occurs at a relatively low level of depressive
symptoms (Beck Depression inventory I score of > 10)
2
Adjusted Depressive Symptoms in
CHD Patients and All-cause Mortality
Barth J, Shumacher M., & Herrmann-Lingen H. Psychosomatic Medicine, 2004
3
Post-MI Depressive Symptoms
and Cardiac Mortality
vanMelle et al., Psychosomatic Medicine 2004
4
Survival Free of Cardiac Mortality or NonFatal MI, Cumulative %
Patients with Unstable Angina
100%
BDI < 10
95%
90%
BDI > 10
N=430
Odds Ratio = 4.7 (1.9 – 11.3)
P< 0.001
85%
80%
0
100
200
300
400
Time After for Unstable
Angina, Discharge Days
Lespérance et al., 2000
5
Survival Free of Cardiac Mortality,
Cumulative %
Long-term Survival Impact of
Increasing Levels of Post-MI
Depression (BDI Score)
BDI < 4
BDI 4 to 9
BDI 10 to 18
N=896
BDI > 19
Time after discharge for MI, days
Lesperance et al. Circulation. 2002
6
Depression Conceptualizations
Current depression/
depressive symptoms
Acute coronary disease event
time
MACE/ACM risk
Assess current depression/
depressive symptoms
7
Depressive Symptoms
and 42-month MACE/ACM
Strata
Low Depressive symptoms
——High Depressive symptoms
——
8
Depression Conceptualizations
Persistent depressive symptoms
Acute coronary disease event
time
MACE/ACM risk
Assess current depression/
depressive symptoms
9
Persistent Depression
and 42-month MACE/ACM
Strata
Non Depressed
——Remitted Depressed
——Persistent Depressed
—
10
Would you rather take medication or
get counseling?
100
Percentage Agreeing
90
80
70
60
55
60
50
40
54
50
43
40
Take Medications
Go to counseling
30
20
Note: sometimes people
check both options, thus
total is > 100%
10
0
BDI 0-4
BDI 10-16
BDI >16
11
A next trial needs to consider:
•
An observation period to rule out those with remittent
depressive symptoms
•
Patients have differing psychosocial reasons
for their depressive symptoms
•
Medical patients are have strong preferences for, and
against, both psychotherapy and medication to treat
their depressive symptoms
12
COPES 2 RCT Aims
To explore in a depression intervention RCT the patient
satisfaction and depressive symptom reduction of a
patient-preference, stepped-care model (problemsolving therapy and antidepressant medication), as
compared to usual cardiology care in patients with Acute
Coronary Syndrome and persistent depressive
symptoms.
Funded by the National Heart Lung and Blood Institute
N01-HC-25197
13
COPES Satisfaction with Care
(Primary Outcome)
Percent Rating
UC
INT
OR
Depression Care as…
(n=77)
(n=80)
(95% CI)
13.2% (6.5-19.6)
21.6% (12.9-29.7)
1.8 (0.8-4.5)
Excellent / very good at 3 mo
Excellent / very good at 9 mo 18.8% (10.4-26.7) 54.2% (41.9-63.6) 5.4 (2.2-12.9)
P
.18
<.001
Percent receiving no care at 3 mo
73.7%
71.6%
…
…
Percent receiving no care at 9 mo
62.3%
27.1%
…
…
14
Satisfaction with Depression Care
Usual care (18%)
vs.
Intervention (54%)
15
Beck Depression Group Differences
INT vs UC
UC
INT
(n=77)
(n=80)
BDI 3 mo
19.6 (18.2-21.1)
19.0 (17.5-20.4)
BDI 9 mo
17.7 (15.6-19.7)
13.2 (11.1-15.3)
Variable
Change
Between-Group
Non-depressed
P
(n=80)
−0.7 (−2.7 to 1.4)
.52
2.8 (2.3-3.3)
−4.5 (−7.4 to −1.6)
.003
3.4 (2.4-4.3)
Difference
−1.9 (−3.8 to −0.1) −5.7 (−7.6 to −3.8) −3.8 (−6.5 to −1.2)
.005 0.5 (−0.3 to 1.4)
Effect size .59
16
Beck Depression Group Differences
17
Average Difference Between Groups
on the Beck Depression Inventory
at Treatment End
BDI-II
{
ACREATE
BCREATE
data for comparison between IPT (Intervention) and Clinical Management (Control)
data for comparison between Citalopram (Intervention) and Placebo (Control)
18
Days to Major Adverse Coronary
Event/Death by Group Status
4% Intervention
and 13% Usual
care; log-rank
test
•
χ2(1)=3.78;
P=.048; 5
nondepressed
patients had
MACE (6%)
•
19
CODIACS Aims
•
To determine the feasibility and effectiveness of the
COPES intervention for depression in post-ACS patients
at other sites
•
To obtain estimates of yield, satisfaction, and retention
for use in planning a large phase 3 clinical trial
Funded by the National Heart Lung and Blood Institute
RC2-HL-101663
20
CODIACS Design
•
Two-parallel arm assessor-blinded trial
•
Randomization in 1:1 manner
•
•
Active: Stepped care
Control: Referred care
•
5-site single-blind randomized feasibility trial
•
Sites: Columbia, Washington U, Emory, Yale, U Penn
21
CODIACS Organizational
Chart
22
CODIACS Endpoints
•
Satisfaction with depression care
•
Depression scores (BDI)
23
CODIACS Inclusion
Criteria
•
Hospitalized for acute coronary syndrome (ACS) in
previous 2-4 months
•
Beck Depression Inventory (BDI) score >10 and
<15 on each of 2 occasions (1-2 weeks apart), or
BDI>15 on one occasion
•
Age >18 years
24
CODIACS Exclusions
•
Inability to complete the baseline assessment within 2-4
months of the index ACS event
•
Presence of non-cardiovascular condition likely to
terminate fatally within 1 year
•
Moderate/sever liver disease
•
Need for immediate psychiatric intervention (i.e., requiring
hospitalization or psychiatric intervention within 72 hours)
•
Major psychiatric co-morbidity including active psychosis,
bipolar disorder, or overt personality disorder; dementia;
active substance abuse or dependency
•
History of bipolar illness
25
CODIACS CONSORT
26
CODIACS 2009 Timeline
October
• Grant awarded
• #1 SC meeting
November
• IRB submission
• #2 SC meeting
• Forms finalized
December
• DSMB protocol review
• IRB approved or modified, if needed
27
CODIACS 2010 Timeline
January
• Staff training
• Screening begins
• First patient randomized CUMC
February
• DMS training
• #3 SC meeting
March
• Event Adjudication Committee training
• All sites randomizing
May
• Preparation of design manuscript
July
• #4 SC meeting
• First patient completes follow-up
28
CODIACS 2010 Timeline
August
• Design manuscript submission
• #1 DSMB meeting
October
• IRB renewal submitted
November
• #1 Event Adjudication Meeting
• #5 SC meeting
December
• Core status reports
• Forms, protocol, and MCPs completed
for Phase III trial
• Last patient randomized
29
CODIACS 2011 Timeline
January
• Review of Milestones and Deliverables
• Last patient randomized
• #2 DSMB meeting
March
• Interim data analysis of yield, acceptance, retention
estimates
April
• #2 Event Adjudication Meeting
• #7 SC in-person meeting to outline R01s, cores, and
finalize budget
• NHLBI over $500k letter submitted
May
• Preparation of design manuscript
30
CODIACS 2011 Timeline
June
• Phase III trial R01 submitted
July
• Last patient completes intervention
• Final data cleaning
August
• Primary Manuscript preparation
September
• Primary Manuscript submission
31
CODIACS 2011 Timeline
June
• Phase III trial R01 submitted
July
• Last patient completes intervention
• Final data cleaning
August
• Primary Manuscript preparation
September
• Primary Manuscript submission
32
Assessment Schedule
Baseline
Index ACS
Screening
Month 0
2-Month
4-Month
6-Month
-4 to -2 mos
-2 weeks
Time=0
8 wks
16 wks
24 wks
Medical
history,
consent,
BDI
Satisfaction
with care,
BDI
BDI
Satisfaction
with care,
BDI
BDI
33
CODIACS
Patient choice
Step 1
Antidepressant (usually sertraline)
Problem solving therapy (PST)
6-8 weeks
Step 2
Insufficient response options:
• Augment with PST
• Switch to different antidepressant type
Full response: Maintenance
Full response: Maintenance
6-8 weeks
Step 3
Insufficient response options:
• Augment with first line antidepressant
• Switch to first line antidepressant
• Switch to different antidepressant type
Insufficient response options:
• Augment with PST
• Augment with other antidepressant
• Referral for Cognitive Behavioral therapy
Full response: Maintenance / Relapse
prevention
Insufficient response options:
• Augment with other antidepressant
• Referral for Cognitive Behavioral therapy
Full response: Maintenance / Relapse
prevention
34
Decision Rules for
Increasing, Augmenting
or Switching Treatment
PHQ9 Score remain
5-10
11-20
> 20
Needed Improvement to
at Treatment Choice
30% (score of 4-7)
50% (score of 6-10)
60% (score of 8-11)
35
Successful Treatment
Patients who have a remission of symptoms (PHQ < 3
for 2 weeks) proceed to relapse prevention planning
and maintenance treatment.
•
If this occurs during PST, then the patient moves to a
monitoring phase. This entails weekly phone contact
for 2 weeks, then every 2 weeks for 4 weeks, then
monthly. If PHQ9 remains < 3, then this is
maintained. If PHQ9score is > 4 during these phone
contacts, treatment is reinitiated
•
Patients on medication will continue until end of study
and then be referred to continuous psychiatric care
36
Referred Care
•
Patient’s primary care provider informed in writing
of elevated depressive symptoms
•
Provider offers usual care treatment
•
We follow for type of treatment offered
37
Stepped Care
•
Patient educated about the costs and benefits of
choosing anti-depressant or psychotherapy or both
•
Patient chooses first step
•
Every 6-8 weeks, depressive symptoms reassessed, and treatment is intensified, augmented,
or switched
•
Maintenance phone calls occur when depression
remission criteria met; treatment can be re-initiated
38
Problem Solving
Treatment
•
Brief form of psychotherapy that teaches people how
to solve the problems that contributed to depression
•
Collaborative care model: depression care specialist,
primary care provider, patient
•
Treatment duration: 4-8 sessions, total treatment time
2.5-4.5 hours
•
Will be conducted by telephone if convenient for
patient
39
Medication Options
•
Provider choice of Sertraline or citalopam
•
Bupropion only used if (either history of no response
to SSRI OR insufficient response to chosen SSRI in
Step 1)
•
Dosing suggestions for initial and incremental
increases
•
Different dose recommendations for younger/healthier
pts and frailer/older patients
40
Treatment Delivery
•
PST will be delivered centrally
•
First session by videocast at a private office in site clinic
•
Subsequent sessions either by telephone, or continue
with videocasts
•
Medication sessions conducted by local
psychiatrist/primary care provider/advanced care nurse
•
Drugs dispensed and adherence tracked centrally by
MEDCO (pending)
41
Assessments
•
Clinical coordinator will be masked to treatment
assignment
•
Second clinical coordinator/site PI will inform patient of
randomization allocation and educate patient on costs
and benefits of choice
•
Data collected on computer and sent to DCC centrally
42
Primary Outcome:
Patient Satisfaction
“Over the last 2 months, how would you rate
the quality of care you have received for your
depression/distress from your health care providers?”
Answer options:
Excellent, Very good vs. poor, fair, good
Outcome:
% satisfied = % very good or excellent ratings
43
Safety Protocol
44
Statistical
Considerations
•
With n=150, 80% chance of detecting difference in
depression scores between groups of 0.46 SD-units (4
point difference in BDI)
•
Estimation of recruitment yield and retention rates will be
used to guide definitive trial
•
Comparison across sites of satisfaction with care,
therapy adherence rates, and event rates
•
Comparison across sites of QA metrics of treatment
delivery
45
Thank you
46
Columbia University team
William Whang, MD (Site PI)
Eileen Rattigan, MD
Peter Shapiro, MD
Vivian M. Medina, Social Worker
Cynthia Morel (Clinical Coordinator)
Elizabeth Capone-Newtown (Clinical Coordinator)
Gabrielle Albanese Osorio (CODIACs Manager)
47
Beck Depression
Inventory (21 items)
#1
•
•
•
•
I do not feel sad
I feel sad
I am sad all the time and I can’t snap out of it
I am so sad or unhappy that I can’t stand it
#2
•
•
•
•
I am not particularly discouraged about the future
I feel discouraged about the future
I feel I have nothing to look forward to
I feel that the future is hopeless and that things cannot improve
#16
•
•
•
•
I can sleep as well as usual
I don’t sleep as well as I used to
I wake up 1-2 hours earlier than usual and find it hard to get back to sleep
I wake up several hours earlier than I used to and cannot get back to sleep
48