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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