Design and baseline data from the vanguard of the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS) randomized controlled trial
Abstract This paper describes the rationale and design of the vanguard for the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS), a multicenter, randomized, controlled trial of a patient preference‐based, stepped care protocol for persistent depressive symptoms after acu...
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| Veröffentlicht in: | Contemporary clinical trials 2012-09, Vol.33 (5), p.1003-1010 |
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| creator | Whang, William Burg, Matthew M Carney, Robert M Freedland, Kenneth E Bigger, J. Thomas Catellier, Diane Czajkowski, Susan Frasure-Smith, Nancy Haas, Donald C Jaffe, Allan S Lespérance, Francois Medina, Vivian Duer-Hefele, Joan Osorio, Gabrielle A Parsons, Faith Shapiro, Peter A Sheps, David S Vaccarino, Viola Davidson, Karina W |
| description | Abstract This paper describes the rationale and design of the vanguard for the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS), a multicenter, randomized, controlled trial of a patient preference‐based, stepped care protocol for persistent depressive symptoms after acute coronary syndrome (ACS). The overall aim of the vanguard phase was to determine whether the patient-preference, stepped care protocol, which is based on the intervention used in the recent Coronary Psychosocial Evaluation Studies (COPES) trial, was feasible in patients with recent ACS who were recruited from 5 geographically diverse sites. Innovative design features of this trial include randomization to either initial patient-preference of treatment or to a referred care arm in which the primary care provider decided upon care. Additionally, delivery of psychotherapy was accomplished by telephone, or webcam, depending upon patient preference. The vanguard phase provides estimates of eligibility and screening/enrollment ratios, patient acceptance of screening, and retention. In this report, we describe the innovative features and the baseline results of the vanguard phase of CODIACS. The data from this vanguard study will be used to finalize planning for a large, phase III clinical trial designed to evaluate the effect of treatment on depressive symptoms, coronary events, and death. |
| doi_str_mv | 10.1016/j.cct.2012.05.005 |
| format | Article |
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Thomas ; Catellier, Diane ; Czajkowski, Susan ; Frasure-Smith, Nancy ; Haas, Donald C ; Jaffe, Allan S ; Lespérance, Francois ; Medina, Vivian ; Duer-Hefele, Joan ; Osorio, Gabrielle A ; Parsons, Faith ; Shapiro, Peter A ; Sheps, David S ; Vaccarino, Viola ; Davidson, Karina W</creator><creatorcontrib>Whang, William ; Burg, Matthew M ; Carney, Robert M ; Freedland, Kenneth E ; Bigger, J. Thomas ; Catellier, Diane ; Czajkowski, Susan ; Frasure-Smith, Nancy ; Haas, Donald C ; Jaffe, Allan S ; Lespérance, Francois ; Medina, Vivian ; Duer-Hefele, Joan ; Osorio, Gabrielle A ; Parsons, Faith ; Shapiro, Peter A ; Sheps, David S ; Vaccarino, Viola ; Davidson, Karina W</creatorcontrib><description>Abstract This paper describes the rationale and design of the vanguard for the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS), a multicenter, randomized, controlled trial of a patient preference‐based, stepped care protocol for persistent depressive symptoms after acute coronary syndrome (ACS). The overall aim of the vanguard phase was to determine whether the patient-preference, stepped care protocol, which is based on the intervention used in the recent Coronary Psychosocial Evaluation Studies (COPES) trial, was feasible in patients with recent ACS who were recruited from 5 geographically diverse sites. Innovative design features of this trial include randomization to either initial patient-preference of treatment or to a referred care arm in which the primary care provider decided upon care. Additionally, delivery of psychotherapy was accomplished by telephone, or webcam, depending upon patient preference. The vanguard phase provides estimates of eligibility and screening/enrollment ratios, patient acceptance of screening, and retention. In this report, we describe the innovative features and the baseline results of the vanguard phase of CODIACS. The data from this vanguard study will be used to finalize planning for a large, phase III clinical trial designed to evaluate the effect of treatment on depressive symptoms, coronary events, and death.</description><identifier>ISSN: 1551-7144</identifier><identifier>EISSN: 1559-2030</identifier><identifier>DOI: 10.1016/j.cct.2012.05.005</identifier><identifier>PMID: 22640924</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Acute coronary syndrome ; Acute Coronary Syndrome - psychology ; Aged ; Cardiovascular ; Clinical Protocols ; Clinical trial ; Depression ; Depression - complications ; Depression - therapy ; Female ; Hematology, Oncology and Palliative Medicine ; Humans ; Male ; Middle Aged ; Myocardial Infarction - etiology ; Patient Preference ; Patient Selection ; Psychotherapy - methods ; Secondary Prevention ; Serotonin Uptake Inhibitors - administration & dosage ; Serotonin Uptake Inhibitors - adverse effects ; Serotonin Uptake Inhibitors - therapeutic use ; Socioeconomic Factors</subject><ispartof>Contemporary clinical trials, 2012-09, Vol.33 (5), p.1003-1010</ispartof><rights>Elsevier Inc.</rights><rights>2012 Elsevier Inc.</rights><rights>Copyright © 2012 Elsevier Inc. All rights reserved.</rights><rights>2012 Elsevier Inc. All rights reserved. 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c506t-7190f85deaffd27ff984b0f9feef40a946cbee8cbe22e5c07b176ede2094f1f03</citedby><cites>FETCH-LOGICAL-c506t-7190f85deaffd27ff984b0f9feef40a946cbee8cbe22e5c07b176ede2094f1f03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1551714412001322$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22640924$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Whang, William</creatorcontrib><creatorcontrib>Burg, Matthew M</creatorcontrib><creatorcontrib>Carney, Robert M</creatorcontrib><creatorcontrib>Freedland, Kenneth E</creatorcontrib><creatorcontrib>Bigger, J. Thomas</creatorcontrib><creatorcontrib>Catellier, Diane</creatorcontrib><creatorcontrib>Czajkowski, Susan</creatorcontrib><creatorcontrib>Frasure-Smith, Nancy</creatorcontrib><creatorcontrib>Haas, Donald C</creatorcontrib><creatorcontrib>Jaffe, Allan S</creatorcontrib><creatorcontrib>Lespérance, Francois</creatorcontrib><creatorcontrib>Medina, Vivian</creatorcontrib><creatorcontrib>Duer-Hefele, Joan</creatorcontrib><creatorcontrib>Osorio, Gabrielle A</creatorcontrib><creatorcontrib>Parsons, Faith</creatorcontrib><creatorcontrib>Shapiro, Peter A</creatorcontrib><creatorcontrib>Sheps, David S</creatorcontrib><creatorcontrib>Vaccarino, Viola</creatorcontrib><creatorcontrib>Davidson, Karina W</creatorcontrib><title>Design and baseline data from the vanguard of the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS) randomized controlled trial</title><title>Contemporary clinical trials</title><addtitle>Contemp Clin Trials</addtitle><description>Abstract This paper describes the rationale and design of the vanguard for the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS), a multicenter, randomized, controlled trial of a patient preference‐based, stepped care protocol for persistent depressive symptoms after acute coronary syndrome (ACS). The overall aim of the vanguard phase was to determine whether the patient-preference, stepped care protocol, which is based on the intervention used in the recent Coronary Psychosocial Evaluation Studies (COPES) trial, was feasible in patients with recent ACS who were recruited from 5 geographically diverse sites. Innovative design features of this trial include randomization to either initial patient-preference of treatment or to a referred care arm in which the primary care provider decided upon care. Additionally, delivery of psychotherapy was accomplished by telephone, or webcam, depending upon patient preference. The vanguard phase provides estimates of eligibility and screening/enrollment ratios, patient acceptance of screening, and retention. In this report, we describe the innovative features and the baseline results of the vanguard phase of CODIACS. The data from this vanguard study will be used to finalize planning for a large, phase III clinical trial designed to evaluate the effect of treatment on depressive symptoms, coronary events, and death.</description><subject>Acute coronary syndrome</subject><subject>Acute Coronary Syndrome - psychology</subject><subject>Aged</subject><subject>Cardiovascular</subject><subject>Clinical Protocols</subject><subject>Clinical trial</subject><subject>Depression</subject><subject>Depression - complications</subject><subject>Depression - therapy</subject><subject>Female</subject><subject>Hematology, Oncology and Palliative Medicine</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Myocardial Infarction - etiology</subject><subject>Patient Preference</subject><subject>Patient Selection</subject><subject>Psychotherapy - methods</subject><subject>Secondary Prevention</subject><subject>Serotonin Uptake Inhibitors - administration & dosage</subject><subject>Serotonin Uptake Inhibitors - adverse effects</subject><subject>Serotonin Uptake Inhibitors - therapeutic use</subject><subject>Socioeconomic Factors</subject><issn>1551-7144</issn><issn>1559-2030</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9Uk2P0zAQjRCIXRZ-ABfkI3toGDtxPoS0UpXyUWmlPRTOlmOPuy6JXdlppfJb-LE4W1gBBy72PHveG4_fZNlrCjkFWr3b5UpNOQPKcuA5AH-SXVLO2wWDAp4-xHRR07K8yF7EuAMoKl7x59kFY1UJLSsvsx8rjHbriHSa9DLiYB0SLSdJTPAjme6RHKXbHmTQxJsH3PlxL4ON3s0nK9wHjNEmtHYThiO6KYFIpEmILNVhminBOxlOZHNyOukiedvdrdbLbnNNQirtR_sdNVHeTcEPQwqnYOXwMntm5BDx1a_9Kvv68cOX7vPi9u7TulveLhSHakodtmAarlEao1ltTNuUPZjWIJoSZFtWqkds0sIYcgV1T-sKNTJoS0MNFFfZzVl3f-hH1Cq1EOQg9sGO6dHCSyv-vnH2Xmz9URQlNA2rkwA9C6jgYwxoHrkUxGyV2IlklZitEsBFsipx3vxZ9JHx25uU8P6cgKn1o8UgorLoFGobMIlpb_8rf_MPWyVvrZLDNzxh3PlDcOlPBRUxccRmnpV5VCgDoAVjxU-Dhr5e</recordid><startdate>20120901</startdate><enddate>20120901</enddate><creator>Whang, William</creator><creator>Burg, Matthew M</creator><creator>Carney, Robert M</creator><creator>Freedland, Kenneth E</creator><creator>Bigger, J. Thomas</creator><creator>Catellier, Diane</creator><creator>Czajkowski, Susan</creator><creator>Frasure-Smith, Nancy</creator><creator>Haas, Donald C</creator><creator>Jaffe, Allan S</creator><creator>Lespérance, Francois</creator><creator>Medina, Vivian</creator><creator>Duer-Hefele, Joan</creator><creator>Osorio, Gabrielle A</creator><creator>Parsons, Faith</creator><creator>Shapiro, Peter A</creator><creator>Sheps, David S</creator><creator>Vaccarino, Viola</creator><creator>Davidson, Karina W</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>20120901</creationdate><title>Design and baseline data from the vanguard of the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS) randomized controlled trial</title><author>Whang, William ; Burg, Matthew M ; Carney, Robert M ; Freedland, Kenneth E ; Bigger, J. 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Thomas</au><au>Catellier, Diane</au><au>Czajkowski, Susan</au><au>Frasure-Smith, Nancy</au><au>Haas, Donald C</au><au>Jaffe, Allan S</au><au>Lespérance, Francois</au><au>Medina, Vivian</au><au>Duer-Hefele, Joan</au><au>Osorio, Gabrielle A</au><au>Parsons, Faith</au><au>Shapiro, Peter A</au><au>Sheps, David S</au><au>Vaccarino, Viola</au><au>Davidson, Karina W</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Design and baseline data from the vanguard of the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS) randomized controlled trial</atitle><jtitle>Contemporary clinical trials</jtitle><addtitle>Contemp Clin Trials</addtitle><date>2012-09-01</date><risdate>2012</risdate><volume>33</volume><issue>5</issue><spage>1003</spage><epage>1010</epage><pages>1003-1010</pages><issn>1551-7144</issn><eissn>1559-2030</eissn><abstract>Abstract This paper describes the rationale and design of the vanguard for the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS), a multicenter, randomized, controlled trial of a patient preference‐based, stepped care protocol for persistent depressive symptoms after acute coronary syndrome (ACS). The overall aim of the vanguard phase was to determine whether the patient-preference, stepped care protocol, which is based on the intervention used in the recent Coronary Psychosocial Evaluation Studies (COPES) trial, was feasible in patients with recent ACS who were recruited from 5 geographically diverse sites. Innovative design features of this trial include randomization to either initial patient-preference of treatment or to a referred care arm in which the primary care provider decided upon care. Additionally, delivery of psychotherapy was accomplished by telephone, or webcam, depending upon patient preference. The vanguard phase provides estimates of eligibility and screening/enrollment ratios, patient acceptance of screening, and retention. In this report, we describe the innovative features and the baseline results of the vanguard phase of CODIACS. The data from this vanguard study will be used to finalize planning for a large, phase III clinical trial designed to evaluate the effect of treatment on depressive symptoms, coronary events, and death.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>22640924</pmid><doi>10.1016/j.cct.2012.05.005</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Contemporary clinical trials, 2012-09, Vol.33 (5), p.1003-1010 |
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| subjects | Acute coronary syndrome Acute Coronary Syndrome - psychology Aged Cardiovascular Clinical Protocols Clinical trial Depression Depression - complications Depression - therapy Female Hematology, Oncology and Palliative Medicine Humans Male Middle Aged Myocardial Infarction - etiology Patient Preference Patient Selection Psychotherapy - methods Secondary Prevention Serotonin Uptake Inhibitors - administration & dosage Serotonin Uptake Inhibitors - adverse effects Serotonin Uptake Inhibitors - therapeutic use Socioeconomic Factors |
| title | Design and baseline data from the vanguard of the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS) randomized controlled trial |
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