Staged Treatment in Early Psychosis: A sequential multiple assignment randomised trial of interventions for ultra high risk of psychosis patients
Aim Previous research indicates that preventive intervention is likely to benefit patients “at risk” of psychosis, in terms of functional improvement, symptom reduction and delay or prevention of onset of threshold psychotic disorder. The primary aim of the current study is to test outcomes of ultra...
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| Veröffentlicht in: | Early intervention in psychiatry 2018-06, Vol.12 (3), p.292-306 |
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| creator | Nelson, Barnaby Amminger, G. Paul Yuen, Hok Pan Wallis, Nicky J. Kerr, Melissa Dixon, Lisa Carter, Cameron Loewy, Rachel Niendam, Tara A. Shumway, Martha Morris, Sarah Blasioli, Julie McGorry, Patrick D. |
| description | Aim
Previous research indicates that preventive intervention is likely to benefit patients “at risk” of psychosis, in terms of functional improvement, symptom reduction and delay or prevention of onset of threshold psychotic disorder. The primary aim of the current study is to test outcomes of ultra high risk (UHR) patients, primarily functional outcome, in response to a sequential intervention strategy consisting of support and problem solving (SPS), cognitive‐behavioural case management and antidepressant medication. A secondary aim is to test biological and psychological variables that moderate and mediate response to this sequential treatment strategy.
Methods
This is a sequential multiple assignment randomised trial (SMART) consisting of three steps: Step 1: SPS (1.5 months); Step 2: SPS vs Cognitive Behavioural Case Management (4.5 months); Step 3: Cognitive Behavioural Case Management + Antidepressant Medication vs Cognitive Behavioural Case Management + Placebo (6 months). The intervention is of 12 months duration in total and participants will be followed up at 18 months and 24 months post baseline.
Conclusion
This paper reports on the rationale and protocol of the Staged Treatment in Early Psychosis (STEP) study. With a large sample of 500 UHR participants this study will investigate the most effective type and sequence of treatments for improving functioning and reducing the risk of developing psychotic disorder in this clinical population. |
| doi_str_mv | 10.1111/eip.12459 |
| format | Article |
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Previous research indicates that preventive intervention is likely to benefit patients “at risk” of psychosis, in terms of functional improvement, symptom reduction and delay or prevention of onset of threshold psychotic disorder. The primary aim of the current study is to test outcomes of ultra high risk (UHR) patients, primarily functional outcome, in response to a sequential intervention strategy consisting of support and problem solving (SPS), cognitive‐behavioural case management and antidepressant medication. A secondary aim is to test biological and psychological variables that moderate and mediate response to this sequential treatment strategy.
Methods
This is a sequential multiple assignment randomised trial (SMART) consisting of three steps: Step 1: SPS (1.5 months); Step 2: SPS vs Cognitive Behavioural Case Management (4.5 months); Step 3: Cognitive Behavioural Case Management + Antidepressant Medication vs Cognitive Behavioural Case Management + Placebo (6 months). The intervention is of 12 months duration in total and participants will be followed up at 18 months and 24 months post baseline.
Conclusion
This paper reports on the rationale and protocol of the Staged Treatment in Early Psychosis (STEP) study. With a large sample of 500 UHR participants this study will investigate the most effective type and sequence of treatments for improving functioning and reducing the risk of developing psychotic disorder in this clinical population.</description><identifier>ISSN: 1751-7885</identifier><identifier>EISSN: 1751-7893</identifier><identifier>DOI: 10.1111/eip.12459</identifier><identifier>PMID: 28719151</identifier><language>eng</language><publisher>Melbourne: Wiley Publishing Asia Pty Ltd</publisher><subject>Adolescent ; Adult ; antidepressant medication ; Antidepressive Agents - therapeutic use ; Case management ; Child ; clinical trial ; Clinical trials ; Cognitive Behavioral Therapy ; Combined Modality Therapy ; Early intervention ; Early Medical Intervention - methods ; Evidence-based medicine ; Humans ; Management ; Patients ; Problem solving ; prodrome ; Psychosis ; Psychotic Disorders - therapy ; Randomization ; Randomized Controlled Trials as Topic ; Risk ; ultra high risk ; Vulnerable Populations - psychology ; Young Adult</subject><ispartof>Early intervention in psychiatry, 2018-06, Vol.12 (3), p.292-306</ispartof><rights>2017 John Wiley & Sons Australia, Ltd</rights><rights>2017 John Wiley & Sons Australia, Ltd.</rights><rights>2018 John Wiley & Sons Australia, Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4439-f4b3e1be3221f0fd2066cd83055a18e2ccb884170caa875c5ecd046a93c935333</citedby><cites>FETCH-LOGICAL-c4439-f4b3e1be3221f0fd2066cd83055a18e2ccb884170caa875c5ecd046a93c935333</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Feip.12459$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Feip.12459$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28719151$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nelson, Barnaby</creatorcontrib><creatorcontrib>Amminger, G. Paul</creatorcontrib><creatorcontrib>Yuen, Hok Pan</creatorcontrib><creatorcontrib>Wallis, Nicky</creatorcontrib><creatorcontrib>J. Kerr, Melissa</creatorcontrib><creatorcontrib>Dixon, Lisa</creatorcontrib><creatorcontrib>Carter, Cameron</creatorcontrib><creatorcontrib>Loewy, Rachel</creatorcontrib><creatorcontrib>Niendam, Tara A.</creatorcontrib><creatorcontrib>Shumway, Martha</creatorcontrib><creatorcontrib>Morris, Sarah</creatorcontrib><creatorcontrib>Blasioli, Julie</creatorcontrib><creatorcontrib>McGorry, Patrick D.</creatorcontrib><title>Staged Treatment in Early Psychosis: A sequential multiple assignment randomised trial of interventions for ultra high risk of psychosis patients</title><title>Early intervention in psychiatry</title><addtitle>Early Interv Psychiatry</addtitle><description>Aim
Previous research indicates that preventive intervention is likely to benefit patients “at risk” of psychosis, in terms of functional improvement, symptom reduction and delay or prevention of onset of threshold psychotic disorder. The primary aim of the current study is to test outcomes of ultra high risk (UHR) patients, primarily functional outcome, in response to a sequential intervention strategy consisting of support and problem solving (SPS), cognitive‐behavioural case management and antidepressant medication. A secondary aim is to test biological and psychological variables that moderate and mediate response to this sequential treatment strategy.
Methods
This is a sequential multiple assignment randomised trial (SMART) consisting of three steps: Step 1: SPS (1.5 months); Step 2: SPS vs Cognitive Behavioural Case Management (4.5 months); Step 3: Cognitive Behavioural Case Management + Antidepressant Medication vs Cognitive Behavioural Case Management + Placebo (6 months). The intervention is of 12 months duration in total and participants will be followed up at 18 months and 24 months post baseline.
Conclusion
This paper reports on the rationale and protocol of the Staged Treatment in Early Psychosis (STEP) study. With a large sample of 500 UHR participants this study will investigate the most effective type and sequence of treatments for improving functioning and reducing the risk of developing psychotic disorder in this clinical population.</description><subject>Adolescent</subject><subject>Adult</subject><subject>antidepressant medication</subject><subject>Antidepressive Agents - therapeutic use</subject><subject>Case management</subject><subject>Child</subject><subject>clinical trial</subject><subject>Clinical trials</subject><subject>Cognitive Behavioral Therapy</subject><subject>Combined Modality Therapy</subject><subject>Early intervention</subject><subject>Early Medical Intervention - methods</subject><subject>Evidence-based medicine</subject><subject>Humans</subject><subject>Management</subject><subject>Patients</subject><subject>Problem solving</subject><subject>prodrome</subject><subject>Psychosis</subject><subject>Psychotic Disorders - therapy</subject><subject>Randomization</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Risk</subject><subject>ultra high risk</subject><subject>Vulnerable Populations - psychology</subject><subject>Young Adult</subject><issn>1751-7885</issn><issn>1751-7893</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kV1LHDEUhoO0-LF64R8ogd7oxWo-JpNMLwSRbSsIFarX4WwmsxubmUyTGWV_hv_YrKtLW2huEjjPec-b8yJ0TMkZzefcuv6MskJUO2ifSkGnUlX8w_atxB46SOmBECFLRnfRHlOSVlTQffT8c4CFrfFdtDC0thuw6_AMol_h27Qyy5Bc-oIvcbK_x1x14HE7-sH13mJIyS2616YIXR1al7LSENdQaLLQYOPjuil0CTch4twYAS_dYomjS7_WUP8-BPcwuAynQ_SxAZ_s0ds9QfdfZ3dX36c3P75dX13eTE1R8GraFHNu6dxyxmhDmpqRsjS14kQIoMoyY-ZKFVQSA6CkMMKamhQlVNxUXHDOJ-hio9uP89bWJs-O4HUfXQtxpQM4_Xelc0u9CI-6JKJQssoCJ28CMeTlpEHnBRjrPXQ2jEnTilHKC5ntTtDnf9CHMMYuf08zkgnCpWKZOt1QJoaUom22ZijR66B1Dlq_Bp3ZT3-635LvyWbgfAM8OW9X_1fSs-vbjeQLpHW2Jg</recordid><startdate>201806</startdate><enddate>201806</enddate><creator>Nelson, Barnaby</creator><creator>Amminger, G. Paul</creator><creator>Yuen, Hok Pan</creator><creator>Wallis, Nicky</creator><creator>J. Kerr, Melissa</creator><creator>Dixon, Lisa</creator><creator>Carter, Cameron</creator><creator>Loewy, Rachel</creator><creator>Niendam, Tara A.</creator><creator>Shumway, Martha</creator><creator>Morris, Sarah</creator><creator>Blasioli, Julie</creator><creator>McGorry, Patrick D.</creator><general>Wiley Publishing Asia Pty Ltd</general><general>Wiley Subscription Services, 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>K9.</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201806</creationdate><title>Staged Treatment in Early Psychosis: A sequential multiple assignment randomised trial of interventions for ultra high risk of psychosis patients</title><author>Nelson, Barnaby ; Amminger, G. Paul ; Yuen, Hok Pan ; Wallis, Nicky ; J. Kerr, Melissa ; Dixon, Lisa ; Carter, Cameron ; Loewy, Rachel ; Niendam, Tara A. ; Shumway, Martha ; Morris, Sarah ; Blasioli, Julie ; McGorry, Patrick D.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4439-f4b3e1be3221f0fd2066cd83055a18e2ccb884170caa875c5ecd046a93c935333</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>antidepressant medication</topic><topic>Antidepressive Agents - therapeutic use</topic><topic>Case management</topic><topic>Child</topic><topic>clinical trial</topic><topic>Clinical trials</topic><topic>Cognitive Behavioral Therapy</topic><topic>Combined Modality Therapy</topic><topic>Early intervention</topic><topic>Early Medical Intervention - methods</topic><topic>Evidence-based medicine</topic><topic>Humans</topic><topic>Management</topic><topic>Patients</topic><topic>Problem solving</topic><topic>prodrome</topic><topic>Psychosis</topic><topic>Psychotic Disorders - therapy</topic><topic>Randomization</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Risk</topic><topic>ultra high risk</topic><topic>Vulnerable Populations - psychology</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nelson, Barnaby</creatorcontrib><creatorcontrib>Amminger, G. Paul</creatorcontrib><creatorcontrib>Yuen, Hok Pan</creatorcontrib><creatorcontrib>Wallis, Nicky</creatorcontrib><creatorcontrib>J. Kerr, Melissa</creatorcontrib><creatorcontrib>Dixon, Lisa</creatorcontrib><creatorcontrib>Carter, Cameron</creatorcontrib><creatorcontrib>Loewy, Rachel</creatorcontrib><creatorcontrib>Niendam, Tara A.</creatorcontrib><creatorcontrib>Shumway, Martha</creatorcontrib><creatorcontrib>Morris, Sarah</creatorcontrib><creatorcontrib>Blasioli, Julie</creatorcontrib><creatorcontrib>McGorry, Patrick D.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Early intervention in psychiatry</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nelson, Barnaby</au><au>Amminger, G. Paul</au><au>Yuen, Hok Pan</au><au>Wallis, Nicky</au><au>J. Kerr, Melissa</au><au>Dixon, Lisa</au><au>Carter, Cameron</au><au>Loewy, Rachel</au><au>Niendam, Tara A.</au><au>Shumway, Martha</au><au>Morris, Sarah</au><au>Blasioli, Julie</au><au>McGorry, Patrick D.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Staged Treatment in Early Psychosis: A sequential multiple assignment randomised trial of interventions for ultra high risk of psychosis patients</atitle><jtitle>Early intervention in psychiatry</jtitle><addtitle>Early Interv Psychiatry</addtitle><date>2018-06</date><risdate>2018</risdate><volume>12</volume><issue>3</issue><spage>292</spage><epage>306</epage><pages>292-306</pages><issn>1751-7885</issn><eissn>1751-7893</eissn><abstract>Aim
Previous research indicates that preventive intervention is likely to benefit patients “at risk” of psychosis, in terms of functional improvement, symptom reduction and delay or prevention of onset of threshold psychotic disorder. The primary aim of the current study is to test outcomes of ultra high risk (UHR) patients, primarily functional outcome, in response to a sequential intervention strategy consisting of support and problem solving (SPS), cognitive‐behavioural case management and antidepressant medication. A secondary aim is to test biological and psychological variables that moderate and mediate response to this sequential treatment strategy.
Methods
This is a sequential multiple assignment randomised trial (SMART) consisting of three steps: Step 1: SPS (1.5 months); Step 2: SPS vs Cognitive Behavioural Case Management (4.5 months); Step 3: Cognitive Behavioural Case Management + Antidepressant Medication vs Cognitive Behavioural Case Management + Placebo (6 months). The intervention is of 12 months duration in total and participants will be followed up at 18 months and 24 months post baseline.
Conclusion
This paper reports on the rationale and protocol of the Staged Treatment in Early Psychosis (STEP) study. With a large sample of 500 UHR participants this study will investigate the most effective type and sequence of treatments for improving functioning and reducing the risk of developing psychotic disorder in this clinical population.</abstract><cop>Melbourne</cop><pub>Wiley Publishing Asia Pty Ltd</pub><pmid>28719151</pmid><doi>10.1111/eip.12459</doi><tpages>15</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Early intervention in psychiatry, 2018-06, Vol.12 (3), p.292-306 |
| issn | 1751-7885 1751-7893 |
| language | eng |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Adolescent Adult antidepressant medication Antidepressive Agents - therapeutic use Case management Child clinical trial Clinical trials Cognitive Behavioral Therapy Combined Modality Therapy Early intervention Early Medical Intervention - methods Evidence-based medicine Humans Management Patients Problem solving prodrome Psychosis Psychotic Disorders - therapy Randomization Randomized Controlled Trials as Topic Risk ultra high risk Vulnerable Populations - psychology Young Adult |
| title | Staged Treatment in Early Psychosis: A sequential multiple assignment randomised trial of interventions for ultra high risk of psychosis patients |
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