The EVIDENT-trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention
Depressive disorders are among the leading causes of worldwide disability with mild to moderate forms of depression being particularly common. Low-intensity treatments such as online psychological treatments may be an effective way to treat mild to moderate depressive symptoms and prevent the emerge...
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creator | Klein, Jan Philipp Berger, Thomas Schröder, Johanna Späth, Christina Meyer, Björn Caspar, Franz Lutz, Wolfgang Greiner, Wolfgang Hautzinger, Martin Rose, Matthias Gräfe, Viola Hohagen, Fritz Andersson, Gerhard Vettorazzi, Eik Moritz, Steffen |
description | Depressive disorders are among the leading causes of worldwide disability with mild to moderate forms of depression being particularly common. Low-intensity treatments such as online psychological treatments may be an effective way to treat mild to moderate depressive symptoms and prevent the emergence or relapse of major depression.
This study is a currently recruiting multicentre parallel-groups pragmatic randomized-controlled single-blind trial. A total of 1000 participants with mild to moderate symptoms of depression from various settings including in- and outpatient services will be randomized to an online psychological treatment or care as usual (CAU). We hypothesize that the intervention will be superior to CAU in reducing depressive symptoms assessed with the Personal Health Questionnaire (PHQ-9, primary outcome measure) following the intervention (12 wks) and at follow-up (24 and 48 wks). Further outcome parameters include quality of life, use of health care resources and attitude towards online psychological treatments.
The study will yield meaningful answers to the question of whether online psychological treatment can contribute to the effective and efficient prevention and treatment of mild to moderate depression on a population level with a low barrier to entry.
NCT01636752. |
doi_str_mv | 10.1186/1471-244X-13-239 |
format | Article |
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This study is a currently recruiting multicentre parallel-groups pragmatic randomized-controlled single-blind trial. A total of 1000 participants with mild to moderate symptoms of depression from various settings including in- and outpatient services will be randomized to an online psychological treatment or care as usual (CAU). We hypothesize that the intervention will be superior to CAU in reducing depressive symptoms assessed with the Personal Health Questionnaire (PHQ-9, primary outcome measure) following the intervention (12 wks) and at follow-up (24 and 48 wks). Further outcome parameters include quality of life, use of health care resources and attitude towards online psychological treatments.
The study will yield meaningful answers to the question of whether online psychological treatment can contribute to the effective and efficient prevention and treatment of mild to moderate depression on a population level with a low barrier to entry.
NCT01636752.</description><identifier>ISSN: 1471-244X</identifier><identifier>EISSN: 1471-244X</identifier><identifier>DOI: 10.1186/1471-244X-13-239</identifier><identifier>PMID: 24074299</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Adult ; Care and treatment ; Clinical Protocols ; Clinical trials ; Clinics ; Cost-of-illness analysis ; Depression, Mental ; Depressive Disorder - psychology ; Depressive Disorder - therapy ; Elektroteknik och elektronik ; Female ; Guided self-help ; Health economic evaluation ; Humans ; Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi ; Hälsovetenskap ; Major depression ; Male ; Medical care, Cost of ; Medicin och hälsovetenskap ; Online psychological treatment ; Patient Satisfaction ; Prevention ; Psychotherapy ; Psychotherapy - methods ; Psykologi ; Quality of Life ; Randomized controlled trial ; Remote Consultation - methods ; Research Design ; Risk factors ; SAMHÄLLSVETENSKAP ; Self Care ; Self-help ; Severity of Illness Index ; Single-Blind Method ; SOCIAL SCIENCES ; Study Protocol ; Subclinical depression ; Teknik ; Telekommunikation ; Tillämpad psykologi ; Treatment ; Treatment Outcome</subject><ispartof>BMC PSYCHIATRY, 2013-09, Vol.13 (1), p.239-239, Article 239</ispartof><rights>COPYRIGHT 2013 BioMed Central Ltd.</rights><rights>Copyright © 2013 Klein et al.; licensee BioMed Central Ltd. 2013 Klein et al.; licensee BioMed Central Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b682t-fa5e9eeccbc6b784281abbb1d22327a2171f5eebea04e1fc6c020de4c77bf6e53</citedby><cites>FETCH-LOGICAL-b682t-fa5e9eeccbc6b784281abbb1d22327a2171f5eebea04e1fc6c020de4c77bf6e53</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3850933/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3850933/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,552,727,780,784,864,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24074299$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-101392$$DView record from Swedish Publication Index$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:127621617$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Klein, Jan Philipp</creatorcontrib><creatorcontrib>Berger, Thomas</creatorcontrib><creatorcontrib>Schröder, Johanna</creatorcontrib><creatorcontrib>Späth, Christina</creatorcontrib><creatorcontrib>Meyer, Björn</creatorcontrib><creatorcontrib>Caspar, Franz</creatorcontrib><creatorcontrib>Lutz, Wolfgang</creatorcontrib><creatorcontrib>Greiner, Wolfgang</creatorcontrib><creatorcontrib>Hautzinger, Martin</creatorcontrib><creatorcontrib>Rose, Matthias</creatorcontrib><creatorcontrib>Gräfe, Viola</creatorcontrib><creatorcontrib>Hohagen, Fritz</creatorcontrib><creatorcontrib>Andersson, Gerhard</creatorcontrib><creatorcontrib>Vettorazzi, Eik</creatorcontrib><creatorcontrib>Moritz, Steffen</creatorcontrib><title>The EVIDENT-trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention</title><title>BMC PSYCHIATRY</title><addtitle>BMC Psychiatry</addtitle><description>Depressive disorders are among the leading causes of worldwide disability with mild to moderate forms of depression being particularly common. Low-intensity treatments such as online psychological treatments may be an effective way to treat mild to moderate depressive symptoms and prevent the emergence or relapse of major depression.
This study is a currently recruiting multicentre parallel-groups pragmatic randomized-controlled single-blind trial. A total of 1000 participants with mild to moderate symptoms of depression from various settings including in- and outpatient services will be randomized to an online psychological treatment or care as usual (CAU). We hypothesize that the intervention will be superior to CAU in reducing depressive symptoms assessed with the Personal Health Questionnaire (PHQ-9, primary outcome measure) following the intervention (12 wks) and at follow-up (24 and 48 wks). Further outcome parameters include quality of life, use of health care resources and attitude towards online psychological treatments.
The study will yield meaningful answers to the question of whether online psychological treatment can contribute to the effective and efficient prevention and treatment of mild to moderate depression on a population level with a low barrier to entry.
NCT01636752.</description><subject>Adult</subject><subject>Care and treatment</subject><subject>Clinical Protocols</subject><subject>Clinical trials</subject><subject>Clinics</subject><subject>Cost-of-illness analysis</subject><subject>Depression, Mental</subject><subject>Depressive Disorder - psychology</subject><subject>Depressive Disorder - therapy</subject><subject>Elektroteknik och elektronik</subject><subject>Female</subject><subject>Guided self-help</subject><subject>Health economic evaluation</subject><subject>Humans</subject><subject>Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi</subject><subject>Hälsovetenskap</subject><subject>Major depression</subject><subject>Male</subject><subject>Medical care, Cost of</subject><subject>Medicin och hälsovetenskap</subject><subject>Online psychological treatment</subject><subject>Patient Satisfaction</subject><subject>Prevention</subject><subject>Psychotherapy</subject><subject>Psychotherapy - methods</subject><subject>Psykologi</subject><subject>Quality of Life</subject><subject>Randomized controlled trial</subject><subject>Remote Consultation - methods</subject><subject>Research Design</subject><subject>Risk factors</subject><subject>SAMHÄLLSVETENSKAP</subject><subject>Self Care</subject><subject>Self-help</subject><subject>Severity of Illness Index</subject><subject>Single-Blind Method</subject><subject>SOCIAL SCIENCES</subject><subject>Study Protocol</subject><subject>Subclinical depression</subject><subject>Teknik</subject><subject>Telekommunikation</subject><subject>Tillämpad psykologi</subject><subject>Treatment</subject><subject>Treatment Outcome</subject><issn>1471-244X</issn><issn>1471-244X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>D8T</sourceid><recordid>eNqNk01vEzEQhlcIREvgzgmtxIXLFo_t_eKAFKUBKlVwCRU3y-udTQxeO7U3ReXH8FvxJm1opBahPXjked7XntlxkrwEcgJQFW-Bl5BRzr9lwDLK6kfJ8X7r8Z34KHkWwndCoKxyeJocUU5KTuv6OPm9WGE6vzg7nX9eZIPX0rxL194NTjmTStumXg7aWWkwdV0q035jBq3QDuhjyrau17-wTZWzg3fGxHBrkg4YBm2X6RDtsetQDfoKLYawtbGps0ZbzBoZomQdrtXKGbfUKkr1aB7h8dznyZNOmoAvbtZJ8vXDfDH7lJ1_-Xg2m55nTVHRIetkjjWiUo0qmrLitALZNA20lDJaSgoldDlig5JwhE4VilDSIldl2XQF5mySZDvf8BPXm0asve6lvxZOanGz9SNGKHJaFKyOfP0gH9vX_hXdCoGWBYUCyn-edaovpsL5pTB6I4AAq2nk3-_4CPfYjs330hweeZCxeiWW7kqwKic1Y9FgtjNotHvA4DCjXC_G2RHj7Ahggm5LfnNzDe8uN_H3il4HhcZIi24ToiCvIWdxwv4D5SyC4zJJXu_QZRwxoW3n4g3UiItpzngBNecQqZN7qPi12Os4e9jpuH8gIDuB8i4Ej92-WiBifDr31ffqbpv3gtu3wv4ABk8axw</recordid><startdate>20130928</startdate><enddate>20130928</enddate><creator>Klein, Jan Philipp</creator><creator>Berger, Thomas</creator><creator>Schröder, Johanna</creator><creator>Späth, Christina</creator><creator>Meyer, Björn</creator><creator>Caspar, Franz</creator><creator>Lutz, Wolfgang</creator><creator>Greiner, Wolfgang</creator><creator>Hautzinger, Martin</creator><creator>Rose, Matthias</creator><creator>Gräfe, Viola</creator><creator>Hohagen, Fritz</creator><creator>Andersson, Gerhard</creator><creator>Vettorazzi, Eik</creator><creator>Moritz, Steffen</creator><general>BioMed Central Ltd</general><general>BioMed Central</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>7TK</scope><scope>7X8</scope><scope>5PM</scope><scope>ABXSW</scope><scope>ADTPV</scope><scope>AOWAS</scope><scope>D8T</scope><scope>DG8</scope><scope>ZZAVC</scope></search><sort><creationdate>20130928</creationdate><title>The EVIDENT-trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention</title><author>Klein, Jan Philipp ; Berger, Thomas ; Schröder, Johanna ; Späth, Christina ; Meyer, Björn ; Caspar, Franz ; Lutz, Wolfgang ; Greiner, Wolfgang ; Hautzinger, Martin ; Rose, Matthias ; Gräfe, Viola ; Hohagen, Fritz ; Andersson, Gerhard ; Vettorazzi, Eik ; Moritz, Steffen</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b682t-fa5e9eeccbc6b784281abbb1d22327a2171f5eebea04e1fc6c020de4c77bf6e53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Care and treatment</topic><topic>Clinical Protocols</topic><topic>Clinical trials</topic><topic>Clinics</topic><topic>Cost-of-illness analysis</topic><topic>Depression, Mental</topic><topic>Depressive Disorder - psychology</topic><topic>Depressive Disorder - therapy</topic><topic>Elektroteknik och elektronik</topic><topic>Female</topic><topic>Guided self-help</topic><topic>Health economic evaluation</topic><topic>Humans</topic><topic>Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi</topic><topic>Hälsovetenskap</topic><topic>Major depression</topic><topic>Male</topic><topic>Medical care, Cost of</topic><topic>Medicin och hälsovetenskap</topic><topic>Online psychological treatment</topic><topic>Patient Satisfaction</topic><topic>Prevention</topic><topic>Psychotherapy</topic><topic>Psychotherapy - methods</topic><topic>Psykologi</topic><topic>Quality of Life</topic><topic>Randomized controlled trial</topic><topic>Remote Consultation - methods</topic><topic>Research Design</topic><topic>Risk factors</topic><topic>SAMHÄLLSVETENSKAP</topic><topic>Self Care</topic><topic>Self-help</topic><topic>Severity of Illness Index</topic><topic>Single-Blind Method</topic><topic>SOCIAL SCIENCES</topic><topic>Study Protocol</topic><topic>Subclinical depression</topic><topic>Teknik</topic><topic>Telekommunikation</topic><topic>Tillämpad psykologi</topic><topic>Treatment</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Klein, Jan Philipp</creatorcontrib><creatorcontrib>Berger, Thomas</creatorcontrib><creatorcontrib>Schröder, Johanna</creatorcontrib><creatorcontrib>Späth, Christina</creatorcontrib><creatorcontrib>Meyer, Björn</creatorcontrib><creatorcontrib>Caspar, Franz</creatorcontrib><creatorcontrib>Lutz, Wolfgang</creatorcontrib><creatorcontrib>Greiner, Wolfgang</creatorcontrib><creatorcontrib>Hautzinger, Martin</creatorcontrib><creatorcontrib>Rose, Matthias</creatorcontrib><creatorcontrib>Gräfe, Viola</creatorcontrib><creatorcontrib>Hohagen, Fritz</creatorcontrib><creatorcontrib>Andersson, Gerhard</creatorcontrib><creatorcontrib>Vettorazzi, Eik</creatorcontrib><creatorcontrib>Moritz, Steffen</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>SWEPUB Linköpings universitet full text</collection><collection>SwePub</collection><collection>SwePub Articles</collection><collection>SWEPUB Freely available online</collection><collection>SWEPUB Linköpings universitet</collection><collection>SwePub Articles full text</collection><jtitle>BMC PSYCHIATRY</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Klein, Jan Philipp</au><au>Berger, Thomas</au><au>Schröder, Johanna</au><au>Späth, Christina</au><au>Meyer, Björn</au><au>Caspar, Franz</au><au>Lutz, Wolfgang</au><au>Greiner, Wolfgang</au><au>Hautzinger, Martin</au><au>Rose, Matthias</au><au>Gräfe, Viola</au><au>Hohagen, Fritz</au><au>Andersson, Gerhard</au><au>Vettorazzi, Eik</au><au>Moritz, Steffen</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The EVIDENT-trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention</atitle><jtitle>BMC PSYCHIATRY</jtitle><addtitle>BMC Psychiatry</addtitle><date>2013-09-28</date><risdate>2013</risdate><volume>13</volume><issue>1</issue><spage>239</spage><epage>239</epage><pages>239-239</pages><artnum>239</artnum><issn>1471-244X</issn><eissn>1471-244X</eissn><abstract>Depressive disorders are among the leading causes of worldwide disability with mild to moderate forms of depression being particularly common. Low-intensity treatments such as online psychological treatments may be an effective way to treat mild to moderate depressive symptoms and prevent the emergence or relapse of major depression.
This study is a currently recruiting multicentre parallel-groups pragmatic randomized-controlled single-blind trial. A total of 1000 participants with mild to moderate symptoms of depression from various settings including in- and outpatient services will be randomized to an online psychological treatment or care as usual (CAU). We hypothesize that the intervention will be superior to CAU in reducing depressive symptoms assessed with the Personal Health Questionnaire (PHQ-9, primary outcome measure) following the intervention (12 wks) and at follow-up (24 and 48 wks). Further outcome parameters include quality of life, use of health care resources and attitude towards online psychological treatments.
The study will yield meaningful answers to the question of whether online psychological treatment can contribute to the effective and efficient prevention and treatment of mild to moderate depression on a population level with a low barrier to entry.
NCT01636752.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>24074299</pmid><doi>10.1186/1471-244X-13-239</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adult Care and treatment Clinical Protocols Clinical trials Clinics Cost-of-illness analysis Depression, Mental Depressive Disorder - psychology Depressive Disorder - therapy Elektroteknik och elektronik Female Guided self-help Health economic evaluation Humans Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi Hälsovetenskap Major depression Male Medical care, Cost of Medicin och hälsovetenskap Online psychological treatment Patient Satisfaction Prevention Psychotherapy Psychotherapy - methods Psykologi Quality of Life Randomized controlled trial Remote Consultation - methods Research Design Risk factors SAMHÄLLSVETENSKAP Self Care Self-help Severity of Illness Index Single-Blind Method SOCIAL SCIENCES Study Protocol Subclinical depression Teknik Telekommunikation Tillämpad psykologi Treatment Treatment Outcome |
title | The EVIDENT-trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention |
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