Cardiovascular Health in Anxiety or Mood Problems Study (CHAMPS): study protocol for a randomized controlled trial
Identifieur interne : 000D17 ( Pmc/Curation ); précédent : 000D16; suivant : 000D18Cardiovascular Health in Anxiety or Mood Problems Study (CHAMPS): study protocol for a randomized controlled trial
Auteurs : Phillip J. Tully [Allemagne, France, Australie] ; Deborah A. Turnbull [Australie] ; John D. Horowitz [Australie] ; John F. Beltrame [Australie] ; Terina Selkow [Australie] ; Bernhard T. Baune [Australie] ; Elizabeth Markwick [Australie] ; Shannon Sauer-Zavala [États-Unis] ; Harald Baumeister [Allemagne] ; Suzanne Cosh [Australie] ; Gary A. Wittert [Australie]Source :
- Trials [ 1745-6215 ] ; 2016.
Abstract
Previous psychological and pharmacological interventions have primarily focused on depression disorders in populations with cardiovascular diseases (CVDs) and the efficacy of anxiety disorder interventions is only more recently being explored. Transdiagnostic interventions address common emotional processes and the full range of anxiety and depression disorders often observed in populations with CVDs. The aim of CHAMPS is to evaluate the feasibility of a unified protocol (UP) for the transdiagnostic treatment of emotional disorders intervention in patients recently hospitalized for CVDs. The current study reports the protocol of a feasibility randomized controlled trial to inform a future trial.
This is a feasibility randomized, controlled trial with a single-center design. A total of 50 participants will be block-randomized to either a UP intervention or enhanced usual care. Both groups will receive standard CVD care. The UP intervention consists of 1) enhancing motivation, readiness for change, and treatment engagement; (2) psychoeducation about emotions; (3) increasing present focused emotion awareness; (4) increasing cognitive flexibility; (5) identifying and preventing patterns of emotion avoidance and maladaptive emotion-driven behaviors (EDBs, including tobacco smoking, and alcohol use); (6) increasing tolerance of emotion-related physical sensations; (7) interoceptive and situation-based emotion-focused exposure; and (8) relapse prevention strategies. Treatment duration is 12 to 18 weeks. Relevant outcomes include the standard deviation of self-rated anxiety, depression and quality of life symptoms. Other outcomes include intervention acceptability, satisfaction with care, rates of EDBs, patient adherence, physical activity, cardiac and psychiatric readmissions. Parallel to the main trial, a nonrandomized comparator cohort will be recruited comprising 150 persons scoring below the predetermined depression and anxiety severity thresholds.
CHAMPS is designed to evaluate the UP for the transdiagnostic treatment of emotional disorders targeting emotional disorder processes in a CVD population. The design will provide preliminary evidence of feasibility, attrition, and satisfaction with treatment to design a definitive trial. If the trial is feasible, it opens up the possibility for interventions to target broader emotional processes in the precarious population with CVD and emotional distress.
Url:
DOI: 10.1186/s13063-015-1109-z
PubMed: 26754447
PubMed Central: 4707770
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Horowitz</name><affiliation wicri:level="1"><nlm:aff id="Aff4">Department of Cardiology, Basil Hetzel Institute, The Queen Elizabeth Hospital and The University of Adelaide, Adelaide, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Cardiology, Basil Hetzel Institute, The Queen Elizabeth Hospital and The University of Adelaide, Adelaide</wicri:regionArea></affiliation></author><author><name sortKey="Beltrame, John F" sort="Beltrame, John F" uniqKey="Beltrame J" first="John F." last="Beltrame">John F. Beltrame</name><affiliation wicri:level="1"><nlm:aff id="Aff4">Department of Cardiology, Basil Hetzel Institute, The Queen Elizabeth Hospital and The University of Adelaide, Adelaide, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Cardiology, Basil Hetzel Institute, The Queen Elizabeth Hospital and The University of Adelaide, Adelaide</wicri:regionArea></affiliation></author><author><name sortKey="Selkow, Terina" sort="Selkow, Terina" uniqKey="Selkow T" first="Terina" last="Selkow">Terina Selkow</name><affiliation wicri:level="1"><nlm:aff id="Aff4">Department of Cardiology, Basil Hetzel Institute, The Queen Elizabeth Hospital and The University of Adelaide, Adelaide, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Cardiology, Basil Hetzel Institute, The Queen Elizabeth Hospital and The University of Adelaide, Adelaide</wicri:regionArea></affiliation></author><author><name sortKey="Baune, Bernhard T" sort="Baune, Bernhard T" uniqKey="Baune B" first="Bernhard T." last="Baune">Bernhard T. Baune</name><affiliation wicri:level="1"><nlm:aff id="Aff5">Discipline of Psychiatry, The University of Adelaide, Adelaide, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Discipline of Psychiatry, The University of Adelaide, Adelaide</wicri:regionArea></affiliation></author><author><name sortKey="Markwick, Elizabeth" sort="Markwick, Elizabeth" uniqKey="Markwick E" first="Elizabeth" last="Markwick">Elizabeth Markwick</name><affiliation wicri:level="1"><nlm:aff id="Aff6">Department of Psychiatry, The Queen Elizabeth Hospital, Woodville West, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Psychiatry, The Queen Elizabeth Hospital, Woodville West</wicri:regionArea></affiliation></author><author><name sortKey="Sauer Zavala, Shannon" sort="Sauer Zavala, Shannon" uniqKey="Sauer Zavala S" first="Shannon" last="Sauer-Zavala">Shannon Sauer-Zavala</name><affiliation wicri:level="1"><nlm:aff id="Aff7">Center for Anxiety & Related Disorders, Department of Psychology, Boston University, Boston, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Center for Anxiety & Related Disorders, Department of Psychology, Boston University, Boston</wicri:regionArea></affiliation></author><author><name sortKey="Baumeister, Harald" sort="Baumeister, Harald" uniqKey="Baumeister H" first="Harald" last="Baumeister">Harald Baumeister</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Rehabilitation Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Engelbergerstr. 41, Freiburg, 79085 Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Rehabilitation Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Engelbergerstr. 41, Freiburg</wicri:regionArea></affiliation></author><author><name sortKey="Cosh, Suzanne" sort="Cosh, Suzanne" uniqKey="Cosh S" first="Suzanne" last="Cosh">Suzanne Cosh</name><affiliation wicri:level="1"><nlm:aff id="Aff3">School of Psychology, The University of Adelaide, Adelaide, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>School of Psychology, The University of Adelaide, Adelaide</wicri:regionArea></affiliation></author><author><name sortKey="Wittert, Gary A" sort="Wittert, Gary A" uniqKey="Wittert G" first="Gary A." last="Wittert">Gary A. Wittert</name><affiliation wicri:level="1"><nlm:aff id="Aff8">Freemasons Foundation Centre for Men’s Health, Discipline of Medicine, School of Medicine, The University of Adelaide, Adelaide, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Freemasons Foundation Centre for Men’s Health, Discipline of Medicine, School of Medicine, The University of Adelaide, Adelaide</wicri:regionArea></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Previous psychological and pharmacological interventions have primarily focused on depression disorders in populations with cardiovascular diseases (CVDs) and the efficacy of anxiety disorder interventions is only more recently being explored. Transdiagnostic interventions address common emotional processes and the full range of anxiety and depression disorders often observed in populations with CVDs. The aim of CHAMPS is to evaluate the feasibility of a unified protocol (UP) for the transdiagnostic treatment of emotional disorders intervention in patients recently hospitalized for CVDs. The current study reports the protocol of a feasibility randomized controlled trial to inform a future trial.</p></sec><sec><title>Methods/Design</title><p>This is a feasibility randomized, controlled trial with a single-center design. A total of 50 participants will be block-randomized to either a UP intervention or enhanced usual care. Both groups will receive standard CVD care. The UP intervention consists of 1) enhancing motivation, readiness for change, and treatment engagement; (2) psychoeducation about emotions; (3) increasing present focused emotion awareness; (4) increasing cognitive flexibility; (5) identifying and preventing patterns of emotion avoidance and maladaptive emotion-driven behaviors (EDBs, including tobacco smoking, and alcohol use); (6) increasing tolerance of emotion-related physical sensations; (7) interoceptive and situation-based emotion-focused exposure; and (8) relapse prevention strategies. Treatment duration is 12 to 18 weeks. Relevant outcomes include the standard deviation of self-rated anxiety, depression and quality of life symptoms. Other outcomes include intervention acceptability, satisfaction with care, rates of EDBs, patient adherence, physical activity, cardiac and psychiatric readmissions. Parallel to the main trial, a nonrandomized comparator cohort will be recruited comprising 150 persons scoring below the predetermined depression and anxiety severity thresholds.</p></sec><sec><title>Discussion</title><p>CHAMPS is designed to evaluate the UP for the transdiagnostic treatment of emotional disorders targeting emotional disorder processes in a CVD population. The design will provide preliminary evidence of feasibility, attrition, and satisfaction with treatment to design a definitive trial. If the trial is feasible, it opens up the possibility for interventions to target broader emotional processes in the precarious population with CVD and emotional distress.</p></sec><sec><title>Trial registration</title><p><ext-link ext-link-type="uri" xlink:href="https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368440">ACTRN12615000555550</ext-link>, registered on 29/05/2015</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Barth, J" uniqKey="Barth J">J Barth</name></author><author><name sortKey="Schumacher, M" uniqKey="Schumacher M">M Schumacher</name></author><author><name sortKey="Herrmann Lingen, C" uniqKey="Herrmann Lingen C">C Herrmann-Lingen</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Samartzis, L" uniqKey="Samartzis L">L Samartzis</name></author><author><name sortKey="Dimopoulos, S" uniqKey="Dimopoulos S">S Dimopoulos</name></author><author><name 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Trials</journal-id><journal-id journal-id-type="iso-abbrev">Trials</journal-id><journal-title-group><journal-title>Trials</journal-title></journal-title-group><issn pub-type="epub">1745-6215</issn><publisher><publisher-name>BioMed Central</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26754447</article-id><article-id pub-id-type="pmc">4707770</article-id><article-id pub-id-type="publisher-id">1109</article-id><article-id pub-id-type="doi">10.1186/s13063-015-1109-z</article-id><article-categories><subj-group subj-group-type="heading"><subject>Study Protocol</subject></subj-group></article-categories><title-group><article-title>Cardiovascular Health in Anxiety or Mood Problems Study (CHAMPS): study protocol for a randomized controlled trial</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Tully</surname><given-names>Phillip J.</given-names></name><address><email>phillip.tully@adelaide.edu.au</email></address><xref ref-type="aff" rid="Aff1"></xref><xref ref-type="aff" rid="Aff2"></xref><xref ref-type="aff" rid="Aff8"></xref></contrib><contrib contrib-type="author"><name><surname>Turnbull</surname><given-names>Deborah A.</given-names></name><address><email>deborah.turnbull@adelaide.edu.au</email></address><xref ref-type="aff" rid="Aff3"></xref><xref ref-type="aff" rid="Aff8"></xref></contrib><contrib contrib-type="author"><name><surname>Horowitz</surname><given-names>John D.</given-names></name><address><email>john.horowitz@adelaide.edu.au</email></address><xref ref-type="aff" rid="Aff4"></xref></contrib><contrib contrib-type="author"><name><surname>Beltrame</surname><given-names>John F.</given-names></name><address><email>john.beltrame@adelaide.edu.au</email></address><xref ref-type="aff" rid="Aff4"></xref></contrib><contrib contrib-type="author"><name><surname>Selkow</surname><given-names>Terina</given-names></name><address><email>Terina.Selkow@health.sa.gov.au</email></address><xref ref-type="aff" rid="Aff4"></xref></contrib><contrib contrib-type="author"><name><surname>Baune</surname><given-names>Bernhard T.</given-names></name><address><email>bernhard.baune@adelaide.edu.au</email></address><xref ref-type="aff" rid="Aff5"></xref></contrib><contrib contrib-type="author"><name><surname>Markwick</surname><given-names>Elizabeth</given-names></name><address><email>Elizabeth.Markwick@health.sa.gov.au</email></address><xref ref-type="aff" rid="Aff6"></xref></contrib><contrib contrib-type="author"><name><surname>Sauer-Zavala</surname><given-names>Shannon</given-names></name><address><email>shannonezavala@gmail.com</email></address><xref ref-type="aff" rid="Aff7"></xref></contrib><contrib contrib-type="author"><name><surname>Baumeister</surname><given-names>Harald</given-names></name><address><email>harald.baumeister@psychologie.uni-freiburg.de</email></address><xref ref-type="aff" rid="Aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Cosh</surname><given-names>Suzanne</given-names></name><address><email>Suzie.cosh@adelaide.edu.au</email></address><xref ref-type="aff" rid="Aff3"></xref></contrib><contrib contrib-type="author"><name><surname>Wittert</surname><given-names>Gary A.</given-names></name><address><email>gary.wittert@adelaide.edu.au</email></address><xref ref-type="aff" rid="Aff8"></xref></contrib><aff id="Aff1"><label></label>Department of Rehabilitation Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Engelbergerstr. 41, Freiburg, 79085 Germany</aff><aff id="Aff2"><label></label>INSERM, U897-Epidemiology and Biostatistics, Bordeaux, France</aff><aff id="Aff3"><label></label>School of Psychology, The University of Adelaide, Adelaide, Australia</aff><aff id="Aff4"><label></label>Department of Cardiology, Basil Hetzel Institute, The Queen Elizabeth Hospital and The University of Adelaide, Adelaide, Australia</aff><aff id="Aff5"><label></label>Discipline of Psychiatry, The University of Adelaide, Adelaide, Australia</aff><aff id="Aff6"><label></label>Department of Psychiatry, The Queen Elizabeth Hospital, Woodville West, Australia</aff><aff id="Aff7"><label></label>Center for Anxiety & Related Disorders, Department of Psychology, Boston University, Boston, USA</aff><aff id="Aff8"><label></label>Freemasons Foundation Centre for Men’s Health, Discipline of Medicine, School of Medicine, The University of Adelaide, Adelaide, Australia</aff></contrib-group><pub-date pub-type="epub"><day>11</day><month>1</month><year>2016</year></pub-date><pub-date pub-type="pmc-release"><day>11</day><month>1</month><year>2016</year></pub-date><pub-date pub-type="collection"><year>2016</year></pub-date><volume>17</volume><elocation-id>18</elocation-id><history><date date-type="received"><day>27</day><month>5</month><year>2015</year></date><date date-type="accepted"><day>8</day><month>12</month><year>2015</year></date></history><permissions><copyright-statement>© Tully et al. 2016</copyright-statement><license license-type="OpenAccess"><license-p><bold>Open Access</bold>This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>) applies to the data made available in this article, unless otherwise stated.</license-p></license></permissions><abstract id="Abs1"><sec><title>Background</title><p>Previous psychological and pharmacological interventions have primarily focused on depression disorders in populations with cardiovascular diseases (CVDs) and the efficacy of anxiety disorder interventions is only more recently being explored. Transdiagnostic interventions address common emotional processes and the full range of anxiety and depression disorders often observed in populations with CVDs. The aim of CHAMPS is to evaluate the feasibility of a unified protocol (UP) for the transdiagnostic treatment of emotional disorders intervention in patients recently hospitalized for CVDs. The current study reports the protocol of a feasibility randomized controlled trial to inform a future trial.</p></sec><sec><title>Methods/Design</title><p>This is a feasibility randomized, controlled trial with a single-center design. A total of 50 participants will be block-randomized to either a UP intervention or enhanced usual care. Both groups will receive standard CVD care. The UP intervention consists of 1) enhancing motivation, readiness for change, and treatment engagement; (2) psychoeducation about emotions; (3) increasing present focused emotion awareness; (4) increasing cognitive flexibility; (5) identifying and preventing patterns of emotion avoidance and maladaptive emotion-driven behaviors (EDBs, including tobacco smoking, and alcohol use); (6) increasing tolerance of emotion-related physical sensations; (7) interoceptive and situation-based emotion-focused exposure; and (8) relapse prevention strategies. Treatment duration is 12 to 18 weeks. Relevant outcomes include the standard deviation of self-rated anxiety, depression and quality of life symptoms. Other outcomes include intervention acceptability, satisfaction with care, rates of EDBs, patient adherence, physical activity, cardiac and psychiatric readmissions. Parallel to the main trial, a nonrandomized comparator cohort will be recruited comprising 150 persons scoring below the predetermined depression and anxiety severity thresholds.</p></sec><sec><title>Discussion</title><p>CHAMPS is designed to evaluate the UP for the transdiagnostic treatment of emotional disorders targeting emotional disorder processes in a CVD population. The design will provide preliminary evidence of feasibility, attrition, and satisfaction with treatment to design a definitive trial. If the trial is feasible, it opens up the possibility for interventions to target broader emotional processes in the precarious population with CVD and emotional distress.</p></sec><sec><title>Trial registration</title><p><ext-link ext-link-type="uri" xlink:href="https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368440">ACTRN12615000555550</ext-link>, registered on 29/05/2015</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>Depression</kwd><kwd>major depression</kwd><kwd>anxiety</kwd><kwd>anxiety disorders</kwd><kwd>cardiovascular disease</kwd><kwd>coronary heart disease</kwd><kwd>randomized controlled trial</kwd><kwd>cognitive behavioral therapy</kwd><kwd>diagnosis</kwd><kwd>prognosis</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© The Author(s) 2016</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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