Cardiovascular Health in Anxiety or Mood Problems Study (CHAMPS): study protocol for a randomized controlled trial
Identifieur interne : 002262 ( Main/Exploration ); précédent : 002261; suivant : 002263Cardiovascular 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.
Descripteurs français
- KwdFr :
- MESH :
English descriptors
- KwdEn :
- MESH :
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
Affiliations:
- Allemagne, Australie, France, États-Unis
- Aquitaine, Bade-Wurtemberg, District de Fribourg-en-Brisgau, Massachusetts, Nouvelle-Aquitaine
- Bordeaux, Boston, Fribourg-en-Brisgau
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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><wicri:noRegion>Adelaide</wicri:noRegion></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><wicri:noRegion>Adelaide</wicri:noRegion></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><wicri:noRegion>Adelaide</wicri:noRegion></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><wicri:noRegion>Adelaide</wicri:noRegion></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><wicri:noRegion>Woodville West</wicri:noRegion></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="3"><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><placeName><settlement type="city">Boston</settlement><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Baumeister, Harald" sort="Baumeister, Harald" uniqKey="Baumeister H" first="Harald" last="Baumeister">Harald Baumeister</name><affiliation wicri:level="3"><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><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Fribourg-en-Brisgau</region><settlement type="city">Fribourg-en-Brisgau</settlement></placeName></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><wicri:noRegion>Adelaide</wicri:noRegion></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><wicri:noRegion>Adelaide</wicri:noRegion></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><keywords scheme="KwdEn" xml:lang="en"><term>Anxiety Disorders (therapy)</term><term>Cardiovascular Diseases (psychology)</term><term>Clinical Protocols</term><term>Data Interpretation, Statistical</term><term>Depressive Disorder (therapy)</term><term>Emotions</term><term>Feasibility Studies</term><term>Humans</term><term>Prospective Studies</term><term>Research Design</term><term>Standard of Care</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Humains</term><term>Interprétation statistique de données</term><term>Maladies cardiovasculaires (psychologie)</term><term>Norme de soins</term><term>Plan de recherche</term><term>Protocoles cliniques</term><term>Trouble dépressif ()</term><term>Troubles anxieux ()</term><term>Émotions</term><term>Études de faisabilité</term><term>Études prospectives</term></keywords><keywords scheme="MESH" qualifier="psychologie" xml:lang="fr"><term>Maladies cardiovasculaires</term></keywords><keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Cardiovascular Diseases</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Anxiety Disorders</term><term>Depressive Disorder</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Clinical Protocols</term><term>Data Interpretation, Statistical</term><term>Emotions</term><term>Feasibility Studies</term><term>Humans</term><term>Prospective Studies</term><term>Research Design</term><term>Standard of Care</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Humains</term><term>Interprétation statistique de données</term><term>Norme de soins</term><term>Plan de recherche</term><term>Protocoles cliniques</term><term>Trouble dépressif</term><term>Troubles anxieux</term><term>Émotions</term><term>Études de faisabilité</term><term>Études prospectives</term></keywords></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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Hartley</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lovibond, Pf" uniqKey="Lovibond P">PF Lovibond</name></author><author><name sortKey="Lovibond, Sh" uniqKey="Lovibond S">SH Lovibond</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Tully, Pj" uniqKey="Tully P">PJ Tully</name></author><author><name sortKey="Baker, Ra" uniqKey="Baker R">RA Baker</name></author><author><name sortKey="Knight, Jl" uniqKey="Knight J">JL Knight</name></author><author><name sortKey="Turnbull, Da" uniqKey="Turnbull D">DA Turnbull</name></author><author><name sortKey="Winefield, Hr" uniqKey="Winefield H">HR Winefield</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Tully, Pj" uniqKey="Tully P">PJ Tully</name></author><author><name sortKey="Baker, Ra" uniqKey="Baker R">RA Baker</name></author><author><name sortKey="Turnbull, Da" uniqKey="Turnbull D">DA Turnbull</name></author><author><name sortKey="Winefield, Hr" uniqKey="Winefield H">HR Winefield</name></author><author><name sortKey="Knight, Jl" uniqKey="Knight J">JL Knight</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Tully, Pj" uniqKey="Tully P">PJ Tully</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Muller Nordhorn, J" uniqKey="Muller Nordhorn J">J Muller-Nordhorn</name></author><author><name sortKey="Roll, S" uniqKey="Roll S">S Roll</name></author><author><name sortKey="Willich, Sn" uniqKey="Willich S">SN Willich</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Bush, K" uniqKey="Bush K">K Bush</name></author><author><name sortKey="Kivlahan, Dr" uniqKey="Kivlahan D">DR Kivlahan</name></author><author><name sortKey="Mcdonell, Mb" uniqKey="Mcdonell M">MB McDonell</name></author><author><name sortKey="Fihn, Sd" uniqKey="Fihn S">SD Fihn</name></author><author><name sortKey="Bradley, Ka" uniqKey="Bradley K">KA Bradley</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Amorim, P" uniqKey="Amorim P">P Amorim</name></author><author><name sortKey="Lecrubier, Y" uniqKey="Lecrubier Y">Y Lecrubier</name></author><author><name sortKey="Weiller, E" uniqKey="Weiller E">E Weiller</name></author><author><name sortKey="Hergueta, T" uniqKey="Hergueta T">T Hergueta</name></author><author><name sortKey="Sheehan, D" uniqKey="Sheehan D">D Sheehan</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Sheehan, Dv" uniqKey="Sheehan D">DV Sheehan</name></author><author><name sortKey="Lecrubier, Y" uniqKey="Lecrubier Y">Y Lecrubier</name></author><author><name sortKey="Sheehan, K" uniqKey="Sheehan K">K Sheehan</name></author><author><name sortKey="Amorim, P" uniqKey="Amorim P">P Amorim</name></author><author><name sortKey="Janavs, J" uniqKey="Janavs J">J Janavs</name></author><author><name sortKey="Weiller, E" uniqKey="Weiller E">E Weiller</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Tully, Pj" uniqKey="Tully P">PJ Tully</name></author><author><name sortKey="Penninx, Bw" uniqKey="Penninx B">BW Penninx</name></author></analytic></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>France</li><li>États-Unis</li></country><region><li>Aquitaine</li><li>Bade-Wurtemberg</li><li>District de Fribourg-en-Brisgau</li><li>Massachusetts</li><li>Nouvelle-Aquitaine</li></region><settlement><li>Bordeaux</li><li>Boston</li><li>Fribourg-en-Brisgau</li></settlement></list><tree><country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="Tully, Phillip J" sort="Tully, Phillip J" uniqKey="Tully P" first="Phillip J." last="Tully">Phillip J. Tully</name></region><name sortKey="Baumeister, Harald" sort="Baumeister, Harald" uniqKey="Baumeister H" first="Harald" last="Baumeister">Harald Baumeister</name></country><country name="France"><region name="Nouvelle-Aquitaine"><name sortKey="Tully, Phillip J" sort="Tully, Phillip J" uniqKey="Tully P" first="Phillip J." last="Tully">Phillip J. Tully</name></region></country><country name="Australie"><noRegion><name sortKey="Tully, Phillip J" sort="Tully, Phillip J" uniqKey="Tully P" first="Phillip J." last="Tully">Phillip J. Tully</name></noRegion><name sortKey="Baune, Bernhard T" sort="Baune, Bernhard T" uniqKey="Baune B" first="Bernhard T." last="Baune">Bernhard T. Baune</name><name sortKey="Beltrame, John F" sort="Beltrame, John F" uniqKey="Beltrame J" first="John F." last="Beltrame">John F. Beltrame</name><name sortKey="Cosh, Suzanne" sort="Cosh, Suzanne" uniqKey="Cosh S" first="Suzanne" last="Cosh">Suzanne Cosh</name><name sortKey="Horowitz, John D" sort="Horowitz, John D" uniqKey="Horowitz J" first="John D." last="Horowitz">John D. Horowitz</name><name sortKey="Markwick, Elizabeth" sort="Markwick, Elizabeth" uniqKey="Markwick E" first="Elizabeth" last="Markwick">Elizabeth Markwick</name><name sortKey="Selkow, Terina" sort="Selkow, Terina" uniqKey="Selkow T" first="Terina" last="Selkow">Terina Selkow</name><name sortKey="Turnbull, Deborah A" sort="Turnbull, Deborah A" uniqKey="Turnbull D" first="Deborah A." last="Turnbull">Deborah A. Turnbull</name><name sortKey="Turnbull, Deborah A" sort="Turnbull, Deborah A" uniqKey="Turnbull D" first="Deborah A." last="Turnbull">Deborah A. Turnbull</name><name sortKey="Wittert, Gary A" sort="Wittert, Gary A" uniqKey="Wittert G" first="Gary A." last="Wittert">Gary A. Wittert</name></country><country name="États-Unis"><region name="Massachusetts"><name sortKey="Sauer Zavala, Shannon" sort="Sauer Zavala, Shannon" uniqKey="Sauer Zavala S" first="Shannon" last="Sauer-Zavala">Shannon Sauer-Zavala</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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