RAndomised controlled trial to imProve depressIon and the quality of life of people with Dementia using cognitive bias modification: RAPID study protocol
Identifieur interne : 000F24 ( Main/Exploration ); précédent : 000F23; suivant : 000F25RAndomised controlled trial to imProve depressIon and the quality of life of people with Dementia using cognitive bias modification: RAPID study protocol
Auteurs : Osvaldo P. Almeida [Australie] ; Colin Macleod [Australie] ; Leon Flicker [Australie] ; Andrew Ford [Australie] ; Ben Grafton [Australie] ; Christopher Etherton-Beer [Australie]Source :
- BMJ Open [ 2044-6055 ] ; 2014.
Abstract
Depressive symptoms are common and undermine the quality of life of people with Alzheimer's disease (AD). Cholinesterase inhibitors and antidepressants have all but no effect on the mood of patients, and their use increases adverse events. Cognitive bias modification (CBM) targets attentional and interpretative biases associated with anxiety, dysphoria and depression and may be useful to treat depression in AD (DAD). This trial aims to determine the effect of CBM on depression scores and the quality of life of people with DAD.
Randomised, double-blind, parallel, controlled trial of CBM (1:1 allocation ratio). Participants will be 80 adults with probable AD living in the Western Australian community who score 8 or more on the Cornell Scale for Depression in Dementia (CSDD). They will have mild to moderate dementia (Mini-Mental State Examination—MMSE score ≥15) and will be free of severe sensory impairment or suicidal intent. The intervention will consist of 10 40 min sessions of CBM delivered over 2 weeks using a high-resolution monitor using a local computer station at the Western Australian Centre for Health and Ageing. The primary outcomes of interest are the 2-week change, from baseline, in the severity of CSDD scores and the Quality of Life AD (QoL-AD) scores. Secondary outcomes include changes in the CSDD, QoL-AD after 12 weeks, and changes in MMSE scores, negative attentional and interpretative bias and the proportion of participants with CSDD <8 after 2 and 12 weeks.
The study will comply with the principles of the Declaration of Helsinki and participants will provide written informed consent. The Ethics Committee of the Royal Perth Hospital will approve and oversee the study (REG14-036). The results of this trial will provide level 2 evidence of efficacy for CBM as a treatment of DAD.
Australian and New Zealand Clinical Trials Registry number ACTRN12614000420640, date registered 06/04/2014.
Url:
DOI: 10.1136/bmjopen-2014-005623
PubMed: 25056981
PubMed Central: 4120303
Affiliations:
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of people with Dementia using cognitive bias modification: RAPID study protocol</title><author><name sortKey="Almeida, Osvaldo P" sort="Almeida, Osvaldo P" uniqKey="Almeida O" first="Osvaldo P" last="Almeida">Osvaldo P. Almeida</name><affiliation wicri:level="1"><nlm:aff id="af1"><institution>Western Australian Centre for Heath & Ageing (M573), Centre for Medical Research of the Perkins Institute for Medical Research, University of Western Australia</institution>,<addr-line>Perth, Western Australia</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="af2"><institution>School of Psychiatry & Clinical Neurosciences, University of Western Australia</institution>,<addr-line>Perth, Western Australia</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="af3"><addr-line>Department of Psychiatry</addr-line>,<institution>Royal Perth Hospital</institution>,<addr-line>Perth, Western Australia</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Macleod, Colin" sort="Macleod, Colin" uniqKey="Macleod C" first="Colin" last="Macleod">Colin Macleod</name><affiliation wicri:level="1"><nlm:aff id="af4"><institution>School of Psychology, University of Western Australia</institution>,<addr-line>Perth, Western Australia</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Flicker, Leon" sort="Flicker, Leon" uniqKey="Flicker L" first="Leon" last="Flicker">Leon Flicker</name><affiliation wicri:level="1"><nlm:aff id="af1"><institution>Western Australian Centre for Heath & Ageing (M573), Centre for Medical Research of the Perkins Institute for Medical Research, University of Western Australia</institution>,<addr-line>Perth, Western Australia</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="af5"><institution>School of Medicine and Pharmacology, University of Western Australia</institution>,<addr-line>Perth, Western Australia</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="af6"><addr-line>Department of Geriatric Medicine</addr-line>,<institution>Royal Perth Hospital</institution>,<addr-line>Perth, Western Australia</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Ford, Andrew" sort="Ford, Andrew" uniqKey="Ford A" first="Andrew" last="Ford">Andrew Ford</name><affiliation wicri:level="1"><nlm:aff id="af1"><institution>Western Australian Centre for Heath & Ageing (M573), Centre for Medical Research of the Perkins Institute for Medical Research, University of Western Australia</institution>,<addr-line>Perth, Western Australia</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="af2"><institution>School of Psychiatry & Clinical Neurosciences, University of Western Australia</institution>,<addr-line>Perth, Western Australia</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="af3"><addr-line>Department of Psychiatry</addr-line>,<institution>Royal Perth Hospital</institution>,<addr-line>Perth, Western Australia</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Grafton, Ben" sort="Grafton, Ben" uniqKey="Grafton B" first="Ben" last="Grafton">Ben Grafton</name><affiliation wicri:level="1"><nlm:aff id="af4"><institution>School of Psychology, University of Western Australia</institution>,<addr-line>Perth, Western Australia</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Etherton Beer, Christopher" sort="Etherton Beer, Christopher" uniqKey="Etherton Beer C" first="Christopher" last="Etherton-Beer">Christopher Etherton-Beer</name><affiliation wicri:level="1"><nlm:aff id="af1"><institution>Western Australian Centre for Heath & Ageing (M573), Centre for Medical Research of the Perkins Institute for Medical Research, University of Western Australia</institution>,<addr-line>Perth, Western Australia</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="af5"><institution>School of Medicine and Pharmacology, University of Western Australia</institution>,<addr-line>Perth, Western Australia</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="af6"><addr-line>Department of Geriatric Medicine</addr-line>,<institution>Royal Perth Hospital</institution>,<addr-line>Perth, Western Australia</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">BMJ Open</title><idno type="eISSN">2044-6055</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Introduction</title><p>Depressive symptoms are common and undermine the quality of life of people with Alzheimer's disease (AD). Cholinesterase inhibitors and antidepressants have all but no effect on the mood of patients, and their use increases adverse events. Cognitive bias modification (CBM) targets attentional and interpretative biases associated with anxiety, dysphoria and depression and may be useful to treat depression in AD (DAD). This trial aims to determine the effect of CBM on depression scores and the quality of life of people with DAD.</p></sec><sec><title>Methods and analysis</title><p>Randomised, double-blind, parallel, controlled trial of CBM (1:1 allocation ratio). Participants will be 80 adults with probable AD living in the Western Australian community who score 8 or more on the Cornell Scale for Depression in Dementia (CSDD). They will have mild to moderate dementia (Mini-Mental State Examination—MMSE score ≥15) and will be free of severe sensory impairment or suicidal intent. The intervention will consist of 10 40 min sessions of CBM delivered over 2 weeks using a high-resolution monitor using a local computer station at the Western Australian Centre for Health and Ageing. The primary outcomes of interest are the 2-week change, from baseline, in the severity of CSDD scores and the Quality of Life AD (QoL-AD) scores. Secondary outcomes include changes in the CSDD, QoL-AD after 12 weeks, and changes in MMSE scores, negative attentional and interpretative bias and the proportion of participants with CSDD <8 after 2 and 12 weeks.</p></sec><sec><title>Ethics and dissemination</title><p>The study will comply with the principles of the Declaration of Helsinki and participants will provide written informed consent. The Ethics Committee of the Royal Perth Hospital will approve and oversee the study (REG14-036). The results of this trial will provide level 2 evidence of efficacy for CBM as a treatment of DAD.</p></sec><sec><title>Trial registration number</title><p>Australian and New Zealand Clinical Trials Registry number ACTRN12614000420640, date registered 06/04/2014.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Ferri, Cp" uniqKey="Ferri C">CP Ferri</name></author><author><name sortKey="Prince, M" uniqKey="Prince M">M Prince</name></author><author><name sortKey="Brayne, C" uniqKey="Brayne C">C Brayne</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Vos, T" uniqKey="Vos T">T Vos</name></author><author><name sortKey="Flaxman, Ad" uniqKey="Flaxman A">AD Flaxman</name></author><author><name sortKey="Naghavi, M" uniqKey="Naghavi M">M Naghavi</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lloyd Sherlock, P" uniqKey="Lloyd Sherlock P">P 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uniqKey="Ballesteros S">S Ballesteros</name></author><author><name sortKey="Reales, Jm" uniqKey="Reales J">JM Reales</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Mckhann, G" uniqKey="Mckhann G">G McKhann</name></author><author><name sortKey="Drachman, D" uniqKey="Drachman D">D Drachman</name></author><author><name sortKey="Folstein, M" uniqKey="Folstein M">M Folstein</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Folstein, Mf" uniqKey="Folstein M">MF Folstein</name></author><author><name sortKey="Folstein, Se" uniqKey="Folstein S">SE Folstein</name></author><author><name sortKey="Mchugh, Pr" uniqKey="Mchugh P">PR McHugh</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Alexopoulos, Gs" uniqKey="Alexopoulos G">GS Alexopoulos</name></author><author><name sortKey="Abrams, Rc" uniqKey="Abrams R">RC Abrams</name></author><author><name sortKey="Young, Rc" uniqKey="Young R">RC Young</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Blackwell, Se" uniqKey="Blackwell S">SE Blackwell</name></author><author><name sortKey="Holmes, Ea" uniqKey="Holmes E">EA Holmes</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Browning, M" uniqKey="Browning M">M Browning</name></author><author><name sortKey="Holmes, Ea" uniqKey="Holmes E">EA Holmes</name></author><author><name sortKey="Charles, M" uniqKey="Charles M">M Charles</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Logsdon, Rg" uniqKey="Logsdon R">RG Logsdon</name></author><author><name sortKey="Gibbons, Le" uniqKey="Gibbons L">LE Gibbons</name></author><author><name sortKey="Mccurry, Sm" uniqKey="Mccurry S">SM McCurry</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Norman, Pe" uniqKey="Norman P">PE Norman</name></author><author><name sortKey="Flicker, L" uniqKey="Flicker L">L Flicker</name></author><author><name sortKey="Almeida, Op" uniqKey="Almeida O">OP Almeida</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ford, Ah" uniqKey="Ford A">AH Ford</name></author><author><name sortKey="Flicker, L" uniqKey="Flicker L">L Flicker</name></author><author><name sortKey="Mccaul, K" uniqKey="Mccaul K">K McCaul</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Almeida, Op" uniqKey="Almeida O">OP Almeida</name></author><author><name sortKey="Pirkis, J" uniqKey="Pirkis J">J Pirkis</name></author><author><name sortKey="Kerse, N" uniqKey="Kerse N">N Kerse</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cyarto, Ev" uniqKey="Cyarto E">EV Cyarto</name></author><author><name sortKey="Cox, Kl" uniqKey="Cox K">KL Cox</name></author><author><name sortKey="Almeida, Op" uniqKey="Almeida O">OP Almeida</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Amir, N" uniqKey="Amir N">N Amir</name></author><author><name sortKey="Beard, C" uniqKey="Beard C">C Beard</name></author><author><name sortKey="Taylor, Ct" uniqKey="Taylor C">CT Taylor</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Schulz, Kf" uniqKey="Schulz K">KF Schulz</name></author><author><name sortKey="Altman, Dg" uniqKey="Altman D">DG Altman</name></author><author><name sortKey="Moher, D" uniqKey="Moher D">D Moher</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Chan, Aw" uniqKey="Chan A">AW Chan</name></author><author><name sortKey="Tetzlaff, Jm" uniqKey="Tetzlaff J">JM Tetzlaff</name></author><author><name sortKey="Altman, Dg" uniqKey="Altman D">DG Altman</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Olin, Jt" uniqKey="Olin J">JT Olin</name></author><author><name sortKey="Katz, Ir" uniqKey="Katz I">IR Katz</name></author><author><name sortKey="Meyers, Bs" uniqKey="Meyers B">BS Meyers</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Olin, Jt" uniqKey="Olin J">JT Olin</name></author><author><name sortKey="Schneider, Ls" uniqKey="Schneider L">LS Schneider</name></author><author><name sortKey="Katz, Ir" uniqKey="Katz I">IR Katz</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Fleischman, Da" uniqKey="Fleischman D">DA Fleischman</name></author><author><name sortKey="Gabrieli, Jd" uniqKey="Gabrieli J">JD Gabrieli</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Australie</li></country></list><tree><country name="Australie"><noRegion><name sortKey="Almeida, Osvaldo P" sort="Almeida, Osvaldo P" uniqKey="Almeida O" first="Osvaldo P" last="Almeida">Osvaldo P. Almeida</name></noRegion><name sortKey="Almeida, Osvaldo P" sort="Almeida, Osvaldo P" uniqKey="Almeida O" first="Osvaldo P" last="Almeida">Osvaldo P. Almeida</name><name sortKey="Almeida, Osvaldo P" sort="Almeida, Osvaldo P" uniqKey="Almeida O" first="Osvaldo P" last="Almeida">Osvaldo P. Almeida</name><name sortKey="Etherton Beer, Christopher" sort="Etherton Beer, Christopher" uniqKey="Etherton Beer C" first="Christopher" last="Etherton-Beer">Christopher Etherton-Beer</name><name sortKey="Etherton Beer, Christopher" sort="Etherton Beer, Christopher" uniqKey="Etherton Beer C" first="Christopher" last="Etherton-Beer">Christopher Etherton-Beer</name><name sortKey="Etherton Beer, Christopher" sort="Etherton Beer, Christopher" uniqKey="Etherton Beer C" first="Christopher" last="Etherton-Beer">Christopher Etherton-Beer</name><name sortKey="Flicker, Leon" sort="Flicker, Leon" uniqKey="Flicker L" first="Leon" last="Flicker">Leon Flicker</name><name sortKey="Flicker, Leon" sort="Flicker, Leon" uniqKey="Flicker L" first="Leon" last="Flicker">Leon Flicker</name><name sortKey="Flicker, Leon" sort="Flicker, Leon" uniqKey="Flicker L" first="Leon" last="Flicker">Leon Flicker</name><name sortKey="Ford, Andrew" sort="Ford, Andrew" uniqKey="Ford A" first="Andrew" last="Ford">Andrew Ford</name><name sortKey="Ford, Andrew" sort="Ford, Andrew" uniqKey="Ford A" first="Andrew" last="Ford">Andrew Ford</name><name sortKey="Ford, Andrew" sort="Ford, Andrew" uniqKey="Ford A" first="Andrew" last="Ford">Andrew Ford</name><name sortKey="Grafton, Ben" sort="Grafton, Ben" uniqKey="Grafton B" first="Ben" last="Grafton">Ben Grafton</name><name sortKey="Macleod, Colin" sort="Macleod, Colin" uniqKey="Macleod C" first="Colin" last="Macleod">Colin Macleod</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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