Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: study protocol for a randomized clinical trial
Abstract Background Given the limitation of pharmacological treatments to treat cognitive symptoms in patients with Major Depressive Disorder (MDD), cognitive remediation programs has been proposed as a possible procognitive intervention but findings are not conclusive. This study investigates the e...
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BMC
2019-05-01
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Series: | BMC Psychiatry |
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Online Access: | http://link.springer.com/article/10.1186/s12888-019-2117-4 |
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doaj-75541a74e9bb40dc8d292240a222a5a4 |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Muriel Vicent-Gil Beatriz Raventós Eduardo D. Marín-Martínez Sara González-Simarro Anabel Martínez-Arán Caterina del Mar Bonnin Joan Trujols Josefina Pérez-Blanco Javier de Diego-Adeliño Dolors Puigdemont Maria Serra-Blasco Narcís Cardoner Maria J. Portella |
spellingShingle |
Muriel Vicent-Gil Beatriz Raventós Eduardo D. Marín-Martínez Sara González-Simarro Anabel Martínez-Arán Caterina del Mar Bonnin Joan Trujols Josefina Pérez-Blanco Javier de Diego-Adeliño Dolors Puigdemont Maria Serra-Blasco Narcís Cardoner Maria J. Portella Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: study protocol for a randomized clinical trial BMC Psychiatry Cognitive remediation Depression Functional remediation Computerized cognitive training Clinical trial |
author_facet |
Muriel Vicent-Gil Beatriz Raventós Eduardo D. Marín-Martínez Sara González-Simarro Anabel Martínez-Arán Caterina del Mar Bonnin Joan Trujols Josefina Pérez-Blanco Javier de Diego-Adeliño Dolors Puigdemont Maria Serra-Blasco Narcís Cardoner Maria J. Portella |
author_sort |
Muriel Vicent-Gil |
title |
Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: study protocol for a randomized clinical trial |
title_short |
Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: study protocol for a randomized clinical trial |
title_full |
Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: study protocol for a randomized clinical trial |
title_fullStr |
Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: study protocol for a randomized clinical trial |
title_full_unstemmed |
Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: study protocol for a randomized clinical trial |
title_sort |
testing the efficacy of integral cognitive remediation (increm) in major depressive disorder: study protocol for a randomized clinical trial |
publisher |
BMC |
series |
BMC Psychiatry |
issn |
1471-244X |
publishDate |
2019-05-01 |
description |
Abstract Background Given the limitation of pharmacological treatments to treat cognitive symptoms in patients with Major Depressive Disorder (MDD), cognitive remediation programs has been proposed as a possible procognitive intervention but findings are not conclusive. This study investigates the efficacy of an INtegral Cognitive REMediation (INCREM) that includes a combination of a Functional Remediation (FR) strategy plus a Computerized Cognitive Training (CCT) in order to improve not only cognitive performance but also the psychosocial functioning and the quality of life. Methods A single blind randomized controlled clinical trial in 81 patients with a diagnosis of MDD in clinical remission or in partial remission. Participants will be randomized to one of three conditions: INCREM (FR + CCT), Psychoeducation plus online games and Treatment As Usual (TAU). Intervention will consist in 12 group sessions, of approximately 110 min once a week. The primary outcome measure will be % of change in psychosocial functioning after treatment measured by the Functional Assessment Short Test (FAST); additionally, number of sick leaves and daily activities will also be recorded as pragmatic outcomes. Discussion To our knowledge, this is the first randomized controlled clinical trial using a combination of two different approaches (FR + CCT) to treat the present cognitive deficits and to promote their improvements into a better psychosocial functioning. Trial registration Clinical Trials NCT03624621. Date registered 10th of August 2018 and last updated 24th August 2018. |
topic |
Cognitive remediation Depression Functional remediation Computerized cognitive training Clinical trial |
url |
http://link.springer.com/article/10.1186/s12888-019-2117-4 |
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doaj-75541a74e9bb40dc8d292240a222a5a42020-11-25T02:13:44ZengBMCBMC Psychiatry1471-244X2019-05-011911810.1186/s12888-019-2117-4Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: study protocol for a randomized clinical trialMuriel Vicent-Gil0Beatriz Raventós1Eduardo D. Marín-Martínez2Sara González-Simarro3Anabel Martínez-Arán4Caterina del Mar Bonnin5Joan Trujols6Josefina Pérez-Blanco7Javier de Diego-Adeliño8Dolors Puigdemont9Maria Serra-Blasco10Narcís Cardoner11Maria J. Portella12Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Institut d’Investigació Biomèdica Sant Pau (IBB-Sant Pau), Universitat Autònoma de Barcelona (UAB)Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Institut d’Investigació Biomèdica Sant Pau (IBB-Sant Pau), Universitat Autònoma de Barcelona (UAB)Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Institut d’Investigació Biomèdica Sant Pau (IBB-Sant Pau), Universitat Autònoma de Barcelona (UAB)Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Institut d’Investigació Biomèdica Sant Pau (IBB-Sant Pau), Universitat Autònoma de Barcelona (UAB)Bipolar and Depressive Disorders Unit, Institute of Neurosciences, Hospital Clínic de Barcelona, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), IDIBAPS, University of Barcelona (UB)Bipolar and Depressive Disorders Unit, Institute of Neurosciences, Hospital Clínic de Barcelona, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), IDIBAPS, University of Barcelona (UB)Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Institut d’Investigació Biomèdica Sant Pau (IBB-Sant Pau), Universitat Autònoma de Barcelona (UAB)Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Institut d’Investigació Biomèdica Sant Pau (IBB-Sant Pau), Universitat Autònoma de Barcelona (UAB)Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Institut d’Investigació Biomèdica Sant Pau (IBB-Sant Pau), Universitat Autònoma de Barcelona (UAB)Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Institut d’Investigació Biomèdica Sant Pau (IBB-Sant Pau), Universitat Autònoma de Barcelona (UAB)Mental Health Unit, Hospital Universitari Parc Taulí, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Institut d’Investigació i Innovació Parc Taulí (I3PT), Universitat Autònoma de Barcelona (UAB)Mental Health Unit, Hospital Universitari Parc Taulí, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Institut d’Investigació i Innovació Parc Taulí (I3PT), Universitat Autònoma de Barcelona (UAB)Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Institut d’Investigació Biomèdica Sant Pau (IBB-Sant Pau), Universitat Autònoma de Barcelona (UAB)Abstract Background Given the limitation of pharmacological treatments to treat cognitive symptoms in patients with Major Depressive Disorder (MDD), cognitive remediation programs has been proposed as a possible procognitive intervention but findings are not conclusive. This study investigates the efficacy of an INtegral Cognitive REMediation (INCREM) that includes a combination of a Functional Remediation (FR) strategy plus a Computerized Cognitive Training (CCT) in order to improve not only cognitive performance but also the psychosocial functioning and the quality of life. Methods A single blind randomized controlled clinical trial in 81 patients with a diagnosis of MDD in clinical remission or in partial remission. Participants will be randomized to one of three conditions: INCREM (FR + CCT), Psychoeducation plus online games and Treatment As Usual (TAU). Intervention will consist in 12 group sessions, of approximately 110 min once a week. The primary outcome measure will be % of change in psychosocial functioning after treatment measured by the Functional Assessment Short Test (FAST); additionally, number of sick leaves and daily activities will also be recorded as pragmatic outcomes. Discussion To our knowledge, this is the first randomized controlled clinical trial using a combination of two different approaches (FR + CCT) to treat the present cognitive deficits and to promote their improvements into a better psychosocial functioning. Trial registration Clinical Trials NCT03624621. Date registered 10th of August 2018 and last updated 24th August 2018.http://link.springer.com/article/10.1186/s12888-019-2117-4Cognitive remediationDepressionFunctional remediationComputerized cognitive trainingClinical trial |