Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: Study protocol for a randomized clinical trial

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

doi:10.1186/s12888-019-2117-4

Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: Study protocol for a randomized clinical trial

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

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L'autor/a o autors/ores. Antecedents: Donades les limitacions dels tractaments farmacològics per tractar els símptomes cognitius en pacients amb trastorn depressiu major (TDM), s'han proposat programes de rehabilitació cognitiva com a possible intervenció procognitiva, però les troballes no són concloents. Aquest estudi investiga l'eficàcia d'una REMediació Cognitiva Integral (INCREM) que inclou una combinació d'una estratègia de Remediació Funcional (FR) més un Entrenament Cognitiu Informatitzat (CCT) per a millorar no només el rendiment cognitiu sinó també el funcionament psicosocial i la qualitat de vida. Mètodes: Un assaig clínic aleatoritzat controlat simple cec en 81 pacients amb diagnòstic de TDM en remissió clínica o en remissió parcial. Els participants s'assignaran aleatòriament a una de les tres condicions següents: INCREM (FR + CCT), Psicoeducació més jocs en línia i Tractament Habitual (TAU). La intervenció consistirà en 12 sessions grupals d'aproximadament 110 minuts un cop per setmana. El mesurament del resultat primari serà el % de canvi en el funcionament psicosocial després del tractament, que es mesurarà amb la prova curta d'avaluació funcional (FAST); a més, també s'enregistrarà el nombre de baixes laborals i activitats diàries com a resultats pragmàtics. Discussió: Fins on sabem, aquest és el primer assaig clínic controlat aleatori que fa servir una combinació de dues aproximacions diferents (FR + CCT) per a tractar els dèficits cognitius actuals i promoure'n la millora cap a un millor funcionament psicosocial. Registre d'assaigs clínics NCT03624621. Data de registre 10 d'agost del 2018 i darrera actualització el 24 d'agost del 2018. © 2019

Idioma original	Anglès
Número d’article	135
Revista	BMC Psychiatry
Volum	19
DOIs	https://doi.org/10.1186/s12888-019-2117-4
Estat de la publicació	Publicada - 6 de maig 2019

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10.1186/s12888-019-2117-4

https://ddd.uab.cat/record/226449

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Vicent-Gil, M., Raventós, B., Marín-Martínez, E. D., González-Simarro, S., Martínez-Arán, A., Bonnin, C. D. M., Trujols, J., Pérez-Blanco, J., De Diego-Adeliño, J., Puigdemont, D., Serra-Blasco, M., Cardoner, N., & Portella, M. J. (2019). Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: Study protocol for a randomized clinical trial. BMC Psychiatry, 19, Article 135. https://doi.org/10.1186/s12888-019-2117-4

@article{4fe9da7d4d6f4d518b03eee28d61782a,

title = "Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: Study protocol for a randomized clinical trial",

abstract = "{\textcopyright} 2019 The Author(s). 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.",

keywords = "Clinical trial, Cognitive remediation, Computerized cognitive training, Depression, Functional remediation",

author = "Muriel Vicent-Gil and Beatriz Ravent{\'o}s and Mar{\'i}n-Mart{\'i}nez, \{Eduardo D.\} and Sara Gonz{\'a}lez-Simarro and Anabel Mart{\'i}nez-Ar{\'a}n and Bonnin, \{Caterina Del Mar\} and Joan Trujols and Josefina P{\'e}rez-Blanco and \{De Diego-Adeli{\~n}o\}, Javier and Dolors Puigdemont and Maria Serra-Blasco and Narc{\'i}s Cardoner and Portella, \{Maria J.\}",

year = "2019",

month = may,

day = "6",

doi = "10.1186/s12888-019-2117-4",

language = "English",

volume = "19",

journal = "BMC Psychiatry",

issn = "1471-244X",

publisher = "BioMed Central Ltd.",

}

Vicent-Gil, M, Raventós, B, Marín-Martínez, ED, González-Simarro, S, Martínez-Arán, A, Bonnin, CDM, Trujols, J, Pérez-Blanco, J, De Diego-Adeliño, J, Puigdemont, D, Serra-Blasco, M, Cardoner, N & Portella, MJ 2019, 'Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: Study protocol for a randomized clinical trial', BMC Psychiatry, vol. 19, 135. https://doi.org/10.1186/s12888-019-2117-4

TY - JOUR

T1 - Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: Study protocol for a randomized clinical trial

AU - Vicent-Gil, Muriel

AU - Raventós, Beatriz

AU - Marín-Martínez, Eduardo D.

AU - González-Simarro, Sara

AU - Martínez-Arán, Anabel

AU - Bonnin, Caterina Del Mar

AU - Trujols, Joan

AU - Pérez-Blanco, Josefina

AU - De Diego-Adeliño, Javier

AU - Puigdemont, Dolors

AU - Serra-Blasco, Maria

AU - Cardoner, Narcís

AU - Portella, Maria J.

PY - 2019/5/6

Y1 - 2019/5/6

N2 - © 2019 The Author(s). 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.

AB - © 2019 The Author(s). 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.

KW - Clinical trial

KW - Cognitive remediation

KW - Computerized cognitive training

KW - Depression

KW - Functional remediation

UR - http://www.mendeley.com/research/testing-efficacy-integral-cognitive-remediation-increm-major-depressive-disorder-study-protocol-rand

UR - https://www.scopus.com/pages/publications/85065667533

U2 - 10.1186/s12888-019-2117-4

DO - 10.1186/s12888-019-2117-4

M3 - Article

C2 - 31060604

SN - 1471-244X

VL - 19

JO - BMC Psychiatry

JF - BMC Psychiatry

M1 - 135

ER -

Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: Study protocol for a randomized clinical trial

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