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
U2 - https://doi.org/10.1186/s12888-019-2117-4
DO - https://doi.org/10.1186/s12888-019-2117-4
M3 - Article
C2 - 31060604
SN - 1471-244X
VL - 19
JO - BMC Psychiatry
JF - BMC Psychiatry
M1 - 135
ER -