Abstract
BackgroundGiven 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.MethodsA 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.DiscussionTo 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 registrationClinical Trials NCT03624621. Date registered 10th of August 2018 and last updated 24th August 2018.
Highlights
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
Vicent-Gil et al BMC Psychiatry (2019) 19:135 have been conducted in MDD patients [12,13,14,15]
It is estimated that 50% of depressed patients [16, 17] present enduring cognitive deficits, which would significantly interfere in workplace and in psychosocial functioning, while another large percentage of patients do not suffer from cognitive dysfunction
Summary
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 cognitive performance and the psychosocial functioning and the quality of life. Cognitive dysfunction is considered a new treatment target to improve psychosocial functioning and enhance the quality of life in patients with Major Depressive Disorder (MDD) [1, 2]. Regarding non-pharmacological treatments, Cognitive Remediation (CR) is a psychotherapeutic approach that has shown improvement in cognition in other neuropsychiatric disorders [10, 11] only few studies. It is estimated that 50% of depressed patients [16, 17] present enduring cognitive deficits, which would significantly interfere in workplace and in psychosocial functioning, while another large percentage of patients do not suffer from cognitive dysfunction
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