Clinical trial NCT07014683: Integral Cognitive Remediation for Depression
Official title: INtegral Cognitive REMediation for Depression (INCREM). Multicentric Randomized Clinical Trial to Investigate Feasibility and Efficacy (Phase II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Keywords: cognitive symptoms
cognitive remediation
rehabilitation
functional recovery
major depressive disorder
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if INCREM intervention can improve psychosocial functioning in patients with remitted major depressive disorder. The main question it aims to answer are:

Does INCREM improve psychosocial functioning compared to psychoeducation? Does the benefits of INCREM remain after six months of the intervention compared to psychoeducation?

Researchers will compare two arms: INCREM; psychoeducation to see if psychosocial functioning improves.

Participants will be allocated to:

* INCREM
* Psychoeducation
* TAU.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-60 y.o. and beyond with a remitted or active episode of major depression (DSM-5 criteria; maximum score of 18-20 on the HDRS-17) showing cognitive symptoms (scores below 80 on the SCIP) with functional difficulties (scores above 12 on the FAST).

Exclusion Criteria:

* IQ below 85;
* any unstable or inadequately-treated medical condition that may affect neuropsychological performance;
* being under drug treatment in the last 4 weeks with glucocorticoids, probiotics, non-steroidal anti-inflammatory drugs, bile acid sequestrants, immunosuppressive drugs, anti-histamines, mast cell stabilizers, and antioxidant supplements;
* use of systemic antibiotics the last 2 months;
* presence of any comorbid psychiatric condition, other than personality disorders or nicotine use disorders, in the last three months;
* accomplish criteria for severe treatment resistant depression;
* patients who had received electroconvulsive therapy in the previous year;
* patients receiving any other structured psychological intervention in the 3 months prior to the study;
* not having the necessary electronic means (computer or tablet) or internet connection to be able to participate.

Primary outcomes:
measure: Functioning Assessment Short Test (FAST)
timeFrame: From enrollment to the end of treatment (12 weeks) and to the end of follow-up (6 months)
Secondary outcomes:
measure: Hamilton Depression Rating Scale-17 items (HDRS_17)
timeFrame: From enrollment to the end of treatment (12 weeks) and to the end of follow-up (6 months)
measure: Screening for Cognitive Impairment in Psychiatry (SCIP)
timeFrame: From enrollment to the end of the intervention (12 weeks) and to the end of the follow-up (6 months)
measure: Perceived Deficits Questionnaire for Depression (PDQ-R)
timeFrame: From enrollment to the end of the intervention (12 weeks) and to the end of follow-up (6 months)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut de Recerca Sant Pau- Mental Health Group
state: Catalonia
Study officials:
affiliation: Fundació Institut de Recerca Hospital de la Santa Creu i Sant Pau
name: Maria J Portella, Dr
role: PRINCIPAL_INVESTIGATOR
References: