Integral Cognitive Remediation for Depression (INCREM)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status

Completed

Conditions

Major Depressive Disorder (MDD)

Treatments

Behavioral: INCREM

Behavioral: Psychoeducation

Study type

Interventional

Funder types

Other

Identifiers

NCT07014683

IIBSP-RID-2021-07

Details and patient eligibility

About

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.

Enrollment

101 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.