Status:
RECRUITING
Study the Efficacy and Safety of the INtegral Cognitive REMediation Program (INCREM) for Depression
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Conditions:
Depression
Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Feeling sad about negative or stressful events has nothing to do with the diagnosis of depression, as this is a very prevalent mental illness among the population with devastating consequences for the...
Detailed Description
BACKGROUND: Major Depressive Disorder (MDD) is a mood disorder that places substantial clinical, social and economic burden onpatients, as well as on their families and wider society. The total cost o...
Eligibility Criteria
Inclusion
- Patients aged 18 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
- 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;
- for bipolar disorders, presence of a manic or mixed episodes 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.
Key Trial Info
Start Date :
September 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT06590025
Start Date
September 13 2023
End Date
December 1 2025
Last Update
October 1 2024
Active Locations (1)
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1
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain, 08041