NCT06590025 Study the Efficacy and Safety of the INtegral Cognitive REMediation Program (INCREM) for Depression
| NCT ID | NCT06590025 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 296 participants |
| Start Date | 2023-09-13 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 296 participants in total. It began in 2023-09-13 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 person suffering from it. Symptoms range from mood swings, extreme sadness, apathy, inability to feel pleasure, to sleep problems, eating disorders, physical problems, and more. Other very common but little-known symptoms are those that affect memory, concentration, and the ability to organize and solve problems. Recent scientific findings have shown that these symptoms, called cognitive symptoms, are the most interfering with day-to-day life, even when other mental symptoms begin to improve or have resolved. Cognitive symptoms are associated with work difficulties, especially in terms of productivity or a decrease in social relationships to the point of isolation, thus interfering with the full recovery from depression. Studies have estimated that the economic and social costs not related to the health costs of depression can be more than 90 million euros per year. The fact that cognitive symptoms are not explored during clinical interviews means that they are not treated adequately, and professionals usually wait for cognitive difficulties to be resolved with the available antidepressant treatments. But more than 30% of people with depression are unable to return to work, and up to 45% of patients are on sick leave a year later, although mood symptoms have often been ameliorated. This opens a new line of research worldwide that aims to find effective treatments for the cognitive symptoms of depression. Some drugs have been developed and cognitive training programs designed for patients with dementia or neurological conditions have been tested, but the results are not convincing enough because there is no transfer of cognitive improvements into people\'s lives. The research team of this proposal designed a comprehensive rehabilitation program for cognition and daily functioning for depression, taking into account the specific cognitive symptoms, and the real difficulties that patients face. Thus was born INCREM (INtegral Cognitive REMediation for Depression), which includes cognitive training and therapy sessions focused on the rehabilitation of daily functioning. The first results in very selected samples have shown an objective improvement in day-to-day functioning, not only after the intervention but up to 6 months later. The aim of this proposal is to demonstrate the effectiveness and benefits of INCREM for depression in a larger and more diverse sample of patients, as well as finding out the effects of INCREM on the brain. The ultimate goal is to implement this type of therapy in mental health care centers in order to treat patients\' cognitive symptoms and get them back to their personal, work and social lives.
Eligibility Criteria
Inclusion Criteria: * 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 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; * 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.
Contact & Investigator
Maria J Portella, Dr
PRINCIPAL INVESTIGATOR
Institut de Recerca Sant Pau
Frequently Asked Questions
Who can join the NCT06590025 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06590025 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 296 participants.
Is NCT06590025 currently recruiting?
Yes, NCT06590025 is actively recruiting participants. Contact the research team at aespinosag@santpau.cat for enrollment information.
Where is the NCT06590025 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06590025 clinical trial?
NCT06590025 is sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. The principal investigator is Maria J Portella, Dr at Institut de Recerca Sant Pau. The trial plans to enroll 296 participants.
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