Study the Efficacy and Safety of the INtegral Cognitive REMediation Program (INCREM) for Depression

Recruiting now · Phase 3

Conditions studied: Depression, Depressive Disorder

In brief

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.

Key facts

Study ID

NCT06590025

Run by

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

People needed

296

Starts

2023-09-13

Expected to finish

2025-12-01

Last updated by the study team

2024-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau — Barcelona, Catalonia, Spain (enrolling)

Full record on ClinicalTrials.gov

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