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

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.

Conditions

• Depression
• Depressive Disorder

Interventions

BEHAVIORAL

INtegral Cognitive REMediation program

This comprehensive functional remediation program includes a traditional CR component with a specialized therapist (based on the compensation model) and a CCT component adapted to the difficulties of each patient. The inclusion of both aspects allows adapting the intervention to the present difficulties by forming new strategies with compensation techniques and promoting translation to everyday life. Therefore, the intervention aims at improving cognitive functioning (beyond a mere training) so as to facilitate the improvement and maintenance of psychosocial functioning for patients with MDD.

BEHAVIORAL

Psychoeducation for depression

Psycho-education refers to educating individuals about depression and the various treatment options. It is a form of therapy that aims to provide individuals with the knowledge and skills to manage their mental health symptoms effectively.

Sponsors & Collaborators

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

  lead OTHER

Principal Investigators

• Maria J Portella, Dr · Institut de Recerca Sant Pau

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-13

Primary Completion

2025-07-31

Completion

2025-12-31

Countries

• Spain

Study Locations