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

NCT06590025 | Recruiting Phase 3

• 1 other identifier: IIBSP-RID-2022-125
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Depressive Disorder

Keywords

cognitive symptoms; cognitive remediation; rehabilitation; major depressive disorder; functional recovery

Outcome Measures

Primary Outcomes (1)

• Functioning Assessment Short Test (FAST)

  The FAST is a valid, widely used instrument to test psychosocial functioning. The main outcome measure will be the percentage of change in FAST scores between T0 and T1 and T2.

  From enrollment to the end of treatment (12 weeks) and to the end of follow-up (6 months)

Secondary Outcomes (5)

• Hamilton Depression Rating Scale-17 items (HDRS_17)

  From enrollment to the end of treatment (12 weeks) and to the end of follow-up (6 months)

• Remission from Depression Questionnaire (RDQ)

  From enrollment to the end of treatment (12 weeks) and to the end of the follow-up (6 months)

• Screening for Cognitive Impairment in Psychiatry (SCIP)

  From enrollment to the end of the intervention (12 weeks) and to the end of the follow-up (6 months)

• Perceived Deficits Questionnaire for Depression (PDQ-R)

  From enrollment to the end of the intervention (12 weeks) and to the end of follow-up (6 months)

• Functional and structural brain changes (magnetic resonance imaging)

  From enrollment to the end of follow-up at 6 months

Study Arms (2)

INtegral Cognitive REMediation program (INCREM)

EXPERIMENTAL

The functional remediation (FR) program of INCREM intervention consists of 12 sessions (1s/wk) in a group format, which is devoted to improve the daily functioning of patients and therefore, is based on very ecological tasks where compensation techniques are used. An computerized cognitive training will follow the INCREM arm in individual sessions. 12 individually tailored modules of 20 minutes will be created with a licensed software (NeuronUp).

Behavioral: INtegral Cognitive REMediation program

PSYCHOEDUCATION

ACTIVE COMPARATOR

The psychoeducation program for Major Depression was also developed in the context of the previous project (PI17/00056). It consists of 12 sessions (1s/wk) in a group format and includes all aspects related to MDD (Raventós, González \& Portella. Protocolo de Psicoeducación para depresión. Ed Permanyer: Barcelona. 2020). To ensure the similarity between the two intervention arms, in the comparator arm, participants will play a previously selected mental skill game on a digital device for 20 minutes.

Behavioral: Psychoeducation for depression

Interventions

INtegral Cognitive REMediation program BEHAVIORAL

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.

Also known as: INCREM

INtegral Cognitive REMediation program (INCREM)

Psychoeducation for depression BEHAVIORAL

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.

PSYCHOEDUCATION

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological sex assigned at birth (female, male, non-binary)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

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

Study Sites (1)

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

Barcelona, Catalonia, 08041, Spain

RECRUITING

MeSH Terms

Conditions

Depression; Depressive Disorder; Neurobehavioral Manifestations; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria J Portella, Dr

  Institut de Recerca Sant Pau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandra Espinosa, Dr.

CONTACT

+34935537791; aespinosag@santpau.cat

UICEC

CONTACT

+34679057557; uicec@santpau.cat

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is randomized clinical trial comparing two psychological interventions: INCREM and psychoeducation, and no drugs or biological/vaccine or combination products are tested, regardless it is a phase 3 study. Included patients can be prescribed pharmacological treatments, but these are not investigated here-in.

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 13, 2023
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-08

Locations

ES (1)