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Completed

NCT Number: NCT07014683

Integral Cognitive Remediation for Depression

The goal of this clinical trial is to learn if INCREM intervention can improve psychosocial functioning in patients with remitted major depressive disorder. The main question it aims to answer are:

Does INCREM improve psychosocial functioning compared to psychoeducation? Does the benefits of INCREM remain after six months of the intervention compared to psychoeducation?

Researchers will compare two arms: INCREM; psychoeducation to see if psychosocial functioning improves.

Participants will be allocated to:

* INCREM * Psychoeducation * TAU.

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Key information

Conditions

Major Depressive Disorder (MDD) Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Recerca Sant Pau- Mental Health Group

Barcelona, Catalonia, 08041, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18-60 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;
  • 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.

Treatment and study plan

INCREM

Behavioral

This is a specifically designed program to improve psychosocial functioning which targets cognitive symptoms.

Other names: cognitive remediation

Psychoeducation

Behavioral

This is a 12-session psychoeducation program designed as an active comparator for the current trial

Primary outcomes

  1. Functioning Assessment Short Test (FAST)

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

    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.

Secondary outcomes

  1. Hamilton Depression Rating Scale-17 items (HDRS_17)

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

    This scale is used to rate the severity of depression symptoms by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms.

  2. Screening for Cognitive Impairment in Psychiatry (SCIP)

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

    The SCIP is a brief and easy-to-administer tool, requiring the test sheet, a clock and a pencil only, specifically targeting psychiatric populations.

  3. Perceived Deficits Questionnaire for Depression (PDQ-R)

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

    The PDQ-D is a self-reported scale for monitoring cognitive dysfunction in patients with major depression. The PDQ-D is a modified version of the original PDQ, which was developed to assess cognitive symptoms in patients with multiple sclerosis.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

INtegral Cognitive REMediation for Depression (INCREM). Multicentric Randomized Clinical Trial to Investigate Feasibility and Efficacy (Phase II)

Acronym: INCREM

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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