Integral Cognitive Remediation for Depression

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau101 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

101

Conditions

Major Depressive Disorder (MDD)

Interventions

INCREMBEHAVIORAL

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

PsychoeducationBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institut de Recerca Sant Pau- Mental Health Group

Barcelona, Catalonia, Spain

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Hamilton Depression Rating Scale-17 items (HDRS_17)

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.

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

Screening for Cognitive Impairment in Psychiatry (SCIP)

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

Time frame: 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)

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.

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

Data from ClinicalTrials.gov

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