Integral Remediation for Major Depression ("Rehabilitación Integral Para la Depresión Mayor", RIDEM)

Hospital de Sant Pau52 enrolled

Overview

Available pharmacological and psychotherapeutic treatments are not effective for the treatment of cognitive symptoms of major depressive disorder (MDD). More recent studies have described that functional disability and the indirect costs of MDD (e.g., sick leaves at work, decreased productivity, ...) are related to persistent cognitive deficits. Some programs of cognitive rehabilitation and cognitive training (developed for other pathologies) have been tested, but the results are inconsistent. There is an imperative need to develop a specific comprehensive rehabilitation program for MDD that includes the benefits of traditional functional remediation (FR) and computerized cognitive training (CCT) programs adjusted for each patient's cognitive deficit.

Objectives: To develop the Integral Rehabilitation Program (FR + CCT) and to demonstrate its efficacy in cognitive and functional remission (i.e. global remission) of patients with MDD in clinical remission. Methodology: The project will consist of two stages: 1. \- Development and adaptation of the Integral Rehabilitation program for MD, based on the program developed for bipolar disorder, and including a computerized cognitive training adjusted to the neuropsychological profile of each patient; 2. \- A clinical trial, randomized, blind evaluator, with three intervention arms: INTEGRAL REHABILITATION (FR + CCT); PSYCHOEDUCATION + online games; and TREATMENT AS USUAL. Sample size will be a total of 90 patients with MDD in remission (full or partial).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Interventions

Functional RemediationBEHAVIORAL

Functional remediation includes directed group sessions tapping into the main cognitive domains affected in depression (executive functioning, attention and memory) as well as their implication in daily living.

Computerized Cognitive Training (CCT)DEVICE

12 add-on sessions (20-minute long) after each group session to train cognitive domains.

PsychoeducationBEHAVIORAL

12 sessions of psychoeducation on depression, providing information about the disease, causes, consequences and other useful data for the management of depression.

Online gamesDEVICE

Participants play non-directed online games during 20 minutes after each psychoeducation grup session to make the two active intervention more similar.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 and 60 years (males and females) * diagnosis of Major Depression (criteria Diagnostic and Statistical Manual 5th edition, DSM-5) in Remission or Partial Remission phase (scores below 14 in the Hamilton Depression Rating Scale-17 items (HDRS-17)) * Cognitive Symptoms (-1.5SD (standar deviation) in objective as subjective tests), * PDQ \> 20 * FAST\> 17 Exclusion Criteria: * Intelligence Quotient (IQ) \< 85 * Any medical condition that may affect cognition * Presence of any comorbid psychiatric condition (including abuse or dependence on substances in the last three months) * Electroconvulsive therapy (ECT) in the previous year * Other psychological intervention in the 6 months prior to the study.

Outcomes

Primary Outcomes

Change from baseline Functioning Assessment Short Test (FAST) score at 6 and 15 months

Assessment of daily functioning of depressed patients, including economics, cognition, social relationships, leisure and personal care

Time frame: 3 and 12 months after intervention

Secondary Outcomes

Change from baseline perceived cognitive deficits (PDQ)

Self-appraisal of cognitive functioning