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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: - 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; - 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).

Official Title
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RIDEM Integral Remediation for Major Depression. Efficacy Study of a Functional Remediation Program and Cognitive Training

Conditions
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Major Depressive Disorder, Cognitive Symptom

Intervention / Treatment
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* Behavioral: Functional Remediation
* Device: Computerized Cognitive Training (CCT)
* Behavioral: Psychoeducation
* Device: Online games


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized single-blind and controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional Remediation + CCT<br>12 sessions (1 per week) of group functional remediation program (90 min/session) plus 20 min of tailored computerized cognitive training (CCT) | Behavioral: Functional Remediation<br>* 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.<br>* Other names: Cognitive Remediation;Device: Computerized Cognitive Training (CCT)<br>* 12 add-on sessions (20-minute long) after each group session to train cognitive domains.<br>* Other names: CogniFit (registered brand);|
| Placebo Comparator: Psychoeducation + Online Games<br>12 sessions (1 per week) of psychoeducation for major depression (90 min/session) plus 20 min of playing freely with online games (pre-selected by investigators) | Behavioral: Psychoeducation<br>* 12 sessions of psychoeducation on depression, providing information about the disease, causes, consequences and other useful data for the management of depression.<br>* Other names: Group sessions;Device: Online games<br>* Participants play non-directed online games during 20 minutes after each psychoeducation grup session to make the two active intervention more similar.<br>* Other names: friv.com;|
| No Intervention: Treatment as usual<br>Usual intervention supervised by their psychiatrist | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 and 12 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline perceived cognitive deficits (PDQ) | Self-appraisal of cognitive functioning | 3 and 12 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder, Cognitive Remediation, Functioning, Full Recovery, Functional Remediation