Integral Remediation for Major Depression ("Rehabilitación Integral Para la Depresión Mayor", RIDEM)
Condition: Major Depressive Disorder; Cognitive Symptom
MeSH terms: Neurobehavioral Manifestations; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      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: 
      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).
    

Intervention name(s): Functional Remediation; Computerized Cognitive Training (CCT); Psychoeducation; Online games
Intervention type(s): Behavioral; Device; Behavioral; Device
Intervention description(s): 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.; 12 add-on sessions (20-minute long) after each group session to train cognitive domains.; 12 sessions of psychoeducation on depression, providing information about the disease, causes, consequences and other useful data for the management of depression.; Participants play non-directed online games during 20 minutes after each psychoeducation grup session to make the two active intervention more similar.
Other intervention name(s): Cognitive Remediation; CogniFit (registered brand); Group sessions; friv.com
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized single-blind and controlled clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Cognitive Remediation; Functioning; Full Recovery; Functional Remediation