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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03624621
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : August 24, 2018
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Maria J Portella, Hospital de Sant Pau

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Cognitive Symptom Behavioral: Functional Remediation Device: Computerized Cognitive Training (CCT) Behavioral: Psychoeducation Device: Online games Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized single-blind and controlled clinical trial
Masking: Single (Outcomes Assessor)
Masking Description: Codification of participants, assessor will never know what treatment arm participant was allocated
Primary Purpose: Treatment
Official Title: RIDEM Integral Remediation for Major Depression. Efficacy Study of a Functional Remediation Program and Cognitive Training
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Functional Remediation + CCT
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
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.
Other Name: Cognitive Remediation

Device: Computerized Cognitive Training (CCT)
12 add-on sessions (20-minute long) after each group session to train cognitive domains.
Other Name: CogniFit (registered brand)

Placebo Comparator: Psychoeducation + Online Games
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
12 sessions of psychoeducation on depression, providing information about the disease, causes, consequences and other useful data for the management of depression.
Other Name: Group sessions

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

No Intervention: Treatment as usual
Usual intervention supervised by their psychiatrist

Primary Outcome Measures :
  1. Change from baseline Functioning Assessment Short Test (FAST) score at 6 and 15 months [ Time Frame: 3 and 12 months after intervention ]
    Assessment of daily functioning of depressed patients, including economics, cognition, social relationships, leisure and personal care

Secondary Outcome Measures :
  1. Change from baseline perceived cognitive deficits (PDQ) [ Time Frame: 3 and 12 months after intervention ]
    Self-appraisal of cognitive functioning

Other Outcome Measures:
  1. Change from baseline cognitive functioning [ Time Frame: baseline and 12 months after intervention ]
    Objective neuropsychological battery to assess cognitive domains

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03624621

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Contact: Maria J Portella, Dr. +34 935537836
Contact: Muriel Vicent-Gil, BSc +34 935537837

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Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Catalonia, Spain, 08025
Contact: Maria J Portella, Dr    +34 935537836   
Contact: Muriel Vicent-Gil, BSc    +34 935537837   
Sub-Investigator: Javier de Diego-Adeliño, Dr         
Sponsors and Collaborators
Hospital de Sant Pau
Instituto de Salud Carlos III
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Principal Investigator: Maria J Portella, Dr IBB-Sant Pau
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Maria J Portella, Head of the Research Group in Psychiatric Disorders, Hospital de Sant Pau Identifier: NCT03624621    
Other Study ID Numbers: IIBSP-rid-2017-107
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Coded database for meta-analysis of cognitive symptoms in MDD (via international consortiums)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria J Portella, Hospital de Sant Pau:
Major Depressive Disorder
Cognitive Remediation
Full Recovery
Functional Remediation
Additional relevant MeSH terms:
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Neurobehavioral Manifestations
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases