Integral Remediation for Major Depression ("Rehabilitación Integral Para la Depresión Mayor", RIDEM) (RIDEM)
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|ClinicalTrials.gov Identifier: NCT03624621|
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : August 24, 2018
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|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|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|
|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|
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)
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: friv.com
No Intervention: Treatment as usual
Usual intervention supervised by their psychiatrist
- 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
- Change from baseline perceived cognitive deficits (PDQ) [ Time Frame: 3 and 12 months after intervention ]Self-appraisal of cognitive functioning
- Change from baseline cognitive functioning [ Time Frame: baseline and 12 months after intervention ]Objective neuropsychological battery to assess cognitive domains
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 ClinicalTrials.gov identifier (NCT number): NCT03624621
|Contact: Maria J Portella, Dr.||+34 firstname.lastname@example.org|
|Contact: Muriel Vicent-Gil, BSc||+34 email@example.com|
|Hospital de la Santa Creu i Sant Pau||Recruiting|
|Barcelona, Catalonia, Spain, 08025|
|Contact: Maria J Portella, Dr +34 935537836 firstname.lastname@example.org|
|Contact: Muriel Vicent-Gil, BSc +34 935537837 email@example.com|
|Sub-Investigator: Javier de Diego-Adeliño, Dr|
|Principal Investigator:||Maria J Portella, Dr||IBB-Sant Pau|