Integral Remediation for Major Depression ("Rehabilitación Integral Para la Depresión Mayor", RIDEM)
RIDEM
RIDEM Integral Remediation for Major Depression. Efficacy Study of a Functional Remediation Program and Cognitive Training
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable major-depressive-disorder
Started Mar 2018
Typical duration for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2018
CompletedFirst Submitted
Initial submission to the registry
August 1, 2018
CompletedFirst Posted
Study publicly available on registry
August 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedAugust 30, 2022
August 1, 2022
2.6 years
August 1, 2018
August 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change from baseline perceived cognitive deficits (PDQ)
3 and 12 months after intervention
Other Outcomes (1)
Change from baseline cognitive functioning
baseline and 12 months after intervention
Study Arms (3)
Functional Remediation + CCT
EXPERIMENTAL12 sessions (1 per week) of group functional remediation program (90 min/session) plus 20 min of tailored computerized cognitive training (CCT)
Psychoeducation + Online Games
PLACEBO COMPARATOR12 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)
Treatment as usual
NO INTERVENTIONUsual intervention supervised by their psychiatrist
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital de Sant Paulead
- Instituto de Salud Carlos IIIcollaborator
Study Sites (1)
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08025, Spain
Related Publications (1)
Vicent-Gil M, Raventos B, Marin-Martinez ED, Gonzalez-Simarro S, Martinez-Aran A, Bonnin CDM, Trujols J, Perez-Blanco J, de Diego-Adelino J, Puigdemont D, Serra-Blasco M, Cardoner N, Portella MJ. Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: study protocol for a randomized clinical trial. BMC Psychiatry. 2019 May 6;19(1):135. doi: 10.1186/s12888-019-2117-4.
PMID: 31060604DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria J Portella, Dr
IBB-Sant Pau
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Codification of participants, assessor will never know what treatment arm participant was allocated
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Research Group in Psychiatric Disorders
Study Record Dates
First Submitted
August 1, 2018
First Posted
August 10, 2018
Study Start
March 15, 2018
Primary Completion
October 31, 2020
Study Completion
December 31, 2020
Last Updated
August 30, 2022
Record last verified: 2022-08