Integral Remediation for Major Depression ("Rehabilitación Integral Para la Depresión Mayor", RIDEM) (RIDEM)
August 29, 2022 updated by: Maria J Portella, Hospital de Sant Pau
RIDEM Integral Remediation for Major Depression. Efficacy Study of a Functional Remediation Program and Cognitive Training
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.
Study Overview
Status
Completed
Conditions
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:
- - 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
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Catalonia
-
Barcelona, Catalonia, Spain, 08025
- Hospital de la Santa Creu i Sant Pau
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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)
|
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 Names:
12 add-on sessions (20-minute long) after each group session to train cognitive domains.
Other Names:
|
|
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 Names:
Participants play non-directed online games during 20 minutes after each psychoeducation grup session to make the two active intervention more similar.
Other Names:
|
|
No Intervention: Treatment as usual
Usual intervention supervised by their psychiatrist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3 and 12 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline perceived cognitive deficits (PDQ)
Time Frame: 3 and 12 months after intervention
|
Self-appraisal of cognitive functioning
|
3 and 12 months after intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline cognitive functioning
Time Frame: baseline and 12 months after intervention
|
Objective neuropsychological battery to assess cognitive domains
|
baseline and 12 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Maria J Portella, Dr, IBB-Sant Pau
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2018
Primary Completion (Actual)
October 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
August 1, 2018
First Submitted That Met QC Criteria
August 7, 2018
First Posted (Actual)
August 10, 2018
Study Record Updates
Last Update Posted (Actual)
August 30, 2022
Last Update Submitted That Met QC Criteria
August 29, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIBSP-rid-2017-107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Coded database for meta-analysis of cognitive symptoms in MDD (via international consortiums)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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