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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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:
Sample size will be a total of 90 patients with MDD in remission (full or partial).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional Remediation + CCT | Experimental | 12 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 Comparator | 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) |
|
| Treatment as usual | No Intervention | Usual intervention supervised by their psychiatrist |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional Remediation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline perceived cognitive deficits (PDQ) | Self-appraisal of cognitive functioning | 3 and 12 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline cognitive functioning | Objective neuropsychological battery to assess cognitive domains | baseline and 12 months after intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria J Portella, Dr | IBB-Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | Catalonia | 08025 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31060604 | Derived | 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. |
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Coded database for meta-analysis of cognitive symptoms in MDD (via international consortiums)
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D019954 | Neurobehavioral Manifestations |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000072466 | Cognitive Remediation |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Randomized single-blind and controlled clinical trial
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Codification of participants, assessor will never know what treatment arm participant was allocated
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| Computerized Cognitive Training (CCT) | Device | 12 add-on sessions (20-minute long) after each group session to train cognitive domains. |
|
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| Psychoeducation | Behavioral | 12 sessions of psychoeducation on depression, providing information about the disease, causes, consequences and other useful data for the management of depression. |
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| Online games | Device | Participants play non-directed online games during 20 minutes after each psychoeducation grup session to make the two active intervention more similar. |
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| D009422 |
| Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |