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

Santa Creu and Sant Pau Hospital

Status: Completed

Conditions: Major Depressive Disorder; Cognitive Symptom

Treatments: Device: Computerized Cognitive Training (CCT); Device: Online games; Behavioral: Functional Remediation; Behavioral: Psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT03624621

IIBSP-rid-2017-107

Details and patient eligibility

About

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.

Full 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).

Enrollment: 52 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 3 patient groups, including a placebo group

Functional Remediation + CCT

Experimental group

Description:

12 sessions (1 per week) of group functional remediation program (90 min/session) plus 20 min of tailored computerized cognitive training (CCT)

Treatment:

Behavioral: Functional Remediation

Device: Computerized Cognitive Training (CCT)

Psychoeducation + Online Games

Placebo Comparator group

Description:

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:

Behavioral: Psychoeducation

Device: Online games

Treatment as usual

No Intervention group

Description:

Usual intervention supervised by their psychiatrist