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

Not Applicable

Completed

• Conditions: Cognitive Symptom; Major Depressive Disorder
• Interventions: Behavioral: Psychoeducation; Behavioral: Functional Remediation; Device: Computerized Cognitive Training (CCT); Device: Online games

• Registration Number: NCT03624621
• Lead Sponsor: Hospital de Sant Pau

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.

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:

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).

Study Timeline

• Study Start: 2018-03-15
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-10
• Primary Completion: 2020-10-31
• Study Completion: 2020-12-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Functional Remediation + CCT	Computerized Cognitive Training (CCT)	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	Psychoeducation	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)
Functional Remediation + CCT	Functional Remediation	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	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)

Primary Outcome Measures

Name	Time	Method
Change from baseline Functioning Assessment Short Test (FAST) score at 6 and 15 months	3 and 12 months after intervention	Assessment of daily functioning of depressed patients, including economics, cognition, social relationships, leisure and personal care

Secondary Outcome Measures

Name	Time	Method
Change from baseline perceived cognitive deficits (PDQ)	3 and 12 months after intervention	Self-appraisal of cognitive functioning

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Catalonia, Spain