NCT03624621

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

RIDEM Integral Remediation for Major Depression. Efficacy Study of a Functional Remediation Program and Cognitive Training

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Hospital de Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Major Depressive Disorder
• Cognitive Symptom

Interventions

Type	Name	Description
BEHAVIORAL	Functional Remediation	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.
DEVICE	Computerized Cognitive Training (CCT)	12 add-on sessions (20-minute long) after each group session to train cognitive domains.
BEHAVIORAL	Psychoeducation	12 sessions of psychoeducation on depression, providing information about the disease, causes, consequences and other useful data for the management of depression.
DEVICE	Online games	Participants play non-directed online games during 20 minutes after each psychoeducation grup session to make the two active intervention more similar.

Timeline

• Start date: 2018-03-15
• Primary completion: 2020-10-31
• Completion: 2020-12-31
• First posted: 2018-08-10
• Last updated: 2022-08-30

Locations

1 site across 1 country: Spain