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

Major Depressive Disorder Clinical Trial

— RIDEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03624621
• Other study ID #: IIBSP-rid-2017-107
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2022
• Source: Hospital de Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Symptom
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Neurobehavioral Manifestations

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalonia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Sant Pau	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline cognitive functioning	Objective neuropsychological battery to assess cognitive domains	baseline and 12 months after intervention
Primary	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
Secondary	Change from baseline perceived cognitive deficits (PDQ)	Self-appraisal of cognitive functioning	3 and 12 months after intervention