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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03624621
Other study ID # IIBSP-rid-2017-107
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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