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

Primary Purpose

Major Depressive Disorder, Cognitive Symptom

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Functional Remediation
Computerized Cognitive Training (CCT)
Psychoeducation
Online games
Sponsored by
Hospital de Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Cognitive Remediation, Functioning, Full Recovery, Functional Remediation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Functional Remediation + CCT

Psychoeducation + Online Games

Treatment as usual

Arm Description

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

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)

Usual intervention supervised by their psychiatrist

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline perceived cognitive deficits (PDQ)
Self-appraisal of cognitive functioning

Full Information

First Posted
August 1, 2018
Last Updated
August 29, 2022
Sponsor
Hospital de Sant Pau
Collaborators
Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT03624621
Brief Title
Integral Remediation for Major Depression ("Rehabilitación Integral Para la Depresión Mayor", RIDEM)
Acronym
RIDEM
Official Title
RIDEM Integral Remediation for Major Depression. Efficacy Study of a Functional Remediation Program and Cognitive Training
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Sant Pau
Collaborators
Instituto de Salud Carlos III

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: - 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; - 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Cognitive Symptom
Keywords
Major Depressive Disorder, Cognitive Remediation, Functioning, Full Recovery, Functional Remediation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized single-blind and controlled clinical trial
Masking
Outcomes Assessor
Masking Description
Codification of participants, assessor will never know what treatment arm participant was allocated
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional Remediation + CCT
Arm Type
Experimental
Arm Description
12 sessions (1 per week) of group functional remediation program (90 min/session) plus 20 min of tailored computerized cognitive training (CCT)
Arm Title
Psychoeducation + Online Games
Arm Type
Placebo Comparator
Arm 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)
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Usual intervention supervised by their psychiatrist
Intervention Type
Behavioral
Intervention Name(s)
Functional Remediation
Other Intervention Name(s)
Cognitive Remediation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Computerized Cognitive Training (CCT)
Other Intervention Name(s)
CogniFit (registered brand)
Intervention Description
12 add-on sessions (20-minute long) after each group session to train cognitive domains.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Other Intervention Name(s)
Group sessions
Intervention Description
12 sessions of psychoeducation on depression, providing information about the disease, causes, consequences and other useful data for the management of depression.
Intervention Type
Device
Intervention Name(s)
Online games
Other Intervention Name(s)
friv.com
Intervention Description
Participants play non-directed online games during 20 minutes after each psychoeducation grup session to make the two active intervention more similar.
Primary Outcome Measure Information:
Title
Change from baseline Functioning Assessment Short Test (FAST) score at 6 and 15 months
Description
Assessment of daily functioning of depressed patients, including economics, cognition, social relationships, leisure and personal care
Time Frame
3 and 12 months after intervention
Secondary Outcome Measure Information:
Title
Change from baseline perceived cognitive deficits (PDQ)
Description
Self-appraisal of cognitive functioning
Time Frame
3 and 12 months after intervention
Other Pre-specified Outcome Measures:
Title
Change from baseline cognitive functioning
Description
Objective neuropsychological battery to assess cognitive domains
Time Frame
baseline and 12 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria J Portella, Dr
Organizational Affiliation
IBB-Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Coded database for meta-analysis of cognitive symptoms in MDD (via international consortiums)
Citations:
PubMed Identifier
31060604
Citation
Vicent-Gil M, Raventos B, Marin-Martinez ED, Gonzalez-Simarro S, Martinez-Aran A, Bonnin CDM, Trujols J, Perez-Blanco J, de Diego-Adelino J, Puigdemont D, Serra-Blasco M, Cardoner N, Portella MJ. Testing the efficacy of INtegral Cognitive REMediation (INCREM) in major depressive disorder: study protocol for a randomized clinical trial. BMC Psychiatry. 2019 May 6;19(1):135. doi: 10.1186/s12888-019-2117-4.
Results Reference
derived

Learn more about this trial

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

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