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CompletedNCT03624621RIDEMUpdated Aug 30, 2022

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

An interventional study of Functional Remediation and Computerized Cognitive Training (CCT) in Major Depressive Disorder and Cognitive Symptom, sponsored by Hospital de Sant Pau. Completed at 1 site in Spain. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-08-30.

Sponsored by Hospital de Sant Pau · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2018, registered Aug 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Major Depressive Disorder
  • Cognitive Symptom

Keywords

  • Major Depressive Disorder
  • Cognitive Remediation
  • Functioning
  • Full Recovery
  • Functional Remediation
03

In context

Depressive Disorder, Major

2,806 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.

This study's enrollment of 52 is below the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Hospital de Sant Pau is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Functional Remediation + CCT

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

    Behavioral: Functional Remediation · Device: Computerized Cognitive Training (CCT)

  • Placebo comparator
    Psychoeducation + 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)

    Behavioral: Psychoeducation · Device: Online games

  • No intervention
    Treatment as usual

    Usual intervention supervised by their psychiatrist

Interventions

  • BehavioralFunctional 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.

    Also known as: Cognitive Remediation

  • DeviceComputerized Cognitive Training (CCT)

    12 add-on sessions (20-minute long) after each group session to train cognitive domains.

    Also known as: CogniFit (registered brand)

  • BehavioralPsychoeducation

    12 sessions of psychoeducation on depression, providing information about the disease, causes, consequences and other useful data for the management of depression.

    Also known as: Group sessions

  • DeviceOnline games

    Participants play non-directed online games during 20 minutes after each psychoeducation grup session to make the two active intervention more similar.

    Also known as: friv.com

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 and 12 months after intervention

Secondary outcomes

  1. Change from baseline perceived cognitive deficits (PDQ)

    Self-appraisal of cognitive functioning

    Time frame: 3 and 12 months after intervention

Other outcomes

  1. Change from baseline cognitive functioning

    Objective neuropsychological battery to assess cognitive domains

    Time frame: baseline and 12 months after intervention

07

Study locations

1 site
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, Catalonia 08025, Spain
08

References and documents

Publications

  • 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. PubMed 31060604 ↗

Individual participant data

Plan to share: Undecided — Coded database for meta-analysis of cognitive symptoms in MDD (via international consortiums)

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Oct 2020, 31 months.

Of 612 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 31 months is close to that.

Counting every sponsor, half of 652 studies reached it within 30 months; a quarter within 16 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2018
First posted
Aug 10, 2018
StartActual
Mar 15, 2018
Primary completionActual
Oct 31, 2020
CompletionActual
Dec 31, 2020
Last update
Aug 30, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03624621
Lead sponsor
Hospital de Sant Pau
Collaborators
Instituto de Salud Carlos III
Responsible party
Maria J Portella (Head of the Research Group in Psychiatric Disorders, Hospital de Sant Pau) — Principal investigator
First posted
Aug 10, 2018
Start date
Mar 15, 2018
Primary completion
Oct 31, 2020
Completion
Dec 31, 2020
Last update
Aug 30, 2022

Study contacts

Maria J Portella, Dr
principal investigator · IBB-Sant Pau

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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