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Completed

NCT Number: NCT03624621

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

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.

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Key information

Conditions

Major Depressive Disorder Cognitive Symptom Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional remediation

Behavioral

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.

Other names: Cognitive Remediation

Computerized Cognitive Training (CCT)

Device

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

Other names: CogniFit (registered brand)

Psychoeducation

Behavioral

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

Other names: Group sessions

Online games

Device

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

Other names: friv.com

Primary outcomes

  1. Change from baseline Functioning Assessment Short Test (FAST) score at 6 and 15 months

    Time frame: 3 and 12 months after intervention

    Assessment of daily functioning of depressed patients, including economics, cognition, social relationships, leisure and personal care

Secondary outcomes

  1. Change from baseline perceived cognitive deficits (PDQ)

    Time frame: 3 and 12 months after intervention

    Self-appraisal of cognitive functioning

Other outcomes

  1. Change from baseline cognitive functioning

    Time frame: baseline and 12 months after intervention

    Objective neuropsychological battery to assess cognitive domains

Sponsors and collaborators

Lead sponsor

Hospital de Sant Pau

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: RIDEM

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 10, 2018
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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