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

Sponsor

Hospital de Sant Pau (Other)

Overall Status

Unknown status

CT.gov ID

NCT03624621

Collaborator

Instituto de Salud Carlos III (Other)

Enrollment

Location

Arms

33.6

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Cognitive Symptom	Behavioral: Functional Remediation Device: Computerized Cognitive Training (CCT) Behavioral: Psychoeducation Device: Online games	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized single-blind and controlled clinical trialRandomized single-blind and controlled clinical trial

Masking:

Single (Outcomes Assessor)

Masking Description:

Codification of participants, assessor will never know what treatment arm participant was allocated

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 15, 2018

Anticipated Primary Completion Date :

Oct 31, 2019

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
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 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 Device: Computerized Cognitive Training (CCT) 12 add-on sessions (20-minute long) after each group session to train cognitive domains. Other Names: CogniFit (registered brand)
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 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 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. Other Names: friv.com
No Intervention: Treatment as usual Usual intervention supervised by their psychiatrist

Arm

Intervention/Treatment

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

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

Device: Computerized Cognitive Training (CCT)

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

Other Names:

CogniFit (registered brand)

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

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

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.

Other Names:

friv.com

No Intervention: Treatment as usual

Usual intervention supervised by their psychiatrist

Outcome Measures

Primary Outcome Measures

Change from baseline Functioning Assessment Short Test (FAST) score at 6 and 15 months [3 and 12 months after intervention]
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) [3 and 12 months after intervention]
Self-appraisal of cognitive functioning

Other Outcome Measures

Change from baseline cognitive functioning [baseline and 12 months after intervention]
Objective neuropsychological battery to assess cognitive domains

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.