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

• ClinicalTrials.gov Identifier: NCT03624621
• Recruitment Status: Unknown
• First Posted: August 10, 2018
• Last Update Posted: August 24, 2018
• Sponsor: Hospital de Sant Pau
• Collaborator: Instituto de Salud Carlos III
• Information provided by (Responsible Party): Maria J Portella, Hospital de Sant Pau

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	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized 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: March 15, 2018
• Estimated Primary Completion Date: October 31, 2019
• Estimated Study Completion Date: December 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 Name: Cognitive Remediation; Device: Computerized Cognitive Training (CCT); 12 add-on sessions (20-minute long) after each group session to train cognitive domains.; Other Name: 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 Name: 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 Name: friv.com
No Intervention: Treatment as usual; Usual intervention supervised by their psychiatrist

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Change from baseline perceived cognitive deficits (PDQ) [ Time Frame: 3 and 12 months after intervention ]
   Self-appraisal of cognitive functioning

Other Outcome Measures:

1. Change from baseline cognitive functioning [ Time Frame: baseline and 12 months after intervention ]
   Objective neuropsychological battery to assess cognitive domains

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Maria J Portella, Dr.; +34 935537836; mportella@santpau.cat

Contact: Muriel Vicent-Gil, BSc; +34 935537837; mvicent@santpau.cat

Locations

Spain

Hospital de la Santa Creu i Sant Pau; Recruiting

Barcelona, Catalonia, Spain, 08025

Contact: Maria J Portella, Dr +34 935537836 mportella@santpau.cat

Contact: Muriel Vicent-Gil, BSc +34 935537837 mvicent@santpau.cat

Sub-Investigator: Javier de Diego-Adeliño, Dr

Sponsors and Collaborators

Hospital de Sant Pau

Instituto de Salud Carlos III

Investigators

• Principal Investigator: Maria J Portella, Dr; IBB-Sant Pau

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vicent-Gil M, Raventós B, Marín-Martínez ED, González-Simarro S, Martínez-Arán A, Bonnin CDM, Trujols J, Pérez-Blanco J, de Diego-Adeliño 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.

• Responsible Party: Maria J Portella, Head of the Research Group in Psychiatric Disorders, Hospital de Sant Pau
• ClinicalTrials.gov Identifier: NCT03624621
• Other Study ID Numbers: IIBSP-rid-2017-107
• First Posted: August 10, 2018
• Last Update Posted: August 24, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Coded database for meta-analysis of cognitive symptoms in MDD (via international consortiums)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maria J Portella, Hospital de Sant Pau:

Major Depressive Disorder; Cognitive Remediation; Functioning; Full Recovery; Functional Remediation

Additional relevant MeSH terms:

Neurobehavioral Manifestations; Depression; Depressive Disorder; Depressive Disorder, Major; Behavioral Symptoms; Mood Disorders; Mental Disorders; Neurologic Manifestations; Nervous System Diseases