Clinical trial NCT03624621: Integral Remediation for Major Depression ("Rehabilitación Integral Para la Depresión Mayor", RIDEM)
Official title: RIDEM Integral Remediation for Major Depression. Efficacy Study of a Functional Remediation Program and Cognitive Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Cognitive Symptom
Keywords: Major Depressive Disorder
Cognitive Remediation
Functioning
Full Recovery
Functional Remediation
Lead sponsor: Hospital de Sant Pau
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2018-08-10
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized single-blind and controlled clinical trial
Primary purpose: TREATMENT

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:

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).

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.

Primary outcomes:
measure: Change from baseline Functioning Assessment Short Test (FAST) score at 6 and 15 months
timeFrame: 3 and 12 months after intervention
Secondary outcomes:
measure: Change from baseline perceived cognitive deficits (PDQ)
timeFrame: 3 and 12 months after intervention
Other outcomes:
measure: Change from baseline cognitive functioning
timeFrame: baseline and 12 months after intervention
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalonia
Study officials:
affiliation: IBB-Sant Pau
name: Maria J Portella, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.