Cognitive Symptom, Major Depressive Disorder
Conditions
Keywords
Major Depressive Disorder, Cognitive Remediation, Functioning, Full Recovery, Functional Remediation
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).
Interventions
BEHAVIORALPsychoeducation
12 sessions of psychoeducation on depression, providing information about the disease, causes, consequences and other useful data for the management of depression.
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.
12 add-on sessions (20-minute long) after each group session to train cognitive domains.
DEVICEOnline games
Participants play non-directed online games during 20 minutes after each psychoeducation grup session to make the two active intervention more similar.
Sponsors
Instituto de Salud Carlos III
Hospital de Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Codification of participants, assessor will never know what treatment arm participant was allocated
Intervention model description
Randomized single-blind and controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline perceived cognitive deficits (PDQ) | 3 and 12 months after intervention | Self-appraisal of cognitive functioning |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline cognitive functioning | baseline and 12 months after intervention | Objective neuropsychological battery to assess cognitive domains |
Countries
Spain
Outcome results
None listed