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ID
Source
Brief title
Health condition
Depression
Sponsors and support
Intervention
Outcome measures
Primary outcome
Depressive symptoms (directly and 3, 6, 12 months after training)
Secondary outcome
Rumination (state en trait)
Working memory
Cognitive functioning
Cognitive coping stra tegy
Emotional executive funct ioning and inhibition
Cost-effectiveness
Budget-impact ana lysis
Implementation study
Background summary
Major Depressive Disorder (MDD) is a severe, highly prevalent (20% lifetime prevalence in the Netherlands) and often chronically recurrent psychiatric illness. Approximately one in every 50 community-dwelling
adults aged 65 years or older meet the criteria for MDD in the past year (Kessler et al., 2010). They suffer from perturbations in their affect, weight, sleep patterns, ability to concentrate, and/or suffer from feelings of
worthlessness. Unfortunately, geriatric depressed patients seem less responsive to standard treatme nt protocols and demonstrate a higher rate of chronicity than younger patients (Netherlands Study of Depression in Old age, NESDO).
The high recurrence rate of depression suggests that current treatments a re not able to modify vulnerability mechanisms that trigger relapse. A major risk factor for depression is impaired cognitive control (De Raedt & Koster, 2010). Therefore, researchers started to use cognitive control training (CCT) as an add-on intervention for depression. Results of this research line are encouraging, as cognitive control training seems to reduce depressive symptoms by targeting a crucial risk factor for the relapse of depression. Importantly, the training of cognitive control has proven to be especially effective in elderly depressed patients (EDP), specifically long-term (Brunoni et al., 2014).
In the proposed project, we aim to implement a promising cognitive control training that is based on (1) an individual computerized assessment, and (2) that trains specific cognitive impairments which are known to be critical for the depressive symptomatology and the recurrence of the disorder. The training will be administered in EDP who continue receiving treatment as usual.
Study objective
It is expected that the add-on intervention will lead to a greater decrease in depressive symptoms than the control condition. Furthermore we expect that the add-on intervention will be cost-effective.
Study design
Preparation 12/2018-4/2019: Medical Ethical approval, completing study materials (quantitative/qualitative, implementation at the clinics, getting the iPads ready, piloting the platform, data plan/data storage,
Inclusion 5/2019 - 1/2022, (incl. follow-up): Quantitative and qualitative data collection, data management
Data preparation and analyses 3/2022-9/2022: Effectiveness and cost-effectiveness
Dissemination and publishing 8/2022-11/2022: Preparing feedback report for participants and scientific papers, contacting stakeholders
Intervention
The CCT will be based on the adaptive PASAT during which participants are presented with a continuous stream of auditory digits and are instructed to respond to the numbers by pressing on a number on a tablet.
Inclusion criteria
Eligible patients are 60 years or older with major depressive disorder who attend out-care geriatric psychiatry.
Exclusion criteria
Psychotic symptoms or diagnoses, (hypo)mania, bipolar disorder, primary diagnosis of substance abuse or dependence or alcohol abuse or dependence, as well as severe neurocognitive disorders, severe visual, auditory disabilities that interfere with the computer task, acute suicidal risk
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL7639 |
Other | METC Arnhem-Nijmegen : 2018-4866 |