Cognitive Stimulation Program With Virtual Reality for Older Adults With Depressive Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive stimulation program.
- Who it may be relevant to
- Registry conditions: Depressive Symptoms. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Randomized Controlled Trial of a Cognitive Stimulation Program With Virtual Reality: Feasibility and Preliminary Efficacy in Older Adults With Depressive Symptoms
Overview
The aim of this pilot RCT is the development, implementation, and evaluation of a cognitive stimulation program with virtual reality for individuals aged 65 or older who have depressive symptoms and attend Portuguese day centers. The program aims to promote their cognitive functioning, well-being and functionality, and to reduce their depressive symptoms. A pilot study of the program will be conducted to assess its feasibility and preliminary efficacy.
Interventions
- Behavioral Cognitive stimulation program
Twelve group sessions of a cognitive stimulation program with virtual reality.
Primary outcome measures
- Adherence [Time frame: Throughout the intervention period (6 weeks)]
- Acceptability and Feasibility [Time frame: Post-intervention (at week 7)]
- Acceptability and perceived barriers (semi-strutured interviews) [Time frame: Post-intervention (at week 7)]
Secondary outcome measures (9)
- Depressive symptoms [Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)]
- Well-being [Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)]
- Functionality [Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)]
- Global cognitive functioning [Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)]
- Visual attention and processing speed [Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)]
- Executive functioning and cognitive flexibility [Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)]
- Frontal executive functioning [Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)]
- Attention and immediate verbal memory [Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)]
- Working memory [Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)]
Eligibility criteria
Inclusion criteria
- Individuals aged 65 years or older attending Portuguese day care centers;
- Presence of mild, moderate, or severe depressive symptomatology;
- Language skills and visual acuity.
Exclusion criteria
- Individuals presenting illiteracy and/or medical diagnosis of neurocognitive disorder or significant cognitive deficits (Mini-Mental State Examination)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07710222 · 2023.03520.BDANA