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Not yet recruiting NCT07710222

Cognitive Stimulation Program With Virtual Reality for Older Adults With Depressive Symptoms

No phase Interventional 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 →
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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗