NCT07710222

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

June 18, 2026

Last Update Submit

July 13, 2026

Conditions

Depressive Symptoms

Keywords

DepressionCognitive functioningWell-beingFunctionalityMental healthCognitive stimulation programVirtual realityOlder adults

Outcome Measures

Primary Outcomes (3)

  • Adherence

    The proportion of participants who complete all intervention sessions. Adherence will be considered achieved if at least 70% of participants complete all scheduled sessions.

    Throughout the intervention period (6 weeks)

  • Acceptability and Feasibility

    Acceptability and feasibility will be assessed through Theoretical Framework of Acceptability Questionnaire (TFA). All items are assessed on a 5-point Likert scale, with scores ranging from 1 to 5. Scores range from 7 to 35, with higher scores indicating better acceptability and feasibility.

    Post-intervention (at week 7)

  • Acceptability and perceived barriers (semi-strutured interviews)

    Acceptability of the intervention will be assessed through semi-structured interviews conducted with each participant after the intervention. The interviews will explore participants' overall evaluation of the program, including its perceived relevance, satisfaction with the intervention, and willingness to continue or recommend it. Perceived barriers to implementation will also be explored by asking participants to describe any difficulties or challenges they experienced during their participation.

    Post-intervention (at week 7)

Secondary Outcomes (9)

  • Depressive symptoms

    Baseline, post-intervention (at week 7) and follow-up (3 months)

  • Well-being

    Baseline, post-intervention (at week 7) and follow-up (3 months)

  • Functionality

    Baseline, post-intervention (at week 7) and follow-up (3 months)

  • Global cognitive functioning

    Baseline, post-intervention (at week 7) and follow-up (3 months)

  • Visual attention and processing speed

    Baseline, post-intervention (at week 7) and follow-up (3 months)

  • +4 more secondary outcomes

Study Arms (2)

Cognitive stimulation + VR

EXPERIMENTAL

Participants receive a cognitive stimulation program with virtual reality.

Behavioral: Cognitive stimulation program

Wait-list Control

NO INTERVENTION

Participants assigned to the waitlist control condition remain on the waitlist throughout the study and are offered the intervention upon completion of the post-intervention assessment phase.

Interventions

Cognitive stimulation programBEHAVIORAL

Twelve group sessions of a cognitive stimulation program with virtual reality.

Cognitive stimulation + VR

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Individuals aged 65 years or older attending Portuguese day care centers;
  • Presence of mild, moderate, or severe depressive symptomatology;
  • Language skills and visual acuity.

You may not qualify if:

  • Individuals presenting illiteracy and/or medical diagnosis of neurocognitive disorder or significant cognitive deficits (Mini-Mental State Examination)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One experimental group and one wait-list control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

June 18, 2026

First Posted

July 17, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

July 17, 2026

Record last verified: 2026-07