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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorGrupo Lusófona

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals aged 65 years or older attending Portuguese day care centers;

Presence of mild, moderate, or severe depressive symptomatology;

Language skills and visual acuity.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cognitive stimulation program

    Behavioral

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Cognitive stimulation + VRExperimental treatment 1 intervention
Group B: Wait-list ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Throughout the intervention period (6 weeks)
2

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.

Time frame
Post-intervention (at week 7)
3

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.

Time frame
Post-intervention (at week 7)

Secondary outcomes

1

Depressive symptoms

Changes in depressive symptoms will be assessed using the Geriatric Depression Scale (GDS-15), a 15-item questionnaire with yes/no responses, with total scores ranging from 0 to 15, where higher scores indicate greater depressive symptomatology.

Time frame
Baseline, post-intervention (at week 7) and follow-up (3 months)
2

Well-being

Changes in well-being will be assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). The scale consists of 14 items rated on a 5-point Likert scale ranging from 1 (never) to 5 (always), with total scores ranging from 14 to 70. Higher scores indicate greater levels of well-being.

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

Functionality

Changes in functional ability will be assessed using the Lawton and Brody Instrumental Activities of Daily Living (IADL) Scale. The scale consists of 8 items and total score ranges from 8 to 30 points, with 8 indicating independence, scores between 9 and 20 indicating moderate dependence and scores above 20 indicating severe dependence.

Time frame
Baseline, post-intervention (at week 7) and follow-up (3 months)
4

Global cognitive functioning

Changes in cognitive functioning will be assessed using the total score of the Neuropsychological Assessment Questionnaire that assesses multiple cognitive functions. The total score ranges from 0 to 112 points, with higher total scores indicating better cognitive performance.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Grupo Lusófona

Lead sponsor

Fundação para a Ciência e a Tecnologia

Collaborator

This trial is not recruiting at the moment. You can still explore other options: