Cognitive Stimulation Program With Virtual Reality for Older Adults With Depressive Symptoms
2026년 7월 13일 업데이트: Sofia Borges de Sousa, Grupo Lusófona
Pilot Randomized Controlled Trial of a Cognitive Stimulation Program With Virtual Reality: Feasibility and Preliminary Efficacy in Older Adults With Depressive Symptoms
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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
60
단계
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Cognitive stimulation + VR
Participants receive a cognitive stimulation program with virtual reality.
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Twelve group sessions of a cognitive stimulation program with virtual reality.
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간섭 없음: Wait-list Control
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adherence
기간: Throughout the intervention period (6 weeks)
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The proportion of participants who complete all intervention sessions.
Adherence will be considered achieved if at least 70% of participants complete all scheduled sessions.
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Throughout the intervention period (6 weeks)
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Acceptability and Feasibility
기간: Post-intervention (at week 7)
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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.
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Post-intervention (at week 7)
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Acceptability and perceived barriers (semi-strutured interviews)
기간: Post-intervention (at week 7)
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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.
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Post-intervention (at week 7)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Depressive symptoms
기간: Baseline, post-intervention (at week 7) and follow-up (3 months)
|
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.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Well-being
기간: Baseline, post-intervention (at week 7) and follow-up (3 months)
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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.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Functionality
기간: Baseline, post-intervention (at week 7) and follow-up (3 months)
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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.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Global cognitive functioning
기간: Baseline, post-intervention (at week 7) and follow-up (3 months)
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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.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Visual attention and processing speed
기간: Baseline, post-intervention (at week 7) and follow-up (3 months)
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Changes in visual attention and processing speed will be assessed using the Trail Making Test Part A (TMT-A).
Performance is measured by the time required to complete the test, with longer completion times indicating poorer visual attention and processing speed.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Executive functioning and cognitive flexibility
기간: Baseline, post-intervention (at week 7) and follow-up (3 months)
|
Changes in executive functioning and cognitive flexibility will be assessed using the Trail Making Test Part B (TMT-B).
Performance is measured by the time required to complete the test, with longer completion times indicating poorer executive functioning and cognitive flexibility.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Frontal executive functioning
기간: Baseline, post-intervention (at week 7) and follow-up (3 months)
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Changes in executive functioning will be assessed using Frontal Assessment Battery (FAB), a brief screening tool composed of 6 subtests.
Total scores range from 0 to 18, with higher scores indicating better executive functioning.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Attention and immediate verbal memory
기간: Baseline, post-intervention (at week 7) and follow-up (3 months)
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Changes in attention and immediate verbal memory will be assessed using the Digit Span Forward subtest of the Wechsler Adult Intelligence Scale-III (WAIS-III).
Performance is measured by the number of correctly recalled digit sequences, with higher scores indicating better attention and immediate verbal memory.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Working memory
기간: Baseline, post-intervention (at week 7) and follow-up (3 months)
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Changes in working memory will be assessed using the Digit Span Backward subtest of the Wechsler Adult Intelligence Scale-III (WAIS-III).
Performance is measured by the number of correctly recalled digit sequences in reverse order, with higher scores indicating better working memory performance.
|
Baseline, post-intervention (at week 7) and follow-up (3 months)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 9월 1일
기본 완료 (추정된)
기본 완료
2027년 3월 1일
연구 완료 (추정된)
연구 완료
2027년 3월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 6월 18일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 13일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 17일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 13일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2023.03520.BDANA
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