Cognitive Stimulation Program With Virtual Reality for Older Adults With Depressive Symptoms
2026年7月13日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adherence
時間枠：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
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Depressive symptoms
時間枠：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
時間枠：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
時間枠：Baseline, post-intervention (at week 7) and follow-up (3 months)
|
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
時間枠：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
時間枠：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
時間枠：Baseline, post-intervention (at week 7) and follow-up (3 months)
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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
時間枠：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
時間枠：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
時間枠：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.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2027年3月1日
研究の完了 (推定)
2027年3月1日
試験登録日
最初に提出
2026年6月18日
QC基準を満たした最初の提出物
2026年7月13日
最初の投稿 (実際)
2026年7月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月17日
QC基準を満たした最後の更新が送信されました
2026年7月13日
最終確認日
2026年7月1日
詳しくは
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