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临床试验/NCT05100849
NCT05100849已完成不适用

Efficacy of Kinect-based Versus Tablet-based Cognitive Training Through Simulations of Instrumental Activities of Daily Living: a Pilot Study With Chronic Psychiatric Patients

Universidade da Madeira1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2020年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Symbol Search and Coding (WAIS-III) (Processing speed)

研究概览

简要总结

This study aims to analyze which cognitive training experimental condition - Tablet versus Kinect - results in greater cognitive, mood, quality of life, and functional gains in a sample of chronic psychiatric patients.

详细描述

Cognitive deficits are a nuclear feature of several psychiatric disorders, leading to a decrease in functional abilities and quality of life. Besides facilitating the inclusion of more ecologically valid stimuli and training tasks, technology-based cognitive training methods allow more dynamic interactions with the cognitive training content, which can result in an enhancement of patients' motivation and engagement in the therapeutic process. The modality of interaction with the cognitive training content may influence patients' response to cognitive training interventions. For instance, cognitive training through the tablet requires essentially hand movements (e.g., interaction with the training tasks by touching the correct stimuli), while cognitive training through the Kinect involves the performance of wide range movements (e.g., interaction with the training tasks by making specific "body" movements to select the correct stimuli). This study aims to analyze which cognitive training experimental condition - Tablet versus Kinect - results in greater cognitive, mood, quality of life, and functional gains in a sample of chronic psychiatric patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 75 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Psychiatric diagnosis;
  • •Maximum age: 75 years old;
  • •Relatively preserved language abilities (expressive and receptive language);
  • •Being able to read and write;
  • •Having no motor limitations;
  • •Having no medical history of neurological conditions (e.g., stroke, traumatic brain injury, multiple sclerosis, etc.)
  • •Preserved visual and auditory acuity;

排除标准

  • •Experiencing an acute psychiatric episode.

研究组 & 干预措施

Kinect-based cognitive training

Experimental

Standard treatment protocol and 14 sessions (biweekly during 30 minutes) of Kinect-based cognitive training inspired by instrumental activities of daily living.

干预措施: Kinect-based cognitive training (Procedure)

Tablet-based cognitive training

Experimental

Standard treatment protocol and 14 sessions (biweekly during 30 minutes) of Tablet-based cognitive training inspired by instrumental activities of daily living.

干预措施: Tablet-based cognitive training (Procedure)

结局指标

主要结局

Symbol Search and Coding (WAIS-III) (Processing speed)

时间窗: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)

Change from baseline in the Symbol Search and Coding (WAIS-III); Min score=0; Max score dependent on patients' performance in a 120 seconds time frame. Higher scores in both subtests mean a better outcome.

Verbal Fluency Tests (semantic and phonemic) (Executive Functions)

时间窗: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)

Change from baseline in the Verbal Fluency Tests (semantic and phonemic); Min score=0; Max score dependent on patients' performance during a 1-minute time frame. Higher scores on both verbal fluency tests mean a better outcome.

Toulouse-Piéron Cancellation Test (TP) (Sustained and selective attention)

时间窗: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)

Change from baseline in the Toulouse-Piéron Cancellation Test (TP); Min score=0; Max score=dependent on patients' performance during a 10-min time frame; A higher work efficiency index means a better outcome, whereas a higher dispersion index means a worse outcome.

Rey Complex Figure Test (RCFT) (Visuospatial skills and visual memory)

时间窗: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)

Change from baseline in the Rey Complex Figure Test (RCFT); Min score=0; Max score=36; Higher scores mean a better outcome.

Montreal Cognitive Assessment (MoCA) (Cognitive screening)

时间窗: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)

Change from baseline in the Montreal Cognitive Assessment (MoCA); Min score=0; Max score=30; Higher scores mean a better outcome

Frontal Assessment Battery (FAB) (Executive functions screening)

时间窗: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)

Change from baseline in the Frontal Assessment Battery (FAB). Min score=0; Max score=18; Higher scores mean a better outcome.

Free and Cued Selective Reminding Test (FCSRT) (Verbal Memory)

时间窗: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)

Change from baseline in the Free and Cued Selective Reminding Test (FCSRT); Min score immediate recall trials=0; Max score immediate recall trials=48; Min score Delayed recall trials=0; Max score delayed recall trials=16. Higher scores on both trials mean a better outcome.

次要结局

  • Adults and Older Adults Functional Assessment Inventory (IAFAI)(Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months))
  • World Health Organization Quality of Life - Bref (WHOQOL-Bref) (Quality of life)(Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months))
  • Beck Depression Inventory II (BDI-II) (Depressive symptomatology)(Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sergi Bermúdez i Badia

Associate Professor at the University of Madeira and Senior Researcher at NOVA LINCS

Universidade da Madeira

研究点 (1)

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