【ChiCTR2500095764】Computer Use for Seniors on Mood Improvement and Logic Enhancement: A randomized waitlist-controlled trial

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基本信息

登记号

ChiCTR2500095764

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2025-01-13

临床申请受理号

靶点

适应症

Depression

试验通俗题目

Computer Use for Seniors on Mood Improvement and Logic Enhancement: A randomized waitlist-controlled trial

试验专业题目

Computer Use for Seniors on Mood Improvement and Logic Enhancement: A randomized waitlist-controlled trial

申办单位信息

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联系人邮编

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临床试验信息

试验目的

The primary objective is to ascertain the treatment effect of CCT on mood in community-living older adults with depression. The secondary objective is to examine the retention effect of CCT on mood 6 weeks after cessation of CCT.

试验分类

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试验类型

随机交叉对照

试验分期

其它

随机化

Participants will be randomly allocated into either the intervention group (CCT) or the waitlist control group in a 1:1 ratio. The randomization will be done using a computer, and participants will be assigned their allocation codes according to the order of their entry into the study.

盲法

Although participants will know which group they are allocated to, they will be advised not to discuss with other participants or the outcome assessor. The research assistant who facilitates the CCT will not be involved in the outcome assessment. The outcome assessor will be blinded to the allocation status and will not participate in delivering the intervention.

试验项目经费来源

Knowledge Transfer Project Fund (KPF) of the Chinese University of Hong Kong, and Social Innovation and Entrepreneurship Development Fund (SIE Fund) of the Government of HKSAR

试验范围

目标入组人数

实际入组人数

第一例入组时间

2025-01-01

试验终止时间

2026-09-30

是否属于一致性

入选标准

community-living Chinese individuals aged 60 years and older and having a primary diagnosis of major depressive disorder (single or recurrent episodes without psychotic features) based on the DSM-5 criteria, with moderate-to-severe depression (HAM-D total score >=17) and cognitive symptoms [Item 8 (slowness of thought and speech, impaired ability to concentrate) score >=2 in HAM-D], but without MCI or dementia (based on the age- and education-specific cutoff of HK-MoCA).；

排除标准

Individuals found to have active suicidal idea, psychotic symptoms, or treatment-resistant [history of electroconvulsive therapy, transcranial magnetic stimulation, or no clinical response to >=2 different classes of antidepressants] will be excluded and referred to the psychiatric services of the Hospital Authority. Other exclusion criteria are non-Chinese; living in care homes; having history or ongoing substance abuse (including alcohol), mania, bipolar or psychotic disorder, posttraumatic stress disorder, anxiety disorder, personality disorder, or mental disorder due to organic cause; having history of traumatic brain injury, Parkinson’s disease, stroke, dementia, or scoring below HK-MoCA cutoff; or having language barrier or impairment in communication (poor vision or hearing despite correction).；

研究者信息

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试验机构

Chinese University of Hong Kong

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