【ChiCTR2600131879】Effects of Brief Behavioural Treatment for Insomnia in Older Adults: A Randomised Controlled Trial

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基本信息

登记号

ChiCTR2600131879

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

2026-09-07

临床申请受理号

靶点

适应症

Insomnia

试验通俗题目

Effects of Brief Behavioural Treatment for Insomnia in Older Adults: A Randomised Controlled Trial

试验专业题目

Effects of Brief Behavioural Treatment for Insomnia in Older Adults: A Randomised Controlled Trial

申办单位信息

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申请人名称

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临床试验信息

试验目的

1. To determine whether older adults receiving Brief Behavioural Treatment for Insomnia (BBTI) demonstrate greater reductions in insomnia severity than those in the control group immediately post-intervention and at 3-month follow-up. 2. To determine whether older adults receiving BBTI demonstrate greater reductions in depressive symptoms than those in the control group immediately post-intervention and at 3-month follow-up. 3. To generate local evidence on the effectiveness of BBTI in improving insomnia severity and depressive symptoms among Chinese older adults in Hong Kong.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

Participants will be randomly allocated to either the BBTI intervention group or the sleep hygiene control group in a 1:1 ratio. Random assignment will follow a computer-generated allocation sequence using permuted block randomization with a block size of four.

盲法

The study is assessor-blinded

试验项目经费来源

The trial is implemented entirely using existing institutional and service resources from Castle Peak Hospital (Hospital Authority) in collaboration with the School of Nursing and Health Sciences, Hong Kong Metropolitan University (which provides academic support and project coordination).

试验范围

目标入组人数

实际入组人数

第一例入组时间

2026-09-09

试验终止时间

2027-12-31

是否属于一致性

入选标准

1. Aged 65 years or older 2. Difficulty initiating sleep and/or maintaining sleep, indicated by a sleep onset latency and/or wake after sleep onset ≥30 minutes, together with a total sleep time <=6.5 hours per night; 3. Symptoms occurring on more than three nights per week for longer than three months; 4. Sleep disturbance and/or associated daytime fatigue causing clinically significant distress or impairment in social, occupational, or other important areas of functioning. 1. Aged 65 years or older2. Difficulty initiating sleep and/or maintaining sleep, indicated by a sleep onset latency and/or wake after sleep onset ≥30 minutes, together with a total sleep time <=6.5 hours per night;3. Symptoms occurring on more than three nights per week for longer than three months;4. Sleep disturbance and/or associated daytime fatigue causing clinically significant distress or impairment in social, occupational, or other important areas of functioning.；

排除标准

1. Have a progressive or unstable physical illness (e.g., cancer, acute pain); 2. Having mild cognitive impairment, as indicated by Montreal Cognitive Assessment 5-Minute Protocol Hong Kong Version (HK-MoCA 5-Min Protocol) or a known neurodegenerative disorder (e.g., dementia); 3. Major psychiatric comorbidities, including a lifetime diagnosis of psychotic or bipolar disorder, more than two lifetime episodes of major depressive disorder, or an untreated current episode of major depressive disorder; 4. Evidence of other sleep disorders, including sleep apnea (apnea–hypopnea index >15), restless legs syndrome or periodic limb movements with arousal (>15 events/hour), or circadian rhythm sleep–wake disorders (e.g., delayed or advanced sleep phase); 5. Currently misuse alcohol or other substances; 6. Work night shifts and are unable to discontinue shift work during the study period; 7. Are unable to attend in-person sessions; 8. are unable to communicate in Chinese.；

研究者信息

研究负责人姓名

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试验机构

Castle Peak Hospital, Hospital Authorit

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