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临床试验/NCT07332624
NCT07332624Enrolling By Invitation不适用

Instant Message-delivered Acceptance and Commitment Therapy (ACT) for Neuropsychiatric Symptoms in Persons Living With Mild Cognitive Impairment: a Pilot Randomised Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月17日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
40
试验地点
1
主要终点
MBI-C scores

研究概览

简要总结

This pilot study aims to develop an automated instant message-delivered intervention (i.e., EMI) for people with mild cognitive impairment, and to investigate the feasibility and effectiveness of the intervention.

详细描述

  1. Message contents: The message content library will consist of two parts: 1. brief mild cognitive impairment messages (optional), and 2. acceptance and commitment therapy messages (mandatory).
  2. Message delivery
  • Regular messages: The messages in the two parts will be sent regularly to each participant. As personalisation is a core process subject to behavioural changes, the content, frequency, and timing of the messages will be determined based on participants' preferences. To save labour and increase efficiency, we will develop a message 'scheduler' program. We will pre-set the message scheduler, which will then automatically send out content to participants according to their preferences. The development of the program is highly useful particularly in cases which participants prefer to receive messages during non-office hours.
  • Therapist-led real-time support messages (chat-type): Chat-based support will be given to the participants as an extension of the regular messages. However, the participants will be informed beforehand that the RA will only play a supportive role and will not provide formal care. The number of the chat messages will not be limited, but the real-time support messages will only be provided during working hours (i.e., 9am-6pm) on weekdays to limit the RA's workload.

Control Group:

The control group will receive instant messages about mental health management from HKSAR Government website (https://www.shallwetalk.hk/en/mental-well-being/mental-well-being-is-related-to-you/), which is open to the public.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Community-dwelling adults aged ≥ 50 years; HK-MoCA score range from 18 to 25; MBI-C ≥7; Able to read and communicate in Chinese (Cantonese or Putonghua); Able to use the text or voice messaging function on a smartphone.

排除标准

  • Diagnosis of dementia; Diagnosis of psychiatric disease; Currently participating in any type of psychological or behavioural intervention for NPSs

研究组 & 干预措施

Intervention group

Experimental

Participants in intervention group will receive the EMI for 8 weeks. Based on the steps of mobile message development recommended by Abroms, et al., our team will develop an ACT message content library and protocol for IM delivery (i.e. EMI).

干预措施: Automated instant message-guided neuropsychiatric symptoms management (Behavioral)

Control group

No Intervention

The control group will receive instant messages about general mental health management from the HKSAR Government website, which is open to the public (https://www.shallwetalk.hk/en/mental-well-being/mental-well-being-is-related-to-you/), with reminder text messages of follow-up surveys.

结局指标

主要结局

MBI-C scores

时间窗: 8 weeks

The primary outcome will be MBI-C scores to assess NPSs. A higher MBI-C scores will indicate a higher level of neuropsychiatric symptoms.

次要结局

  • Depressive symptoms (PHQ-9)(8 weeks)
  • Anxiety symptoms (GAD-7)(8 weeks)
  • Cognitive functions (HK-MoCA)(8 weeks)
  • Acceptance of negative emotions and valued-based actions (AAQ-II)(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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