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临床试验/NCT06521099
NCT06521099招募中不适用

A Novel Conditioning Approach to Counter Loneliness in Adults

Education University of Hong Kong1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2025年8月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
136
试验地点
1
主要终点
Self-reported loneliness

研究概览

简要总结

This study aims to test the efficacy of a 6-session conditioning paradigm by investigating the conditioning-induced change in the socio-affective processing, loneliness, depressive symptoms, and neural correlates of lonely adults.

详细描述

Potential participants will first be invited to complete a loneliness questionnaire online. Lonely adults will then be invited to undergo further screening. At baseline prior to the intervention training sessions, participants will first complete tests and questionnaires on loneliness, mood and depressive symptoms in addition to other socio-affective measures, and they will also be invited to receive resting-state functional MRI scanning in a 3T MRI scanner. Participants will then be allocated to one of the two intervention arms (the evaluative conditioning, and the control) in a randomized fashion with approximately half in each group. They will then complete the pre-conditioning phase of the allocated intervention arm, and their ratings on the stimuli presented during this phase will be assessed. In the conditioning phase, they will be invited to attend 6 sessions. After completing the conditioning phase, participants will be invited to complete the post- conditioning phase, providing ratings on the stimuli like the pre-conditioning phase. Immediately after, and also 3 months after, participants will be invited to complete again tests and questionnaires on loneliness, mood and depressive symptoms in addition to other socio-affective measures, and they will also be invited to receive resting-state functional MRI scanning in a 3T MRI scanner.

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
Single (Participant)

入排标准

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

入选标准

  • No histories of learning impairment, major psychiatric disorders or neurological disorders other than depression
  • Normal intelligence
  • At least primary school education

排除标准

  • On medication or treatments within 2 weeks prior to the beginning of the study that would affect the individual's brain, cognitive and affective functions

研究组 & 干预措施

Evaluative conditioning group with positive stimuli

Experimental

Participants will be exposed to social stimuli paired with positive stimuli across multiple sessions.

干预措施: Evaluative Conditioning with positive stimuli (Behavioral)

Control group with neutral stimuli

Active Comparator

Participants will be exposed to social stimuli paired with neutral stimuli across multiple sessions.

干预措施: Conditioning with neutral stimuli (Behavioral)

结局指标

主要结局

Self-reported loneliness

时间窗: Baseline, immediately after, and 3 months after the intervention

Loneliness is assessed based on the UCLA loneliness scale (Version 3), a 20-item 4-point Likert scale (score range 20 - 80) in which higher scores indicate greater degrees of loneliness.

Implicit loneliness

时间窗: Baseline, immediately after, and 3 months after the intervention

Implicit loneliness will be measured by Implicit Association Test about the relative strength of association between our participants' target concept 'Self' and attribute 'Lonely'.

Self-reported loneliness

时间窗: Baseline, immediately after, and 3 months after the intervention

Loneliness is assessed based on the UCLA loneliness scale (Version 3), a 20-item 4-point Likert scale (score range 20 - 80) in which higher scores indicate greater degrees of loneliness.

Implicit loneliness

时间窗: Baseline, immediately after, and 3 months after the intervention

Implicit loneliness will be measured by Implicit Association Test about the relative strength of association between our participants' target concept 'Self' and attribute 'Lonely'.

次要结局

  • Depressive symptoms(Baseline, immediately after, and 3 months after the intervention)
  • Daily loneliness(Through study completion, on average of 4 months)
  • Valence of social stimuli(Baseline, immediately after, and 3 months after the intervention)
  • Social motivation towards social stimuli(Baseline, immediately after, and 3 months after the intervention)
  • Loneliness-related activation patterns and connectivity in neural networks(Baseline, immediately after, and 3 months after the intervention)
  • Valence of social stimuli(Baseline, immediately after, and 3 months after the intervention)
  • Social motivation towards social stimuli(Baseline, immediately after, and 3 months after the intervention)
  • Loneliness-related activation patterns and connectivity in neural networks(Baseline, immediately after, and 3 months after the intervention)
  • Depressive symptoms(Baseline, immediately after, and 3 months after the intervention)
  • Daily loneliness(Through study completion, on average of 4 months)

研究者

发起方
Education University of Hong Kong
申办方类型
Other
责任方
Principal Investigator
主要研究者

WONG Man Lok Nichol

Assistant Professor

Education University of Hong Kong

研究点 (1)

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