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一项针对年轻人孤独感的同伴树数字干预措施的初步随机对照试验:研究方案。

A pilot randomised controlled trial of the Peer Tree digital intervention targeting loneliness in young people: a study protocol.

机构信息

Prevention Research Collaboration, School of Public Health, University of Sydney, Camperdown, Australia.

Iverson Health Innovation Research Institute, Swinburne University of Technology, Hawthorn, Victoria, Australia.

出版信息

Trials. 2023 Feb 2;24(1):77. doi: 10.1186/s13063-022-07029-7.

Abstract

BACKGROUND

Young people are vulnerable to experiencing problematic levels of loneliness which can lead to poor mental health outcomes. Loneliness is a malleable treatment target and preliminary evidence has shown that it can be addressed with digital platforms. Peer Tree is a strength-based digital smartphone application aimed at reducing loneliness. The study aim is to reduce loneliness and assess the acceptability, usability, and feasibility of Peer Tree in young people enrolled at university.

METHODS

This will be a pilot randomised controlled trial (RCT) comparing a strength-based digital smartphone application (Peer Tree) with a control condition. Forty-two young people enrolled at university will be recruited for this pilot RCT. Participants with suicidal ideation or behaviours, acute psychiatric symptoms in the past month, or a current diagnosis of a mood or social anxiety disorder will be excluded. Allocation will be made on a 1:1 ratio and will occur after the initial baseline assessment. Assessments are completed at baseline, at post-intervention, and at follow-up. Participants in the control condition complete the same three assessment sessions. The primary outcome of the study will be loneliness. Depression, social anxiety, quality of life, acceptability, usability, feasibility, and safety of Peer Tree will also be measured as secondary outcomes.

DISCUSSION

This trial will report the findings of implementing Peer Tree, a smartphone application aimed at reducing loneliness in university students. Findings from this trial will highlight the initial efficacy, acceptability, and feasibility of using digital positive psychology interventions to reduce subthreshold mental health concerns. Findings from this trial will also describe the safety of Peer Tree as a digital tool. Results will contribute evidence for positive psychology interventions to address mental ill-health.

TRIAL REGISTRATION

Australian New Zealand Clinical Trial Registry ACTRN12619000350123. Registered on 6 March 2020.

摘要

背景

年轻人容易感到孤独,而孤独程度过高会导致心理健康状况不佳。孤独是一种可以改变的治疗目标,初步证据表明,它可以通过数字平台来解决。Peer Tree 是一款基于优势的数字智能手机应用程序,旨在减少孤独感。本研究旨在降低孤独感,并评估 Peer Tree 在大学生中应用的可接受性、可用性和可行性。

方法

这将是一项比较基于优势的数字智能手机应用程序(Peer Tree)与对照组的试点随机对照试验(RCT)。将招募 42 名在大学注册的年轻人参加这项试点 RCT。有自杀意念或行为、过去一个月有急性精神症状或目前患有情绪或社交焦虑障碍的参与者将被排除在外。所有分配将按照 1:1 的比例进行,并将在初始基线评估后进行。评估在基线、干预后和随访时进行。对照组的参与者完成相同的三次评估。该研究的主要结局将是孤独感。抑郁、社交焦虑、生活质量、可接受性、可用性、可行性和 Peer Tree 的安全性也将作为次要结局进行测量。

讨论

本试验将报告实施 Peer Tree 的结果,这是一款旨在减少大学生孤独感的智能手机应用程序。该试验的结果将突出使用数字积极心理学干预措施来解决亚临床心理健康问题的初步疗效、可接受性和可行性。该试验还将描述 Peer Tree 作为一种数字工具的安全性。结果将为积极心理学干预措施应对精神健康不良提供证据。

试验注册

澳大利亚新西兰临床试验注册中心 ACTRN12619000350123。于 2020 年 3 月 6 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c50b/9893654/2cf3af330f83/13063_2022_7029_Fig1_HTML.jpg

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