A three-arm randomized controlled trial protocol: Effects of telephone-based, layperson-delivered wisdom-enhancement narrative therapy and empathy-focused interventions on loneliness, social, and mental health in older adults

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2025-03-29 DOI:10.1016/j.conctc.2025.101479

Vivien Foong Yee Tang , Da Jiang , Maninder Kahlon , Esther Oi-wah Chow , Dannii Yuen-lan Yeung , Rhonda Aubrey , Kee-Lee Chou

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Abstract

Background

Loneliness is an increasingly widespread issue among older adults globally, with significant implications on physical, social, and mental health. While various interventions exist to address this challenge, their long-term effects remain unclear. Using a 3-arm randomized controlled trial, this study aims to evaluate the efficacy of a telephone-based and layperson-delivered wisdom-enhancement narrative therapy (Tele-NT) and empathy-focused program (Tele-EP) against an active control group (ACG) in reducing loneliness.

Methods

282 community-dwelling lonely older adults will be recruited and randomly allocated into 1 of the 3 interventions. Older adults will receive two 30-min intervention per week, over the course of 4 weeks, delivered over the phone by a layperson. Assessments will be conducted in-person at baseline (T0), 1-month (T1), 6-month (T2), and 12-month (T3) post-intervention. The primary outcome will be assessed using the Chinese validated 6-item De Jong Gierveld Loneliness Scale and the Revised UCLA Loneliness Scale. The secondary outcomes will include sleep quality, perceived social support, and depressive symptoms. Potential mediators and moderators will also be explored. The data will be analysed using linear mixed models on an intention-to-treat basis.

Discussion

This RCT is effective, Tele-NT and/or Tele-EP could serve as a model for broader implementation in the community, offering practical solutions to mitigate loneliness and its associated health burdens in the aging populations.

Trial registration

This trial is registered with the Chinese Clinical Trial Registry; ChiCTR2300070179 on April 4, 2024.

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一项三组随机对照试验方案：基于电话的、外行人提供的智慧增强叙事疗法和以移情为重点的干预对老年人孤独、社会和心理健康的影响

孤独是全球老年人中日益普遍的问题，对身体、社会和心理健康都有重大影响。虽然存在各种干预措施来应对这一挑战，但其长期影响尚不清楚。本研究采用三组随机对照试验，旨在评估基于电话和外行人提供的智慧增强叙事疗法（Tele-NT）和共情聚焦疗法（Tele-EP）对主动对照组（ACG）减少孤独感的效果。方法招募282名社区独居老年人，随机分为3个干预组。老年人每周将接受两次30分钟的干预，为期4周，由外行通过电话提供。评估将在干预后基线（T0）、1个月（T1）、6个月（T2）和12个月（T3）进行。主要结果将使用中国验证的6项De Jong Gierveld孤独量表和修订的UCLA孤独量表进行评估。次要结果包括睡眠质量、感知到的社会支持和抑郁症状。还将探讨潜在的调解人和调解人。数据将在意向治疗基础上使用线性混合模型进行分析。该随机对照试验是有效的，Tele-NT和/或Tele-EP可以作为在社区更广泛实施的模型，为减轻老年人的孤独感及其相关健康负担提供切实可行的解决方案。试验注册本试验已在中国临床试验注册中心注册；ChiCTR2300070179在2024年4月4日。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.