Personalised and standardised wafer-based open-label placebos reduce perceived stress among university students: A three-arm randomised controlled trial

IF 3.3 2区医学 Q2 PSYCHIATRY

Journal of Psychosomatic Research Pub Date : 2026-01-01 Epub Date: 2025-11-12 DOI:10.1016/j.jpsychores.2025.112450

Johannes C. Fendel , Corinna Ketter , Paulina Liese , Dimitri Nalezinski , Magdalena Schiele , Frederic Linßen , Stefan Schmidt

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引用次数: 0

Abstract

Background

Open-label placebos (OLPs) are placebos administered transparently, without deception that can nonetheless yield beneficial effects. We tested a novel OLP delivery format—printed edible wafers, with or without individualised coaching-based personalisation, in highly stressed university students.

Methods

In this superiority randomised controlled trial, N = 137 highly stressed university students were randomly assigned for three weeks to a personalised OLP (personalised printed image, label, desired effects) a standardised OLP (standardised for stress reduction), or a waitlist control. The primary objective was to test whether the personalised OLP reduces perceived stress compared to waitlist. Secondary objectives included examining whether the standardised OLP also improves outcomes relative to control and whether personalisation yields incremental benefits. Assessments were conducted at baseline, post-intervention, and at a three-month follow-up. The primary outcome was perceived stress; secondary outcomes included anxiety, depression, sleep, well-being, and life satisfaction; moderators were treatment expectancy (TE) and general self-efficacy (GSE).

Results

Both OLP arms reduced perceived stress vs. waitlist; these effects were maintained at follow-up. Anxiety decreased only in the personalised arm. The OLP arms did not differ significantly. In the standardised arm, lower GSE predicted larger depressive-symptom reductions and higher TE predicted greater well-being gains (vs. waitlist).

Conclusions

Wafers may be a versatile OLP delivery method with potential for mechanism-guided refinement and targeted personalisation in preventive and clinical contexts.

Trial registration

https://osf.io/8afdz.

查看原文本刊更多论文

个性化和标准化的基于薄片的开放标签安慰剂减轻大学生的感知压力：一项三组随机对照试验。

背景：开放标签安慰剂（olp）是一种透明的安慰剂，没有欺骗，但仍然可以产生有益的效果。我们在压力很大的大学生中测试了一种新颖的OLP递送形式——打印的可食用硅片，有或没有个性化指导。方法：在这项优势随机对照试验中，N = 137名压力很大的大学生被随机分配到个性化OLP（个性化印刷图像、标签、期望效果）、标准化OLP（标准化减压）或候补组，为期三周。主要目的是测试与等候名单相比，个性化的OLP是否减少了感知压力。次要目标包括检查标准化的OLP是否也相对于控制改善了结果，以及个性化是否产生了增量效益。评估分别在基线、干预后和三个月随访时进行。主要结果是感知压力；次要结局包括焦虑、抑郁、睡眠、幸福感和生活满意度；调节因子为治疗期望（TE）和一般自我效能（GSE）。结果：与等候名单组相比，两组均降低了感知压力；这些效果在随访中保持不变。焦虑只在个性化治疗组中有所减少。OLP组没有显著差异。在标准化组中，较低的GSE预示着更大的抑郁症状减轻，而较高的TE预示着更大的幸福感（与等候组相比）。结论：晶圆片可能是一种多功能的OLP输送方法，在预防和临床环境中具有机制指导的改进和针对性个性化的潜力。试验注册：https://osf.io/8afdz。

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

Journal of Psychosomatic Research 医学-精神病学

CiteScore

7.40

自引率

6.40%

发文量

314

审稿时长

6.2 weeks

期刊介绍： The Journal of Psychosomatic Research is a multidisciplinary research journal covering all aspects of the relationships between psychology and medicine. The scope is broad and ranges from basic human biological and psychological research to evaluations of treatment and services. Papers will normally be concerned with illness or patients rather than studies of healthy populations. Studies concerning special populations, such as the elderly and children and adolescents, are welcome. In addition to peer-reviewed original papers, the journal publishes editorials, reviews, and other papers related to the journal''s aims.