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参与者对预防抑郁症干预措施随机对照试验中动机、随机分组和退出的看法。

Participants' perceptions of motivation, randomisation and withdrawal in a randomised controlled trial of interventions for prevention of depression.

机构信息

Centre for Applied Psychology Faculty of Health, University of Canberra, Canberra, ACT 2601, Australia.

出版信息

J Med Ethics. 2009 Dec;35(12):768-73. doi: 10.1136/jme.2008.028035.

Abstract

AIMS AND BACKGROUND

Little is known about how participants perceive prevention trials, particularly trials designed to prevent mental illness. This study examined participants' motives for participating in a trial and their views of randomisation and the ability to withdraw from a randomised controlled trial (RCT) for prevention of depression.

METHODS

Participants were older adults reporting elevated depression symptoms (N = 900) living in urban and regional locations in Australia who had consented to participate in an RCT of interventions to prevent depression. Participants rated their agreement with various statements describing motivations for enrolment in the trial and opinions regarding randomisation and withdrawal.

RESULTS

The majority of participants expressed a triad of altruistic motivation for participation, relative lack of concern about randomisation and commitment to the trial. Certain subgroups of participants, such as women and those with higher depression scores, reported higher levels of concern about specific issues.

CONCLUSIONS

The findings suggest that participants enrolled in prevention trials for mental illness are likely to hold positive attitudes (eg, high commitment, low expectation of personal gain) towards research trials. The identification of relationships between key person factors and trial-related attitudes enabled profiling of participant groups, which can inform recruitment strategies and interactions of participants and research projects in future prevention trials.

摘要

目的和背景

对于参与者如何看待预防试验,尤其是旨在预防精神疾病的试验,我们知之甚少。本研究考察了参与者参与试验的动机,以及他们对随机化和从预防抑郁症的随机对照试验(RCT)中退出的看法。

方法

参与者为居住在澳大利亚城市和地区的报告有较高抑郁症状的老年人(N=900),他们同意参加预防抑郁症干预措施的 RCT。参与者对描述参与试验动机的各种陈述以及对随机化和退出的看法进行了评价。

结果

大多数参与者表示参与试验有三重利他动机,对随机化的关注相对较少,对试验有承诺。某些亚组参与者,如女性和抑郁评分较高者,报告对特定问题的关注度更高。

结论

研究结果表明,参加精神疾病预防试验的参与者可能对研究试验持有积极的态度(例如,高度的承诺、低个人收益预期)。关键个体因素与试验相关态度之间关系的确定,使参与者群体能够进行特征分析,从而为未来预防试验中的招募策略以及参与者和研究项目的互动提供信息。

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