一项关于 Truce 的研究方案：一项为期七周的接受和承诺疗法方案对有癌症父母的年轻人的实用对照试验。

A study protocol for Truce: a pragmatic controlled trial of a seven-week acceptance and commitment therapy program for young people who have a parent with cancer.

机构信息

Research, Evaluation and Social Policy, CanTeen, Sydney, Australia.

Cancer Nursing Research Unit, Faculty Nursing, University of Sydney, Sydney, Australia.

出版信息

BMC Psychol. 2015 Sep 9;3(1):31. doi: 10.1186/s40359-015-0087-y.

DOI:10.1186/s40359-015-0087-y

PMID:26353784

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4564955/

Abstract

BACKGROUND

This paper presents the rationale and study protocol for a pragmatic controlled effectiveness trial of Truce, a prevention-based selective intervention targeting the significant mental health needs of young people who have a parent with cancer.

METHODS/DESIGN: Truce is a seven week, facilitated, face-to-face group program. The design is a 2 groups (intervention vs control) x 3 (pre-treatment vs post-treatment vs 2 month follow-up) repeated measures. Allocation to groups will be dependent upon recruitment; when groups have sufficient numbers, they will be assigned to the intervention condition, but participants recruited without a viable group will be assigned to the wait-list control condition. Eligible participants are young people aged 14 to 22 years who have a parent diagnosed with cancer within the last 5 years. Wait-list controls are offered the opportunity to participate in the program once they have completed their follow-up questionnaires. The target sample size is 65 participants in each condition. The primary hypothesis is that participants in the intervention will show significant reductions in distress and increases in psychological well-being relative to participants in the wait-list control group, and these effects will continue through two-month follow-up. Mixed-models analysis of variance will be used to measure differences between the two conditions. Secondary analyses will focus on variables which may relate to the effectiveness of the intervention: ACT-related concepts of experiential avoidance and mindfulness, family functioning, unmet needs and demographic variables. We will also assess program fidelity and satisfaction.

DISCUSSION

The development and evaluation of a manualised intervention for young people with a parent with cancer responds to a gap in the provision of empirically-based psychological support for this vulnerable group.

TRIAL REGISTRATION

Australian and New Zealand Clinical Trials Registry ACTRN12615000761561. Registered 22(nd) July 2015.

摘要

背景

本文介绍了 Truce 的基本原理和研究方案，这是一项基于实用主义的对照有效性试验，针对有癌症患者父母的年轻人的重要心理健康需求，提供一种预防为导向的选择性干预措施。

方法/设计：Truce 是一个为期七周、由专业人员主持的面对面小组项目。设计采用 2 组（干预组与对照组）x 3 （治疗前、治疗后和 2 个月随访）重复测量的方式。分组将取决于招募情况；当各组有足够数量的参与者时，他们将被分配到干预组，但没有可行小组的参与者将被分配到等待名单对照组。符合条件的参与者是年龄在 14 至 22 岁之间、父母在过去 5 年内被诊断患有癌症的年轻人。等待名单对照组在完成随访问卷后将有机会参加该项目。目标样本量为每组 65 名参与者。主要假设是干预组的参与者在痛苦方面会显著减少，在心理幸福感方面会显著增加，而这些效果将持续到两个月的随访。混合模型方差分析将用于测量两组之间的差异。二级分析将侧重于可能与干预有效性相关的变量：接受性和正念的 ACT 相关概念、家庭功能、未满足的需求和人口统计学变量。我们还将评估计划的忠实度和满意度。