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心理促进治疗康复研究(PATH):一项随机对照试验的研究方案。

Psychological advocacy toward healing (PATH): study protocol for a randomized controlled trial.

机构信息

Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK.

出版信息

Trials. 2013 Jul 17;14:221. doi: 10.1186/1745-6215-14-221.

DOI:10.1186/1745-6215-14-221
PMID:23866771
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3718639/
Abstract

BACKGROUND

Domestic violence and abuse (DVA), defined as threatening behavior or abuse by adults who are intimate partners or family members, is a key public health and clinical priority. The prevalence of DVA in the United Kingdom and worldwide is high, and its impact on physical and mental health is detrimental and persistent. There is currently little support within healthcare settings for women experiencing DVA. Psychological problems in particular may be difficult to manage outside specialist services, as conventional forms of therapy such as counseling that do not address the violence may be ineffective or even harmful. The aim of this study is to assess the overall effectiveness and cost-effectiveness of a novel psychological intervention tailored specifically for survivors of DVA and delivered by domestic violence advocates based in third-sector organizations.

METHODS AND STUDY DESIGN

This study is an open, pragmatic, parallel group, individually randomized controlled trial. Women ages 16 years and older experiencing domestic violence are being enrolled and randomly allocated to receive usual DVA agency advocacy support (control) or usual DVA agency support plus psychological intervention (intervention). Those in the intervention group will receive eight specialist psychological advocacy (SPA) sessions weekly or fortnightly, with two follow-up sessions, 1 month and then 3 months later. This will be in addition to any advocacy support sessions each woman receives. Women in the control group will receive usual DVA agency support but no additional SPA sessions. The aim is to recruit 250 women to reach the target sample size. The primary outcomes are psychological well-being and depression severity at 1 yr from baseline, as measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) and the Patient Health Questionnaire (PHQ-9), respectively. Secondary outcome measures include anxiety, posttraumatic stress, severity and frequency of abuse, quality of life and cost-effectiveness of the intervention. Data from a subsample of women in both groups will contribute to a nested qualitative study with repeat interviews during the year of follow-up.

DISCUSSION

This study will contribute to the evidence base for management of the psychological needs of women experiencing DVA. The findings will have important implications for healthcare commissioners and providers, as well as third sector specialist DVA agencies providing services to this client group.

TRIAL REGISTRATION

ISRCTN58561170.

摘要

背景

家庭暴力和虐待(DVA)定义为亲密伴侣或家庭成员之间的威胁行为或虐待,是一个主要的公共卫生和临床重点。在英国和全球范围内,DVA 的患病率很高,其对身心健康的影响是有害且持久的。目前,医疗保健环境中几乎没有为遭受 DVA 的女性提供支持。特别是心理问题可能难以在专门服务之外得到管理,因为传统的治疗形式,如不解决暴力问题的咨询,可能无效甚至有害。本研究旨在评估专门针对 DVA 幸存者量身定制的新型心理干预措施的整体有效性和成本效益,该干预措施由第三部门组织中的家庭暴力倡导者提供。

方法和研究设计

这是一项开放、实用、平行组、个体随机对照试验。正在招募年龄在 16 岁及以上、遭受家庭暴力的女性,并随机分配接受常规 DVA 机构倡导支持(对照组)或常规 DVA 机构支持加心理干预(干预组)。干预组将每周或每两周接受 8 次专业心理倡导(SPA)会议,并在 1 个月和 3 个月后进行两次随访。这将是在每位女性接受的任何倡导支持会议之外进行的。对照组将接受常规 DVA 机构支持,但不接受额外的 SPA 会议。目标是招募 250 名女性以达到目标样本量。主要结局是从基线起 1 年时的心理健康和抑郁严重程度,分别通过临床结果在常规评估-结局测量量表(CORE-OM)和患者健康问卷(PHQ-9)进行评估。次要结局指标包括焦虑、创伤后应激、虐待的严重程度和频率、生活质量以及干预的成本效益。两组女性的子样本数据将为嵌套定性研究做出贡献,该研究将在随访的一年期间进行重复访谈。

讨论

本研究将为管理遭受 DVA 的女性的心理需求提供证据基础。研究结果将对医疗保健专员和提供者以及为这一客户群体提供服务的第三部门专业 DVA 机构产生重要影响。

试验注册

ISRCTN58561170。

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