针对幻听的相关疗法(R2V研究):一项初步随机对照试验的研究方案

Relating therapy for voices (the R2V study): study protocol for a pilot randomized controlled trial.

作者信息

Hayward Mark, Strauss Clara, Bogen-Johnston Leanne

机构信息

School of Psychology, University of Sussex, BN1 9RH Brighton, UK.

出版信息

Trials. 2014 Aug 16;15:325. doi: 10.1186/1745-6215-15-325.

Abstract

BACKGROUND

Evidence exists for the effectiveness of cognitive behaviour therapy for psychosis with moderate effect sizes, but the evidence for cognitive behaviour therapy specifically for distressing voices is less convincing. An alternative symptom-based approach may be warranted and a body of literature has explored distressing voices from an interpersonal perspective. This literature has informed the development of relating therapy and findings from a case series suggested that this intervention was acceptable to hearers and therapists.

METHODS/DESIGN: An external pilot randomized controlled trial (RCT) comparing outcomes for 15 patients receiving 16 hours (weekly sessions of one hour) of relating therapy and their usual treatment with 15 patients receiving only their usual treatment. Participants will be assessed using questionnaires at baseline, 16 weeks (post-intervention), and 36 weeks (follow-up).

DISCUSSION

Expected outcomes will include a refined study protocol and an estimate of the effect size to inform the sample size of a definitive RCT. If evidence from a fully powered RCT suggests that relating therapy is effective, the therapy will extend the range of evidence-based psychological therapies available to people who hear distressing voices.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN registration number 44114663. Registered on 13 June 2013.

摘要

背景

有证据表明认知行为疗法对治疗精神病有效,效应量中等,但专门针对困扰性幻听的认知行为疗法的证据说服力较弱。可能需要一种基于症状的替代方法,并且有大量文献从人际角度探讨了困扰性幻听。这些文献为关系疗法的发展提供了参考,一个病例系列的研究结果表明,这种干预对幻听者和治疗师来说是可以接受的。

方法/设计:一项外部预试验随机对照试验(RCT),比较15名接受16小时(每周一次,每次一小时)关系疗法及常规治疗的患者与15名仅接受常规治疗的患者的治疗效果。将在基线、16周(干预后)和36周(随访)时使用问卷对参与者进行评估。

讨论

预期结果将包括完善的研究方案和效应量估计,以为确定性RCT的样本量提供参考。如果来自充分有力的RCT证据表明关系疗法有效,该疗法将扩大为有困扰性幻听的人提供的循证心理疗法的范围。

试验注册

当前受控试验ISRCTN注册号44114663。于2013年6月13日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93ca/4150948/773f1929bbcd/13063_2014_2205_Fig1_HTML.jpg

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