Thomas Neil, Shawyer Frances, Castle David J, Copolov David, Hayes Steven C, Farhall John
School of Psychological Science, La Trobe University, Melbourne, Victoria 3086, Australia.
BMC Psychiatry. 2014 Jul 11;14:198. doi: 10.1186/1471-244X-14-198.
Cognitive behavior therapy for psychosis has been a prominent intervention in the psychological treatment of psychosis. It is, however, a challenging therapy to deliver and, in the context of increasingly rigorous trials, recent reviews have tempered initial enthusiasm about its effectiveness in improving clinical outcomes. Acceptance and commitment therapy shows promise as a briefer, more easily implemented therapy but has not yet been rigorously evaluated in the context of psychosis. The purpose of this trial is to evaluate whether Acceptance and Commitment Therapy could reduce the distress and disability associated with psychotic symptoms in a sample of community-residing patients with chronic medication-resistant symptoms.
METHODS/DESIGN: This is a single (rater)-blind multi-centre randomised controlled trial comparing Acceptance and Commitment Therapy with an active comparison condition, Befriending. Eligible participants have current residual hallucinations or delusions with associated distress or disability which have been present continuously over the past six months despite therapeutic doses of antipsychotic medication. Following baseline assessment, participants are randomly allocated to treatment condition with blinded, post-treatment assessments conducted at the end of treatment and at 6 months follow-up. The primary outcome is overall mental state as measured using the Positive and Negative Syndrome Scale. Secondary outcomes include preoccupation, conviction, distress and disruption to life associated with symptoms as measured by the Psychotic Symptom Rating Scales, as well as social functioning and service utilisation. The main analyses will be by intention-to-treat using mixed-model repeated measures with non-parametric methods employed if required. The model of change underpinning ACT will be tested using mediation analyses.
This protocol describes the first randomised controlled trial of Acceptance and commitment therapy in chronic medication-resistant psychosis with an active comparison condition. The rigor of the design will provide an important test of its action and efficacy in this population.
Australian New Zealand Clinical Trials Registry: ACTRN12608000210370. Date registered: 18 April 2008.
针对精神病的认知行为疗法一直是精神病心理治疗中的一项重要干预措施。然而，实施该疗法具有挑战性，并且在越来越严格的试验背景下，近期的综述已减弱了最初对其改善临床结局有效性的热情。接纳与承诺疗法有望成为一种更简短、更易于实施的疗法，但尚未在精神病背景下进行严格评估。本试验的目的是评估接纳与承诺疗法能否减轻社区居住的慢性药物抵抗性症状患者样本中与精神病症状相关的痛苦和残疾。
方法/设计：这是一项单（评估者）盲多中心随机对照试验，将接纳与承诺疗法与积极对照条件“交友疗法”进行比较。符合条件的参与者目前存在残留幻觉或妄想，并伴有痛苦或残疾，尽管服用了治疗剂量的抗精神病药物，但在过去六个月中这些症状持续存在。在基线评估后，参与者被随机分配到治疗组，治疗结束时和6个月随访时进行盲法的治疗后评估。主要结局是使用阳性和阴性症状量表测量的总体精神状态。次要结局包括通过精神病症状评定量表测量的与症状相关的专注、坚信、痛苦和生活干扰，以及社会功能和服务利用情况。主要分析将采用意向性分析，使用混合模型重复测量，必要时采用非参数方法。将使用中介分析检验接纳与承诺疗法的潜在变化模型。
本方案描述了第一项针对慢性药物抵抗性精神病的接纳与承诺疗法随机对照试验，并设有积极对照条件。该设计的严谨性将为其在该人群中的作用和疗效提供重要检验。
澳大利亚新西兰临床试验注册中心：ACTRN12608000210370。注册日期：2008年4月18日。
