Assessing the Effectiveness of Acceptance and Commitment Therapy for Distress Following Psychosis (PACT)
2010年11月8日 更新者:University of Glasgow
A Pilot Randomised Controlled Trial of Acceptance and Commitment Therapy for Distress Following Psychosis
This research investigates a new talking therapy aimed at helping people to come to terms with the experience of psychosis. The new therapy is called Acceptance and Commitment Therapy for psychosis (PACT). PACT aims to help people:
- Develop a sense of "mindfulness." Mindfulness allows you to be fully aware of your here-and-now experience, with an attitude of openness and curiosity. It is hoped that this will help reduce the impact of painful thoughts and feelings.
- Take effective action that is conscious and deliberate, rather than impulsive. It is hoped that this will allow people to be motivated, guided, and inspired by the things that they value in life.
It is hoped that PACT will help to reduce the level of distress that individuals diagnosed with psychosis have been experiencing and help them to stay well in the future.
研究概览
详细说明
Emphasis has been placed on treating the 'positive symptoms' of psychosis (e.g.
hallucinations and delusions).
Concordance rates with anti-psychotic medication can be low.
Even when positive symptoms are successfully treated, emotional distress can remain e.g.
depression, anxiety and trauma.
Relapse occurs in up to two thirds of patients within two years of the first episode.
The treatment of subsequent episodes has been shown to be progressively less efficacious.
Research has shown that fear of recurrence patients can experience following psychosis is predictive of relapse.
Randomised clinical trials have found that Cognitive Behaviour Therapy (CBTp) is efficacious for treating residual distressing positive and negative symptoms.
However, the evidence for treating emotional dysfunction (e.g.
social anxiety, post-psychotic depression) is less clear.
Acceptance and Commitment Therapy (ACT) incorporates acceptance and mindfulness elements into a CBT framework.
Rather than altering the content or frequency of cognitions, ACT seeks to alter the individual's psychological relationship with thoughts, feelings and sensations to promote psychological flexibility.
This research will be a pilot randomised control trial of ACT for treating distress following psychosis.
This pilot study will establish (a) whether a larger scale multi-centre randomised controlled trial is warranted, (b) the acceptability of Acceptance and Commitment Therapy (c) the expected primary and secondary outcomes for such a trial and (d) the sample size required to detect such outcomes.
It is hypothesised that ACT plus treatment as usual will be associated with a greater reduction in levels of distress than treatment as usual only.
研究类型
介入性
注册 (实际的)
27
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Scotland
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Glasgow、Scotland、英国、G3 8YZ
- Greater Glasgow and Clyde NHS
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Participants will meet DSM-IV-TR (APA, 2000) criteria for a psychotic disorder determined by a diagnosis of a psychotic disorder (i.e., Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder, Brief Psychotic Disorder, Psychotic Disorder NOS) or Bipolar Disorder (with psychotic features).
- Participants will also be aged 18-65
Exclusion Criteria:
Participants will be excluded if there is a
- diagnosis of learning disability
- inability to participate in psychotherapy/research due to acute medical condition or florid psychosis (as defined by a score of 5 or over on the Positive Syndrome scale of the PANSS)
- psychotic symptoms due to a general medical condition
- they are receiving a systematic psychological therapy at the point of recruitment/randomization.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:Treatment As Usual
Treatment as usual as determined by the clinical team responsible for the individual's care
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有源比较器:Acceptance and Commitment Therapy
Up to 10 sessions of Acceptance and Commitment Therapy plus treatment as usual
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Up to 10 sessions of a psychological therapy called Acceptance and Commitment Therapy
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Measuring change in depression and anxiety
大体时间:Baseline and 3 month follow-up
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The Hospital Anxiety and Depression Scale
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Baseline and 3 month follow-up
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Changes in believability, distress and frequency of positive symptoms
大体时间:Baseline and up to 9 months follow-up
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Baseline and up to 9 months follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Measuring change in mindfulness skills and psychological flexibility
大体时间:Baseline and up to 9 month follow-up
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The Kentucky Inventory of Mindfulness Skills, The Acceptance and Action Questionnaire
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Baseline and up to 9 month follow-up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Ross G White, BSc, PhD, DClinPsy、University of Glasgow
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Bach P, Hayes SC. The use of acceptance and commitment therapy to prevent the rehospitalization of psychotic patients: a randomized controlled trial. J Consult Clin Psychol. 2002 Oct;70(5):1129-39. doi: 10.1037//0022-006x.70.5.1129.
- Gaudiano BA, Herbert JD. Acute treatment of inpatients with psychotic symptoms using Acceptance and Commitment Therapy: pilot results. Behav Res Ther. 2006 Mar;44(3):415-37. doi: 10.1016/j.brat.2005.02.007. Erratum In: Behav Res Ther. 2020 Jan;124:103534.
- Hayes, S.C., Strosahl, K. and Wilson, K.G. (1999). Acceptance and Commitment Therapy: An experiential approach to behavior change, The Guilford Press, New York
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年10月1日
初级完成 (实际的)
2010年10月1日
研究完成 (实际的)
2010年10月1日
研究注册日期
首次提交
2009年10月27日
首先提交符合 QC 标准的
2009年10月27日
首次发布 (估计)
2009年10月28日
研究记录更新
最后更新发布 (估计)
2010年11月9日
上次提交的符合 QC 标准的更新
2010年11月8日
最后验证
2010年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.