Cognitive Behavioral Social Skills Training for Youth at Risk of Psychosis
2022年5月17日 更新者:Jean Addington, PhD、University of Calgary
Schizophrenia and other psychotic disorders are serious and debilitating mental illnesses that incur substantial suffering for patients and major challenges to the investigators health care and legal systems.
The prodrome is the period prior to onset of psychosis when functional decline and clinical symptoms gradually emerge.
The presence of a clinical high-risk (CHR) syndrome in young adults is associated with heightened risk (25-35%) for the later development of psychosis, and for those who do not necessarily go on to develop a psychotic illness, research has suggested that the majority continue to have fluctuating subthreshold symptoms and poor social and role functioning.
There are no specific treatments to help with these functional difficulties.
However, recent findings suggest that in people with schizophrenia, Cognitive Behavioral and Social Skills Training (CBSST) leads to significantly greater increase in the frequency of social functioning activities compared to treatment as usual or goal-focused supportive therapy, and preliminary data suggest CBSST is a feasible treatment for CHR.
This proposal is a competitive application for a three-site, longitudinal study aimed at testing the effectiveness and feasibility as well as mediators and mechanisms of action of a manualized CBSST intervention that will target functional difficulties associated with clinical risk states for psychosis.
The goals are 1) to examine whether CBSST compared to a placebo intervention (psychoeducation) matched for group involvement and therapist time improves functioning in youth at CHR and 2) to determine whether reduction in defeatist beliefs and improvement in social competence mediate change in psychosocial functioning in CHR youth in the CBSST.
In this single-blind randomized 2-arm trial participants will be randomized to one of two treatments: CBSST, an 18-week group comprised of three modules; 1) Cognitive Skills; 2) Social Skills; and 3) Problem Solving, or a psychoeducation support group that does not teach active cognitive behavioral therapy or social skills training.
Over a five-year period, the multi-site collaboration will follow large CHR sample that will undergo comprehensive assessments of psychosocial and behavioral changes, to examine changes in social and role functioning, as well as symptom changes from baseline to the end of treatment, and to 6 month follow-up.
This approach will demonstrate the feasibility of a treatment for which it is easy to train therapists and which can readily be disseminated to regular clinical community practice.
In addition, it will provide insights into likely approaches to halting or mitigating the pathological process and advance the investigators understanding of risk prediction; both critical steps in prevention.
研究概览
研究类型
介入性
注册 (实际的)
203
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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Alberta
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Calgary、Alberta、加拿大、T2N4Z6
- Mathison Centre for Research and Education, University of Calgary
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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
14年 至 30年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- have prodromal criteria in the past 4 years
- one attenuated psychotic symptom rated 3 or more
- rating on social functioning <6
Exclusion Criteria:
- meet criteria for a psychotic disorder neurological disorder IQ<70
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:单组作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Cognitive behavioral social skills
In Cognitive behavioral social skills training (CBSST), skills-based CBT is used to teach individuals how to correct inaccurate dysfunctional thoughts that interfere with goal-directed activities, including defeatist expectancies, low self-efficacy beliefs, and anomalous beliefs.
SST focuses on behaviorally-based instruction of interpersonal social skills, utilizing role-modeling, rehearsal, corrective feedback, and positive reinforcement to facilitate learning.
In the modified version of CBSST used in this project: 1) we will strengthen the focus on corrective feedback from successful social interactions; 2) focus on normalization and destigmatization of attenuated psychotic symptoms; 3) add motivational interviewing techniques to promote treatment engagement; and 4) use examples and role plays.
CBSST will be delivered in three 6-session modules (i.e., Cognitive Skills, Social Skills, and Problem Solving Skills), a total of 18 90-minute group sessions.
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有源比较器:Psychoeducation
The purpose of this alternative treatment is to match CBSST for the nonspecific effects of therapist contact and interest, social interaction and support.
Common factors include client expectancy, providing a rationale for change, therapist factors and therapeutic alliance.
The psychoeducation group will meet weekly, for a total of 18 90-minute sessions.
Therapists will follow brief guidelines as to what they can and cannot do.
In each session the therapists will ask how the previous week had been.
Any crises will be dealt with, and advice will be offered to help with any immediate problems.
No active CBT or SST techniques will be taught or used.
Psychoeducational information about high risk for psychosis will be offered.
There will be a focus on listening, reflecting and empathizing, and demonstrating uncritical acceptance and genuineness.
Social exchanges amongst participants will be encouraged.
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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 |
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Change in the Global Social Functioning Scale
大体时间:6 and 12 months
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This is a clinical rating scale that will be given to all participants at baseline, then 6 months which is the end of treatment and then 6 months after the end of treatment so approximately 12 months after baseline to determine if there is an improvement in social functioning
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6 and 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change in Defeatist Beliefs
大体时间:6 and 12 months
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This is a clinical rating scale that will be administer at the end of treatment (6 months) and 6 months after the end of treatment (12 months).
This will be administered to all participants
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6 and 12 months
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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:Jean M Addington, PhD、University Of Calgary
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
2015年1月1日
初级完成 (实际的)
2021年8月1日
研究完成 (实际的)
2021年8月1日
研究注册日期
首次提交
2014年9月3日
首先提交符合 QC 标准的
2014年9月8日
首次发布 (估计)
2014年9月9日
研究记录更新
最后更新发布 (实际的)
2022年5月24日
上次提交的符合 QC 标准的更新
2022年5月17日
最后验证
2022年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- MH105178
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.