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临床试验/NCT04819230
NCT04819230Unknown不适用

Attention and Interpretation Bias Modification for Aggression Difficulties

Temple University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
45
试验地点
2
主要终点
Change in a Aggression from pretreatment to end of treatment (4 weeks later) and 1-month follow-up

研究概览

简要总结

This randomized controlled trial will test a computerized cognitive bias modification program (CBM) to treat attention and interpretive biases in patients with primary aggression.

详细描述

The objective of the proposed study is to test a computerized cognitive bias modification program (CBM) to treat attention and interpretive biases in patients with Intermittent Explosive Disorder, a disorder characterized by habitual engagement in aggressive behavior. Efficacy of the CBM program will be assessed via a small randomized controlled trial comparing CBM to a computerized control condition. This training program would consist of a four-week regimen of twice-weekly 30-minute sessions (8 sessions total) during which individuals would learn to: (a) focus attention away from threatening words toward neutral words [attention bias], and (b) to disambiguate ambiguous interpersonal scenarios using more benign, rather than threatening, interpretations [interpretive bias]. Participants will be asked to complete behavioral measures of attention bias and interpretive bias, as well as self-report measures of anger / aggression, interpretive bias, emotion regulation and life satisfaction at baseline (pre-training), post-training, and 1-month follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants in the control condition will see the same stimuli with a different contingency for correct vs incorrect response on the computerized training task (participant masking)

Outcome assessors will not be involved in administration of the intervention and will not be informed of participant condition (outcomes assessor masking)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Meet DSM-5 criteria for current IED, as assessed via phone screen and confirmed during an in-person diagnostic interview conducted during visit one of the study
  • Are able and willing to cooperate with study protocol; i.e. keep appointments, read and understand consent form, etc.
  • Have written and verbal English proficiency for understanding consent and study materials

排除标准

  • Have a lifetime history of psychosis
  • Have current moderate to severe substance use disorder
  • Have a history of bipolar disorder
  • Have current major depressive disorder
  • Are younger than 18 or older than 55 years old
  • Are currently (past month) receiving treatment for anger or aggression
  • Recently (past month) started or changed psychotropic medications

结局指标

主要结局

Change in a Aggression from pretreatment to end of treatment (4 weeks later) and 1-month follow-up

时间窗: preatment, post-treatment (4 weeks later) and 1-month follow-up. Total of 2 months

Overt Aggression Scale-Modified (higher score means more aggression)

Change in a Anger from pretreatment to end of treatment (4 weeks later) and 1-month follow-up

时间窗: pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months

State-Trait Anger Expression Inventory-2:state anger scale modified(higher score means more anger)

Change in Social Information Processing from pretreatment to end of treatment (4 weeks later) and 1-month follow-up

时间窗: pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months

Social Information Processing - Attribution and Emotional Response Questionnaire

次要结局

  • Change in Emotion Regulation from pretreatment to end of treatment (4 weeks later) and 1-month follow-up(pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months)
  • Change in IED diagnosis from pretreatment to end of treatment (4 weeks later) and 1-month follow-up(pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael McCloskey

Professor

Temple University

研究点 (2)

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