Attention-Bias Modification Treatment for PTSD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Primary Outcome: Clinician Administered PTSD Scale (CAPS)
研究概览
简要总结
Emerging research implicates biased attention to threat in the pathophysiology of anxiety disorders. Recent findings demonstrate significant associations between attention bias and stress vulnerability. This work has motivated the development of a novel therapy, attention-bias-modification (ABM) treatment . ABM is designed to implicitly modify patients' biased threat attendance via computerized training protocols. Emerging evidence indicates that ABM is effective in modifying threat-related attention biases and in ameliorating anxiety symptoms. However, it is unclear whether ABM is efficacious for posttraumatic stress disorder (PTSD). The present pilot study is a double blind trial that seeks to examine feasibility, acceptability, safety, efficacy, and risk/benefit ratio of ABM in individuals with PTSD. In addition this pilot study seeks to identify specific genes associated with anxiety disorders and to examine whether these can predict the success of the ABM.
详细描述
ABM is designed to implicitly modify patients' biased threat attendance via computerized training protocols. Emerging evidence indicates that ABM is effective in modifying threat-related attention biases and in ameliorating anxiety symptoms.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females between the ages of 18 and 60;
- •Current DSM-IV PTSD for the last 12 months or more;
- •Fluent in English and willing and able to give informed written consent and participate responsibly in the protocol;
- •Attention bias toward or away from threat assessed by Dot-probe attention bias task
排除标准
- •Current DSM-IV Axis I disorder other than PTSD.
- •Patients with comorbid (i.e., secondary diagnosis of) major depressive disorder (MDD) will be allowed for enrollment if their HAM-D score doesn't exceed 25;
- •Prior or current diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial, schizotypal, and schizoid personality disorders;
- •Suicidal ideation or behavior that poses a significant danger to the subject. Unstable clinical condition such that participation in a controlled trial would pose a significant danger;
- •Prior participation in attention bias modification treatment (ABMT);
- •Current or past history of seizure disorder (except febrile seizure in childhood);
- •Currently on psychotropic medication. (excluding the use of hypnotics);
- •Currently participating in formal psychotherapy. This includes:
- •psychodynamic,
- •cognitive behavioral and interpersonal therapies
- •Current unstable or untreated medical illness;
- •Vision loss.
结局指标
主要结局
Primary Outcome: Clinician Administered PTSD Scale (CAPS)
时间窗: 4 weeks
Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).
次要结局
- Secondary Outcome: PTSD Check List-Civilian (PCL-C)(4 weeks)
研究者
Yuval Y Neria
Professor of Medical Psychology and Director of Trauma and PTSD
Research Foundation for Mental Hygiene, Inc.