跳至主要内容
临床试验/NCT03549455
NCT03549455已完成不适用

Augmenting Exposure Therapy With Self-Distancing

University of Michigan1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年8月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Acceptability of Self Distancing with exposure therapy

研究概览

简要总结

Anxiety is prevalent, impairing, and costly in childhood. Evidence-based treatments for pediatric anxiety exist; however, as many as 40-60% of youth do not demonstrate optimal response. By identifying psychological factors that potentiate symptom severity and treatment response, it may be possible to strengthen these factors to treat, or even prevent the development of youth emotional disorders.

This study aims to examine whether the combination of Exposure and Self-Distancing is a feasible, acceptable, and efficient intervention for increasing perseverance in the face of exposures. This will be measured by child and parent report of treatment acceptability, examination of attendance and dropout rates, as well as participant and therapist report of participant engagement during exposures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Parent or guardian willing to give informed consent to participate
  • •Children who give written or oral assent
  • •Ages 7 and older to under 18 years old
  • •Has a historical anxiety diagnosis (diagnosed within the last year either within a clinical or clinical research setting) and have moderate or greater levels of current anxiety symptoms
  • •Current or past history of elevated symptoms of depression, obsessive-compulsive disorder and posttraumatic stress are allowable, but anxiety must be the chief complaint
  • •No evidence of acute risk due to suicidal intentions or behaviors in the past 6 months.

排除标准

  • •Currently receiving cognitive behavioral therapy or any other form of psychotherapy
  • •Have elevated symptoms of bipolar I/II disorder, schizophrenia/schizoaffective disorder, schizophreniform disorder, psychosis Not otherwise specified (NOS), mental retardation, severe behavioral concerns, or autism
  • •History of current substance/alcohol abuse/dependence (Past history abuse is allowable if in remission for greater than 1 year)

研究组 & 干预措施

Exposure Therapy and Self Distancing

Experimental

All subjects will have 2 introduction sessions and then receive Exposure therapy with Self-Distancing (2 weeks) following Exposure therapy without Self-Distancing (2 weeks) followed by 2 more weeks of Exposure therapy with Self-Distancing.

干预措施: Exposure Therapy and Self Distancing (Behavioral)

结局指标

主要结局

Acceptability of Self Distancing with exposure therapy

时间窗: Week 8

Treatment Acceptability Questionnaire version for the child and parent. Five Item scale (a score of 1 indicates that the care was not at all acceptable and a score of 7 would indicate a high level of acceptability). The treatment will be determined to have adequate acceptability and self-reported feasibility if parent and child report mean values greater than or equal to 5.

Feasibility of Self Distancing based on treatment completion rates

时间窗: Week 8

Total number of sessions attended. Treatment will be determined to have adequate feasibility if participants attend, on average, greater than or equal to 70% of sessions, and high feasibility if participants attend, on average greater than or equal to 80% of sessions.

次要结局

  • Treatment adherence and engagement(Weeks 3, 4, 5, 6, 7, 8)
  • Change in anxiety severity(Screening, Week 8)
  • Change in Clinical Global Impressions - Severity and improvement scale (CGI)(Weeks, 1, 2, 3, 4, 5, 6, 7, 8)
  • Change in Clinical Global Impressions - Severity and improvement scale (CGI)(Screening, Weeks 1, 2, 3, 4, 5, 6, 7, 8)

研究者

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

Emily Bilek

Clinical Assistant Professor

University of Michigan

研究点 (1)

Loading locations...

相似试验

Augmenting Exposure Therapy With Self-Distancing | 临床试验