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临床试验/NCT04060940
NCT04060940已完成不适用

Emotion Regulation Therapy for Young Adults With Clinical Worry and Rumination

Douglas Mennin1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2015年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Changes in Worry

研究概览

简要总结

The present project aims to broaden our understanding of neural mechanisms which may underlie change in symptoms occurring over the course of Emotion Regulation Therapy. Specifically, we aim to examine neural changes as a result of either an 8-session or 16-session version of the treatment.

详细描述

This study aims to examine the utility of Emotion Regulation Training (ERT) in reducing symptoms of anxiety and/or depression in young adults aged 18 to 29 years old. Additionally, we are interested in assessing neural, cardiac, and immunological changes associated with psychological symptom reduction in these individuals. Lastly, we are interested in examining whether an abbreviated 8-session version of ERT produces similar results to a longer (16-session) version of ERT.

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
None

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-29 years during the time of participation
  • Meets diagnostic criteria for an anxiety and/or depressive disorder
  • Endorses significant worry and/or rumination

排除标准

  • Active suicidal intent
  • Current substance dependence disorder (within the past year)
  • Current or past psychotic disorder, bipolar-I disorder, or dementia
  • Not currently received any other form of psychosocial treatment
  • Not being on a stabilized dose of medication (less than 3 months) during enrollment
  • Pregnancy or plans to become pregnant during active participation
  • Irremovable metal objects in the body
  • Neurological disorder, traumatic brain injury, or loss of consciousness
  • Tattoos if/when posing risks for involvement in the MRI component of the study

结局指标

主要结局

Changes in Worry

时间窗: Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

Penn State Worry Questionnaire (PSWQ)

Changes in Rumination

时间窗: Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

Rumination-Reflection Questionnaire (RRQ)

Changes in Functional Impairment

时间窗: Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

Sheehan Disability Scale (SDS)

Changes in Life Satisfaction

时间窗: Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

Quality of Life Inventory (QOLI)

Changes in Diagnostic Criteria, Severity, and Improvement

时间窗: Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

Structured Clinical Interview for DSM-IV-TR; Clinical Severity Ratings from Anxiety Disorders Interview Schedule, Lifetime version for DSM-IV

次要结局

  • Model-Related Changes: Attention Regulation(Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up)
  • Model-Related Changes: Metacognitive Regulation(Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up)
  • Changes in Anxiety and Depression(Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up)

研究者

发起方
Douglas Mennin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Douglas Mennin

Professor of Clinical Psychology

Teachers College, Columbia University

研究点 (1)

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