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临床试验/NCT05779761
NCT05779761招募中不适用

A Randomized Controlled Trial of Brief Interventions for Coping with Distress

Teachers College, Columbia University2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年5月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
2
主要终点
Changes in Ability to Distancing From Emotional Experience: Experiences Questionnaire (EQ)

研究概览

简要总结

This study is being done to compare the effectiveness of three different skills trainings to cope with distress. These three trainings are: 1) an attention skills training, 2) an attention and reflective thought skills training, and 3) a health and wellness education training.

详细描述

Adults living in New York City between the ages of 18-65 and experiencing elevated levels of worry, rumination, and/or self-criticism may be eligible to participate. After being informed about the study and potential risks, participants giving written informed consent will complete an online screening visit to determine full study eligibility. Eligible participant will then be randomized to complete 6-weeks of one of three self-directed, online skills training about coping with distress.

The present study is evaluating whether these skills trainings demonstrate efficacy in: 1) improving outcomes specific to an emotion regulation model of emotional distress (e.g., attentional control, decentering, reappraisal); 2) reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination). Primary assessment points will take place before and after the skills training, and will include self-report measures, brief surveys during daily life, as well as computer tasks and measures of brain and body activity (e.g., EEG).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 18 and 65
  • Fluent in English (and therefore able to provide consent)
  • Currently living in New York City
  • Access to a smartphone and the internet
  • High self-reported worry, rumination, and/or self-criticism
  • Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for at least one, current psychological disorder

排除标准

  • Active suicidal ideation or intent
  • Substance dependence disorder, schizophrenia, bipolar-I disorder, or a primary DSM-5 diagnosis of borderline or narcissistic personality disorder
  • Individuals currently receiving therapy or psychosocial treatment who do not plan to continue with the same treatment throughout the study period
  • Individuals taking psychotropic mediation that has not been stabilized for a period of at least 3 months
  • Current students at Teachers College, Columbia University
  • Individuals with cardiac conditions, diagnosed hyperhidrosis, and traumatic brain injuries or other neurological conditions (e.g., dementia, Parkinson's, epilepsy)

结局指标

主要结局

Changes in Ability to Distancing From Emotional Experience: Experiences Questionnaire (EQ)

时间窗: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up

Changes in Positive and Negative Emotions: Modified Differential Emotions Scale (mDES)

时间窗: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up

Changes in Ability to Regulate Attention: Attentional Control Scale (ACS)

时间窗: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up

Changes in Ability to Regulate Attention in Emotional Contexts: Emotional Attentional Control Scale (eACS)

时间窗: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up

Changes in Ability to Regulate Emotions: Emotion Regulation Questionnaire (ERQ)

时间窗: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up

Changes in Approach-Avoidance Motivation: Mental Representation of Approach Avoidance Questionnaire (MRAAQ)

时间窗: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up

Change in Behavioral Dysregulation: Behavioral Dysregulation Scale (BDRS)

时间窗: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up

次要结局

  • Changes in Functional Impairment: Sheehan Disability Scale (SDS)(Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up)
  • Changes in Worry: Penn State Worry Questionnaire (PSWQ)(Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up)
  • Changes in Mood and Anxiety Symptoms: Mood and Anxiety Symptoms Questionnaire (MASQ-90)(Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up)
  • Changes in Rumination: Rumination-Reflection Questionnaire (RRQ)(Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up)
  • Changes in Life Satisfaction: Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS)(Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up)
  • Changes in Self-Criticism: Self-Judgement Subscale of the Self-Compassion Scale (SCS)(Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up)
  • Changes in Valued Living/Action: Valuing Questionnaire (VQ)(Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up)
  • Satisfaction and Usability of Treatment: Client Satisfaction Questionnaire (CSQ)(Post-Training (6 weeks after starting the training))

研究者

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

Douglas Mennin

Professor of Clinical Psychology

Teachers College, Columbia University

研究点 (2)

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