Open Trial of Emotion Regulation Training Via Telehealth for Distressed Adults During the COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Changes in Life Satisfaction: Patient-Reported Outcomes Measurement Information System (PROMIS): Meaning and Purpose
研究概览
简要总结
This study is an open trial designed specifically to address the need for evidence-based treatment delivered via telehealth to individuals that are currently struggling with mental health issues during the COVID-19 pandemic, with the overarching goal of helping residents of New York adversely impacted by the pandemic to effectively manage their anxiety, stress, and depression during this unprecedented time in human history.
详细描述
The present study is evaluating whether this ERT treatment program delivered via telehealth demonstrates efficacy in: 1) reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination); 2) improving outcomes specific to the ERT mechanism-based model (e.g., attentional control, decentering, reappraisal); 3) improving quality of life and functioning, for adults aged 18-65 years old.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years during the time of participation
- •Endorses distress and worry/rumination exacerbated by the COVID-19 pandemic
- •Access to a mobile device (e.g., smartphone, personal computer, laptop, tablet) connected to the Internet
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
- •Primary DSM-5 diagnosis of borderline or narcissistic personality disorder
- •Currently receiving any other form of psychosocial treatment
结局指标
主要结局
Changes in Life Satisfaction: Patient-Reported Outcomes Measurement Information System (PROMIS): Meaning and Purpose
时间窗: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Scale = 1-5 (minimum = 4; maximum = 20; higher scores indicate better outcomes)
Changes in Worry: Penn State Worry Questionnaire (PSWQ)
时间窗: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Scale = 1-5 (minimum = 12; maximum = 60; higher scores indicate worse outcomes)
Changes in Rumination: Rumination-Reflection Questionnaire (RRQ)
时间窗: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Scale = 1-5 (minimum = 12; maximum = 60; higher scores indicate worse outcomes)
Changes in Functional Impairment: Sheehan Disability Scale (SDS)
时间窗: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Scale = 0-10 (minimum = 0; maximum = 30; higher scores indicate worse outcomes)
Changes in Life Satisfaction: Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS)
时间窗: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Scale = 1-6 (minimum = 5; maximum = 30; higher scores indicate better outcomes)
Changes in Anxiety, Depression, and Distress: Mood and Anxiety Symptoms Questionnaire (MASQ)
时间窗: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Scale = 1-5 (minimum = 30; maximum = 150; higher scores indicate worse outcomes)
Changes in Anxiety, Depression, and Distress: Depression Anxiety Stress Scale (DASS)
时间窗: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Scale = 0-4 (minimum = 0; maximum = 84; higher scores indicate worse outcomes)
次要结局
- Satisfaction and Usability of Treatment: Client Satisfaction Questionnaire (CSQ)(Post-Treatment (4-5 weeks after starting treatment))
- Semi-Weekly Measures of Treatment Changes in Distress(Semi-weekly over the course of four weeks)
- Semi-Weekly Measures of Treatment Changes in Rumination: Brief Rumination-Reflection Questionnaire (RRQ)(Semi-weekly over the course of four weeks)
- Semi-Weekly Measures of Treatment Changes in Metacognitive Regulation: Emotion Regulation Questionnaire (ERQ)(Semi-weekly over the course of four weeks)
- Semi-Weekly Measures of Treatment Changes in Metacognitive Regulation: Experiences Questionnaire (EQ)(Semi-weekly over the course of four weeks)
- Semi-Weekly Measures of Treatment Changes in Attentional Regulation: The Attentional Control Scale (ACS)(Semi-weekly over the course of four weeks)
- Semi-Weekly Measures of Treatment Changes in Depression: Patient-Reported Outcomes Measurement Information System (PROMIS): Depression(Semi-weekly over the course of four weeks)
- Semi-Weekly Measures of Treatment Changes in Depression Symptoms(Semi-weekly over the course of four weeks)
- Semi-Weekly Measures of Treatment Changes in Worry: Brief Penn State Worry Questionnaire (PSWQ)(Semi-weekly over the course of four weeks)
- Semi-Weekly Measures of Treatment Changes in Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS): Anxiety(Semi-weekly over the course of four weeks)
研究者
Douglas Mennin
Professor of Clinical Psychology
Teachers College, Columbia University