Pilot Randomized Trial of Visitor Mindset: A Single-Session Self-Guided Digital Intervention Targeting Emotional Awareness, Clarity, and Acceptance Among Adults With Anxiety and/or Depression Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 530
- 试验地点
- 2
- 主要终点
- Change in anxiety and depression symptoms
研究概览
简要总结
Two-arm, parallel group randomized clinical trial conducted via Mturk comparing a single-session web-based intervention called Visitor Mindset versus a control intervention (nature videos with relaxing music) for adults with depression and/or anxiety symptoms
详细描述
Procedures include completing: (1) pre-intervention assessments; (2) one of two single-session web-based intervention (approximately 30 to 45 minutes each); (3) post-intervention assessments, including survey questions following a negative affect induction (brief film clip); and (4) a 2-week follow-up assessment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years and older
- •English-speaking
- •At least mild anxiety and/or depression symptoms, as indicated by a score of 3 or greater on the 4-item Patient Health Questionnaire (PHQ-4)
排除标准
- •fail to meet above-listed inclusion criteria
- •exit the study prior to condition randomization
- •obvious lack of English fluency in open response questions
- •responding with random text in open response questions
- •respond with either copy/pasted responses from text earlier in the intervention to any of free response questions
- •participants with a completion time less than 180 seconds for the baseline survey assessment (taking about 1.5 seconds per question) OR who fail all three attention check questions in the baseline survey, indicating very careless, random, inattentive and/or hasty responding
结局指标
主要结局
Change in anxiety and depression symptoms
时间窗: Baseline to 2-week follow-up
Patient Health Questionnaire-Anxiety Depression Scale (PHQ-ADS). Total scores range from 0 to 27, with higher scores indicating greater anxiety/depression symptoms.
次要结局
- State emotional awareness, clarity, and acceptance following negative affect induction(Immediate post-intervention)
- State non-acceptance of emotions(Immediate post-intervention)
- Change over time in non-acceptance of emotions(Baseline to 2-week follow-up)
- Change over time in emotional awareness, clarity, and acceptance(Baseline to 2-week follow-up)
- Change over time in beliefs about the usefulness of negative emotions(Baseline to 2-week follow-up)
- Change over time in functional impairment(Baseline to 2-week follow-up)
- Change over time in beliefs about the duration of negative emotions(Baseline to 2-week follow-up)
研究者
Corey Roos
Assistant Professor of Psychiatry
Yale University