Pilot Randomized Trial of Compassionate Care: A Single-Session Web-Based Training in Self-Compassion Among Adults With Stress, Anxiety, and/or Depressive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 365
- 试验地点
- 2
- 主要终点
- Change in Stress 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 Compassionate Care versus a control intervention (nature videos with relaxing music) for adults with moderate-to-severe stress, depression and/or anxiety symptoms.
详细描述
Procedures include completing: (1) pre-intervention baseline assessment; (2) one of two single-session web-based intervention (approximately 30 to 45 minutes each); (3) a brief post-intervention survey; 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
- Double (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
- 是
入选标准
- •18 years of age or older
- •Fluent in English
- •At least moderate stress, anxiety and/or depressive symptoms, as indicated by a score of:
- •14 or higher on the PSS-10, and/or 10 or higher on the GAD-7, and/or 10 or higher on the PHQ-9
排除标准
- •Fail to meet above-listed inclusion criteria
- •Do not pass attention/data quality checks in initial screening or study assessments, including:
- •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 an average of 1.5 seconds per question for the baseline survey assessment OR who fail all three attention check questions in the baseline survey, indicating very careless, random, inattentive and/or hasty responding
- •Exit the study prior to condition randomization
结局指标
主要结局
Change in Stress symptoms
时间窗: Baseline to 2-week follow-up
Perceived Stress Scale (PSS-10). Total scores range from 0 to 40 with higher scores indicating greater stress symptoms
Change in Depressive symptoms
时间窗: Baseline to 2-week follow-up
Patient Health Questionnaire-9 (PHQ-9). Total scores range from 0 to 27, with higher scores indicating greater depressive symptoms.
Change in Functional Impairment
时间窗: Baseline to 2-week follow-up
Work and Social Adjustment Scale (WSAS). Total scores range from 0 to 40, with higher scores indicating greater functional impairment.
Change in Anxiety symptoms
时间窗: Baseline to 2-week follow-up
General Anxiety Disorder-7 (GAD-7). Total scores range from 0 to 21, with higher scores indicating greater anxiety symptoms.
次要结局
- Change in Mindfulness(Baseline to 2-week follow-up)
- Change in Self-Compassion(Baseline to 2-week follow-up)