Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Treatment acceptability
研究概览
简要总结
Project RISE is a randomized control trial. The intervention consists of four modules that focus on multiple aspects of interoception including: body awareness, body sensations/movement, eating, health and self-care, emotional awareness, and understanding the self in relation to others. The comparator condition is called "Health Habits" and is matched for time and attention; participants complete modules related to healthy habits such as financial planning, hygiene, stretching, and healthy eating. Variables of interest include self-report measures of interoception, eating pathology, suicidality, physiological measures of interoception (electrocardiograph; ECG; pain tolerance measured via algometer), and an implicit association test (IAT) with death and life stimuli (meant to measure implicit associations with suicidality). The population will be college students, with current or past suicidality or low interoception.
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 (Participant, Investigator)
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
- 是
入选标准
- •Low interoceptive awareness
- •History of suicidal ideation or attempt
- •18 or older
排除标准
- •*Below the age of 18
结局指标
主要结局
Treatment acceptability
时间窗: within one week of Post-test
Feasibility and Acceptability questions. Scores range from 4-28. Higher scores indicate a better outcome.
Multidimensional Assessment of Interoceptive Awareness
时间窗: within one week of Post-test
Assessment of Interoceptive Awareness. Total scores range from 0-175. Higher scores indicate a better outcome.
次要结局
- Depression Screening Inventory-Suicidality Subscale(within one week of Post-test)
- Eating Disorder Examination Questionnaire(within one week of Post-test)
- Heartbeat perception task(within one week of Post-test)
- Brief Symptom Inventory(within one week of Post-test)
研究者
April Smith
Assistant Professor
Auburn University
