Audio-based Mental Health Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Change in symptoms of depression
研究概览
简要总结
This is a study on an audio-based digital intervention designed to reduce symptoms of depression. Participants who experience at least moderate symptoms of depression will be invited to participate in the study. Participants will be randomly assigned to receive one of two audio-based digital interventions. The experimental intervention based on behavioral activation treatment for depression. The control intervention is based on self-monitoring. Depression symptoms and related mental health symptoms, as well as experiences with the intervention, will be assessed at baseline (pre-randomization), mid-intervention (1 week post-randomization), post-intervention (2 weeks post-randomization) and follow-up (5 weeks post-randomization)
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
- None
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
- •Adult age 18 or older
- •Score in the moderate or higher range on the BDI-FastScreen
- •Moderate or higher depression confirmed by DIAMOND interview
- •Proficient English reading, writing, and speaking ability
- •Able to provide consent
- •Provide informed consent
排除标准
- •Below 18 years of age
- •Score below the moderate range on the BDI-FastScreen
- •DIAMOND interview does not confirm moderate or higher depression
- •Unable to read, write, and speak in English
- •Unable to provide consent
- •Do not provide informed consent
研究组 & 干预措施
Audio-based behavioral activation intervention
This intervention consists of two audio-based sessions delivered one week apart. The first session lasts approximately 30 minutes, and the second session lasts approximately 15 minutes. The sessions are audio recordings. The first session introduces behavioral activation and provides instruction for how to schedule and engage in positively reinforcing activities. The second session recaps the principles of behavioral activation and guides participants through methods of troubleshooting. After each session, participants are asked to create an activity schedule for the coming week. Then, each day in the week following each session, participants receive an email with a survey asking them to report on their activity and mood in the previous day.
干预措施: Audio-based behavioral activation intervention (Device)
Audio-based self-monitoring intervention
This intervention consists of two audio-based sessions delivered one week apart. The first session lasts approximately 30 minutes, and the second session lasts approximately 15 minutes. The sessions are audio recordings. The first session introduces information about emotion and provides instruction for how to track emotion using self-monitoring. The second session provides more information about emotion and recaps instructions for self-monitoring. Each day in the week following each session, participants receive an email with a survey asking them to report on their mood in the previous day.
干预措施: Audio-based self-monitoring intervention (Device)
结局指标
主要结局
Change in symptoms of depression
时间窗: Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.
Change in symptoms of depression as measured by Beck Depression Inventory-FastScreen (7 items, possible range = 0-21)
次要结局
- Change in negative affect(Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.)
- Change in symptoms of depression(Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.)
- Change in positive affect(Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.)
- Change in symptoms of depression, anxiety, and stress(Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.)
- Change in behavioral activation(Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.)
研究者
Michelle G. Newman
Professor
Penn State University