Using Mobile Phones to Reduce Negative Rumination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in Rumination focus ( immediately after intervention)
研究概览
简要总结
This clinical trial intends to study the efficacy of a mobile phone delivered intervention in reducing depression-related rumination.
详细描述
Here we propose to test a novel intervention to help individuals manage their depressive rumination. The intervention is based on a just-in-time, adaptive-intervention (JITAI) design. A JITAI is "an intervention designed to address the dynamically changing needs of individuals via the provision of the type/amount of support needed, at the right time, and only when needed ." This study is also to address one major concern regarding designing JITAI interventions: the burden on participants in having to be engaged with the intervention through diaries, self-reports, and other forms of assessment procedures daily. To reduce this burden, we first pilot test an interactive narrative form. An interactive narrative is an essential form of storytelling that involves certain interactive features such that audiences or readers of the story can have the feeling that they are actively engaging in certain forms of interactions with the story characters.
To test the efficacy of such an intervention, there will be a one-month three-arm clinical control trial to reduce depressive rumination. There are three conditions: a JITAI interactive narrative condition, a non-narrative JTIAI condition, and a wait-list control condition. This study could contribute to our knowledge in designing more effective interventions in curbing depression using mobile technology. It can also advance our theoretical knowledge of the role of interactive narratives in reducing user burden in mobile health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participant blind to condition assigned to (compared to alternatives), assignment is automatic/random via computer so investigator blind to participant assignment; analyst is blind to meaning of condition codes.
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
- •Participants who have a current self-reported clinical diagnosis of being depressed ( mild to moderate depression and major depressive disorder)
- •Participants should be 18 or older.
- •Participants should have a working smartphone and daily access to the internet.
排除标准
- •Participants who do not have regular access to the internet and a smart phones will be excluded.
结局指标
主要结局
Change in Rumination focus ( immediately after intervention)
时间窗: Change in Rumination focus at the baseline and immediate-post intervention (measured baseline, immediate-post intervention, and two-week follow-up).
Momentary Ruminative Self-Focus Inventory-Abbreviated (MRSI-A). The MRSI is a 6-item questionnaire measuring state-level fluctuations in ruminative self-focus. Each item ranges from 1 (Strongly disagree) to 7 (Strongly agree).
Change in Depressive Symptoms (baseline and two weeks after intervention.)
时间窗: Change in depressive symptoms at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up).
a 3-item scale in which participants rated their level of depressed mood, anhedonia, and irritability on 7-point Likert scales ranging from 1 (Not at all) to 7 (Very much) at the time of the alert. The SDS is in part modeled after a scale used in a previous EMA study of rumination and depression (Moberly \& Watkins, 2008a). The scale was presented as a slider bar on participants' smartphones."
Change in Heart-rate( baseline and immediately after intervention)
时间窗: Change in heart rates at the baseline and immediate-post intervention .(measured baseline, immediate-post intervention, and two-week follow-up)
Participants self-report their heart-rate by using a moblie phone app by the name of Instant Heart rate (see example outcome report: https://www.azumio.com/heartrate/report.jsp?token=28928192047-28935807244-3eb659-334dc9f600fc7084f8cda95b135396673b2bd118-1588095873083#)
Change in Rumination focus ( two weeks after intervention)
时间窗: Change in Rumination focus at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up).
Momentary Ruminative Self-Focus Inventory-Abbreviated (MRSI-A). The MRSI is a 6-item questionnaire measuring state-level fluctuations in ruminative self-focus. Each item ranges from 1 (Strongly disagree) to 7 (Strongly agree).
Change in Heart-rate (baseline and two weeks after intervention.)
时间窗: Change in heart rates at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up).
Participants self-report their heart-rate by using a moblie phone app by the name of Instant Heart rate (see example outcome report: https://www.azumio.com/heartrate/report.jsp?token=28928192047-28935807244-3eb659-334dc9f600fc7084f8cda95b135396673b2bd118-1588095873083#)
Change in Depressive Symptoms ( baseline and immediately after intervention)
时间窗: Change in depressive symptoms at the baseline and immediate-post intervention .(measured baseline, immediate-post intervention, and two-week follow-up)
a 3-item scale in which participants rated their level of depressed mood, anhedonia, and irritability on 7-point Likert scales ranging from 1 (Not at all) to 7 (Very much) at the time of the alert. The SDS is in part modeled after a scale used in a previous EMA study of rumination and depression (Moberly \& Watkins, 2008a). The scale was presented as a slider bar on participants' smartphones."
次要结局
未报告次要终点
研究者
Lynn Miller
Professor of Communication
University of Southern California