Evaluation of Text Message Engagement Support of Mindfulness Smartphone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Anxiety at Week 2 and Week 4
研究概览
简要总结
The aim of this study is to assess the usability of two mindfulness smartphone applications (apps) and to evaluate whether text message support can promote engagement with those apps through a 4-week trial comparing support vs. no support.
详细描述
Part one of this study is to conduct usability testing to understand more about the acceptability and usability of these existing mindfulness apps in a population with depression and anxiety. The goal of usability testing is to identify any usability problems, provide information for future app development, and determine the participant's satisfaction with the apps. Participants will then be randomized to receive either engagement support or no support which will be delivered via text messaging, and will be randomized to use one of the two mindfulness applications for the 4 week period. Specific Aim 2.1 is to evaluate any differences on outcome measures between the two mindfulness apps. Specific Aim 2.2 is to evaluate the differences of outcome measures between text message engagement support versus no support, regardless of the mindfulness app. For Aim 2.1, the investigators predict that all mindfulness apps will be capable of leading to improvements on outcome measures. For Aim 2.2, the investigators predict that the text message engagement support arm will engage more with the mindfulness app and will see greater improvements in outcome measures regardless of the mindfulness app.
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
- 否
入选标准
- •meet criteria for clinically significant distress caused by anxiety defined by a Generalized Anxiety Disorder-7 (GAD-7) greater than a 10 or clinically significant distress caused my depression defined by a Patient Health Questionnaire (PHQ-9) greater than 10
- •18 years of age or older;
- •fluent in English;
- •lives in the Chicago area and are able to attend and in person session;
- •own an internet ready smartphone with data and text plans.
排除标准
- •have visual, hearing, voice, or motor impairment that would prevent completion treatment procedures;
- •past or current diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, substance or alcohol abuse dependence, or other diagnosis for which participation in the trial would be dangerous;
- •suicidal, defined as a 1 or higher on item 9 of the Patient Health Questionnaire (PHQ-9);
- •adults unable to consent.
研究组 & 干预措施
Engagement Support
In the engagement support group, participants will be sent text messages that will encourage use of the app through tips, reminders, and encouraging messages.
干预措施: Headspace - Meditation and Mindfulness App (Behavioral)
Engagement Support
In the engagement support group, participants will be sent text messages that will encourage use of the app through tips, reminders, and encouraging messages.
干预措施: Stop, Breathe, & Think - Meditation and Mindfulness App (Behavioral)
No Engagement Support
Participants in this group will receive no text message support.
干预措施: Headspace - Meditation and Mindfulness App (Behavioral)
No Engagement Support
Participants in this group will receive no text message support.
干预措施: Stop, Breathe, & Think - Meditation and Mindfulness App (Behavioral)
结局指标
主要结局
Change in Anxiety at Week 2 and Week 4
时间窗: Baseline, Week 2, Week 4
Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 is a 7-item self-report measure of anxiety. Scores on this measure range from 0 (Not At All) to 3 (Nearly Every Day).
Change in Depression and Anxiety at Week 2 and Week 4
时间窗: Baseline, Week 2, Week 4
Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report measure of depression. Scores on this measure range from 0 (Not At All) to 3 (Nearly Every Day).
次要结局
- App Satisfaction(Week 1, Week 2, Week 3, Week 4)
- App Usage(Week 1, Week 2, Week 3, Week 4)
研究者
Stephen Schueller
Adjunct Assistant Professor
Northwestern University