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临床试验/NCT05784831
NCT05784831已完成不适用

Development and Feasibility Test of an Ecological Momentary Intervention (EMI) - ReApp, to Promote and Improve Stress Resilience, Specifically to Increase Reappraisal.

University of Zurich2 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2021年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
146
试验地点
2
主要终点
Perceived Stress Scale (PSS)

研究概览

简要总结

The aim of the current project is to develop and test Ecological Momentary Interventions (EMIs) to promote and improve stress resilience, specifically, an EMI to increase positive reappraisal.

EMIs are mostly smartphone-based applications that deliver interventions to people as they go about in their daily lives. The EMI tested here is based on theoretical and empirical findings and consists of several items and repeated training using various individual scenarios from participants' life that will be presented to participants via an app on their smartphones.

This study tests the efficacy of the EMI on a change in (i) reappraisal and (ii) indices of perceived stress. One hundred twenty healthy student participants, aged 18-29 will be invited to the study. Participants will be screened and those who score below 13 points of reappraisal skills in a Cognitive Emotion Regulation Questionnaire, will be included in the study. This is necessary in order to avoid a ceiling effect on reappraisal skills, which may be high in students.

Then, the participants will be randomly assigned to experimental (reappraisal EMI in regular and burst design) and control conditions (control EMA) and fill in questionnaires. The reappraisal EMI groups will be taught reappraisal skills and will be asked to apply them to personal situations repeatedly. The control EMA group will have the same app consisting of Ecological Momentary Assessment only. The training will last 21 consecutive days and the app will send (i) 5 prompts per day to ask about the current mood of the user in control and both experimental groups and (ii) at least two prompts per day resulting in a total of min. 42 reappraisal training sessions in the regular experimental group or 28 reappraisal training sessions in the burst experimental group. What is more, every participant has the possibility to trigger the EMA or EMI anytime they wish to. After using the app, participants will fill in some questionnaires again. The whole study will be conducted remotely (Video calls and app use) to avoid unnecessary COVID-related risks for participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • being a student
  • having sufficient knowledge of the German language
  • being a smartphone user
  • low results in a CERQ questionnaire (less than 13 points in the Positive Reappraisal subscale).

排除标准

  • (1) having a current mental illness reported in the screening process.

结局指标

主要结局

Perceived Stress Scale (PSS)

时间窗: 21 days

Self-reported level of stress, scale range \[0-40\], higher score = worse outcome

State-Trait Anxiety Inventory (STAI)

时间窗: 21 days

Self-reported anxiety symptoms, scale range \[20-80\], higher score = worse outcome

Beck Depression Inventory II (BDI-II)

时间窗: 21 days

Self-reported depressive symptoms, scale range \[0-63\], higher score = worse outcome

Cognitive Emotion Regulation Questionnaire (CERQ)

时间窗: 21 days

Self-reported reappraisal skills, scale range \[5-20\], higher score = better outcome

Emotion Regulation Questionnaire (ERQ)

时间窗: 21 days

Self-reported reappraisal use, scale range \[6-42\], higher score = better outcome

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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