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临床试验/NCT06085872
NCT06085872已完成不适用

Testing the REThinkACADEMY Interventions in Prevention of Emotional Disorders in First Year College Students.

Babes-Bolyai University1 个研究点 分布在 1 个国家目标入组 327 人开始时间: 2023年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
327
试验地点
1
主要终点
Changes in emotional distress

研究概览

简要总结

Entry in the REThinkACADEMY trial will be based on the high distress range on a psychological validate instrument to assess stress. After participants are enrolled in the REThinkACADEMY trial and randomized, those in the experimental condition ill access a ecological momentary intervention (EMI) app for the prevention of emotional disorders for 4 weeks. In the second stage, for the non-responders to the ecological supportive intervention, the online game will be implemented while the rest of the groups will be monitored for another 4 weeks. At the next step, post-test outcomes assessment will be implemented. Long term assessments will be conducted at 6 months for the college student's naturalistic follow-up phase.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Single (Participant)

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

  • •to a first year student enorlled in Babes-Bolyai University of Cluj-Napoca
  • •internet and PC access to complete the scales and game
  • •high level of distress based on PDa scores

排除标准

  • •no internet or PC access

研究组 & 干预措施

PsyPills - Experimental

Experimental

Each recruited student randomized in the experimental group will receive the PsyPills app.

干预措施: PsyPills (Behavioral)

MoodWheel - Monitoring

Active Comparator

The students randomized in the control group will complete the MoodWheel app.

干预措施: MoodWheel (Behavioral)

REThink Life Game

Experimental

Students from experimental group who do not respond to PsyPills alone will play the REThink Life Game

干预措施: REThink Life Game (Behavioral)

REThink Life Game

Experimental

Students from experimental group who do not respond to PsyPills alone will play the REThink Life Game

干预措施: PsyPills (Behavioral)

结局指标

主要结局

Changes in emotional distress

时间窗: Post-intervention (one week after the intervention)

Distress and positive emotions: Profile of Affective Distress Plus; PED Opris \& Macavei, 2007 is a self-report scale that measure distress. It had 42 items rated on a 5 point Liker scale ranging from "not al all" to "a lot" and grater scores represent grated level of distress.

Emotion regulation

时间窗: baseline, pre-intervention

Emotion regulation abilities will be measured using the Emotion Regulation Questionnaire (ERQ), which is composed of 10 items, rated on a 7-point Likert scale, from 0 - strongly disagree to 7 - strongly agree. The scale has two subscales: cognitive reappraisal and expressive suppression emotional regulation strategies. The two subscales had Cronbach's Alphas of .85, respectively .76, similar to those reported in previous studies40.

Levels of emotion regulation

时间窗: 6 months follow-up

Emotion regulation abilities will be measured using the Emotion Regulation Questionnaire (ERQ39), which is composed of 10 items, rated on a 7-point Likert scale, from 0 - strongly disagree to 7 - strongly agree. The scale has two subscales: cognitive reappraisal and expressive suppression emotional regulation strategies. The two subscales had Cronbach's Alphas of .85, respectively .76, similar to those reported in previous studies40.

Emotional Distress

时间窗: Pre-intervention (one week before the intervention)

Distress and positive emotions: Profile of Affective Distress Plus; PED Opris \& Macavei, 2007 is a self-report scale that measure distress. It had 42 items rated on a 5 point Liker scale ranging from "not al all" to "a lot" and grater scores represent grated level of distress.

Levels of emotional distress

时间窗: 6 months follow-up

Distress and positive emotions: Profile of Affective Distress Plus; PED Opris \& Macavei, 2007 is a self-report scale that measure distress. It had 42 items rated on a 5 point Liker scale ranging from "not al all" to "a lot" and grater scores represent grated level of distress.

Changes in emotion regulation

时间窗: Post-intervention (one week after the intervention)

Emotion regulation abilities will be measured using the Emotion Regulation Questionnaire (ERQ39), which is composed of 10 items, rated on a 7-point Likert scale, from 0 - strongly disagree to 7 - strongly agree. The scale has two subscales: cognitive reappraisal and expressive suppression emotional regulation strategies. The two subscales had Cronbach's Alphas of .85, respectively .76, similar to those reported in previous studies40.

次要结局

  • Changes in mood disorders(Post-intervention (one week after the intervention))
  • Trauma(baseline, pre-intervention)
  • Mood disorders(baseline, pre-intervention)

研究者

发起方
Babes-Bolyai University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oana David

Professor Ph.D of Clinical Psychology

Babes-Bolyai University

研究点 (1)

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