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

Not Applicable

Completed

• Conditions: Stress; Emotion Regulation
• Interventions: Behavioral: REThink Life Game; Behavioral: MoodWheel; Behavioral: PsyPills

• Registration Number: NCT06085872
• Lead Sponsor: Babes-Bolyai University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-17
• Study Start: 2023-11-20
• Primary Completion: 2024-04-20
• Status Verified: 2024-10
• Study Completion: 2024-12-25
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

Inclusion Criteria

• 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

Exclusion Criteria

• no internet or PC access

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
REThink Life Game	PsyPills	Students from experimental group who do not respond to PsyPills alone will play the REThink Life Game
PsyPills - Experimental	PsyPills	Each recruited student randomized in the experimental group will receive the PsyPills app.
REThink Life Game	REThink Life Game	Students from experimental group who do not respond to PsyPills alone will play the REThink Life Game
MoodWheel - Monitoring	MoodWheel	The students randomized in the control group will complete the MoodWheel app.

Primary Outcome Measures

Name	Time	Method
Changes in emotional distress	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	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	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Changes in mood disorders	Post-intervention (one week after the intervention)	The Depression Anxiety Stress Scale (DASS; Parkitny \& McAuley, 2010) is a 24 items scale that has three sub scales each measuring a specific problem: depression, anxiety and stress.A higher score at each subscale represents higher levels of depression, anxiety or stress.
Trauma	baseline, pre-intervention	Childhood Trauma Screener is a scale composed of five items, measuring different traumatic events. It has five items and each item represent a category of trauma. Higher scores represent higher/worse trauma level.
Mood disorders	baseline, pre-intervention	The Depression Anxiety Stress Scale (DASS; Parkitny \& McAuley, 2010) is a 24 items scale that has three sub scales each measuring a specific problem: depression, anxiety and stress.A higher score at each subscale represents higher levels of depression, anxiety or stress.

Trial Locations

Locations (1)

Babes-Bolyai University; 🇷🇴 Cluj-Napoca, Romania