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

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

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.

Study Overview

• Status: Completed
• Conditions: Stress; Emotion Regulation
• Intervention / Treatment: Behavioral: MoodWheel; Behavioral: REThink Life Game; Behavioral: PsyPills

• Study Type: Interventional
• Enrollment (Actual): 327
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Cluj-Napoca, Romania
    • Babes-Bolyai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PsyPills - Experimental; Each recruited student randomized in the experimental group will receive the PsyPills app.	Behavioral: PsyPills; PsyPills is a self-help psycho-educational instrument intended to build stress resilience and to target (only) mild and transient negative mood states, alone or in combination with other methods/instruments. Psychological Pills (PsyPills) are inspired by Rational-Emotive & Cognitive-Behavioral Therapy (CBT/REBT), which has strong evidence for its efficacy/effectiveness in human development/health promotion and in the treatment of a variety of psychological conditions. The PsyPills app was tested in a pilot study and showed positive effects on reducing distress. The efficacy of the app adjunct to other therapeutic tools within the platform in our projects will be tested.
Active Comparator: MoodWheel - Monitoring; The students randomized in the control group will complete the MoodWheel app.	Behavioral: MoodWheel; Mood Wheel is a web and mobile-based app that uses experience sampling procedures for the assessment of current/previous distress and positive emotions. The aim of the app is to inquire about the valence, control and functionality of users' emotions.
Experimental: REThink Life Game; Students from experimental group who do not respond to PsyPills alone will play the REThink Life Game	Behavioral: REThink Life Game; REThink Life Game is the therapeutic game that uses psychological science to help youths find their superhero emotional strengths! It is composed of four levels, each training a specific emotion regulation ability: emotion recognition, mindfulness and relaxation, cognitive change and positive bias.; Behavioral: PsyPills; PsyPills is a self-help psycho-educational instrument intended to build stress resilience and to target (only) mild and transient negative mood states, alone or in combination with other methods/instruments. Psychological Pills (PsyPills) are inspired by Rational-Emotive & Cognitive-Behavioral Therapy (CBT/REBT), which has strong evidence for its efficacy/effectiveness in human development/health promotion and in the treatment of a variety of psychological conditions. The PsyPills app was tested in a pilot study and showed positive effects on reducing distress. The efficacy of the app adjunct to other therapeutic tools within the platform in our projects will be tested.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional Distress	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.	Pre-intervention (one week before the intervention)
Changes in emotional distress	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.	Post-intervention (one week after the intervention)
Levels of emotional distress	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.	6 months follow-up
Emotion regulation	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.	baseline, pre-intervention
Changes in emotion regulation	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.	Post-intervention (one week after the intervention)
Levels of emotion regulation	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.	6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood disorders	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.	baseline, pre-intervention
Changes in mood disorders	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.	Post-intervention (one week after the intervention)
Trauma	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.	baseline, pre-intervention

Collaborators and Investigators

• Sponsor: Babes-Bolyai University
• Collaborators: The Executive Agency for Higher Education, Research, Development and Innovation Funding

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Actual): April 20, 2024
• Study Completion (Actual): December 25, 2024

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: REThink Academy- SMARTrial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No