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

NCT06085872 | Completed

• 1 other identifier: REThink Academy- SMARTrial
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotion Regulation; Stress

Outcome Measures

Primary Outcomes (6)

• 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

• 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

Secondary Outcomes (3)

• Mood disorders

  baseline, pre-intervention

• Changes in mood disorders

  Post-intervention (one week after the intervention)

• Trauma

  baseline, pre-intervention

Study Arms (3)

PsyPills - Experimental

EXPERIMENTAL

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

Behavioral: PsyPills

MoodWheel - Monitoring

ACTIVE COMPARATOR

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

Behavioral: MoodWheel

REThink Life Game

EXPERIMENTAL

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

Behavioral: REThink Life Game; Behavioral: PsyPills

Interventions

REThink Life Game BEHAVIORAL

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.

REThink Life Game

PsyPills BEHAVIORAL

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.

PsyPills - Experimental; REThink Life Game

MoodWheel BEHAVIORAL

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.

MoodWheel - Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• no internet or PC access

Sponsors & Collaborators

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

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Romania

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Ph.D of Clinical Psychology

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 17, 2023
• Study Start: November 20, 2023
• Primary Completion: April 20, 2024
• Study Completion: December 25, 2024
• Last Updated: January 22, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)