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Completed

NCT Number: NCT06085872

Testing the REThinkACADEMY Interventions in Prevention of Emotional Disorders in 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.

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Key information

Conditions

Emotion Regulation Behavior Emotional Regulation Self-Control Social Behavior Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Babes-Bolyai University

Cluj-Napoca, Romania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Emotion regulation

    Time frame: 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.

  2. Changes in emotion regulation

    Time frame: 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.

  3. Levels of emotion regulation

    Time frame: 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.

  4. Emotional Distress

    Time frame: 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.

  5. Changes in emotional distress

    Time frame: 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.

  6. Levels of emotional distress

    Time frame: 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.

Secondary outcomes

  1. Mood disorders

    Time frame: 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.

  2. Changes in mood disorders

    Time frame: 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.

  3. Trauma

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Collaborators

  • The Executive Agency for Higher Education, Research, Development and Innovation Funding

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2023
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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