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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stress, Emotion Regulation

Intervention / Treatment
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* Behavioral: REThink Life Game
* Behavioral: PsyPills
* Behavioral: MoodWheel


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: no internet or PC access

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PsyPills - Experimental<br>Each recruited student randomized in the experimental group will receive the PsyPills app. | Behavioral: PsyPills<br>* 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. We will test the efficacy of the app adjunct to other therapeutic tools within the platform in our projects.<br>|
| Active Comparator: MoodWheel - Monitoring<br>The students randomized in the control group will complete the MoodWheel app. | Behavioral: MoodWheel<br>* 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.<br>|
| Experimental: REThink Life Game<br>Students from experimental group who do not respond to PsyPills alone will play the REThink Life Game | Behavioral: REThink Life Game<br>* 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.<br>Behavioral: PsyPills<br>* 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. We will test the efficacy of the app adjunct to other therapeutic tools within the platform in our projects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion regulation | The Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij, & Spinhoven, 2001) is a self-report scale measuring emotion regulation on a 5 point Likert scale ranging from almost never to almost always. It had 9 subscales representing 9 emotion regulation strategies and grater scores represents grater involvement in using that strategy. | baseline, pre-intervention | 
| Changes in emotion regulation | The Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij, & Spinhoven, 2001) is a self-report scale measuring emotion regulation on a 5 point Likert scale ranging from almost never to almost always. It had 9 subscales representing 9 emotion regulation strategies and grater scores represents grater involvement in using that strategy. | Post-intervention (one week after the intervention) | 
| Levels of emotion regulation | The Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij, & Spinhoven, 2001) is a self-report scale measuring emotion regulation on a 5 point Likert scale ranging from almost never to almost always. It had 9 subscales representing 9 emotion regulation strategies and grater scores represents grater involvement in using that strategy. | 6 months follow-up | 
| Mental Health | The General Health Questionnaire, 12-item version (GHQ-12 by Goldberg &Williams,1988 is a self-report scale measuring mental health on a 6-point Likert scale ranging from 0 never to 5 everyday where grater scores represents better mental health. | baseline, pre-intervention | 
| Changes in mental health | The General Health Questionnaire, 12-item version (GHQ-12 by Goldberg &Williams,1988 is a self-report scale measuring mental health on a 6-point Likert scale ranging from 0 never to 5 everyday where grater scores represents better mental health. | Post-intervention (one week after the intervention) | 
| Fluctuations in mental health | The General Health Questionnaire, 12-item version (GHQ-12 by Goldberg &Williams,1988 is a self-report scale measuring mental health on a 6-point Likert scale ranging from 0 never to 5 everyday where grater scores represents better mental health. | After first stage of the intervention (after 5 weeks) | 
| Levels of mental health | The General Health Questionnaire, 12-item version (GHQ-12 by Goldberg &Williams,1988 is a self-report scale measuring mental health on a 6-point Likert scale ranging from 0 never to 5 everyday where grater scores represents better mental health. | 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 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) | 
| Levels of 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. | 6 months follow-up | 
| Rational and irrational cognitions | Attitudes and Beliefs Scale 2 Abbreviated Version (ABS-2 - AV; Hyland et al. 2014) is a 24-items self-report scale that measures the presence of rational and irrational cognitions. It has two subscales one for rational cognitions and one for irrational cognitions. Greater scores at each scale represents more rational/irrational cognitions in an individual. Items are rated on a 5 point Liker scale ranging from totally disagree to totally agree. | baseline, pre-intervention | 
| Changes in rational and irrational cognition | Attitudes and Beliefs Scale 2 Abbreviated Version (ABS-2 - AV; Hyland et al. 2014) is a 24-items self-report scale that measures the presence of rational and irrational cognitions. It has two subscales one for rational cognitions and one for irrational cognitions. Greater scores at each scale represents more rational/irrational cognitions in an individual. Items are rated on a 5 point Liker scale ranging from totally disagree to totally agree. | Post-intervention (one week after the intervention) | 
| Levels of rational and irrational cognition | Attitudes and Beliefs Scale 2 Abbreviated Version (ABS-2 - AV; Hyland et al. 2014) is a 24-items self-report scale that measures the presence of rational and irrational cognitions. It has two subscales one for rational cognitions and one for irrational cognitions. Greater scores at each scale represents more rational/irrational cognitions in an individual. Items are rated on a 5 point Liker scale ranging from totally disagree to totally agree. | 6 months follow-up | 
| 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 |