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

Sponsor
Babes-Bolyai University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06085872
Collaborator
The Executive Agency for Higher Education, Research, Development and Innovation Funding (Other)
211
3
8.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: REThink Life Game
  • Behavioral: PsyPills
  • Behavioral: MoodWheel
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
211 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Testing the REThinkACADEMY Interventions in Prevention of Emotional Disorders in First Year College Students.
Anticipated Study Start Date :
Oct 20, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

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. We will test the efficacy of the app adjunct to other therapeutic tools within the platform in our projects.

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. We will test the efficacy of the app adjunct to other therapeutic tools within the platform in our projects.

Outcome Measures

Primary Outcome Measures

  1. Emotion regulation [baseline, pre-intervention]

    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.

  2. Changes in emotion regulation [Post-intervention (one week after the intervention)]

    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.

  3. Levels of emotion regulation [6 months follow-up]

    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.

  4. Mental Health [baseline, pre-intervention]

    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.

  5. Changes in mental health [Post-intervention (one week after the intervention)]

    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. Fluctuations in mental health [After first stage of the intervention (after 5 weeks)]

    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.

  7. Levels of mental health [6 months follow-up]

    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.

  8. 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.

  9. 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.

  10. 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.

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. Levels of mood disorders [6 months follow-up]

    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.

  4. Rational and irrational cognitions [baseline, pre-intervention]

    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".

  5. Changes in rational and irrational cognition [Post-intervention (one week after the intervention)]

    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. Levels of rational and irrational cognition [6 months follow-up]

    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".

  7. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oana David, Professor Ph.D of Clinical Psychology, Babes-Bolyai University
ClinicalTrials.gov Identifier:
NCT06085872
Other Study ID Numbers:
  • REThink Academy- SMARTrial
First Posted:
Oct 17, 2023
Last Update Posted:
Oct 17, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 17, 2023