Emotion RegulationNCT06085872
Testing the REThinkACADEMY Interventions in Prevention of Emotional Disorders in College Students.
A study testing REThink Life Game, PsyPills and MoodWheel in people with Emotion Regulation and Stress, run by Babes-Bolyai University at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation, Stress
- What is being tested?
- REThink Life Game, PsyPills and MoodWheel
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 1 siteRomania
- Study dates
- 20 Nov 2023to 25 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- no internet or PC access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Emotion Regulation, Stress
- Being tested
- REThink Life Game, PsyPills, MoodWheel
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REThink Life GameBehavioural
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.
PsyPillsBehavioural
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.
MoodWheelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PsyPills - Experimental | Experimental | Each recruited student randomized in the experimental group will receive the PsyPills app. Receives: Behavioral: PsyPills |
| MoodWheel - Monitoring | Active comparator | The students randomized in the control group will complete the MoodWheel app. Receives: Behavioral: MoodWheel |
| REThink Life Game | Experimental | Students from experimental group who do not respond to PsyPills alone will play the REThink Life Game Receives: Behavioral: REThink Life Game; Behavioral: PsyPills |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months follow-up
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: baseline, pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start20 Nov 2023
- Primary completion20 Apr 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Collaborators
- The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Responsible party
- Principal investigator, Oana David, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085872
- Sponsor's protocol ID
- REThink Academy- SMARTrial
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2023
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the REThinkACADEMY Interventions in Prevention of Emotional Disorders in First Year College Students.
- ClinicalTrials.gov ID
- NCT06085872
- Acronym / sponsor ID
- REThink Academy- SMARTrial
- Conditions
- Emotion Regulation, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Collaborators
- The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PsyPills - Experimental | Experimental | Behavioral: PsyPillsEach recruited student randomized in the experimental group will receive the PsyPills app. |
| MoodWheel - Monitoring | Active comparator | Behavioral: MoodWheelThe students randomized in the control group will complete the MoodWheel app. |
| REThink Life Game | Experimental | Behavioral: REThink Life Game, Behavioral: PsyPillsStudents from experimental group who do not respond to PsyPills alone will play the REThink Life Game |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- no internet or PC access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REThink Life GameREThink 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. | Behavioural | REThink Life Game |
| PsyPillsPsyPills 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. | Behavioural | PsyPills - Experimental, REThink Life Game |
| MoodWheelMood 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. | Behavioural | MoodWheel - Monitoring |
Primary outcome
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Mood disorders
Time frame: baseline, pre-intervention
Changes in mood disorders
Time frame: Post-intervention (one week after the intervention)
Trauma
Time frame: baseline, pre-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REThink Life Game, PsyPills and MoodWheel in people with Emotion Regulation and Stress, run by Babes-Bolyai University at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion regulation (time frame: baseline, pre-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.