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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06085872
Other study ID # REThink Academy- SMARTrial
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 20, 2024
Est. completion date July 2024

Study information

Verified date November 2023
Source Babes-Bolyai University
Contact Oana David
Phone 40-264-434141
Email oanadavid@psychology.ro
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 211
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
n/a

Sponsors (2)

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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)
Primary 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
Primary 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
Primary 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)
Primary 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)
Primary 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
Primary 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)
Primary 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)
Primary 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 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
Secondary 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)
Secondary 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
Secondary 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
Secondary 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)
Secondary 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
Secondary 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
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