- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07926919
Beary's GEM Project: Emotion Regulation Flexibility Among College Students
Understanding and Supporting Emotion Regulation Flexibility Among College Students - Beary's GEM Program
The goal of this clinical trial is to evaluate a single-session intervention program on emotion regulation flexibility in college students. The main questions it aims to answer are:
- To evaluate the effectiveness of the digital single-session intervention program in improving emotion regulation flexibility among college students.
- To examine the effectiveness of the intervention in supporting well-being, including psychological distress and subjective well-being.
- To examine the acceptability and utility of the emotion regulation flexibility single-session intervention program.
- To explore participants' personal understanding of emotion regulation flexibility and the experience of intervention through semi-structured interviews.
Researchers will compare the experimental group (Beary's GEM program) and the active control group (Sharing Feelings Project) to answer the first two research questions.
Participants will
- Be randomly assigned and complete a digital single-session intervention
- Complete pre- and post-intervention questionnaires on emotion regulation flexibility and well-being
- Have a video chat with a researcher (optional)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Wenqi Zhang
- Numéro de téléphone: 413-552-9158
- E-mail: wenqiz11@uci.edu
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age: >=18 and <=25 as of 2026 November
- To be assigned to the experimental group or the waitlist control group, participants who score below the median (ERFS <= 33) on the 9-item Emotion Regulation Flexibility Scale will be redirected and randomly assigned to a study condition. This decision was made based on a previous study on the emotion regulation flexibility intervention to reduce the ceiling effect. However, all the questionnaire responses (regardless of scores on ERFS) for assessment 1 will be maintained.
- Able to comprehend and complete the questionnaire and intervention in English
Exclusion Criteria:
- Not within the target age range
- Participants who had a score greater than 33 on the 9-item Emotion Regulation Flexibility Scale will not be assigned to a study condition after completing assessment 1.
- Not able to comprehend and complete the questionnaire in English
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Beary's GEM Project
Participants will complete a series of brief, structured activities that are designed to introduce and practice emotion regulation strategies and their flexibility. |
Participants in the experimental group will be directed to a digital, single-session intervention (Beary's GEM Project) that targets three aspects of emotion regulation flexibility: context sensitivity, repertoire, and feedback responsiveness. |
|
Comparateur actif: Sharing Feelings Project
The Sharing Feeling Project will be administered as the placebo intervention for the active control group. This condition focuses on content that encourages participants to share feelings with people in their support circle. |
Participants in the active control group will be directed to a digital single-session intervention (Sharing Feelings Project) aiming to encourage participants to share feelings with people in their support circle. However, unlike the experimental intervention, it does not teach a specific psychological mechanism (i.e., emotion regulation flexibility). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Emotion Regulation Flexibility
Délai: Baseline, post-intervention (around 1 week after baseline), 1-week follow-up, and 2-week follow-up
|
12 indicates the lowest emotion regulation flexibility, and 60 indicates the highest. |
Baseline, post-intervention (around 1 week after baseline), 1-week follow-up, and 2-week follow-up
|
|
Depression, Anxiety & Stress
Délai: Baseline, 1-week follow-up, and 2-week follow-up
|
0 indicates the lowest psychological distress, and 126 indicates the highest. |
Baseline, 1-week follow-up, and 2-week follow-up
|
|
Resilience
Délai: Baseline, 1-week follow-up, and 2-week follow-up
|
6 indicates the lowest resilience, and 30 indicates the highest. |
Baseline, 1-week follow-up, and 2-week follow-up
|
|
Program Feedback
Délai: Post-intervention (around 1 week after baseline)
|
0 indicates the lowest user experience, and 28 indicates the highest. |
Post-intervention (around 1 week after baseline)
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
- Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- Schleider JL, Mullarkey MC, Weisz JR. Virtual Reality and Web-Based Growth Mindset Interventions for Adolescent Depression: Protocol for a Three-Arm Randomized Trial. JMIR Res Protoc. 2019 Jul 9;8(7):e13368. doi: 10.2196/13368.
- Schleider JL, Abel MR, Weisz JR. Do Immediate Gains Predict Long-Term Symptom Change? Findings from a Randomized Trial of a Single-Session Intervention for Youth Anxiety and Depression. Child Psychiatry Hum Dev. 2019 Oct;50(5):868-881. doi: 10.1007/s10578-019-00889-2.
- Sharma P, Singh P. Translating theoretical insights into an emotion regulation flexibility intervention: assessing effectiveness. Cogn Emot. 2025 Mar;39(2):355-376. doi: 10.1080/02699931.2024.2413366. Epub 2024 Oct 10.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- STUDY00002365
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
All of the de-identified data collected in this research will be maintained and possibly shared, including (but not limited to questionnaire responses and electronic files containing coded data.
Critères d'accès au partage IPD
De-identified data will be made available to researchers unassociated with the UCI study team upon reasonable request, as determined by the lead researcher of this protocol. De-identified data will also be made available on the Open Science Framework or similar sites in accordance with journal requirements for the purposes of transparency in scientific practices. Identifiable information will not be shared.
Type d'informations de prise en charge du partage d'IPD
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
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