- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Wenqi Zhang
- Numero di telefono: 413-552-9158
- Email: wenqiz11@uci.edu
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Comparatore attivo: 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). |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Emotion Regulation Flexibility
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- STUDY00002365
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano 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.
Criteri di accesso alla condivisione 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.
Tipo di informazioni di supporto alla condivisione IPD
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .