- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Wenqi Zhang
- Número de teléfono: 413-552-9158
- Correo electrónico: wenqiz11@uci.edu
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
|
Comparador activo: 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). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Emotion Regulation Flexibility
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- STUDY00002365
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Criterios de acceso compartido de 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 de información de apoyo para compartir IPD
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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