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Replication: Meaning-centered Intervention for Internalizing Symptoms

11 de agosto de 2026 actualizado por: University of Groningen

Testing the Efficacy of a Meaning-centered Intervention for Individuals Who Tend to Feel Down or Anxious: a Replication

Young adults who experience depression and/or anxiety symptoms (i.e., internalizing symptoms) will be randomly allocated to a six-session meaning-centered intervention condition or a waitlist condition. Both conditions receive the same questionnaires at baseline, post assessment (intervention condition: immediately after the final session; waitlist: four weeks after baseline), and follow-up.

The researchers hypothesize that a meaning-centered intervention for individuals with internalizing symptoms will increase participants' meaning in life and reduce their internalizing symptoms at post assessment and 4-week follow-up when compared to a waitlist condition.

Descripción general del estudio

Descripción detallada

First-year psychology students at the University of Groningen will be screened for depression and anxiety symptoms. Those with heightened symptoms will be invited via e-mail to participate in the study. After filling out the baseline assessment online, participants will be randomly assigned to either a meaning-centered intervention condition, which will receive a meaning-centered intervention taking place approximately every four days, or a waitlist condition, which will be assigned no task. Participants in the intervention condition will follow six 1-hour online intervention sessions led by a trainer and conduct intervention-related homework assignments. The sessions can be followed in English, Dutch, or German. The intervention aims to increase participants' meaning in life and reduce their internalizing symptoms. Immediately after the final session (i.e. approximately one month after the baseline assessment), participants in the intervention condition will be asked to fill in the post assessment, which includes the same questionnaires as the baseline assessment. Additionally, they will be ask to provide feedback about the intervention regarding session and homework content. Participants in the waitlist control will be asked to complete the post assessment one month after their baseline assessment. One month after the post assessment, participants in both conditions are asked to fill in same set of questionnaires. Waitlist participants are offered to receive the intervention sessions after the study has finished. Participants are compensated with SONA credits. This study will replicate a previous study initially testing the meaning-centered intervention (https://clinicaltrials.gov/study/NCT07058181?aggFilters=status:,phase:&tab=researcher#trial-description).

Tipo de estudio

Intervencionista

Inscripción (Estimado)

140

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • heightened internalizing symptoms (depression and/or anxiety symptoms) as indicated by PHQ-4 score of 2 or above on either the anxiety or depression subscale

Exclusion Criteria:

  • receiving psychotherapeutic treatment for a depressive or anxiety disorder
  • suicidality

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Meaning-centered intervention
  • Participants receive a meaning-centered intervention consisting of six 1-hour online sessions led by a trainer.
  • Interventions: Behavioral: Meaning-centered intervention for individuals who tend to feel down or anxious
  • Six 1-hour individual online sessions, approximately every 4 days
  • Sessions led by a certified trainer based on intervention manual
  • Four sources of meaning will be explored: personal life story, dealing with life's limitations, creating one's own life, and meaningful experiences
  • Participants follow intervention using intervention the workbook
  • Homework assignments designed to deepen participants' experience and reflection on meaning in their daily lives
Otros nombres:
  • Meaning-centered intervention for internalizing symptoms adapted from the intervention "Meaning-centered intervention for youth worrying about their weight and shape".
Sin intervención: Waitlist control
- No task or intervention is assigned to participants in this arm.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Depression Anxiety Stress Scale (DASS-21)
Periodo de tiempo: Time Frame: at baseline; post (one month after baseline); one-month follow-up (one month after post)
self-report questionnaire: DASS-21: sum score (0-63), 4-point Likert scale (0-3), higher scores indicating higher internalizing symptoms)
Time Frame: at baseline; post (one month after baseline); one-month follow-up (one month after post)
Meaning in Life Questionnaire (MLQ); presence of meaning subscale
Periodo de tiempo: Time Frame: at baseline; post (one month after baseline); one-month follow-up (one month after post)
self-report questionnaire: MLQ: sum score (5-35), 7-point Likert scale (1-7), higher scores indicating higher presence of life meaning
Time Frame: at baseline; post (one month after baseline); one-month follow-up (one month after post)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

1 de febrero de 2028

Finalización del estudio (Estimado)

1 de febrero de 2028

Fechas de registro del estudio

Enviado por primera vez

23 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de julio de 2026

Publicado por primera vez (Actual)

20 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

11 de agosto de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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