- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07579767
Positive Psychology Based Psychoeducation for Psychological Flexibility and Perceived Stress in University Students
The Effect of a Multi-Component Positive Psychology-Based Psychoeducation Program on Psychological Flexibility and Perceived Stress in University Students: A Controlled Pretest-Posttest Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is designed as a two-arm, parallel-group, waitlist-controlled randomized trial with a pretest-posttest design. The study will be conducted among first-year undergraduate nursing students at Harran University.
After eligibility screening and informed consent, participants will complete baseline assessments and will then be randomly assigned in a 1:1 ratio to either the intervention group or the waitlist control group. Randomization will be performed by an independent person who is not involved in the study design, intervention delivery, or data analysis. Allocation will be concealed until eligibility and baseline assessment procedures are completed.
The intervention group will receive an 8-week multi-component positive psychology-based psychoeducation program. Sessions will be conducted once weekly and will last approximately 60-75 minutes. The program includes positive psychology components such as gratitude, savoring, signature strengths, hope and goal-setting, meaning and values-based action, self-compassion, and maintenance of personal wellbeing practices. Each session will include brief psychoeducation, an experiential exercise, group reflection, and a home practice assignment.
The waitlist control group will continue their usual routine during the 8-week study period and will not receive the intervention before post-test assessment. After post-test data collection is completed, the waitlist control group will be offered the psychoeducation program content as a booklet.
Assessments will be conducted at baseline and immediately after the 8-week intervention. The main analysis will evaluate between-group differences in post-intervention outcomes while controlling for baseline scores.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Rabia Kaya, PhD
- Número de teléfono: +90 414 318 30 00
- Correo electrónico: r.kurumluoglugil@harran.edu.tr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Being a first-year undergraduate student in the Department of Nursing at Harran University.
- Volunteering to participate in the study and providing informed consent.
- Having no reading, comprehension, or communication difficulty that would prevent completion of the data collection tools.
- Being 18 years of age or older.
Exclusion Criteria:
- Receiving regular psychotherapy or psychoeducation during the same academic period.
- Having participated in a structured positive psychology-based psychoeducation or intervention program within the last 6 months.
- Having a history of psychiatric hospitalization within the last 3 months or having an acute psychiatric crisis or instability that would make participation in the sessions inappropriate.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Positive Psychology Based Psychoeducation Program
Participants in this arm will receive an 8-week multi-component positive psychology based psychoeducation program.
Sessions will be delivered once weekly and will last approximately 60-75 minutes.
Each session will include brief psychoeducation, experiential exercises, shared reflection, and home practice assignments.
|
The intervention is an 8-week multi-component positive psychology based psychoeducation program delivered once weekly in 60-75 minute sessions.
The program includes psychoeducation and experiential practices related to gratitude, savoring, signature strengths, hope and goal-setting, meaning and values-based action, self-compassion, and maintenance of wellbeing practices.
Each session includes brief psychoeducation, practice exercises, shared reflection, and a home practice assignment.
|
|
Sin intervención: Waitlist Control
Participants in this arm will continue their usual routine during the 8-week study period and will not receive the psychoeducation program before post-test assessment.
After post-test data collection is completed, they will be offered the psychoeducation program content as a booklet.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Perceived Stress Scale-14 Total Score From Baseline to Post-intervention
Periodo de tiempo: Baseline and immediately after the 8-week intervention
|
Perceived stress will be assessed using the Perceived Stress Scale-14.
The scale consists of 14 self-report items scored on a 5-point Likert scale from 0 to 4. Total scores range from 0 to 56, with higher scores indicating higher perceived stress.
Change will be evaluated from baseline to immediately after the 8-week intervention.
|
Baseline and immediately after the 8-week intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Acceptance and Action Questionnaire-II Total Score From Baseline to Post-intervention
Periodo de tiempo: Baseline and immediately after the 8-week intervention
|
Psychological inflexibility and experiential avoidance will be assessed using the Acceptance and Action Questionnaire-II.
The scale consists of 7 self-report items scored on a 7-point Likert scale.
Total scores range from 7 to 49, with higher scores indicating greater psychological inflexibility and experiential avoidance.
Change will be evaluated from baseline to immediately after the 8-week intervention.
|
Baseline and immediately after the 8-week intervention
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rabia Kaya, PhD, Harran University
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HU-SOBEK-2026-00108
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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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