- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05688254
Programa de recuperación del estrés basado en Internet para adolescentes (FOREST-A)
The study aims to evaluate the feasibility and efficacy of the internet-based stress recovery program for adolescents.
Descripción general del estudio
Descripción detallada
The FOREST-A is a third-wave cognitive behavioral therapy and mindfulness-based internet-delivered 4-week psychosocial intervention for recovery from stress, which was initially developed for healthcare workers and is now adapted for adolescents. The program comprises six modules: introduction, relaxation, psychological detachment, mastery, control, and summary, with psychologist engagement on-demand. Each module includes psychoeducation and exercises. The program will be delivered in Lithuanian.
The intervention will be evaluated using the two-arm randomized controlled trial with intervention and care as usual condition at pre-test and post-test.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Vilnius, Lituania
- Vilnius University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Recent exposure to life-stressor.
- Students of high schools in Lithuania.
- Comprehending Lithuanian.
- Parental and own consent for minor-aged participants (< 18 years)/only own consent for adolescents aged 18 years or older to participate in the study provided.
- Have access to a device (such as a tablet, phone or computer) with an internet connection.
Exclusion Criteria:
- Acute psychiatric condition/crisis.
- No recent life-stressor exposure, or low levels of stress.
Plan de estudios
¿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 |
|---|---|
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Experimental: Intervention group
The intervention group will get a 4-week online stress recovery intervention. |
The internet-based psychosocial intervention will be delivered. The intervention comprises six modules: introduction, relaxation, psychological detachment, mastery, control, and summary, within psychoeducation and exercises in each module. The interactions with psychologists will be on demand. The whole intervention duration will be 4 weeks. |
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Sin intervención: Control group
The control group will take care as usual. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Recovery Experience Questionnaire
Periodo de tiempo: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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The Recovery Experience Questionnaire (Sonnentag & Fritz, 2007) adapted Child and Adolescent version will be used to measure the changes in recovery from stress experience. It is a self-report measure comprising 16 items, with provided 5-point Likert scale, ranging from Totally disagree (=1) to Totally agree (=5). Total scores may range from 16 to 80, and higher scores will indicate higher recovery. |
Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Adjustment Disorder New Module-8 Child and Adolescent Version Questionnaire
Periodo de tiempo: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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The Adjustment Disorder New Module-8 Child and Adolescent Version (Kazlauskas et al., 2018) will be used to measure the changes in symptoms of adjustment disorder, which are described in the International Classification of diseases 11th edition (WHO, 2018). The measure includes a list of 16 potentially stressful events (with binary answers Yes and No, indicating whether the participant has experienced a stressor) and 8 items for adjustment disorder symptoms evaluation (with a 4-point Likert scale ranging from Never (=1) to Often (=4)). Total scores may range from 8 to 32, and higher scores will indicate higher adjustment problems. |
Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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The Generalized Anxiety Disorder-7 scale
Periodo de tiempo: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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The Generalized Anxiety Disorder-7 scale (Spitzer, Kroenke, Williams, & Löwe, 2007) will be used to measure the changes in generalized anxiety symptoms.The measure comprises 7 items with the possible answers ranging on a 4-point Likert scale from Not at all (=0) to Nearly every day (=3). Total scores may range from 0 to 21. Higher scores will indicate higher generalized anxiety symptoms. |
Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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The Patient Health Questionnaire-9 questionnaire
Periodo de tiempo: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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The Patient Health Questionnaire-9 (Löwe, Kroenke, Herzog, & Gräfe, 2004) will be used to measure changes in depressive symptoms. The measure comprises 9 items, with provided a 4-point Likert scale, ranging from Not at all (=0) to Nearly every day (=3). Total scores may range from 0 to 27. Higher scores will indicate higher depressive symptoms. |
Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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The WHO-5 Well-being Index Questionnaire
Periodo de tiempo: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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The WHO-5 Well-being Index (Topp, Østergaard, Søndergaard, & Bech, 2015) will be used to measure changes in general psychological well-being. The measure comprises 5 items with a Likert scale ranging At no time (=0) to All of the time (=5). Total scores may range from 0 to 25. Higher scores will indicate better psychological well-being. |
Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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The Perceived Positive Social Support Scale
Periodo de tiempo: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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The Perceived Positive Social Support Scale (Kazlauskas et al., 2022) will be used to measure changes in social support. The measure comprises 4 items, with provided an 8-point Likert scale ranging from Never (=0) to Always (=7). Total scores may range from 0 to 28. Higher scores will indicate higher perceived positive support. |
Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Program evaluation questions
Periodo de tiempo: Post-treatment (after 4 weeks)
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Participants will be given questions regarding the usage, general satisfaction, usefulness of the program, and subjective impact on psychological and physical well-being. |
Post-treatment (after 4 weeks)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Paulina Zelviene, PhD, Vilnius University, Institute of Psychology
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- (1.5 E) 250000-S-646
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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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