- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07808762
Feasibility of Implementing the Internet-Delivered Stress Recovery Intervention FOREST for Healthcare Staff in a Real-World Healthcare Setting (FOREST-IN)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The feasibility of implementing the evidence-based, internet-delivered stress recovery intervention FOREST for healthcare staff in a real-world healthcare setting will be evaluated using a single-arm pre-post study design. The study aims to assess the feasibility of implementing the intervention within a hospital setting and to obtain preliminary estimates of changes in stress recovery and mental health outcomes to inform broader implementation across healthcare settings. Information about the intervention and the study will be disseminated within participating healthcare settings. Interested healthcare staff will complete an online eligibility screening. Individuals who meet the inclusion criteria will be invited to provide informed consent and complete the baseline assessment before being enrolled in and granted access to the FOREST intervention.
The FOREST intervention consists of six sessions (Introduction, Psychological Detachment, Distancing, Mastery, Control, and Keeping the Change Alive) delivered over a four-week period. Each session includes psychoeducational content presented through text and video materials, as well as practical stress recovery exercises. Participants will also have access to support from a trained psychologist on demand throughout the intervention.
Assessments will be conducted at baseline, immediately after the four-week intervention, and at a 12-week follow-up after baseline. The study's primary outcomes will assess implementation at the individual level, guided by Proctor et al.'s Implementation Outcomes Framework to evaluate acceptability and appropriateness, alongside intervention uptake (initiation), and complemented by feasibility and process indicators capturing reach, recruitment, engagement, and retention. Secondary outcomes will provide preliminary estimates of changes in stress recovery and other mental health outcomes.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Austeja Dumarkaite, PhD
- Número de teléfono: +37052686952
- Correo electrónico: austeja.dumarkaite@fsf.vu.lt
Copia de seguridad de contactos de estudio
- Nombre: Evaldas Kazlauskas, PhD
- Número de teléfono: +37052686952
- Correo electrónico: evaldas.kazlauskas@fsf.vu.lt
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- being at least 18 years old
- working in a healthcare setting;
- understanding Lithuanian;
- living in Lithuania;
- having access to an internet-enabled device.
Exclusion Criteria: No additional exclusion criteria will be applied in order to maximize inclusiveness and reflect real-world implementation.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention group
The intervention group will get a four-week internet-delivered stress recovery intervention FOREST.
|
The internet-delivered stress recovery intervention FOREST consists of six sessions (Introduction, Psychological Detachment, Distancing, Mastery, Control, and Keeping the Change Alive) delivered over a four-week period.
Each session includes psychoeducational content presented through text and video materials, as well as practical stress recovery exercises.
Participants also have access to support from a trained psychologist on demand throughout the intervention.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reach
Periodo de tiempo: Through completion of recruitment, up to 9 months.
|
Measurement: study recruitment records. Reach will be assessed as the proportion of the target healthcare workforce that enrolls in the intervention. It will be calculated as the number of enrolled participants divided by the estimated number of healthcare staff in the target workforce, expressed as a percentage. |
Through completion of recruitment, up to 9 months.
|
|
Recruitment
Periodo de tiempo: Through completion of recruitment, up to 9 months.
|
Measurement: Study screening, eligibility, and informed consent records. Recruitment will be assessed as the number and proportion of eligible healthcare staff who provide informed consent and enroll in the study. |
Through completion of recruitment, up to 9 months.
|
|
Intervention uptake
Periodo de tiempo: Through completion of the intervention period, up to 10 months.
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Measurement: FOREST intervention platform usage records. Intervention uptake will be assessed as the number and proportion of enrolled participants who initiate the intervention by completing the first FOREST session. |
Through completion of the intervention period, up to 10 months.
|
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Number of intervention sessions completed
Periodo de tiempo: Through completion of the intervention period, up to 10 months.
|
Number of intervention sessions completed will be assessed using FOREST intervention platform usage records.
The number of FOREST intervention sessions completed by each participant will be recorded.
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Through completion of the intervention period, up to 10 months.
|
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Percentage of participants completing all six intervention sessions
Periodo de tiempo: Through completion of the intervention period, up to 10 months.
|
Percentage of participants completing all six FOREST intervention sessions will be assessed using FOREST intervention platform usage records.
The percentage of participants who complete all six FOREST intervention sessions will be calculated as the number of participants completing all six sessions divided by the total number of participants who initiated the intervention, multiplied by 100.
|
Through completion of the intervention period, up to 10 months.
|
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Retention
Periodo de tiempo: Through completion of the 12-week follow-up, up to 12 months.
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Measurement: Study assessment completion records. Retention will be assessed as the number and proportion of enrolled participants who complete the post-intervention assessment and the 12-week follow-up assessment. Unit of Measure: Number and percentage of participants completing each assessment time point. |
Through completion of the 12-week follow-up, up to 12 months.
|
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Intervention acceptability
Periodo de tiempo: Through completion of the post-intervention assessment period, up to 10 months.
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Measurement: Post-intervention acceptability questions developed by study researchers. Acceptability will be assessed using post-intervention participant questions evaluating satisfaction with the FOREST intervention, perceived usefulness, and likelihood of recommending the intervention to colleagues. Each item will be reported according to its response scale, with descriptive summary statistics presented for participant responses. Higher scores indicate more pronounced acceptability. |
Through completion of the post-intervention assessment period, up to 10 months.
|
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Intervention appropriateness
Periodo de tiempo: Post-intervention assessment, up to 10 months.
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Measurement: Post-intervention appropriateness question developed by study researchers. Appropriateness will be assessed using a post-intervention participant question evaluating participants' perceptions of whether the FOREST intervention is relevant and suitable for healthcare staff working in a hospital setting. The item will be reported according to its response scale, with descriptive summary statistics presented for participant responses. A higher score indicates more pronounced appropriateness. |
Post-intervention assessment, up to 10 months.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in stress recovery
Periodo de tiempo: Baseline, post-test after four weeks, follow-up after 12 weeks
|
Changes in stress recovery are measured.
The Recovery Experiences Questionnaire (Sonnentag & Fritz, 2007) is a self-report measure consisting of 16 questions.
All items are answered on a 5-point Likert scale ranging from 1 (Totally disagree) to 5 (Totally agree).
A higher score indicates more pronounced stress recovery.
|
Baseline, post-test after four weeks, follow-up after 12 weeks
|
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Changes in perceived stress
Periodo de tiempo: Baseline, post-test after four weeks, follow-up after 12 weeks
|
Changes in perceived stress are measured.
Perceived Stress Scale (PSS-4, Cohen et al., 1983) is a self-report measure consisting of four questions.
All items are answered on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often).
A higher score indicates more pronounced perceived stress.
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Baseline, post-test after four weeks, follow-up after 12 weeks
|
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Changes in symptoms of anxiety and depression
Periodo de tiempo: Baseline, post-test after four weeks, follow-up after 12 weeks
|
Changes in symptoms of anxiety and depression are measured.
The Patient Health Questionnaire-4 (PHQ-4; Kroenke et al., 2009) is a self-report measure consisting of four questions.
All items are answered on a 4-point Likert scale ranging from 0 (Not at all) to 3 (Nearly every day).
A higher score indicates more pronounced symptoms of anxiety and depression.
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Baseline, post-test after four weeks, follow-up after 12 weeks
|
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Changes in mental well-being
Periodo de tiempo: Baseline, post-test after four weeks, follow-up after 12 weeks
|
Changes in mental well-being are measured.
Well-being Index (WHO-5, Bech, 2004) is a self-report measure consisting of five questions.
All items are answered on a 6-point Likert scale ranging from 0 (At no time) to 5 (All of the time).
A higher score indicates more pronounced mental well-being.
|
Baseline, post-test after four weeks, follow-up after 12 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Austeja Dumarkaite, PhD, Vilnius 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
- 3.7 E-10000-KT-2858
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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