- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT05688254
Programa de recuperação de estresse baseado na Internet para adolescentes (FOREST-A)
The study aims to evaluate the feasibility and efficacy of the internet-based stress recovery program for adolescents.
Visão geral do estudo
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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-
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Vilnius, Lituânia
- Vilnius University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
|
Sem intervenção: Control group
The control group will take care as usual. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The Recovery Experience Questionnaire
Prazo: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
|
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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The Adjustment Disorder New Module-8 Child and Adolescent Version Questionnaire
Prazo: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
|
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
|
|
The Generalized Anxiety Disorder-7 scale
Prazo: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
|
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
Prazo: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
|
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
Prazo: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
|
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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Program evaluation questions
Prazo: Post-treatment (after 4 weeks)
|
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
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- (1.5 E) 250000-S-646
Plano para dados de participantes individuais (IPD)
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