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- Ensaio Clínico NCT06651411
A viabilidade da intervenção STARS de gerenciamento de estresse baseada em chatbot para jovens na Lituânia
The Feasibility of Chatbot-based Stress Management Intervention STARS for Youth in Lithuania: A Pilot Randomized Controlled Trial
The study aims to assess the feasibility of a chatbot-based stress management intervention among youth in Lithuania.
Visão geral do estudo
Status
Condições
Descrição detalhada
The intervention is a chatbot-based stress management intervention developed by the World Health Organization (WHO). It consists of 10 sessions which include: Introduction (1), Psychoeducation (2), Emotion Regulation (3, 4), Behavior Activation (5, 6), Managing Problems (7), Thought Challenging (8, 9), and Relapse Prevention (10). Each session consists of psychoeducation and exercise parts. Trained e-helpers contact participants to support them individually on a weekly basis.
The effect of the intervention will be compared against a control group which gets basic psychoeducation. The intervention is provided in Lithuanian.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Vilnius, Lituânia, 01131
- 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:
- Age of 18-25 years
- Understanding the Lithuanian language
- Having access to a device for intervention delivery
- Experiencing moderate levels of psychological distress
Exclusion Criteria:
- People at imminent risk of suicide
- People currently experiencing a psychotic episode
- People currently experiencing interpersonal violence
- Current dependency on alcohol/drugs
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intervention group
The intervention group will get a 10-session chatbot-based stress management intervention. |
The intervention is a chatbot-based stress management intervention developed by the World Health Organization (WHO). It consists of 10 sessions, which include: Introduction (1), Psychoeducation (2), Emotion Regulation (3, 4), Behavior Activation (5, 6), Managing Problems (7), Thought Challenging (8, 9), and Relapse Prevention (10). Each session consists of psychoeducation and exercise parts. Trained e-helpers contact participants to support them individually weekly. The effect of the intervention will be compared against a control group that receives basic psychoeducation. The intervention is provided in Lithuanian. |
|
Outro: Control group
The control group will get basic psychoeducation. |
Basic psychoeducation includes basic information on stress management. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes in The Patient Health Questionnaire-9
Prazo: Before the intervention, immediately after the intervention, 3-months after the intervention
|
Changes in symptoms of depression are measured. The Patient Health Questionnaire-9 (PHQ-9, Kroenke et al., 2001) is a self-report measure comprising 9 items about symptoms of depression. All items are answered on a 4-point Likert scale that ranges from 0 (not at all) to 3 (nearly every day). A higher score indicates more pronounced symptoms. |
Before the intervention, immediately after the intervention, 3-months after the intervention
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Changes in The Generalized Anxiety Disorder-7
Prazo: Before the intervention, immediately after the intervention, 3-months after the intervention
|
Changes in symptoms of anxiety are measured. The Generalized Anxiety Disorder-7 (GAD-7, Spitzer et al., 2006) is a self-report measure comprising 7 items about symptoms of anxiety. All items are answered on a 4-point Likert scale that ranges from 0 (not at all) to 3 (nearly every day). A higher score indicates more pronounced symptoms. |
Before the intervention, immediately after the intervention, 3-months after the intervention
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes in Kessler-6
Prazo: Before the intervention, immediately after the intervention, 3-months after the intervention
|
Changes in psychological distress are measured. Kessler-6 (K6, Kessler et al., 2002) is a self-report measure comprising 6 questions about psychological distress. All items are answered on a 5-point Likert scale that ranges from 0 (none of the time) to 4 (all of the time). A higher score indicates more pronounced symptoms. |
Before the intervention, immediately after the intervention, 3-months after the intervention
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Changes in The Brief Adjustment Disorder Measure-8
Prazo: Before the intervention, immediately after the intervention, 3-months after the intervention
|
Changes in symptoms of adjustment disorder are measured. The Brief Adjustment Disorder Measure-8 (ADNM-8, Kazlauskas et al., 2018) is a self-report measure comprising 8 items about symptoms of adjustment disorder. All items are answered on a 4-point Likert scale that ranges from 1 (never) to 4 (often). A higher score indicates more pronounced symptoms. |
Before the intervention, immediately after the intervention, 3-months after the intervention
|
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Changes in The SIDAS
Prazo: Before the intervention, immediately after the intervention, 3-months after the intervention
|
Changes in suicidal ideation are measured. The SIDAS (Van Spijker et al., 2014) is a self-report measure comprising 5 questions about suicidal ideation. All items are answered on a 10-point Likert scale that ranges from 0 (never, no control, not close at all, not at all) to 10 (always, full control, made an attempt, extremely). A higher score indicates more pronounced symptoms. |
Before the intervention, immediately after the intervention, 3-months after the intervention
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Changes in The WHODAS 2.0
Prazo: Before the intervention, immediately after the intervention, 3-months after the intervention
|
Changes in functioning are measured. The WHODAS 2.0 (Ustun et al., 2010) is a self-report measure comprising 12 questions about functioning. All items are answered on a 5-point Likert scale that ranges from 0 (none) to 4 (extreme or cannot do). A higher score indicates more pronounced symptoms. |
Before the intervention, immediately after the intervention, 3-months after the intervention
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Changes in The World Health Organization Well-being Index-5
Prazo: Before the intervention, immediately after the intervention, 3-months after the intervention
|
Changes in psychological well-being are measured. The World Health Organization Well-being Index-5 (WHO-5, Bech, 2004) is a self-report measure comprising 5 items about psychological well-being. All items are answered on a 5-point Likert scale that ranges from 0 (at no time) to 4 (all of the time). A higher score indicates more pronounced psychological well-being. |
Before the intervention, immediately after the intervention, 3-months after the intervention
|
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Changes in The International Trauma Questionnaire
Prazo: Before the intervention, immediately after the intervention, 3-months after the intervention
|
Changes in symptoms of post-traumatic stress disorders are measured. International Trauma Questionnaire (ITQ, Cloitre et al., 2018) is a self-report measure comprising 18 items. All items are answered on a 5-point Likert scale that ranges from 0 (not at all) to 4 (extremely). A higher score indicates more pronounced symptoms. |
Before the intervention, immediately after the intervention, 3-months after the intervention
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Changes in The Resilience scale
Prazo: Before the intervention, immediately after the intervention, 3-months after the intervention
|
Changes in resilience are measured. The Resilience scale (RS-14, Wagnild, 2011) is a self-report measure comprising 14 items about resilience. All items are answered on a 7-point Likert scale that ranges from 1 (strongly disagree) to 7 (strongly agree). A higher score indicates more pronounced resilience. |
Before the intervention, immediately after the intervention, 3-months after the intervention
|
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Changes in The Client Services Receipt Inventory
Prazo: Before the intervention, 3-months after the intervention
|
Changes in client service are measured. The Client Services Receipt Inventory (CSRI, Beeacham and Knapp, 2001) is a self-report measure comprising questions about client service. The CSRI covers a broad range of services that may be utilized, including primary and secondary care services, other services, and informal care. |
Before the intervention, 3-months after the intervention
|
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Changes in The EQ-5D-5L
Prazo: Before the intervention, immediately after the intervention, 3-months after the intervention
|
Changes in health are measured. The EQ-5D-5L (EuroQol Research Foundation, 2019) is a self-report measure comprising 5 items about health. All items are answered on a 5-point Likert scale that ranges from 1 (I have no problems or similar) to 5 (I am unable or similar). A higher score indicates more pronounced symptoms. |
Before the intervention, immediately after the intervention, 3-months after the intervention
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Recruitment rate
Prazo: Before the intervention
|
Recruitment rate recorded as the number of eligible participants who consent to participate in the study will be assessed. |
Before the intervention
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Drop-out rates
Prazo: Immediately after the intervention, 3-months after the intervention
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Drop-out rates recorded as the number of randomized participants who do not complete the intervention, the post-test assessment, and three-month follow-up assessment will be assessed. |
Immediately after the intervention, 3-months after the intervention
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Number of adverse events and serious adverse events
Prazo: Immediately after the intervention
|
Number of adverse events and serious adverse events will be assessed. |
Immediately after the intervention
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- (1.13E)250000-KT-67/ERC0004137
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Individual participant data can be shared upon a reasonable request.
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