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A viabilidade da intervenção STARS de gerenciamento de estresse baseada em chatbot para jovens na Lituânia

3 de novembro de 2026 atualizado por: Evaldas Kazlauskas, Vilnius University

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

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

Intervencional

Inscrição (Real)

80

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Vilnius, Lituânia, 01131
        • Vilnius University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 25 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

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

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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
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
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
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
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
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
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
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
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
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
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
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
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
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
Drop-out rates
Prazo: Immediately after the intervention, 3-months after the intervention

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
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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

30 de outubro de 2024

Conclusão Primária (Real)

30 de junho de 2025

Conclusão do estudo (Real)

30 de junho de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

17 de outubro de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de outubro de 2024

Primeira postagem (Real)

21 de outubro de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de novembro de 2026

Última verificação

1 de outubro de 2024

Mais Informações

Termos relacionados a este estudo

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)?

SIM

Descrição do plano IPD

Individual participant data can be shared upon a reasonable request.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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