- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT06828276
Adaptado culturalmente I-CBT para migrantes falados de farsi/dari (i-CBT)
Culturalmente e Idiumed I-CBT para problemas comuns de saúde mental: um estudo controlado randomizado com migrantes de língua farsi/dari
The aim of this randomized controlled trial (RCT) is to investigate the effectiveness of a culturally adapted internet-based cognitive behavioral therapy (i-CBT) intervention in reducing symptoms of common mental health issues among Farsi/Dari-speaking youth migrants and refugees. Investigator hypothesizes that there will be a significant decrease in psychological symptoms after participants receive the intervention compared to a control group.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Participants who are included in the study will be allocated to the experimental group and the control group (waiting list). Participants will be invited to participate tailored i-CBT intervention over 10-weeks. Intervention covers common psychological issues. Participants will have access to support through a chatting function, during the interventional period. Intervention effects will be measured prior-treatment, post-treatment, and 6 months post-treatment.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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-
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Stockholm, Suécia, 113 64
- Karolinska Institutet
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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:
- Between the ages of 15 and 29.
- A score above the cut-off 1.75 on HSCL-25
- Has a refugee or migrant background
- Has a good and stable internet connection
- Has access to a computer, tablet or smartphone
- Is fluent in reading and writing Arabic
- Has the ability to dedicate time to take part in the intervention for 6-10 weeks.
Exclusion Criteria:
- Is suffering from a severe mental illness, such as psychosis or severe depression.
- Is suffering from substance abuse
- Is undergoing a psychological treatment
- Has a high risk of suicide
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: Active group
Tailored I-CBT for mild to moderate common mental health problems over a 10-weeks-period. |
A culturally and language adapted i-CBT intervention for Farsi/Dari speaking youth migrants and refugees. The intervention targets mild to moderate common mental health problems. |
|
Sem intervenção: Waiting-list
Control group |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hopkins Symptom Checklist-25 (HSCL-25)
Prazo: Pre-intervention, up to 5 weeks, immediately after the intervention, 6 months after completion of the intervention
|
Assessment of anxiety and depressive symptoms. HSCL-25 consists of 25 items.Each item is rated on a scale from 1 to 4, where 1 means "Not at all" and 4 means "Extremely".Higher scores indicate a worse outcome, as they reflect greater severity of symptoms. |
Pre-intervention, up to 5 weeks, immediately after the intervention, 6 months after completion of the intervention
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Psychological Outcome Profiles (PSYCHLOPS)
Prazo: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
Impact of problematic area on function. PSYCHLOPS questionnaire consists of 4 items. These items are designed to capture the patient's main problem, the impact of this problem on their daily life, and their overall well-being. Each question in PSYCHLOPS is scored on a scale from 0 to 5, where 0 indicates no problem and 5 indicates the most severe problem. Higher scores indicate a worse outcome, as they reflect greater severity of problems or distress. |
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
|
Insomnia Severity Index (ISI)
Prazo: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
Assessment of severity of insomnia symptoms. ISI consists of 7 items, each rated on a scale from 0 to 4.Higher scores indicate a worse outcome, as they reflect more severe insomnia symptoms. |
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
|
Prolonged Grief Disorder (PG-13)
Prazo: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
Assessment of prolonged grief disorder. The PG-13 consists of 13 items, each rated on a scale from 1 to 5, where 1 means "Not at all" and 5 means "Several times a day". Higher scores indicate a worse outcome, as they reflect more severe symptoms of prolonged grief. |
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
|
Posttraumatic Stress Disorder Checklist (PCL-5)
Prazo: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
Assessment of symptoms of post-traumatic stress disorder. The PCL-5 consists of 20 items, each rated on a scale from 0 to 4. The total score ranges from 0 to 80. Higher scores indicate a worse outcome, as they reflect greater severity of PTSD symptoms. |
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
|
The World Health Organization-Five Well-Being Index (WHO-5)
Prazo: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
Assessment of subjective psychological well-being.The WHO-5 consists of 5 items, each rated on a scale from 0 to 5. Higher scores indicate a better outcome, as they reflect higher levels of well-being. |
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
|
Brief Resilience Scale (BRS)
Prazo: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
Assessment of resilience.The BRS consists of 6 items, each rated on a scale from 1 to 5. Higher scores indicate a better outcome, as they reflect greater resilience. |
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
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Client Satisfaction Questionnaire (CSQ-3)
Prazo: Immediately after the intervention, 6 months after completion of the intervention
|
Assessment of the levels of satisfaction of the participant with the intervention.CSQ-3 consists of 3 items. Each item is rated on a scale from 1 to 4. Higher scores indicate a better outcome, as they reflect greater satisfaction with the services received. |
Immediately after the intervention, 6 months after completion of the intervention
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Gerhard Andersson, PhD, Linkoeping University
Publicações e links úteis
Publicações Gerais
- Lindegaard T, Wasteson E, Demetry Y, Andersson G, Richards D, Shahnavaz S. Investigating the potential of a novel internet-based cognitive behavioural intervention for Dari and Farsi speaking refugee youth: A feasibility study. Internet Interv. 2022 Apr 1;28:100533. doi: 10.1016/j.invent.2022.100533. eCollection 2022 Apr.
- Demetry Y, Wasteson E, Lindegaard T, Abuleil A, Geranmayeh A, Andersson G, Shahnavaz S. Individually Tailored and Culturally Adapted Internet-Based Cognitive Behavioral Therapy for Arabic-Speaking Youths With Mental Health Problems in Sweden: Qualitative Feasibility Study. JMIR Form Res. 2023 Nov 24;7:e46253. doi: 10.2196/46253.
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
- Transtornos Relacionados a Traumas e Estressores
- Doenças do Sistema Nervoso
- Transtornos Mentais, Desordem Mental
- Sintomas Comportamentais
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Distúrbios do Sono Vigília
- Distúrbios do Sono Intrínsecos
- Dissônias
- Alimentação e Distúrbios Alimentares
- Transtornos de Estresse Traumático
- Comportamento
- Satisfação pessoal
- Síndrome da Ruminação
- Trauma psicológico
- Transtornos de ansiedade
- Depressão
- Distúrbios de Iniciação e Manutenção do Sono
- Bem-estar psicológico
Outros números de identificação do estudo
- KI-CNS-20250117
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