- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07643714
Effects of ACT-Based Psychoeducation on Caregivers of Individuals With Mental Disorders
The Effect of Acceptance and Commitment Therapy-Based Psychoeducation on Psychological Resilience, Stress Management, and Caregiver Burden in Caregivers of Individuals With Mental Disorders
This randomized controlled trial aimed to examine the effects of Acceptance and Commitment Therapy (ACT)-based psychoeducation program on psychological resilience, stress management, and caregiver burden in caregivers of individuals with mental disorders. Participants were randomly assigned to either the intervention or control group. The intervention group received ACT-based psychoeducation while the control group received no intervention.
H1-1: The mean psychological resilience scores of caregivers in the intervention group who received the ACT-based psychoeducation program are significantly higher compared to caregivers in the control group.
H1-2: The mean stress management scores of caregivers in the intervention group who received the ACT-based psychoeducation program are significantly higher compared to caregivers in the control group.
H1-3: The mean caregiver burden scores of caregivers in the intervention group who received the ACT-based psychoeducation program are significantly lower compared to caregivers in the control group.
H1-4: The effects of the ACT-based psychoeducation program on psychological resilience, stress management, and caregiver burden differ significantly between caregivers of individuals diagnosed with schizophrenia and caregivers of individuals diagnosed with bipolar disorder.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Kahramanmaraş, Turquia (Türkiye)
- Kahramanmaras Necip Fazil City Hospital, Psychiatry Outpatient Clinic and Community Mental Health Center
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
Aged 18 years or older Being a first-degree caregiver of an individual with severe mental disorder followed at a CMHC or outpatient clinic Turkish-speaking and at least primary school graduate No communication problems and open to cooperation Not having participated in any ACT-based or similar psychoeducation program in the last 6 months No alcohol/substance use disorder No psychiatric diagnosis Having regularly attended the intervention sessions -
Exclusion Criteria:Not meeting the inclusion criteria
-
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Schizophrenia - Intervention Group
Caregivers of individuals diagnosed with schizophrenia who participated in the ACT-based psychoeducation program
|
ACT-based psychoeducation program delivered to caregivers of individuals with mental disorders (schizophrenia and bipolar disorder).
The program was based on Acceptance and Commitment Therapy principles and consisted of 8 sessions.
It aimed to improve psychological resilience, stress management, and reduce caregiver burden.
Sessions were conducted in group format.
|
|
Sem intervenção: Schizophrenia - Control Group (No intervention)
Caregivers of individuals with schizophrenia who received no intervention.
|
|
|
Experimental: Bipolar Disorder - Intervention Group
Caregivers of individuals with bipolar disorder who received ACT-based psychoeducation.
|
ACT-based psychoeducation program delivered to caregivers of individuals with mental disorders (schizophrenia and bipolar disorder).
The program was based on Acceptance and Commitment Therapy principles and consisted of 8 sessions.
It aimed to improve psychological resilience, stress management, and reduce caregiver burden.
Sessions were conducted in group format.
|
|
Sem intervenção: Bipolar Disorder - Control Group
Caregivers of individuals with bipolar disorder who received no intervention
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Psychological Resilience
Prazo: Baseline, post-intervention (8 weeks), and 2-month follow-up
|
Measured with the Psychological Resilience Scale for Adults at baseline, post-intervention, and at 2-month follow-up
|
Baseline, post-intervention (8 weeks), and 2-month follow-up
|
|
Stress Management
Prazo: Baseline, post-intervention (8 weeks), and 2-month follow-up
|
Measured with the Stress Coping Styles Scale at baseline, post-intervention, and at 2-month follow-up
|
Baseline, post-intervention (8 weeks), and 2-month follow-up
|
|
Caregiver Burden
Prazo: Baseline, post-intervention (8 weeks), and 2-month follow-up
|
Measured with the Caregiver Burden Scale at baseline, post-intervention, and at 2-month follow-up
|
Baseline, post-intervention (8 weeks), and 2-month follow-up
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Psychological Flexibility
Prazo: Baseline, post-intervention (8 weeks), and 2-month follow-up
|
Measured with the Acceptance and Action Questionnaire-II (AAQ-II) at baseline, post-intervention, and at 2-month follow-up
|
Baseline, post-intervention (8 weeks), and 2-month follow-up
|
Colaboradores e Investigadores
Patrocinador
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
- 2025-13.01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .