- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07656558
ACT-Based Psychoeducation for Caregivers of Patients With Schizophrenia
The Effect of Acceptance and Commitment Therapy-Based Psychoeducation Applied to Caregivers of Schizophrenia Patients Attending the Community Mental Health Center on Emotional Expression, Perceived Family Burden, and Psychological Flexibility: A Randomized Controlled Trial
This randomized controlled trial aims to examine the effects of an Acceptance and Commitment Therapy (ACT)-based psychoeducation program on expressed emotion, perceived family burden, and psychological flexibility among caregivers of patients with schizophrenia attending a Community Mental Health Center.
The main questions this study aims to answer are:
- Does ACT-based psychoeducation reduce expressed emotion among caregivers of patients with schizophrenia?
- Does ACT-based psychoeducation reduce perceived family burden among caregivers of patients with schizophrenia?
- Does ACT-based psychoeducation improve psychological flexibility among caregivers of patients with schizophrenia?
Researchers will randomly assign eligible caregivers to either an intervention group receiving an 8-session ACT-based psychoeducation program or a control group receiving routine care.
Participants will:
- Complete assessment measures before the intervention (pre-test).
- Participate in 8 ACT-based psychoeducation sessions if assigned to the intervention group.
- Continue receiving routine care if assigned to the control group.
- Complete assessment measures immediately after the intervention (post-test).
- Complete follow-up assessments at 1 month and 3 months after the intervention.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Schizophrenia is a severe mental disorder that affects millions of people worldwide. It has devastating consequences that impact not only the health of affected individuals but also their social, occupational, and economic functioning. The effects of schizophrenia extend beyond patients and significantly influence family members who assume caregiving responsibilities. The behavioral and emotional difficulties experienced by individuals with schizophrenia may expose caregivers to various physical and psychological challenges.
Family caregivers frequently experience emotions such as anger, helplessness, anxiety, and uncertainty, and they may have difficulty managing these emotional reactions. With the increasing adoption of community-based mental health care services, families have assumed greater responsibility for the care of individuals with schizophrenia. As a result, caregivers often face substantial caregiving demands, contributing to increased family burden and emotional distress.
Psychological flexibility refers to the ability to maintain or change behavior in accordance with personal values and long-term goals despite the presence of distressing thoughts, emotions, or experiences. Caregivers of individuals with schizophrenia are frequently exposed to stressful situations and negative emotional experiences that may adversely affect their psychological flexibility.
Acceptance and Commitment Therapy (ACT) is a behavioral intervention that aims to enhance psychological flexibility through acceptance, mindfulness, values clarification, and committed action. Previous studies have suggested that ACT-based interventions may help family members develop more adaptive beliefs and attitudes, reduce psychological distress, and improve coping with caregiving challenges. Through the acceptance process, caregivers may learn to engage more effectively with difficult thoughts and emotions associated with long-term caregiving responsibilities.
The aim of this randomized controlled trial is to determine the effects of an ACT-based psychoeducation program on expressed emotion, perceived family burden, and psychological flexibility among caregivers of patients with schizophrenia attending a Community Mental Health Center. Eligible caregivers will be randomly assigned to either an intervention group receiving an eight-session ACT-based psychoeducation program or a control group receiving routine care. Outcome measures will be assessed at baseline (pre-test), immediately after the intervention (post-test), at 1-month follow-up, and at 3-month follow-up.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Sinem Sönmez, Msc
- Número de telefone: 09+539-816-4391
- E-mail: snmz.sinem@hotmail.com
Estude backup de contato
- Nome: Hülya ARSLANTAŞ, PhD
- Número de telefone: 09+532-202-5329
- E-mail: harslantas@adu.edu.tr
Locais de estudo
-
-
Merkez
-
Nevşehir, Merkez, Turquia (Türkiye), 50040
- Nevşehir State Hospital Community Mental Health Center
-
Contato:
- Sinem Sönmez, MSc
- Número de telefone: -90+539-816-4391
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Living with an individual diagnosed with schizophrenia who has been followed and actively receiving services from a Community Mental Health Center for at least one year.
- Being the primary caregiver responsible for the care of the individual diagnosed with schizophrenia.
- Having been involved in the care and treatment of the individual diagnosed with schizophrenia for at least 12 months prior to the study.
- Being between 18 and 65 years of age.
- Being literate.
- Being able to speak and understand Turkish.
- Willing to participate in the study and providing informed consent.
Exclusion Criteria:
- Having a medically diagnosed psychiatric disorder.
- Having a diagnosis of an organic mental disorder or intellectual disability.
- Having a physical impairment that may interfere with participation in the study or data collection process (e.g., hearing or speech impairment).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: ACT-Based Psychoeducation Group
Caregivers of patients with schizophrenia attending a Community Mental Health Center will receive an Acceptance and Commitment Therapy (ACT)-based psychoeducation program developed in accordance with expert opinions.
The intervention consists of eight structured group sessions lasting approximately 60-90 minutes each.
Session topics include introduction to the program and ACT principles, contact with the present moment, acceptance, cognitive defusion, self-as-context (observing self), values, values-based actions, and review of the psychoeducation process.
Outcome measures will be assessed at baseline (pre-test), immediately after the intervention (post-test), at 1-month follow-up, and at 3-month follow-up.
|
The intervention consists of an Acceptance and Commitment Therapy (ACT)-based psychoeducation program developed in accordance with expert opinions.
The program is delivered in a group format and includes eight structured sessions lasting approximately 60-90 minutes each.
Session topics include introduction to the program and ACT principles, contact with the present moment, acceptance, cognitive defusion, self-as-context (observing self), values, values-based actions, and review and evaluation of the psychoeducation process.
The intervention is designed to reduce expressed emotion and perceived family burden and to improve psychological flexibility among caregivers of patients with schizophrenia attending a Community Mental Health Center.
|
|
Sem intervenção: Routine Care Group
Caregivers of patients with schizophrenia attending a Community Mental Health Center will continue to receive routine care and services provided by the center.
Outcome measures will be assessed at baseline (pre-test), immediately after the intervention period (post-test), at 1-month follow-up, and at 3-month follow-up.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Perceived Family Burden
Prazo: Time Frame: Baseline (pre-test), immediately post-intervention (post-test), 1-month follow-up, and 3-month follow-up.
|
Change in scores obtained from the Family Burden Scale.
|
Time Frame: Baseline (pre-test), immediately post-intervention (post-test), 1-month follow-up, and 3-month follow-up.
|
|
Psychological Flexibility
Prazo: Time Frame: Baseline (pre-test), immediately post-intervention (post-test), 1-month follow-up, and 3-month follow-up.
|
Change in scores obtained from the Psychological Flexibility Scale.
|
Time Frame: Baseline (pre-test), immediately post-intervention (post-test), 1-month follow-up, and 3-month follow-up.
|
|
Expressed Emotion
Prazo: Time Frame: Baseline (pre-test), immediately post-intervention (post-test), 1-month follow-up, and 3-month follow-up.
|
Change in scores obtained from the Expressed Emotion Scale.
|
Time Frame: Baseline (pre-test), immediately post-intervention (post-test), 1-month follow-up, and 3-month follow-up.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hülya Arslantaş, Aydin Adnan Menderes University
Publicações e links úteis
Publicações Gerais
- Berksun OE (1992) Şizofrenide aile faktörü: expressed emotion (EE): ölçek geliştirme ve uyarlama denemesi. Doktora Tezi, Ankara Üniversitesi Sağlık Bilimleri Enstitüsü, Ankara.
- Arslantas, H., Adana, F., Dereboy, F., Altinyazar, V., İnal, S., Ildirli, G. S., Kirci, Ç. (2011). Algılanan Aile Yükü Ölçeği'nin Türkçe Sürümünün Geçerlilik ve Güvenilirlik Çalışması. Archives of Neuropsychiatry/Nöropsikiyatri Arşivi, 48(1): 53-8.
- Karakuş, S. ve Akbay, S. E. (2020). Psikolojik esneklik ölçeği: Uyarlama, geçerlik ve güvenirlik çalışması. Mersin Üniversitesi Eğitim Fakültesi Dergisi, 16(1), 32-43.
- Tunc E, Orak OS, Avci IA. Acceptance and Commitment Therapy-Based Counseling Among Family Members of Individuals With Schizophrenia: A Randomized Controlled Trial. J Psychosoc Nurs Ment Health Serv. 2025 Aug;63(8):24-32. doi: 10.3928/02793695-20250314-02. Epub 2025 Mar 27.
- Wright, S. R., Graham, C. D., Houghton, R., Ghiglieri, C. and Berry, E. (2023). Acceptance and commitment therapy (ACT) for caregivers of children with chronic conditions: A mixed methods systematic review (MMSR) of efficacy, process, and acceptance. Journal of Contextual Behavioral Science, 27, 72-97.
- Koujalgi, S. R., & Nayak, R. B. (2021). Family burden among caregivers of patients with chronic mental disorders. BLDE University Journal of Health Sciences, 6(2), 164-167.
- James, R., & Tungol, J. (2022). Wellness Enhancement Therapy (WET) to Reduce Expressed Emotion and Subjective Burden among the Family Caregivers of Schizophrenia Patients: A Pilot Study. Indian Journal of Positive Psychology, 13(1), 1-5.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
- E-50107718-050.04-782534
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 .