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ACT-Based Psychoeducation for Caregivers of Patients With Schizophrenia

14. června 2026 aktualizováno: Hülya Arslantaş, Aydin Adnan Menderes University

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

60

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Turecko (Türkiye)
    • Merkez
      • Nevşehir, Merkez, Turecko (Türkiye), 50040
        • Nevşehir State Hospital Community Mental Health Center
        • Kontakt:
          • Sinem Sönmez, MSc
          • Telefonní číslo: -90+539-816-4391

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: Acceptance and Commitment Therapy (ACT)-Based Psychoeducation Program
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.
Žádný zásah: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Perceived Family Burden
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Aydin Adnan Menderes University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Hülya Arslantaş, Aydin Adnan Menderes University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

  • 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.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

30. prosince 2026

Dokončení studie (Odhadovaný)

15. ledna 2027

Termíny zápisu do studia

První předloženo

14. června 2026

První předloženo, které splnilo kritéria kontroly kvality

14. června 2026

První zveřejněno (Aktuální)

18. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

14. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • E-50107718-050.04-782534

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

The decision to share the study results will be made during the study period or when it is concluded.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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