- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sinem Sönmez, Msc
- Phone Number: 09+539-816-4391
- Email: snmz.sinem@hotmail.com
Study Contact Backup
- Name: Hülya ARSLANTAŞ, PhD
- Phone Number: 09+532-202-5329
- Email: harslantas@adu.edu.tr
Study Locations
-
-
Merkez
-
Nevşehir, Merkez, Turkey (Türkiye), 50040
- Nevşehir State Hospital Community Mental Health Center
-
Contact:
- Sinem Sönmez, MSc
- Phone Number: -90+539-816-4391
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Family Burden
Time Frame: 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
Time Frame: 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
Time Frame: 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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hülya Arslantaş, Aydin Adnan Menderes University
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-50107718-050.04-782534
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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