ACT-Based Psychoeducation for Caregivers of Patients With Schizophrenia

NCT07656558 | Not Yet Recruiting DMC

• 1 other identifier: E-50107718-050.04-782534
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SCHIZOPHRENIA 1 (Disorder)

Keywords

Acceptance and Commitment Therapy; Psychoeducation; Community Mental Health Center; Family Caregiver; Expressed Emotion; Family Burden; Psychological Flexibility; Randomized Controlled Trial; Schizophrenia

Outcome Measures

Primary Outcomes (3)

• Perceived Family Burden

  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

  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

  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.

Study Arms (2)

ACT-Based Psychoeducation Group

EXPERIMENTAL

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.

Behavioral: Acceptance and Commitment Therapy (ACT)-Based Psychoeducation Program

Routine Care Group

NO INTERVENTION

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.

Interventions

Acceptance and Commitment Therapy (ACT)-Based Psychoeducation Program BEHAVIORAL

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.

ACT-Based Psychoeducation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Nevşehir State Hospital Community Mental Health Center

Nevşehir, Merkez, 50040, Turkey (Türkiye)

Location

Related Publications (7)

• Berksun OE (1992) Şizofrenide aile faktörü: expressed emotion (EE): ölçek geliştirme ve uyarlama denemesi. Doktora Tezi, Ankara Üniversitesi Sağlık Bilimleri Enstitüsü, Ankara.

  BACKGROUND

• 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.

  BACKGROUND

• Karakuş, S. ve Akbay, S. E. (2020). Psikolojik esneklik ölçeği: Uyarlama, geçerlik ve güvenirlik çalışması. Mersin Üniversitesi Eğitim Fakültesi Dergisi, 16(1), 32-43.

  BACKGROUND

• 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.

  PMID: 40145690 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Hülya Arslantaş

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sinem Sönmez, Msc

CONTACT

09+539-816-4391; snmz.sinem@hotmail.com

Hülya ARSLANTAŞ, PhD

CONTACT

09+532-202-5329; harslantas@adu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The family members in the intervention and control groups will be kept secret from the family members in the research group, thus blinding the participants. After the data collection is complete, the patient data from the intervention and control groups will be coded into the SPSS program as group 1 and group 2, and the statistical consultant will not be informed, and the statistical expert and results evaluations will be done blindly.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to either an intervention group or a control group in a parallel-group design. The intervention group will receive an eight-session Acceptance and Commitment Therapy (ACT)-based psychoeducation program, while the control group will receive 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 Record Dates

• First Submitted: June 14, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)