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NCT Number: NCT07656558

ACT-Based Psychoeducation for Caregivers of Patients With Schizophrenia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nevşehir State Hospital Community Mental Health Center

Nevşehir, Merkez, 50040, Turkey (Türkiye)

Location contact

Sinem Sönmez, MSc

CONTACT

-90+539-816-4391

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hülya ARSLANTAŞ, PhD

CONTACT

[email protected]

09+532-202-5329

Sinem Sönmez, Msc

CONTACT

[email protected]

09+539-816-4391

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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