Schizophrenia PatientsNCT06971328
ACT-Based Psychoeducation for Schizophrenia Caregivers
A study testing ACT-based psychoeducation in people with Schizophrenia Patients, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Schizophrenia is an important mental health problem that requires caregivers because it causes disability. With the efforts to move from a hospital-based model to a community-based model in mental health services, the care of schizophrenia patients is mainly provided by their families at home, creating a significant… Read more about this study
- Who is it for?
- Ages 18 months and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia Patients
- What is being tested?
- ACT-based psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jul 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Providing primary care to an individual diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) V
- Living with the patient and providing care for at least 6 months
- Being over 18 years of age
- Being literate
- Not having been diagnosed with any mental illness
- Agreeing to participate in the study and being a volunteer
Who cannot join
- The patient must live in a different house and spend less than 6 hours together per day
- Having previously attended ACT or Psychoeducation programs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Erzurum Şehir Hastanesi
Erzurum, Yakutiye, 25000
merve Bakar Gürcüoğlu, +90530-723-3533, bakarmerve71@gmail.com
About this study
Official title: Effects of Acceptance and Commitment-Based (ACT) Psychoeducation on Caregiver Burden, Posttraumatic Growth and Psychological Resilience in Caregivers of Patients With Schizophrenia
Schizophrenia is an important mental health problem that requires caregivers because it causes disability. With the efforts to move from a hospital-based model to a community-based model in mental health services, the care of schizophrenia patients is mainly provided by their families at home, creating a significant care burden on caregivers or, on the contrary, post-traumatic development is reported. Psychiatric nurses are responsible for evaluating the patient together with their family by taking these conditions into consideration when providing care to individuals with mental illness. As a principle of humanistic and holistic care, nursing interventions to be implemented by psychiatric nurses to develop caregivers' coping methods, reduce their care burden and contribute to their post-traumatic development are extremely important in terms of the effectiveness and efficiency of care. Acceptance and Commitment (ACT)-based psychoeducation, whose effectiveness has been reported in the literature, is an important application in providing care to patients and families in psychiatric nursing practices. ACT is among the third generation therapies that aim to keep individuals in the moment with awareness, adopt the willingness to accept events instead of struggling with them, and create an important source of power in taking actions in line with life values. In this study, 17 out of 34 individuals determined by statistical methods among the caregivers of schizophrenia patients will be included in the control group and monitored, while 17 will receive 8 sessions of ACT-based psychoeducation in the intervention group, and the effects of the education on caregiver burden, post-traumatic development, and psychological resilience will be evaluated. There are very few studies in the literature where ACT-based psychoeducation is applied to caregivers of schizophrenia patients. Although studies examining the effects on individuals' caregiver burden and psychological resilience are limited, no study has been found examining its effects on post-traumatic development, and this constitutes the original value of the study. As a result of this study, it is expected that ACT-based education will reduce the caregiver burden in schizophrenia caregivers and increase their psychological resilience through post-traumatic development.
Read the detailed description
Schizophrenia is a significant mental health problem in terms of its prevalence and disability. Individuals who experience significant loss of professional/social functioning and inability to perform self-care activities need a caregiver. Many physical, psychological, and economic problems and a related high care burden have been reported in caregivers. These difficulties increase the entry of caregivers into the health system along with sick individuals, contributing to the increase in health costs and mental problems. Studies have shown that interventions to be applied to caregivers will reduce the care burden and increase the coping capacities of individuals. While a relative being diagnosed with schizophrenia can cause trauma in individuals in itself, on the contrary, they can also experience post-traumatic development, and their high post-traumatic development is effective in reducing the care burden experienced by caregivers. Another important factor in caregivers' struggle with the mentioned difficulties is psychological resilience. Interventions to strengthen psychological resilience are gaining importance in this context. Considering the contemporary roles of psychiatric nursing, it is inevitable for the family to be treated holistically, to reduce the burden of care, and to provide therapeutic interventions that will strengthen the caregiver spiritually. When the literature is examined, it is seen that Acceptance and Commitment (ACT) based interventions are highly effective for individuals providing care to schizophrenia patients, but it is noteworthy that there are not enough studies. In particular, no study has been found examining the effect of ACT based psychoeducation on the post-traumatic development levels of caregivers. This study was planned to reveal the effect of Acceptance and Commitment based psychoeducation applied to individuals providing care to schizophrenia patients on the burden of care, post-traumatic development, and psychological resilience of individuals in order to contribute to its inclusion in psychiatric nursing practices.
- Conditions
- Schizophrenia Patients
- Being tested
- ACT-based psychoeducation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-based psychoeducationOther
It is thought that ACT-based psychoeducation will be an effective psychiatric nursing practice in reducing the care burden of individuals caring for schizophrenia patients and increasing their post-traumatic development and psychological resilience. However, no study has been found in the literature evaluating the effects of these three parameters. In general, the number of ACT-based psychoeducation studies applied to schizophrenia caregivers is quite low. Three thesis studies were found in our country, and no study examining the effect of ACT-based psychoeducation on the post-traumatic development levels of schizophrenia caregivers was found in the domestic and foreign literature. Based on this gap in the literature, the planned study is aimed to be presented to the literature as an intervention that can be used in holistic psychiatric nursing care and to reveal its effects in the specified parameters.
| Study group | Role | What they receive |
|---|---|---|
| Deney Grubu | Experimental | ACT-based psychoeducation will be applied to schizophrenia caregivers in the experimental group. Receives: Other: ACT-based psychoeducation |
| Kontrol grubu | No intervention | Schizophrenia caregivers in the control group will be monitored without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic Data Form
The experimental and control groups will be given a pre-test at the beginning of the study, a post-test after 8 weeks, and a follow-up test after four weeks. The questionnaire form to be applied in the pre-test and post-test is the Sociodemographic Data Form prepared by the researcher. Sociodemographic Data Form prepared by the researcher. The sociodemographic data form consists of age, gender, marital status, education level, degree of closeness to the patient, and duration of care.
Measured: The measurement tests to be applied to the experimental and control groups will be the first test at the beginning of the study, the second test 8 weeks after the beginning, and the follow-up test four weeks after the second test.
Secondary outcomes (1)
Zarit Caregiver Burden Scale
Zarit Caregiver Burden Scale (scale consists of 19 items and will be scored from 1 to 5 from low to high (never, rarely, occasionally, quite often, almost always).
Measured: The measurement tests to be applied to the experimental and control groups will be the first test at the beginning of the study, the second test 8 weeks after the beginning, and the follow-up test four weeks after the second test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start7 Jul 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In order to prevent bias in the study, the pre-test, post-test and follow-up application will be conducted by the interviewer. Data from the experimental and control groups will be collected simultaneously. Individuals in both groups will be interviewed one-on-one, and the psychoeducation application will be applied individually to the experimental group. Written and verbal consent will be obtained from the caregivers, and an explanation will be made regarding the purpose of the study. The Sociodemographic Data Form, Zarit Caregiver Burden, Post-Traumatic Development, and Brief Psychological Resilience Scale (Appendix 1) created by the researcher at the beginning of the study will be applied to the control group, and the control group, which received the pre-test, will be monitored. No application will be made to the control group. Afterwards, the forms specified in the pre-test will be applied to the control group, which will be monitored for 8 weeks, as a post-test. A follow-up test
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Bakar Gürcüoğlu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971328
- Sponsor's protocol ID
- AIBU-SBF-MBG-01
- Status last verified
- May 2025
- First submitted
- 15 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acceptance and Commitment-Based (ACT) Psychoeducation on Caregiver Burden, Posttraumatic Growth and Psychological Resilience in Caregivers of Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT06971328
- Acronym / sponsor ID
- AIBU-SBF-MBG-01
- Conditions
- Schizophrenia Patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 7 Jul 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Schizophrenia is an important mental health problem that requires caregivers because it causes disability. With the efforts to move from a hospital-based model to a community-based model in mental health services, the care of schizophrenia patients is mainly provided by their families at home, creating a significant care burden on caregivers or, on the contrary, post-traumatic development is reported. Psychiatric nurses are responsible for evaluating the patient together with their family by taking these conditions into consideration when providing care to individuals with mental illness. As a principle of humanistic and holistic care, nursing interventions to be implemented by psychiatric nurses to develop caregivers' coping methods, reduce their care burden and contribute to their post-traumatic development are extremely important in terms of the effectiveness and efficiency of care. Acceptance and Commitment (ACT)-based psychoeducation, whose effectiveness has been reported in the literature, is an important application in providing care to patients and families in psychiatric nursing practices. ACT is among the third generation therapies that aim to keep individuals in the moment with awareness, adopt the willingness to accept events instead of struggling with them, and create an important source of power in taking actions in line with life values. In this study, 17 out of 34 individuals determined by statistical methods among the caregivers of schizophrenia patients will be included in the control group and monitored, while 17 will receive 8 sessions of ACT-based psychoeducation in the intervention group, and the effects of the education on caregiver burden, post-traumatic development, and psychological resilience will be evaluated. There are very few studies in the literature where ACT-based psychoeducation is applied to caregivers of schizophrenia patients. Although studies examining the effects on individuals' caregiver burden and psychological resilience are limited, no study has been found examining its effects on post-traumatic development, and this constitutes the original value of the study. As a result of this study, it is expected that ACT-based education will reduce the caregiver burden in schizophrenia caregivers and increase their psychological resilience through post-traumatic development.
Detailed description
Schizophrenia is a significant mental health problem in terms of its prevalence and disability. Individuals who experience significant loss of professional/social functioning and inability to perform self-care activities need a caregiver. Many physical, psychological, and economic problems and a related high care burden have been reported in caregivers. These difficulties increase the entry of caregivers into the health system along with sick individuals, contributing to the increase in health costs and mental problems. Studies have shown that interventions to be applied to caregivers will reduce the care burden and increase the coping capacities of individuals. While a relative being diagnosed with schizophrenia can cause trauma in individuals in itself, on the contrary, they can also experience post-traumatic development, and their high post-traumatic development is effective in reducing the care burden experienced by caregivers. Another important factor in caregivers' struggle with the mentioned difficulties is psychological resilience. Interventions to strengthen psychological resilience are gaining importance in this context. Considering the contemporary roles of psychiatric nursing, it is inevitable for the family to be treated holistically, to reduce the burden of care, and to provide therapeutic interventions that will strengthen the caregiver spiritually. When the literature is examined, it is seen that Acceptance and Commitment (ACT) based interventions are highly effective for individuals providing care to schizophrenia patients, but it is noteworthy that there are not enough studies. In particular, no study has been found examining the effect of ACT based psychoeducation on the post-traumatic development levels of caregivers. This study was planned to reveal the effect of Acceptance and Commitment based psychoeducation applied to individuals providing care to schizophrenia patients on the burden of care, post-traumatic development, and psychological resilience of individuals in order to contribute to its inclusion in psychiatric nursing practices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In order to prevent bias in the study, the pre-test, post-test and follow-up application will be conducted by the interviewer. Data from the experimental and control groups will be collected simultaneously. Individuals in both groups will be interviewed one-on-one, and the psychoeducation application will be applied individually to the experimental group. Written and verbal consent will be obtained from the caregivers, and an explanation will be made regarding the purpose of the study. The Sociodemographic Data Form, Zarit Caregiver Burden, Post-Traumatic Development, and Brief Psychological Resilience Scale (Appendix 1) created by the researcher at the beginning of the study will be applied to the control group, and the control group, which received the pre-test, will be monitored. No application will be made to the control group. Afterwards, the forms specified in the pre-test will be applied to the control group, which will be monitored for 8 weeks, as a post-test. A follow-up test
| Arm | Type | Receives |
|---|---|---|
| Deney Grubu | Experimental | Other: ACT-based psychoeducationACT-based psychoeducation will be applied to schizophrenia caregivers in the experimental group. |
| Kontrol grubu | No intervention | –Schizophrenia caregivers in the control group will be monitored without any intervention. |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Providing primary care to an individual diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) V
- Living with the patient and providing care for at least 6 months
- Being over 18 years of age
- Being literate
- Not having been diagnosed with any mental illness
Key exclusion criteria (2 listed)
- The patient must live in a different house and spend less than 6 hours together per day
- Having previously attended ACT or Psychoeducation programs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-based psychoeducationIt is thought that ACT-based psychoeducation will be an effective psychiatric nursing practice in reducing the care burden of individuals caring for schizophrenia patients and increasing their post-traumatic development and psychological resilience. However, no study has been found in the literature evaluating the effects of these three parameters. In general, the number of ACT-based psychoeducation studies applied to schizophrenia caregivers is quite low. Three thesis studies were found in our country, and no study examining the effect of ACT-based psychoeducation on the post-traumatic development levels of schizophrenia caregivers was found in the domestic and foreign literature. Based on this gap in the literature, the planned study is aimed to be presented to the literature as an intervention that can be used in holistic psychiatric nursing care and to reveal its effects in the specified parameters. | Other | Deney Grubu |
Primary outcome
Sociodemographic Data Form
Time frame: The measurement tests to be applied to the experimental and control groups will be the first test at the beginning of the study, the second test 8 weeks after the beginning, and the follow-up test four weeks after the second test.
The experimental and control groups will be given a pre-test at the beginning of the study, a post-test after 8 weeks, and a follow-up test after four weeks. The questionnaire form to be applied in the pre-test and post-test is the Sociodemographic Data Form prepared by the researcher. Sociodemographic Data Form prepared by the researcher. The sociodemographic data form consists of age, gender, marital status, education level, degree of closeness to the patient, and duration of care.
1 secondary outcome
Zarit Caregiver Burden Scale
Time frame: The measurement tests to be applied to the experimental and control groups will be the first test at the beginning of the study, the second test 8 weeks after the beginning, and the follow-up test four weeks after the second test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-based psychoeducation in people with Schizophrenia Patients, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve Bakar Gürcüoğlu (+905307233533 ext. 05307233533, bakarmerve71@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sociodemographic Data Form (time frame: The measurement tests to be applied to the experimental and control groups will be the first test at the beginning of the study, the second test 8 weeks after the beginning, and the follow-up test four weeks after the second test.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.