NCT06971328

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Jul 2025Jun 2027

First Submitted

Initial submission to the registry

April 15, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

July 7, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

1.5 years

First QC Date

April 15, 2025

Last Update Submit

May 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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.

Other Outcomes (2)

  • Posttraumatic Growth Questionnaire

    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.

  • Brief Resilience Scale

    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.

Study Arms (2)

Deney Grubu

EXPERIMENTAL

ACT-based psychoeducation will be applied to schizophrenia caregivers in the experimental group.

Other: ACT-based psychoeducation

Kontrol grubu

NO INTERVENTION

Schizophrenia caregivers in the control group will be monitored without any intervention.

Interventions

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.

Deney Grubu

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • The patient must live in a different house and spend less than 6 hours together per day
  • Having previously attended ACT or Psychoeducation programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum Şehir Hastanesi

Erzurum, Yakutiye, 25000, Turkey (Türkiye)

Location

Central Study Contacts

Merve Bakar Gürcüoğlu

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
• During the data evaluation process, the data of the experimental and control groups will be given a code (random, from 1 to 34) to ensure blinding of the statistician. In this way, the triple blinding method will be applied.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nursing

Study Record Dates

First Submitted

April 15, 2025

First Posted

May 14, 2025

Study Start

July 7, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations