Mindfulness-Based Education for Caregivers of Individuals Diagnosis With Schizophrenia

NCT ID: NCT07076940

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2025-06-16

Brief Summary

The research is carried out by PhD student Azize Gözde Atakoğlu under the supervision of Associate Professor Gülcan Kendirkıran.

This study was conducted with a randomized control group, experimental research design in order to determine the effects of mindfulness-based training on stress perception and well-being in caregivers of individuals diagnosed with schizophrenia. The research data were collected at the Community Mental Health Center affiliated with a Training and Research Hospital in Istanbul between 15 September 2022 and 1 February 2023. Before commencing the study, an ethical approval decision was obtained from the Haliç University Non-Interventional Clinical Research Ethics Committee (May 25, 2022-90). Subsequently, an institutional permit for the study (June 28, 2022-637) was obtained from the Istanbul Provincial Health Directorate Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital, along with the ethics committee approval. The sample of the study consisted of caregivers of individuals diagnosed with schizophrenia, 15 in the intervention group, 15 in the psychoeducation group, and 30 in the control group (n=60). The study data were collected using the Personal Information Form, Perceived Stress Scale (PSS), Psychological Well-Being Scale (PWS), Participant Experience Form (PEF), Post-Experience Stress Assessment Questionnaire (PSSQ), and Home Application Note Form. Frequency tables and descriptive statistics were used in the interpretation of the findings. For measurement values suitable for normal distribution, "ANOVA" test (F-table value), "Repeated Measures" test (F-table value), for measurement values not suitable for normal distribution, Kruskal-Wallis H" test (χ2-table value), "Friedman" test (χ2-table value) method was used. "Pearson-χ2" was used to examine the relationships between two qualitative variables, and "Spearman" correlation coefficient was used to examine the relationships between two quantitative variables not having normal distribution. As a result of this study, it was found that mindfulness-based intervention reduced stress in caregivers and contributed to psychological well-being (p<0.05). In addition, it was observed that the effect continued even though it decreased in follow-up tests. In this direction, it is recommended that follow-up tests be kept longer and intermediate interventions be added in other studies to be conducted. It is also recommended that qualitative studies be conducted on this subject in order to obtain detailed feedback on the processes related to the initiatives.

Conditions

Mindfulness; Mindfulness Based Stress Reduction; Caregivers; Stress Perception; Psychological Well-being; Schizophrenia Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Mindfulness Group

The mindfulness-based training program was completed in a total of five sessions (one day per week, 60 minutes, for a total of five consecutive weeks).

Group Type: EXPERIMENTAL

Mindfulness-based Training Program

Intervention Type: OTHER

The mindfulness-based training program was completed in a total of five sessions (one day per week, 60 minutes, for a total of five consecutive weeks).

Psychoeducation Group

The "Psychoeducational Program," themed around stress, well-being, and mindfulness, was completed in two sessions (two sessions over five weeks, each lasting 60 minutes).

Group Type: OTHER

Psychoeducational Program

Intervention Type: OTHER

The "Psychoeducational Program," themed around stress, well-being, and mindfulness, was completed in two sessions (two sessions over five weeks, each lasting 60 minutes).

Control Group

No intervention was administered.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness-based Training Program

The mindfulness-based training program was completed in a total of five sessions (one day per week, 60 minutes, for a total of five consecutive weeks).

Intervention Type: OTHER

Psychoeducational Program

The "Psychoeducational Program," themed around stress, well-being, and mindfulness, was completed in two sessions (two sessions over five weeks, each lasting 60 minutes).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being over 18 years of age
• The patient they are caring for must have been diagnosed with schizophrenia according to the DSM-V (Diagnostic and Statistical Manual of Mental Disorders) classification at least one year ago
• Living together in the same house for at least one year
• Being directly responsible for the patient's treatment arrangements and care
• Being open to communication and collaboration.

Exclusion Criteria

• Having any condition that may prevent them from receiving education.
• Having a vision, hearing, or comprehension problem.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Halic University

OTHER

Sponsor Role: lead

Responsible Party

Azize Gözde Atakoğlu

Principal Investigator, PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gülcan KENDİRKIRAN, Associate Professor

Role: STUDY_DIRECTOR

Halic University

Locations

Zeytinburnu Community Mental Health Center, affiliated with the Istanbul Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital.

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

25.05.2022 / 90

Identifier Type: -

Identifier Source: org_study_id