Mindfulness-Based Education for Caregivers of Individuals Diagnosis With Schizophrenia

NCT07076940 | Completed

• 1 other identifier: 25.05.2022 / 90
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Keywords

Mindfulness; Caregivers; Stress perception; Psychological well-being; Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Perceived Stress Scale

  The scale consists of 14 items in a 5-point Likert type. 7 items with positive expressions (4, 5, 6, 7, 9, 10, 13) are reverse coded and high scores indicate a high level of perceived stress. The scale has 2 sub-dimensions as "perception of inadequacy" and "perception of stress/discomfort." The score to be obtained from PSS-14 varies between 0 and 56. The Cronbach's Alpha coefficient of the Turkish scale was determined as 0.84 and its reliability as 0.87. Cronbach's Alpha values obtained in this study are as follows in the whole sample; inadequate self-efficacy perception is 0.89, stress discomfort perception is 0.79, PSS total is 0.89.

  Before the intervention, immediately after the intervention, and 1 month after the last measurement

• Psychological Well-Being Scale

  The items of PWB are answered on a scale of 1-7, from strongly disagree (1) to strongly agree (7). All items are expressed positively. Scores range from 8 (if strongly disagree is answered to all items) to 56 (if strongly agree is answered to all items). A high score indicates that the person has many psychological resources and strengths. Although the scale does not provide separate measurements of aspects of well-being, it provides an overview of positive functions in different areas that are believed to be important. The Cronbach's alpha internal consistency coefficient obtained in the reliability study of the scale was calculated as .80 (Telef, 2013). Cronbach's Alpha values obtained in this study; is 0.91 in the entire sample.

  Before the intervention, immediately after the intervention, and 1 month after the last measurement

Secondary Outcomes (2)

• Personal Information Form

  Before the intervention

• Participant Experience Form

  Immediately after the intervention

Study Arms (3)

Mindfulness Group

EXPERIMENTAL

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).

Other: Mindfulness-based Training Program

Psychoeducation Group

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).

Other: Psychoeducational Program

Control Group

NO INTERVENTION

No intervention was administered.

Interventions

Mindfulness-based Training Program 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).

Mindfulness Group

Psychoeducational Program 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).

Psychoeducation Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Halic University: lead

Study Sites (1)

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)

Location

MeSH Terms

Conditions

Psychological Well-Being; Schizophrenia

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Gülcan KENDİRKIRAN, Associate Professor

  Halic University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were assigned to different groups. Intervention plans were made for each group on different days to minimize contact between groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD Student

Model Details: The study included the "Mindfulness Group (n: 15), "Psychoeducation Group (n: 15)," and control group (n: 30). Different patient relatives were randomly assigned to each group. The mindfulness group received five sessions (one day per week, 60 minutes, for a total of five consecutive weeks). The psychoeducation group completed a "Psychoeducation Program" themed around stress, well-being, and mindfulness in two sessions (two sessions over five weeks, each session lasting 60 minutes). The control group received no intervention. Posttest measurements (n: 30) were taken after the completion of the training program for the mindfulness and psychoeducation groups. Follow-up tests (n: 30) were conducted simultaneously with the mindfulness and psychoeducation groups one month later.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 22, 2025
• Study Start: September 15, 2022
• Primary Completion: February 1, 2023
• Study Completion: June 16, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)