MindfulnessMBECIDSNCT07076940
Mindfulness-Based Education for Caregivers of Individuals Diagnosis With Schizophrenia
A study testing Mindfulness-based Training Program and Psychoeducational Program in people with Mindfulness and Mindfulness Based Stress Reduction, run by Halic University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Mindfulness Based Stress Reduction, Caregivers
- What is being tested?
- Mindfulness-based Training Program and Psychoeducational Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2022to 16 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Having any condition that may prevent them from receiving education.
- Having a vision, hearing, or comprehension problem.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeytinburnu Community Mental Health Center, affiliated with the Istanbul Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital.
Istanbul
About this study
Official title: The Effect of Mindfulness-Based Education on Stress Perception and Well-Being in Caregivers of Individuals Diagnosis With Schizophrenia
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
- Being tested
- Mindfulness-based Training Program, Psychoeducational Program
- Keywords
- Mindfulness, Caregivers, Stress perception, Psychological well-being, Schizophrenia
- Medical subject headings
- Psychological Well-Being, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Training ProgramOther
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).
Psychoeducational ProgramOther
The "Psychoeducational Program," themed around stress, well-being, and mindfulness, was completed in two sessions (two sessions over five weeks, each lasting 60 minutes).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Psychoeducational Program |
| Control Group | No intervention | No intervention was administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before the intervention, immediately after the intervention, and 1 month after the last measurement
Secondary outcomes (2)
Personal Information Form
This form consisted of 23 multiple-choice and open-ended questions regarding the participants' individual characteristics, their knowledge of caregiving, and their perceptions of mental health-related stress and well-being. The form was developed by the researchers based on literature. Expert opinion was obtained to determine its appropriateness.
Measured: Before the intervention
Participant Experience Form
This form was developed by researchers to identify the experiences of mindfulness group members participating in a mindfulness-based training program, including their emotions, thoughts, and perceptions, as well as their subjective evaluations of the training process. The form consists of nine items, with responses ranging from 1 to 5, from not at all (1) to completely (5).
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start15 Sep 2022
- Primary completion1 Feb 2023
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies 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
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azize Gözde Atakoğlu, Halic University
- Investigators
- Gülcan KENDİRKIRAN, Associate Professor, Study director, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076940
- Sponsor's protocol ID
- 25.05.2022 / 90
- Acronym
- MBECIDS
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Education on Stress Perception and Well-Being in Caregivers of Individuals Diagnosis With Schizophrenia
- ClinicalTrials.gov ID
- NCT07076940
- Acronym / sponsor ID
- MBECIDS / 25.05.2022 / 90
- Conditions
- Mindfulness, Mindfulness Based Stress Reduction, Caregivers, Stress Perception, Psychological Well-being, Schizophrenia Disorder
- Keywords
- Mindfulness, Caregivers, Stress perception, Psychological well-being, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 22 Jul 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Group | Experimental | Other: Mindfulness-based Training ProgramThe 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 | Other | Other: Psychoeducational ProgramThe "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 | –No intervention was administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Having any condition that may prevent them from receiving education.
- Having a vision, hearing, or comprehension problem.
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 |
|---|---|---|
| Mindfulness-based Training ProgramThe 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 Group |
| Psychoeducational ProgramThe "Psychoeducational Program," themed around stress, well-being, and mindfulness, was completed in two sessions (two sessions over five weeks, each lasting 60 minutes). | Other | Psychoeducation Group |
Primary outcome
Perceived Stress Scale
Time frame: Before the intervention, immediately after the intervention, and 1 month after the last measurement
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.
Psychological Well-Being Scale
Time frame: Before the intervention, immediately after the intervention, and 1 month after the last measurement
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.
2 secondary outcomes
Personal Information Form
Time frame: Before the intervention
Participant Experience Form
Time frame: Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 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. This study is not recruiting at the moment.
Gülcan KENDİRKIRAN, Associate Professor study director
Halic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Training Program and Psychoeducational Program in people with Mindfulness and Mindfulness Based Stress Reduction, run by Halic 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 5 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: finished, as of the sponsor's last update on 22 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (time frame: Before the intervention, immediately after the intervention, and 1 month after the last measurement). The study lists 2 primary outcomes in all. 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 22 Jul 2025.