- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07076940
- Original Trial
Mindfulness-Based Education for Caregivers of Individuals Diagnosis With Schizophrenia (MBECIDS)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Zeytinburnu Community Mental Health Center, affiliated with the Istanbul Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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).
|
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: 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).
|
The "Psychoeducational Program," themed around stress, well-being, and mindfulness, was completed in two sessions (two sessions over five weeks, each lasting 60 minutes).
|
|
No Intervention: Control Group
No intervention was administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Before the intervention, immediately after the intervention, and 1 month after the last measurement
|
|
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.
|
Before the intervention, immediately after the intervention, and 1 month after the last measurement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Personal Information Form
Time Frame: Before the intervention
|
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.
|
Before the intervention
|
|
Participant Experience Form
Time Frame: Immediately after the intervention
|
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).
|
Immediately after the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gülcan KENDİRKIRAN, Associate Professor, Haliç University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25.05.2022 / 90
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mindfulness
-
Kayseri Training and Research HospitalActive, not recruitingMindfulness | Mindfulness Based Stress ReductionTurkey
-
Northwestern UniversityUniversity of Pittsburgh; National Institutes of Health (NIH); National Center...CompletedCreating and Optimizing Mindfulness Measures to Enhance and Normalize Clinical Evaluation (COMMENCE)MindfulnessUnited States
-
Colorado State UniversityCompleted
-
Bahcesehir Cyprus UniversityCompleted
-
Loma Linda UniversityCompleted
-
Suleyman Demirel UniversityCompletedStress | Mindfulness | Clinical Practice | Mindfulness Based Stress Reduction | Mindful Breathing MeditationTurkey (Türkiye)
-
Education University of Hong KongLAU Ngar SzeCompleted
-
University of OxfordMind and Life EuropeCompleted
-
Pacific UniversityCompletedMindfulnessUnited States
Clinical Trials on Mindfulness-based Training Program
-
Kyungpook National University Chilgok HospitalActive, not recruitingHealth Adult Subjects | MaltreamentKorea, Republic of
-
Comenius UniversityCompletedBurnout, Professional | Occupational Stress | Mental Health | Emotional RegulationSlovakia
-
Rabin Medical CenterUnknown
-
Singapore General HospitalDuke-NUS Graduate Medical SchoolCompletedMild Cognitive ImpairmentSingapore
-
Dalhousie UniversityUnknownMindfulness | Students | Adverse Childhood ExperiencesCanada
-
Bout Me HealingCompletedSubstance Use Disorder (SUD) | Anxiety Disorder GeneralizedUnited States
-
University of BarcelonaUniversity of Pittsburgh; Germans Trias i Pujol Hospital; Fundació La Marató... and other collaboratorsCompleted
-
IRCCS Fondazione Stella MarisUniversity of Pisa; University of Florence; John Cabot UniversityRecruitingCompassion | Emotion Regulation | School-based Intervention | Mindfulness-based InterventionItaly
-
Hasan Kalyoncu UniversityCompletedSelf Regulation | School Readiness | Attention and FocusTurkey (Türkiye)
-
Yazgulu HemedogluNot yet recruitingChild | Mindfulness | Media UseTurkey (Türkiye)