MBSRMindfulnessNCT05245305
The Effect of Mindfulness-Based Stress Reduction Program
A study testing Mindfulness Based Stress Reduction Program in people with MBSR and Caregiver, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study evaluate the effect of the Mindfulness-Based Stress Reduction Program on the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Mindfulness Based Stress Reduction Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 28 Feb 2023
- 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
- Above 18 years old
- Able to read and understand Turkish
- Taking care of the sick individual at home
- Living in the same house with the sick individual
- No psychiatric illness
- No problems with movement, sight, hearing or understanding
Show all 11Show fewer
- Volunteer to participate in the study
- Able to access the internet with their phone or computer
- Those who did not receive any other psychological therapy during their working dates
- No previous meditation experience
- Having no practice in daily mind-body practices
Who cannot join
- Under 18 years old
- Can't read and understand Turkish
- Any psychiatric illness receiving another psychological therapy on working dates
- Meditation experience before the study; having practice in daily mind-body practices
- Having problems with movement, vision, hearing, understanding
- Not willing to participate in the study
- Participants who participated in more than 50% of a mindfulness-based intervention prior to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindfulness-Based Stress Reduction Program on Mental Status and Care Burden of Psychotic Patients' Families
This randomized controlled study evaluate the effect of the Mindfulness-Based Stress Reduction Program on the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients. The hypothesis of this study is that the Mindfulness-Based Stress Reduction Program improves the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients.
Read the detailed description
Introduction: One of the chronic mental diseases, psychosis causes social and economic losses by negatively affecting the patient's feelings, thoughts and behaviors, interpersonal relations, work and social harmony, and the patient and family may experience different difficulties. With the transition to the community-based model in the provision of mental health services, the relatives of the patients have become the primary caregivers in the care of the patient and their responsibilities have increased even more.When the family is considered as a system, there is a constant interaction between the parts of the system and the change in the patient in case of illness can affect the whole family.When the disease occurs, one of the family members has to take care of the sick individual and caregivers experience emotional (decreased self-esteem, restlessness, depression, insomnia, social isolation, etc.), social (restriction of entertaining, relaxing and leisure time activities, reduction in the role of self-care, etc.). ) and economically (expenses not covered by social security creating an additional burden, reducing working hours, etc.). It is emphasized that psychosocial interventions for families increase the perception of social support, self-efficacy and satisfaction with treatment among caregivers, and reduce the perceived burden and recurrence of the disease.However, the high level of emotional expression and perceived stress of the families may trigger the recurrence of the disease. For this reason, family is naturally emphasized as an important factor in the recovery of the individual with a psychotic illness. Therefore, rehabilitation processes should be aimed not only at patients, but also towards caregivers. One of the interventions used for this purpose today is the Mindfulness-Based Stress Reduction (MBSR) program, which is an evidence-based intervention that teaches skills to reduce stress and manage challenging emotions in a group setting. Although the MBSR intervention is usually aimed at people with chronic physical and mental illnesses, the purpose of the intervention is not to replace medical treatment, but can be used as a supplement, supportive, preventive, complementary or simply a stand-alone method to heal patients. In this respect, it is thought that it is important for psychiatric nurses to use the MBSR program, which is a complementary, supportive, preventive and protective program, in the protection and strengthening of mental health in family members who care for psychosis patients. When the literature is examined, it is emphasized that the MBSR program has positive effects on caregiver family members. In this context, this study is planned to determine the effect of the Mindfulness-Based Stress Reduction Program on the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients.
Methods: In the study, 60 family members caring for an individual with psychotic illness were randomly assigned to the study and control groups. 11-week MBSR program will be apply to study group (n = 28). No intervention will be made to the control group (n = 28). The primary outcome of the study is the effect of MBSR on the state-trait anxiety, hopelessness, and self-compassion levels of caregiver family members. The secondary outcome of the study is the effect of MBSR on the caregiving burden of family members. Data will be collected pre-intervention, post-intervention, 3 and 6 months after the intervention.
- Being tested
- Mindfulness Based Stress Reduction Program
- Keywords
- MBSR, Anxiety, Hopelessness, Care burden, Nursing
- Medical subject headings
- Anxiety Disorders, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction ProgramOther
Also called MBSR
The intervention was structured as 11 weeks, taking into account the group. The program takes 2-2.5 hours per week. The program includes raisin exercise, body scanning meditation, breath awareness meditation, sitting meditation, mindfull movement, walking meditation, vision meditation, compassion meditation,mindfulness communication and day of silence.
| Study group | Role | What they receive |
|---|---|---|
| MBSR Intervention | Experimental | The intervention group will take part in mindfulness-based stress reduction (MBSR) program led by a certified MBSR instructor via Zoom. The MBSR program was structured as 11 weeks, taking into account the characteristics of the participants. Receives: Other: Mindfulness Based Stress Reduction Program |
| Control | No intervention | No intervention was applied to the control group. Data will be collected from the control group simultaneously with the study group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety will be evaluated using the State-Trait Anxiety Scale
The total score obtained from both scales varies between 20 and 80. It states that 0-19 points mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.
Measured: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
Secondary outcomes (4)
Care burden will be assessed using the Caregiver Burden Scale.
A score between 22 and 110 is taken from the scale. Obtained points; It is evaluated by grading as "light load" between 22-46, "medium load" between 47-55, "severe load" between 56-110.
Measured: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
Hopelessness will be measured using the Beck Hopelessness Scale.
The score range of the scale is 0-20. When the scores obtained are high, hopelessness in the individual is considered high
Measured: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
Self-compassion will be assessed using the Self-Compassion Scale.
To calculate the total self-compassion score, the "self-judgmental", "social isolation" and "over-identification" subscale items are reverse coded.
Then, the self-compassion level is calculated by taking the average of all the items.
The higher the score for each sub-dimension, the higher the level of self-compassion.
Measured: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
Focus Group Interview Questionnaire I
Focus Group Interview Questionnaire I was created by the researcher in order to evaluate the experiences of the individuals in the study group regarding the MBSR program. There are five questions in the form.
Measured: Within 1 week postintervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 May 2022
- Primary completion15 May 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MBSRStudies 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
- Prospective, parallel, two-arm randomized controlled clinical trial Masking: Single (Participant)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Munevver Bogahan, Mersin University
- Investigators
- Münevver Boğahan, Assistant, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245305
- Sponsor's protocol ID
- munevverbghn
- Other IDs
- Münevver Boğahan
- Acronym
- Mindfulness
- Status last verified
- Oct 2026
- First submitted
- 24 Jan 2022
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caqueo-Urizar A, Miranda-Castillo C, Lemos Giraldez S, Lee Maturana SL, Ramirez Perez M, Mascayano Tapia F. An updated review on burden on caregivers of schizophrenia patients. Psicothema. 2014 May;26(2):235-43. doi: 10.7334/psicothema2013.86.
PubMed 24755026Liu Z, Chen QL, Sun YY. Mindfulness training for psychological stress in family caregivers of persons with dementia: a systematic review and meta-analysis of randomized controlled trials. Clin Interv Aging. 2017 Sep 22;12:1521-1529. doi: 10.2147/CIA.S146213. eCollection 2017.
PubMed 29026290Smith JM, Bright KS, Mader J, Smith J, Afzal AR, Patterson C, Dimitropolous G, Crowder R. A pilot of a mindfulness based stress reduction intervention for female caregivers of youth who are experiencing substance use disorders. Addict Behav. 2020 Apr;103:106223. doi: 10.1016/j.addbeh.2019.106223. Epub 2019 Nov 30.
PubMed 31838440Stjernsward S, Hansson L. Outcome of a web-based mindfulness intervention for families living with mental illness - A feasibility study. Inform Health Soc Care. 2017 Jan;42(1):97-108. doi: 10.1080/17538157.2016.1177533. Epub 2016 May 31.
PubMed 27245198Williams H, Simmons LA, Tanabe P. Mindfulness-Based Stress Reduction in Advanced Nursing Practice: A Nonpharmacologic Approach to Health Promotion, Chronic Disease Management, and Symptom Control. J Holist Nurs. 2015 Sep;33(3):247-59. doi: 10.1177/0898010115569349. Epub 2015 Feb 11.
PubMed 25673578Whitebird RR, Kreitzer M, Crain AL, Lewis BA, Hanson LR, Enstad CJ. Mindfulness-based stress reduction for family caregivers: a randomized controlled trial. Gerontologist. 2013 Aug;53(4):676-86. doi: 10.1093/geront/gns126. Epub 2012 Oct 15.
PubMed 23070934Bogahan M, Yilmaz S, Yilmaz M. Effects of Mindfulness-Based Stress Reduction Program on the Mental Health and Care Burden in Family Caregivers of Individuals with Psychosis. Community Ment Health J. 2026 Feb;62(2):335-345. doi: 10.1007/s10597-025-01527-z. Epub 2025 Oct 17.
PubMed 41105316
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Stress Reduction Program on Mental Status and Care Burden of Psychotic Patients' Families
- ClinicalTrials.gov ID
- NCT05245305
- Acronym / sponsor ID
- Mindfulness / munevverbghn
- Keywords
- MBSR, Anxiety, Hopelessness, Care burden, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 17 Feb 2022 (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.
This randomized controlled study evaluate the effect of the Mindfulness-Based Stress Reduction Program on the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients. The hypothesis of this study is that the Mindfulness-Based Stress Reduction Program improves the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients.
Detailed description
Introduction: One of the chronic mental diseases, psychosis causes social and economic losses by negatively affecting the patient's feelings, thoughts and behaviors, interpersonal relations, work and social harmony, and the patient and family may experience different difficulties. With the transition to the community-based model in the provision of mental health services, the relatives of the patients have become the primary caregivers in the care of the patient and their responsibilities have increased even more.When the family is considered as a system, there is a constant interaction between the parts of the system and the change in the patient in case of illness can affect the whole family.When the disease occurs, one of the family members has to take care of the sick individual and caregivers experience emotional (decreased self-esteem, restlessness, depression, insomnia, social isolation, etc.), social (restriction of entertaining, relaxing and leisure time activities, reduction in the role of self-care, etc.). ) and economically (expenses not covered by social security creating an additional burden, reducing working hours, etc.). It is emphasized that psychosocial interventions for families increase the perception of social support, self-efficacy and satisfaction with treatment among caregivers, and reduce the perceived burden and recurrence of the disease.However, the high level of emotional expression and perceived stress of the families may trigger the recurrence of the disease. For this reason, family is naturally emphasized as an important factor in the recovery of the individual with a psychotic illness. Therefore, rehabilitation processes should be aimed not only at patients, but also towards caregivers. One of the interventions used for this purpose today is the Mindfulness-Based Stress Reduction (MBSR) program, which is an evidence-based intervention that teaches skills to reduce stress and manage challenging emotions in a group setting. Although the MBSR intervention is usually aimed at people with chronic physical and mental illnesses, the purpose of the intervention is not to replace medical treatment, but can be used as a supplement, supportive, preventive, complementary or simply a stand-alone method to heal patients. In this respect, it is thought that it is important for psychiatric nurses to use the MBSR program, which is a complementary, supportive, preventive and protective program, in the protection and strengthening of mental health in family members who care for psychosis patients. When the literature is examined, it is emphasized that the MBSR program has positive effects on caregiver family members. In this context, this study is planned to determine the effect of the Mindfulness-Based Stress Reduction Program on the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients.
Methods: In the study, 60 family members caring for an individual with psychotic illness were randomly assigned to the study and control groups. 11-week MBSR program will be apply to study group (n = 28). No intervention will be made to the control group (n = 28). The primary outcome of the study is the effect of MBSR on the state-trait anxiety, hopelessness, and self-compassion levels of caregiver family members. The secondary outcome of the study is the effect of MBSR on the caregiving burden of family members. Data will be collected pre-intervention, post-intervention, 3 and 6 months after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, parallel, two-arm randomized controlled clinical trial Masking: Single (Participant)
| Arm | Type | Receives |
|---|---|---|
| MBSR Intervention | Experimental | Other: Mindfulness Based Stress Reduction ProgramThe intervention group will take part in mindfulness-based stress reduction (MBSR) program led by a certified MBSR instructor via Zoom. The MBSR program was structured as 11 weeks, taking into account the characteristics of the participants. |
| Control | No intervention | –No intervention was applied to the control group. Data will be collected from the control group simultaneously with the study group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Above 18 years old
- Able to read and understand Turkish
- Taking care of the sick individual at home
- Living in the same house with the sick individual
- No psychiatric illness
Key exclusion criteria (7 listed)
- Under 18 years old
- Can't read and understand Turkish
- Any psychiatric illness receiving another psychological therapy on working dates
- Meditation experience before the study; having practice in daily mind-body practices
- Having problems with movement, vision, hearing, understanding
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 Stress Reduction ProgramAlso: MBSRThe intervention was structured as 11 weeks, taking into account the group. The program takes 2-2.5 hours per week. The program includes raisin exercise, body scanning meditation, breath awareness meditation, sitting meditation, mindfull movement, walking meditation, vision meditation, compassion meditation,mindfulness communication and day of silence. | Other | MBSR Intervention |
Primary outcome
Anxiety will be evaluated using the State-Trait Anxiety Scale
Time frame: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
The total score obtained from both scales varies between 20 and 80. It states that 0-19 points mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.
4 secondary outcomes
Care burden will be assessed using the Caregiver Burden Scale.
Time frame: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
Hopelessness will be measured using the Beck Hopelessness Scale.
Time frame: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
Self-compassion will be assessed using the Self-Compassion Scale.
Time frame: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
Focus Group Interview Questionnaire I
Time frame: Within 1 week postintervention
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 6 Oct 2026.
- Background: PubMed 24755026Caqueo-Urizar A, Miranda-Castillo C, Lemos Giraldez S, Lee Maturana SL, Ramirez Perez M, Mascayano Tapia F. An updated review on burden on caregivers of schizophrenia patients. Psicothema. 2014 May;26(2):235-43. doi: 10.7334/psicothema2013.86.
- Background: PubMed 29026290Liu Z, Chen QL, Sun YY. Mindfulness training for psychological stress in family caregivers of persons with dementia: a systematic review and meta-analysis of randomized controlled trials. Clin Interv Aging. 2017 Sep 22;12:1521-1529. doi: 10.2147/CIA.S146213. eCollection 2017.
- Background: PubMed 31838440Smith JM, Bright KS, Mader J, Smith J, Afzal AR, Patterson C, Dimitropolous G, Crowder R. A pilot of a mindfulness based stress reduction intervention for female caregivers of youth who are experiencing substance use disorders. Addict Behav. 2020 Apr;103:106223. doi: 10.1016/j.addbeh.2019.106223. Epub 2019 Nov 30.
- Background: PubMed 27245198Stjernsward S, Hansson L. Outcome of a web-based mindfulness intervention for families living with mental illness - A feasibility study. Inform Health Soc Care. 2017 Jan;42(1):97-108. doi: 10.1080/17538157.2016.1177533. Epub 2016 May 31.
- Background: PubMed 25673578Williams H, Simmons LA, Tanabe P. Mindfulness-Based Stress Reduction in Advanced Nursing Practice: A Nonpharmacologic Approach to Health Promotion, Chronic Disease Management, and Symptom Control. J Holist Nurs. 2015 Sep;33(3):247-59. doi: 10.1177/0898010115569349. Epub 2015 Feb 11.
- Background: PubMed 23070934Whitebird RR, Kreitzer M, Crain AL, Lewis BA, Hanson LR, Enstad CJ. Mindfulness-based stress reduction for family caregivers: a randomized controlled trial. Gerontologist. 2013 Aug;53(4):676-86. doi: 10.1093/geront/gns126. Epub 2012 Oct 15.
- Derived from this study: PubMed 41105316Bogahan M, Yilmaz S, Yilmaz M. Effects of Mindfulness-Based Stress Reduction Program on the Mental Health and Care Burden in Family Caregivers of Individuals with Psychosis. Community Ment Health J. 2026 Feb;62(2):335-345. doi: 10.1007/s10597-025-01527-z. Epub 2025 Oct 17.
- An updated review on burden on caregivers of schizophrenia patientsLink provided by the sponsor.
- Mindfulness training for psychological stress in family caregivers of persons with dementia: a systematic review and meta-analysis of randomized controlled trialsLink provided by the sponsor.
- A pilot of a mindfulness based stress reduction intervention for female caregivers of youth who are experiencing substance use disordersLink provided by the sponsor.
- Outcome of a web-based mindfulness intervention for families living with mental illness - A feasibility studyLink provided by the sponsor.
- Mindfulness-Based Stress Reduction in Advanced Nursing Practice: A Nonpharmacologic Approach to Health Promotion, Chronic Disease Management, and Symptom ControlLink provided by the sponsor.
- Mindfulness-based stress reduction for family caregivers: a randomized controlled trialLink provided by the sponsor.
- 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.
Münevver Boğahan, Assistant principal investigator
Mersin 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 Stress Reduction Program in people with MBSR and Caregiver, run by Mersin 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 11 inclusion and 7 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 6 Oct 2026. 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?
Anxiety will be evaluated using the State-Trait Anxiety Scale (time frame: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05245305, which also lists 7 linked publications.
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 6 Oct 2026.