Caregiver Stress in Chronic Mental IllnessMBSR-CGNCT07322081
Effect of a Mindfulness-Based Stress Reduction Program on Caregivers
A study testing The Mindfulness-Based Stress Reduction program consists of structured mindfulness practices, psychoeducation, and experiential exercises delivered to caregivers. in people with Caregiver Stress in Chronic Mental Illness and Psychosocial Burden in Psychiatric Caregivers, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This study is designed to investigate the effects of a Mindfulness-Based Stress Reduction (MBSR) program on cognitive control and flexibility, psychological well-being, and self-compassion among primary caregivers of individuals with chronic mental illnesses. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregiver Stress in Chronic Mental Illness, Psychosocial Burden in Psychiatric Caregivers, Chronic Mental Illness Caregiving
- What is being tested?
- The Mindfulness-Based Stress Reduction program consists of structured mindfulness practices, psychoeducation, and experiential exercises delivered to caregivers.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2023to 15 Nov 2024
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being the primary caregiver of an individual with a chronic mental illness who is registered at the Community Mental Health Center (CMHC) of Söke Fehime Faik Kocagöz State Hospital
- Residing in the Söke district of Aydın province
- Being literate
- Having been the primary caregiver of the patient for at least six months
Who cannot join
- Having been diagnosed with any psychiatric disorder
- Having an intellectual disability
- Data from caregivers who submitted incomplete data collection forms were excluded from the study
- Caregivers who chose to withdraw from the study during the research process were excluded, and any data obtained from them were not used in the analysis
- Individuals who missed more than two sessions of the Mindfulness-Based Stress Reduction Program were excluded, and their data were not included in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Söke Fehime Faik Kocagöz State Hospital Community Mental Health Center
Aydin, Söke, 09200
About this study
Official title: Effect of a Mindfulness-Based Stress Reduction Program for Caregivers of Individuals With Chronic Mental Illness on Cognitive Control and Flexibility , Psychological Well-Being and Self-Compassion
This study is designed to investigate the effects of a Mindfulness-Based Stress Reduction (MBSR) program on cognitive control and flexibility, psychological well-being, and self-compassion among primary caregivers of individuals with chronic mental illnesses. Caregivers of individuals with chronic mental health conditions are exposed to prolonged psychological, emotional, and cognitive demands, which may negatively affect their mental well-being and coping capacities.
The study adopts a mixed-methods approach using an exploratory sequential design in order to obtain a comprehensive understanding of caregivers' needs and experiences and to evaluate the potential impact of the intervention. Qualitative findings are intended to inform the development and structuring of the MBSR program, while the quantitative phase is designed to examine changes in key psychological outcomes following the intervention. The study aims to contribute to the growing body of evidence supporting mindfulness-based interventions for caregiver populations and to inform future mental health service practices.
Read the detailed description
The primary objective of this study is to evaluate the effects of a Mindfulness-Based Stress Reduction (MBSR) program on cognitive control and flexibility, psychological well-being, and self-compassion in primary caregivers of individuals with chronic mental illnesses receiving services from a community mental health center. Caregiving for individuals with chronic mental health conditions often involves sustained emotional, cognitive, and social demands, which may increase vulnerability to psychological distress and reduce adaptive coping capacities.
The study is designed as a mixed-methods research utilizing an exploratory sequential design, integrating qualitative and quantitative research components. In the initial qualitative phase, in-depth, face-to-face interviews are planned to explore caregivers' experiences, perceived challenges, coping strategies, and expectations related to caregiving and psychological support. The qualitative findings are intended to guide the development, adaptation, and content refinement of the MBSR intervention in accordance with the specific needs of the caregiver population.
Following the qualitative phase, the quantitative component of the study is designed as a randomized controlled experimental trial. Eligible caregivers are planned to be randomly assigned to either an intervention group receiving the MBSR program or a control group receiving routine services. The MBSR program is structured to include mindfulness practices, psychoeducation, and experiential exercises aimed at enhancing present-moment awareness, emotional regulation, cognitive flexibility, and self-compassion.
Standardized self-report instruments are planned to be used to assess cognitive control and flexibility, psychological well-being, and self-compassion at predefined assessment points. The quantitative findings are intended to complement the qualitative results and to provide a systematic evaluation of the potential effects of the MBSR program.
The integration of qualitative and quantitative findings is expected to provide a comprehensive understanding of the intervention process and outcomes, supporting the development of evidence-based psychosocial interventions for caregivers of individuals with chronic mental illnesses within community mental health service settings.
- Conditions
- Caregiver Stress in Chronic Mental Illness, Psychosocial Burden in Psychiatric Caregivers, Chronic Mental Illness Caregiving, Cognitive and Emotional Outcomes in Caregivers, Mental Illness Caregiver Support
- Being tested
- The Mindfulness-Based Stress Reduction program consists of structured mindfulness practices, psychoeducation, and experiential exercises delivered to caregivers., Usual Care Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Mindfulness-Based Stress Reduction program consists of structured mindfulness practices, psychoeducation, and experiential exercises delivered to caregivers.Behavioural
The Mindfulness-Based Stress Reduction (MBSR) program is a structured behavioral intervention designed for primary caregivers of individuals with chronic mental illnesses. The program includes mindfulness practices, psychoeducation, and experiential exercises aimed at increasing present-moment awareness and adaptive coping skills. Sessions are delivered in a group format according to a standardized program structure.
Usual Care GroupOther
Also called Standard Care
Usual care consists of standard support and services routinely provided by the community mental health center.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction Program | Experimental | Participants assigned to this arm receive the Mindfulness-Based Stress Reduction (MBSR) program designed for primary caregivers of individuals with chronic mental illnesses, in addition to routine services provided by the community mental health center. Receives: Behavioral: The Mindfulness-Based Stress Reduction program consists of structured mindfulness practices, psychoeducation, and experiential exercises delivered to caregivers.; Other: Usual Care Group |
| Control Group (Usual Care) | No intervention | Participants assigned to this arm receive routine care and standard support services provided by the community mental health center and do not receive the Mindfulness-Based Stress Reduction program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Control and Flexibility Questionnaire (CCFQ)
Cognitive Control and Flexibility (Cognitive Control and Flexibility Questionnaire) Outcome Measure Description: Cognitive control and flexibility are assessed using the Cognitive Control and Flexibility Questionnaire (CCFQ), a self-report scale designed to evaluate caregivers' perceived ability to regulate thoughts and behaviors and to adapt flexibly to changing environmental demands. The total score ranges from 18 to 126, with higher scores indicating greater cognitive control and flexibility.
Measured: Baseline, immediately post-intervention, and 3-month follow-up
Secondary outcomes (1)
Psychological Well-Being Scale (PWBS)
Psychological well-being is assessed using the Psychological Well-Being Scale (PWB Scale), a self-report instrument that measures multiple dimensions of well-being, including autonomy, personal growth, purpose in life, self-acceptance, environmental mastery, and positive relations with others. The scale consists of 42 items rated on a 6-point Likert scale, yielding a total score ranging from 42 to 252, with higher scores indicating greater psychological well-being.
Measured: Baseline, immediately post-intervention, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Jan 2023
- Primary completion11 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver Stress in Chronic Mental IllnessStudies 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
- This study is designed as a randomized controlled trial with a parallel assignment model. Eligible participants are planned to be randomly assigned to either an intervention group receiving the Mindfulness-Based Stress Reduction program or a control group receiving usual care throughout the study period.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer USLU, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322081
- Sponsor's protocol ID
- MBSR-Caregivers-2025
- Other IDs
- PhD-Thesis-2025
- Acronym
- MBSR-CG
- Status last verified
- Jan 2026
- First submitted
- 4 Jul 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymized individual participant data (IPD) that underlie the results reported in this study, including demographic characteristics, outcome measures, and group assignment, will be shared with qualified researchers upon reasonable request. Personal identifiers will be removed to ensure confidentiality and compliance with ethical standards.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Mindfulness-Based Stress Reduction Program for Caregivers of Individuals With Chronic Mental Illness on Cognitive Control and Flexibility , Psychological Well-Being and Self-Compassion
- ClinicalTrials.gov ID
- NCT07322081
- Acronym / sponsor ID
- MBSR-CG / MBSR-Caregivers-2025
- Conditions
- Caregiver Stress in Chronic Mental Illness, Psychosocial Burden in Psychiatric Caregivers, Chronic Mental Illness Caregiving, Cognitive and Emotional Outcomes in Caregivers, Mental Illness Caregiver Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 7 Jan 2026 (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 study is designed to investigate the effects of a Mindfulness-Based Stress Reduction (MBSR) program on cognitive control and flexibility, psychological well-being, and self-compassion among primary caregivers of individuals with chronic mental illnesses. Caregivers of individuals with chronic mental health conditions are exposed to prolonged psychological, emotional, and cognitive demands, which may negatively affect their mental well-being and coping capacities.
The study adopts a mixed-methods approach using an exploratory sequential design in order to obtain a comprehensive understanding of caregivers' needs and experiences and to evaluate the potential impact of the intervention. Qualitative findings are intended to inform the development and structuring of the MBSR program, while the quantitative phase is designed to examine changes in key psychological outcomes following the intervention. The study aims to contribute to the growing body of evidence supporting mindfulness-based interventions for caregiver populations and to inform future mental health service practices.
Detailed description
The primary objective of this study is to evaluate the effects of a Mindfulness-Based Stress Reduction (MBSR) program on cognitive control and flexibility, psychological well-being, and self-compassion in primary caregivers of individuals with chronic mental illnesses receiving services from a community mental health center. Caregiving for individuals with chronic mental health conditions often involves sustained emotional, cognitive, and social demands, which may increase vulnerability to psychological distress and reduce adaptive coping capacities.
The study is designed as a mixed-methods research utilizing an exploratory sequential design, integrating qualitative and quantitative research components. In the initial qualitative phase, in-depth, face-to-face interviews are planned to explore caregivers' experiences, perceived challenges, coping strategies, and expectations related to caregiving and psychological support. The qualitative findings are intended to guide the development, adaptation, and content refinement of the MBSR intervention in accordance with the specific needs of the caregiver population.
Following the qualitative phase, the quantitative component of the study is designed as a randomized controlled experimental trial. Eligible caregivers are planned to be randomly assigned to either an intervention group receiving the MBSR program or a control group receiving routine services. The MBSR program is structured to include mindfulness practices, psychoeducation, and experiential exercises aimed at enhancing present-moment awareness, emotional regulation, cognitive flexibility, and self-compassion.
Standardized self-report instruments are planned to be used to assess cognitive control and flexibility, psychological well-being, and self-compassion at predefined assessment points. The quantitative findings are intended to complement the qualitative results and to provide a systematic evaluation of the potential effects of the MBSR program.
The integration of qualitative and quantitative findings is expected to provide a comprehensive understanding of the intervention process and outcomes, supporting the development of evidence-based psychosocial interventions for caregivers of individuals with chronic mental illnesses within community mental health service settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is designed as a randomized controlled trial with a parallel assignment model. Eligible participants are planned to be randomly assigned to either an intervention group receiving the Mindfulness-Based Stress Reduction program or a control group receiving usual care throughout the study period.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction Program | Experimental | Behavioral: The Mindfulness-Based Stress Reduction program consists of structured mindfulness practices, psychoeducation, and experiential exercises delivered to caregivers., Other: Usual Care GroupParticipants assigned to this arm receive the Mindfulness-Based Stress Reduction (MBSR) program designed for primary caregivers of individuals with chronic mental illnesses, in addition to routine services provided by the community mental health center. |
| Control Group (Usual Care) | No intervention | –Participants assigned to this arm receive routine care and standard support services provided by the community mental health center and do not receive the Mindfulness-Based Stress Reduction program. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being the primary caregiver of an individual with a chronic mental illness who is registered at the Community Mental Health Center (CMHC) of Söke Fehime Faik Kocagöz State Hospital
- Residing in the Söke district of Aydın province
- Being literate
- Having been the primary caregiver of the patient for at least six months
Key exclusion criteria (5 listed)
- Having been diagnosed with any psychiatric disorder
- Having an intellectual disability
- Data from caregivers who submitted incomplete data collection forms were excluded from the study
- Caregivers who chose to withdraw from the study during the research process were excluded, and any data obtained from them were not used in the analysis
- Individuals who missed more than two sessions of the Mindfulness-Based Stress Reduction Program were excluded, and their data were not included in the study
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 |
|---|---|---|
| The Mindfulness-Based Stress Reduction program consists of structured mindfulness practices, psychoeducation, and experiential exercises delivered to caregivers.The Mindfulness-Based Stress Reduction (MBSR) program is a structured behavioral intervention designed for primary caregivers of individuals with chronic mental illnesses. The program includes mindfulness practices, psychoeducation, and experiential exercises aimed at increasing present-moment awareness and adaptive coping skills. Sessions are delivered in a group format according to a standardized program structure. | Behavioural | Mindfulness-Based Stress Reduction Program |
| Usual Care GroupAlso: Standard CareUsual care consists of standard support and services routinely provided by the community mental health center. | Other | Mindfulness-Based Stress Reduction Program |
Primary outcome
Cognitive Control and Flexibility Questionnaire (CCFQ)
Time frame: Baseline, immediately post-intervention, and 3-month follow-up
Cognitive Control and Flexibility (Cognitive Control and Flexibility Questionnaire) Outcome Measure Description: Cognitive control and flexibility are assessed using the Cognitive Control and Flexibility Questionnaire (CCFQ), a self-report scale designed to evaluate caregivers' perceived ability to regulate thoughts and behaviors and to adapt flexibly to changing environmental demands. The total score ranges from 18 to 126, with higher scores indicating greater cognitive control and flexibility.
1 secondary outcome
Psychological Well-Being Scale (PWBS)
Time frame: Baseline, immediately post-intervention, and 3-month follow-up
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 23 Jan 2026.
- No external links are available at this time.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The anonymized individual participant data (IPD) that underlie the results reported in this study, including demographic characteristics, outcome measures, and group assignment, will be shared with qualified researchers upon reasonable request. Personal identifiers will be removed to ensure confidentiality and compliance with ethical standards.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Mindfulness-Based Stress Reduction program consists of structured mindfulness practices, psychoeducation, and experiential exercises delivered to caregivers. in people with Caregiver Stress in Chronic Mental Illness and Psychosocial Burden in Psychiatric Caregivers, run by Aydin Adnan Menderes 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 4 inclusion and 5 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 23 Jan 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?
Cognitive Control and Flexibility Questionnaire (CCFQ) (time frame: Baseline, immediately post-intervention, and 3-month follow-up). 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 23 Jan 2026.