Care GiversNCT06941909
The Effect of a Mindfulness-Based Self-Compassion Program on Care Burden, Life Satisfaction, and Coping Levels of Caregivers of Individuals With Schizophrenia
A study testing Mindfulness-Based Self-Compassion in people with Care Givers and Burden, Caregiver, run by Neslihan Lok at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the effect of the Mindfulness-Based Self-Compassion Program on caregiver burden, life satisfaction, and coping with stress levels among caregivers of individuals diagnosed with schizophrenia. This is a randomized controlled trial with a parallel-group design. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Care Givers, Burden, Caregiver, Stress
- What is being tested?
- Mindfulness-Based Self-Compassion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jan 2024to 24 Mar 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 18 years of age or older and providing care for an individual diagnosed with schizophrenia according to ICD-10 criteria
- The care recipient must be registered with the Psychiatry Outpatient Clinic of Selçuk University Faculty of Medicine Hospital and attend regular follow-up appointments
- Providing care for a period of at least 3 months within the last year
- Having access to a mobile phone or computer to participate in online sessions
Who cannot join
- Having a diagnosed organic mental disorder
- Having any chronic psychiatric illness
- Experiencing hearing, comprehension, or speech impairments
- Concurrent participation in a similar intervention program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF A MINDFULNESS-BASED SELF-COMPASSION PROGRAM ON CARE BURDEN, LIFE SATISFACTION, AND COPING LEVELS OF CAREGIVERS OF INDIVIDUALS WITH SCHIZOPHRENIA: A RANDOMIZED CONTROLLED TRIAL PROTOCOL
This study aims to examine the effect of the Mindfulness-Based Self-Compassion Program on caregiver burden, life satisfaction, and coping with stress levels among caregivers of individuals diagnosed with schizophrenia. This is a randomized controlled trial with a parallel-group design. The study sample consists of caregivers of individuals diagnosed with schizophrenia who have applied to the psychiatry outpatient clinic of a university hospital within the past year. Caregivers who meet the inclusion criteria will be randomly assigned to intervention and control groups. The program was delivered over eight weeks through group training and counseling sessions. The findings of this study are expected to guide the development of interventions targeting caregiver burden, life satisfaction, and coping strategies among caregivers.
Research Hypotheses H1.1: The caregiver burden of the intervention group receiving the Mindfulness-Based Self-Compassion Program is lower than that of the control group.
Read more
H1.2: The life satisfaction of the intervention group receiving the Mindfulness-Based Self-Compassion Program is higher than that of the control group.
H1.3: The coping level of the intervention group receiving the Mindfulness-Based Self-Compassion Program is higher than that of the control group.
H1.3.1: The self-confident coping approach of the intervention group is higher than that of the control group.
H1.3.2: The optimistic coping approach of the intervention group is higher than that of the control group.
H1.3.3: The tendency to seek social support in the intervention group is higher than in the control group.
H1.3.4: The helpless coping approach of the intervention group is lower than that of the control group.
H1.3.5: The submissive coping approach of the intervention group is lower than that of the control group.
Read the detailed description
In this randomized controlled trial, the effect of the Mindfulness-Based Self-Compassion Program on caregiver burden, life satisfaction, and coping styles of individuals providing care for people diagnosed with schizophrenia was evaluated. The study was designed with a parallel-group structure consisting of an intervention and a control group.
The sample size was calculated using the G*Power 3.1.9.4 software at a 95% confidence level. Based on the mean scores of the Functional Recovery Scale from a previous study, a total of 40 participants (20 in each group) were determined to be sufficient, with 80% power, an effect size of 0.9237531, and a 5% margin of error. To account for potential attrition, the sample size was increased by 10%, and the study was completed with 44 participants.
Caregivers who met the inclusion and exclusion criteria and voluntarily agreed to participate were randomly assigned to the intervention and control groups using a simple randomization method performed by an independent statistician. This approach was chosen to minimize selection bias and control for potential confounding variables.
Participants in the intervention group received weekly online group training and counseling sessions for a duration of 8 weeks. After each session, participants were provided with a practice guide and audio recordings to support home practice. The control group did not receive any intervention during the study period.
Pre-tests and informed consent were obtained prior to randomization, while post-tests were conducted by the researchers at the end of the 8-week program. Upon completion of data collection, the Mindfulness-Based Self-Compassion Program was also offered to the control group.
The program was based on the theoretical framework developed by Germer and Neff (2019) and Neff and Germer (2018), and structured as an eight-week curriculum centered around the concepts of mindfulness and self-compassion. Each session lasted approximately 90 minutes and was conducted once a week.
The content of the program was developed based on existing literature and training materials. Expert opinions were sought during the development process, including feedback from six faculty members-three from psychiatric nursing, two from public health nursing, and one from the field of guidance and psychological counseling. The final version of the program was shaped in accordance with these expert recommendations.
The primary outcome variables of the study were caregiver burden, life satisfaction, and coping styles. Data were collected using the Personal Information Form, Zarit Burden Interview, Satisfaction with Life Scale, and Coping Styles Inventory
- Conditions
- Care Givers, Burden, Caregiver, Stress, Satisfaction With Life
- Being tested
- Mindfulness-Based Self-Compassion
- Keywords
- Care burden; Mindfulness-Based Self-Compassion Programme; Life Satisfaction; Coping with Stress; Schizophrenia.
- Medical subject headings
- Caregiver Burden, Personal Satisfaction, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Self-CompassionOther
Also called Mindfulness-Based Self-Compassion Program
The intervention consisted of weekly online group training and counseling sessions over an 8-week period. Following each session, participants were provided with a practice guide and audio recordings to support home-based practice.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Participants in the intervention group received weekly online group training and counseling sessions for a duration of 8 weeks. After each session, participants were provided with a practice guide and audio recordings to support home practice. Receives: Other: Mindfulness-Based Self-Compassion |
| control group | No intervention | The control group did not receive any intervention during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in caregiver burden (Zarit Caregiver Burden Scale)
Caregiver burden levels will be assessed using the Zarit Caregiver Burden Scale. Higher scores indicate greater burden. Comparison will be made between baseline and 8th week post-intervention.
Measured: Baseline and 8 weeks after the intervention
Change in life satisfaction as measured by the Satisfaction with Life Scale (SWLS)
This outcome evaluates the effect of the Mindfulness-Based Self-Compassion Program on life satisfaction levels among caregivers of individuals diagnosed with schizophrenia. The SWLS will be used to assess participants' perceptions of life satisfaction at baseline and post-intervention.
Measured: Baseline and 8 weeks post-intervention
Change in coping strategies as measured by the Coping Styles Inventory
This outcome examines changes in coping styles (self-confident, optimistic, seeking social support, helpless, and submissive) in caregivers who participate in the Mindfulness-Based Self-Compassion Program. The Coping Styles Inventory will be administered before and after the program to assess differences in adaptive and maladaptive coping strategies.
Measured: Baseline and 8 weeks after the intervention
Secondary outcomes (5)
Change in self-confident coping style
This secondary outcome evaluates the change in the use of self-confident coping strategies among caregivers following participation in the Mindfulness-Based Self-Compassion Program. Measured using the self-confident subscale of the Coping Styles Inventory.
Measured: Baseline and 8 weeks after the intervention
Change in optimistic coping style
This secondary outcome measures changes in the use of optimistic coping strategies among caregivers after completing the Mindfulness-Based Self-Compassion Program. Measured by the optimistic subscale of the Coping Styles Inventory.
Measured: Baseline and 8 weeks after the intervention
Change in seeking social support coping style
This outcome assesses whether participants demonstrate an increased tendency to seek social support as a coping strategy after participating in the program. Data will be collected via the social support subscale of the Coping Styles Inventory.
Measured: Baseline and 8 weeks post-intervention
Change in helpless coping style
This outcome evaluates whether the program decreases the use of helpless coping strategies among participants. Assessed using the helpless subscale of the Coping Styles Inventory.
Measured: Baseline and 8 weeks after the intervention
Change in submissive coping style
This outcome examines whether the intervention reduces submissive coping strategies among caregivers. It is measured by the submissive subscale of the Coping Styles Inventory.
Measured: Baseline and 8 weeks 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 posted24 Apr 2025
- Study start13 Jan 2024
- Primary completion20 Jan 2024
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Care GiversStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neslihan Lok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Neslihan Lok, Selcuk University
- Investigators
- Neslihan Lök, Prof. Dr., Study director, Selcuk University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941909
- Sponsor's protocol ID
- 2025-BK-01
- Other IDs
- 23212021
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical concerns and privacy considerations. The study involves a sensitive population, and sharing such data is not deemed appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF A MINDFULNESS-BASED SELF-COMPASSION PROGRAM ON CARE BURDEN, LIFE SATISFACTION, AND COPING LEVELS OF CAREGIVERS OF INDIVIDUALS WITH SCHIZOPHRENIA: A RANDOMIZED CONTROLLED TRIAL PROTOCOL
- ClinicalTrials.gov ID
- NCT06941909
- Acronym / sponsor ID
- 2025-BK-01
- Conditions
- Care Givers, Burden, Caregiver, Stress, Satisfaction With Life
- Keywords
- Care burden; Mindfulness-Based Self-Compassion Programme; Life Satisfaction; Coping with Stress; Schizophrenia.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Neslihan LokUniversity, hospital or other
- Study start
- 13 Jan 2024 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 24 Apr 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.
This study aims to examine the effect of the Mindfulness-Based Self-Compassion Program on caregiver burden, life satisfaction, and coping with stress levels among caregivers of individuals diagnosed with schizophrenia. This is a randomized controlled trial with a parallel-group design. The study sample consists of caregivers of individuals diagnosed with schizophrenia who have applied to the psychiatry outpatient clinic of a university hospital within the past year. Caregivers who meet the inclusion criteria will be randomly assigned to intervention and control groups. The program was delivered over eight weeks through group training and counseling sessions. The findings of this study are expected to guide the development of interventions targeting caregiver burden, life satisfaction, and coping strategies among caregivers.
Research Hypotheses H1.1: The caregiver burden of the intervention group receiving the Mindfulness-Based Self-Compassion Program is lower than that of the control group.
H1.2: The life satisfaction of the intervention group receiving the Mindfulness-Based Self-Compassion Program is higher than that of the control group.
H1.3: The coping level of the intervention group receiving the Mindfulness-Based Self-Compassion Program is higher than that of the control group.
H1.3.1: The self-confident coping approach of the intervention group is higher than that of the control group.
H1.3.2: The optimistic coping approach of the intervention group is higher than that of the control group.
H1.3.3: The tendency to seek social support in the intervention group is higher than in the control group.
H1.3.4: The helpless coping approach of the intervention group is lower than that of the control group.
H1.3.5: The submissive coping approach of the intervention group is lower than that of the control group.
Detailed description
In this randomized controlled trial, the effect of the Mindfulness-Based Self-Compassion Program on caregiver burden, life satisfaction, and coping styles of individuals providing care for people diagnosed with schizophrenia was evaluated. The study was designed with a parallel-group structure consisting of an intervention and a control group.
The sample size was calculated using the G*Power 3.1.9.4 software at a 95% confidence level. Based on the mean scores of the Functional Recovery Scale from a previous study, a total of 40 participants (20 in each group) were determined to be sufficient, with 80% power, an effect size of 0.9237531, and a 5% margin of error. To account for potential attrition, the sample size was increased by 10%, and the study was completed with 44 participants.
Caregivers who met the inclusion and exclusion criteria and voluntarily agreed to participate were randomly assigned to the intervention and control groups using a simple randomization method performed by an independent statistician. This approach was chosen to minimize selection bias and control for potential confounding variables.
Participants in the intervention group received weekly online group training and counseling sessions for a duration of 8 weeks. After each session, participants were provided with a practice guide and audio recordings to support home practice. The control group did not receive any intervention during the study period.
Pre-tests and informed consent were obtained prior to randomization, while post-tests were conducted by the researchers at the end of the 8-week program. Upon completion of data collection, the Mindfulness-Based Self-Compassion Program was also offered to the control group.
The program was based on the theoretical framework developed by Germer and Neff (2019) and Neff and Germer (2018), and structured as an eight-week curriculum centered around the concepts of mindfulness and self-compassion. Each session lasted approximately 90 minutes and was conducted once a week.
The content of the program was developed based on existing literature and training materials. Expert opinions were sought during the development process, including feedback from six faculty members-three from psychiatric nursing, two from public health nursing, and one from the field of guidance and psychological counseling. The final version of the program was shaped in accordance with these expert recommendations.
The primary outcome variables of the study were caregiver burden, life satisfaction, and coping styles. Data were collected using the Personal Information Form, Zarit Burden Interview, Satisfaction with Life Scale, and Coping Styles Inventory
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Mindfulness-Based Self-CompassionParticipants in the intervention group received weekly online group training and counseling sessions for a duration of 8 weeks. After each session, participants were provided with a practice guide and audio recordings to support home practice. |
| control group | No intervention | –The control group did not receive any intervention during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 18 years of age or older and providing care for an individual diagnosed with schizophrenia according to ICD-10 criteria
- The care recipient must be registered with the Psychiatry Outpatient Clinic of Selçuk University Faculty of Medicine Hospital and attend regular follow-up appointments
- Providing care for a period of at least 3 months within the last year
- Having access to a mobile phone or computer to participate in online sessions
Key exclusion criteria (4 listed)
- Having a diagnosed organic mental disorder
- Having any chronic psychiatric illness
- Experiencing hearing, comprehension, or speech impairments
- Concurrent participation in a similar intervention program
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 Self-CompassionAlso: Mindfulness-Based Self-Compassion ProgramThe intervention consisted of weekly online group training and counseling sessions over an 8-week period. Following each session, participants were provided with a practice guide and audio recordings to support home-based practice. | Other | intervention group |
Primary outcome
Change in caregiver burden (Zarit Caregiver Burden Scale)
Time frame: Baseline and 8 weeks after the intervention
Caregiver burden levels will be assessed using the Zarit Caregiver Burden Scale. Higher scores indicate greater burden. Comparison will be made between baseline and 8th week post-intervention.
Change in life satisfaction as measured by the Satisfaction with Life Scale (SWLS)
Time frame: Baseline and 8 weeks post-intervention
This outcome evaluates the effect of the Mindfulness-Based Self-Compassion Program on life satisfaction levels among caregivers of individuals diagnosed with schizophrenia. The SWLS will be used to assess participants' perceptions of life satisfaction at baseline and post-intervention.
Change in coping strategies as measured by the Coping Styles Inventory
Time frame: Baseline and 8 weeks after the intervention
This outcome examines changes in coping styles (self-confident, optimistic, seeking social support, helpless, and submissive) in caregivers who participate in the Mindfulness-Based Self-Compassion Program. The Coping Styles Inventory will be administered before and after the program to assess differences in adaptive and maladaptive coping strategies.
5 secondary outcomes
Change in self-confident coping style
Time frame: Baseline and 8 weeks after the intervention
Change in optimistic coping style
Time frame: Baseline and 8 weeks after the intervention
Change in seeking social support coping style
Time frame: Baseline and 8 weeks post-intervention
Change in helpless coping style
Time frame: Baseline and 8 weeks after the intervention
Change in submissive coping style
Time frame: Baseline and 8 weeks 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 24 Apr 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical concerns and privacy considerations. The study involves a sensitive population, and sharing such data is not deemed appropriate.
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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.
Neslihan Lök, Prof. Dr. study director
Selcuk University Faculty of Nursing
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 Self-Compassion in people with Care Givers and Burden, Caregiver, run by Neslihan Lok 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 4 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 24 Apr 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?
Change in caregiver burden (Zarit Caregiver Burden Scale) (time frame: Baseline and 8 weeks after the intervention). The study lists 3 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 24 Apr 2025.