The Effect of a Mindfulness-Based Self-Compassion Program on Care Burden, Life Satisfaction, and Coping Levels of Caregivers of Individuals With Schizophrenia
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
2 other identifiers
interventional
44
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2025
CompletedFirst Submitted
Initial submission to the registry
April 16, 2025
CompletedFirst Posted
Study publicly available on registry
April 24, 2025
CompletedApril 24, 2025
April 1, 2025
7 days
April 16, 2025
April 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Baseline and 8 weeks after the intervention
Secondary Outcomes (5)
Change in self-confident coping style
Baseline and 8 weeks after the intervention
Change in optimistic coping style
Baseline and 8 weeks after the intervention
Change in seeking social support coping style
Baseline and 8 weeks post-intervention
Change in helpless coping style
Baseline and 8 weeks after the intervention
Change in submissive coping style
Baseline and 8 weeks after the intervention
Study Arms (2)
intervention group
EXPERIMENTALParticipants 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 INTERVENTIONThe control group did not receive any intervention during the study period.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Having a diagnosed organic mental disorder
- Having any chronic psychiatric illness
- Experiencing hearing, comprehension, or speech impairments
- Concurrent participation in a similar intervention program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neslihan Loklead
Study Sites (1)
Selcuk University
Konya, Selçuklu, 42130, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Neslihan Lök, Prof. Dr.
Selcuk University Faculty of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
April 16, 2025
First Posted
April 24, 2025
Study Start
January 13, 2024
Primary Completion
January 20, 2024
Study Completion
March 24, 2025
Last Updated
April 24, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share
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.