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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in caregiver burden (Zarit Caregiver Burden Scale)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Having a diagnosed organic mental disorder
- •Having any chronic psychiatric illness
- •Experiencing hearing, comprehension, or speech impairments
- •Concurrent participation in a similar intervention program
研究组 & 干预措施
intervention group
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.
干预措施: Mindfulness-Based Self-Compassion (Other)
control group
The control group did not receive any intervention during the study period.
结局指标
主要结局
Change in caregiver burden (Zarit Caregiver Burden Scale)
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Neslihan Lok
Prof. Dr.
Selcuk University