Clinical trial NCT06941909: The Effect of a Mindfulness-Based Self-Compassion Program on Care Burden, Life Satisfaction, and Coping Levels of Caregivers of Individuals With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Care Givers
Burden, Caregiver
Stress
Satisfaction With Life
Keywords: Care burden; Mindfulness-Based Self-Compassion Programme; Life Satisfaction; Coping with Stress; Schizophrenia.
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Having a diagnosed organic mental disorder
* Having any chronic psychiatric illness
* Experiencing hearing, comprehension, or speech impairments
* Concurrent participation in a similar intervention program

Primary outcomes:
measure: Change in caregiver burden (Zarit Caregiver Burden Scale)
timeFrame: Baseline and 8 weeks after the intervention
measure: Change in life satisfaction as measured by the Satisfaction with Life Scale (SWLS)
timeFrame: Baseline and 8 weeks post-intervention
measure: Change in coping strategies as measured by the Coping Styles Inventory
timeFrame: Baseline and 8 weeks after the intervention
Secondary outcomes:
measure: Change in self-confident coping style
timeFrame: Baseline and 8 weeks after the intervention
measure: Change in optimistic coping style
timeFrame: Baseline and 8 weeks after the intervention
measure: Change in seeking social support coping style
timeFrame: Baseline and 8 weeks post-intervention
measure: Change in helpless coping style
timeFrame: Baseline and 8 weeks after the intervention
measure: Change in submissive coping style
timeFrame: Baseline and 8 weeks after the intervention
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selçuklu
Study officials:
affiliation: Selcuk University Faculty of Nursing
name: Neslihan Lök, Prof. Dr.
role: STUDY_DIRECTOR
References: