NCT06941909

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2025

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

7 days

First QC Date

April 16, 2025

Last Update Submit

April 16, 2025

Conditions

Keywords

Care burden; Mindfulness-Based Self-Compassion Programme; Life Satisfaction; Coping with Stress; Schizophrenia.

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

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.

Other: Mindfulness-Based Self-Compassion

control group

NO INTERVENTION

The 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.

Also known as: Mindfulness-Based Self-Compassion Program
intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Selcuk University

Konya, Selçuklu, 42130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Caregiver BurdenPersonal SatisfactionSchizophrenia

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Neslihan Lök, Prof. Dr.

    Selcuk University Faculty of Nursing

    STUDY DIRECTOR

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.

Locations