The Effect of an Individual Empowerment Program Provided to Relatives of Schizophrenia Patients

NCT07173192 | Enrolling By Invitation

• 1 other identifier: ARELU-SBF-ZD-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Psychoeducation provided to family members caring for individuals with schizophrenia. Has been found to positively impact caregivers' psychological well-being and the effective management of schizophrenia patients.However, further experimental studies are recommended in this area, along with support for caregivers' psychological well-being. Primary caregivers, which includes both psychoeducation and applications aimed at developing coping skills, on the care burden, psychological well-being,and self-efficacy. Considering the gaps in the literature, the aim of this study is to evaluate the effect of an individual empowerment program applied to primary caregivers of patients diagnosed with schizophrenia on the burden of care, psychological well-being, and self-efficacy.

Conditions

Schizophrenia

Keywords

Self Efficacy; Burden, Caregiver; Psychological Well Being; schizophrenia

Outcome Measures

Primary Outcomes (3)

• The psychological well-being scale based on the individual empowerment program will be used to measure the care burden of individuals providing primary care to those diagnosed with schizophrenia. (time frame: 6 week)

  The training will be conducted in person.

  6 week

• The care burden scale based on the individual empowerment program will be used to measure the care burden for individuals providing primary care to individuals diagnosed with schizophrenia. (Time frame: 6 weeks)

  Face-to-face training will be provided.

  6 week

• The self-efficacy scale based on the individual empowerment program will be used to measure the care burden of individuals providing primary care to people diagnosed with schizophrenia. (time frame: 6 weeks)

  The training will be conducted in person.

  6 week

Study Arms (2)

experimental group

EXPERIMENTAL

Data collection tools will be administered as a pre-test to individuals in the experimental and control groups. Individuals in the experimental group will receive individual empowerment training sessions as part of a six-session individual empowerment program.

Behavioral: Individual empowerment program

control group

NO INTERVENTION

No intervention will be performed on individuals in the control group; these individuals will receive standard discharge education.

Interventions

Individual empowerment program BEHAVIORAL

Data collection tools will be applied to individuals in the experimental and control groups as a pre-test. Individual empowerment training sessions will be applied to individuals in the experimental group totaling (6 sessions) as part of the individual empowerment program. No intervention will be performed on individuals in the control group; they will receive standard discharge education. Data collection tools will be applied to individuals in both groups for post-tests immediately after the experimental group completes all individual empowerment program sessions.

experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being the primary caregiver of a patient diagnosed with schizophrenia and other psychotic disorders Volunteering to participate in the study Being 18 years of age or older Being literate Not having a psychiatric illness (diagnosis) Not having a serious mental or physical disorder that prevents communication

You may not qualify if:

• Providing care to patients with severe organic brain syndrome such as alcohol or substance dependence, intellectual disability, dementia, or delirium, or with a previous or current general medical condition that could impair cognitive function Withdrawal from the study

Sponsors & Collaborators

• Istanbul Arel University: lead

Study Sites (1)

Istanbul Arel University

Istanbul, Cevizlibağ, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Schizophrenia; Caregiver Burden; Psychological Well-Being

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• zeynep dağ psychiatric nurse

  Istanbul Arel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Servis Hemşiresi

Model Details: Data will be collected face-to-face from primary caregivers of patients diagnosed with schizophrenia who are receiving treatment at Istanbul Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital using data collection forms. Individuals who agree to participate in the study and meet the inclusion criteria will be randomized into experimental and control groups. Which caregivers included in the study will be in the intervention group and which will be in the control group will be determined according to the randomization table generated online at https://www.randomizer.org/. Group 1 will be designated as the Intervention Group, and Group 2 will be designated as the Control Group. Data collection tools will be administered to individuals in the experimental and control groups as a pre-test. Individuals in the experimental group will undergo an individual empowerment program consisting of a total of 6 individual empowerment training sessions

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 15, 2025
• Study Start: May 15, 2025
• Primary Completion: November 30, 2025
• Study Completion: February 15, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

TU (1)