NCT06882538

Brief Summary

Schizophrenia is a chronic, recurrent and disabling illness that usually lasts a lifetime and causes serious problems in quality of life and functioning. Psychoeducation programmes added to drug treatment in the treatment of schizophrenia have been shown to increase the knowledge of patients and their relatives about the disease, coping skills, prevention of exacerbations and relapses of the disease, social functioning, insight into the disease, compliance with drug treatment and quality of life. Rehabilitated individuals diagnosed with schizophrenia who are registered and continuing at Kastamonu Training and Research Community Mental Health Centre will constitute the population, and individuals who continue between April 2024 and May 2024 will constitute the sample. The research will be conducted with schizophrenic patients in a pre-test-post-test, experimental and control group experimental design. Power analysis will be performed to determine the number of people to be sampled and calculated with the G\*Power 3.1 programme. 40 people will be reached in the groups, 20 people in the experimental group and 20 people in the control group. In the evaluation of the data, descriptive statistical methods (Mean, Standard deviation) as well as the correlation test will be used to evaluate the relationship between the average scores before and after the training in the comparison of quantitative data. Wilcoxon related sample test will be used to make comparisons before and after the training. Personal Information Form, Internalised Stigma Scale in Mental Illness (ISIS) and Healthy Lifestyle Behaviours (HBSB) scale will be used to collect the data. Awareness-based psychoeducation programme will be applied to the experimental group. The aim of psychoeducation is to create a change in knowledge and behaviour towards healthy lifestyle behaviours (1- Self-actualisation, 2- Health responsibility, 3- Exercise, 4- Nutrition, 5- Interpersonal support, 6- Stress management) by reducing internalised stigma. Therefore, it will be evaluated whether the applied psychoeducation programme creates the intended change in knowledge and behaviour. This study will be conducted to examine the effect of a 6-week 12-session self-awareness-based psychoeducation programme given to schizophrenia patients on internalised stigma and healthy lifestyle behaviours. In this study, schizophrenic patients will be provided with regular psychoeducation to provide individual support, to ensure the development of coping skills for self-protection, and to gain knowledge and skills to gain a healthy lifestyle. After the prepared psychoeducation, a training guide will be created for the participants and will be given after the training, thus ensuring continuity of education.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

February 14, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 14, 2025

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
Last Updated

March 18, 2025

Status Verified

February 1, 2025

Enrollment Period

6 days

First QC Date

February 14, 2025

Last Update Submit

March 16, 2025

Conditions

Keywords

schizophreniapsychoeducationinternalised stigmatisationhealthy lifestyle behaviour

Outcome Measures

Primary Outcomes (1)

  • The level of internalized stigma of schizophrenia patients

    In this study, the level of internalized stigma in schizophrenia patients will be measured with the internalized stigma scale.

    Four Week

Secondary Outcomes (1)

  • Healthy lifestyle behaviors of schizophrenia patients participating in psychoeducation will be evaluated.

    Four Week

Study Arms (1)

Awareness-Based Psychoeducation

EXPERIMENTAL

Sessions 1. Meeting with the group members, introduction of the group process, explanation of the session topics, 2. Information about the management of schizophrenia 3. Information about the management of schizophrenia 4. Taking Responsibility in Health, 5. Gaining Positive Health Behaviours: Nutrition and Exercise, Hygiene practices skills training 6. Gaining Positive Health Behaviours: Using Interpersonal Communication and Supports, Anger Management 7. Acquiring Positive Health Behaviours: Self-actualisation, 8. Gaining Positive Health Behaviours: Managing Stress, 9. Gaining Positive Health Behaviours: Managing Stress, Progressive relaxation techniques 10. Dealing with stigmatisation 11. Dealing with stigmatisation

Other: awareness-based psychoeducation

Interventions

The aim of psychoeducation is to create a change in knowledge and behaviour towards healthy lifestyle behaviours (1- Self-actualisation, 2- Health responsibility, 3- Exercise, 4- Nutrition, 5- Interpersonal support, 6- Stress management) by reducing internalised stigma. Therefore, it will be evaluated whether the applied psychoeducation programme creates the intended change in knowledge and behaviour.

Awareness-Based Psychoeducation

Eligibility Criteria

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

You may qualify if:

  • Having been diagnosed with schizophrenia
  • TRSM registered and continuing
  • Acceptance to work and training

You may not qualify if:

  • Have not been diagnosed with schizophrenia
  • If he/she does not agree to participate in the study
  • If not registered with TRSM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kastamonu Community Mental Health Centre

Kastamonu, Central, 37100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Havva K KAÇAN, ASSOCIATE PROFESSOR DOCTOR

    Kastamonu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Havva K KAÇAN, ASSOCIATE PROFESSOR DOCTOR

CONTACT

Şevval Y YEYİT, Research Assistant

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Patients who were followed up at Kastamonu University Training and Research Hospital Community Mental Health Centre between April 2024 and May 2024 with a diagnosis of schizophrenia according to DSM-5 diagnostic criteria will be included in the study. All patients will be informed about the nature of the interview and scales and written informed consent will be obtained from patients who accept the evaluation. Written permission will be obtained from the Provincial Directorate of Health for the study. The study group patients will be divided into two groups and the training will be given in 12 sessions as two lessons of forty-five minutes each once a week and will be completed in approximately 6 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOCIATE PROFESSOR

Study Record Dates

First Submitted

February 14, 2025

First Posted

March 18, 2025

Study Start

February 14, 2025

Primary Completion

February 20, 2025

Study Completion

March 15, 2025

Last Updated

March 18, 2025

Record last verified: 2025-02

Locations