The Effect of Mindfulness-Based Psychoeducation Programme Given Individually to Schizophrenia Patients on Internalised Stigma and Healthy Lifestyle Behaviours

NCT ID: NCT06882538

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-14
• Study Completion Date: 2025-03-15

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.

Detailed Description

Research Population/Sample or Study Group: If appropriate in terms of the study method, the population and sample should be explained here. Specify how the sample/study group will be selected, how they will be assigned to groups and which sampling method(s) (e.g. random-probability, snowball, convenience, purposive, cluster sampling) will be used.

Rehabilitated individuals diagnosed with schizophrenia who are registered and attending the Community Mental Health Centre will constitute the population, and individuals attending between April 2024 and May 2024 will constitute the sample. Power analysis will be performed to determine the number of people to be sampled and calculated with the G*Power 3.1 programme. In the literature, while there is an interventional study on stigmatisation among similar interventional studies for previously diagnosed schizophrenic patients, there is no study investigating stigmatisation and healthy lifestyle behaviours. The effect size was taken as 0.80 as a high level according to the t-test determined by Cohen (1988). In order to exceed the 95% value in determining the power of the study; 40 people, including 20 people in groups with a significance level of 5% and an effect size of 0.80, should be reached (df=68; t=1.668). Since the training covers a period of 6 weeks, schizophrenic individuals who are willing and will continue the training will be accepted.

Data Collection Tool:

Personal Information Form, Internalised Stigma Scale in Mental Illness (ISIS) and Healthy Lifestyle Behaviours (HBSB) scale will be used to collect the data.

Internalised Stigma Scale in Mental Illness (ISIS): Developed by Ritsher et al. (2003), RHIAS is a self-report scale consisting of 29 items and assessing internalised stigma . Turkish adaptation study was conducted by Ersoy and Varan 6. RHIDÖ is a four-point Likert-type scale. The scale has five subscales; 1. Alienation, 2. Confirmation of Stereotypes, 3. Perceived Discrimination, 4. Social Withdrawal and 5. Resistance to Stigmatisation. The items of the 'Resistance to Stigmatisation' subscale are reverse scored.

Total score varies between 29 and 116 points. High scores obtained from the RHIDÖ indicate a high level of internalised stigma. In Ersoy and Varan's study, the Cronbach Alpha value of the scale was 0.93. The scale has been authorised for use and is available in the appendices.

Healthy Lifestyle Behaviours (HLSB) Scale: Developed in 1987 by Walker, Sechrist and Pender, the HLSBS measures the health-promoting behaviours of the individual in relation to healthy lifestyle. It was adapted into Turkish by Esin, a validity and reliability study was conducted and Cronbach's Alpha internal consistency coefficient was found to be 0.91. The scale is a four-point Likert-type scale consisting of a total of 48 items and six subgroups. The score of each subgroup of the scale can be used alone or the total score of the whole scale can be used and gives the score of healthy lifestyle behaviours. The highest score for the whole scale is 192 and the lowest score is 48. A high score on the scale indicates better healthy lifestyle behaviours. All items of the scale are positive and there is no reverse-scored item. The subgroups of the scale are as follows: Self-actualisation; It consists of a total of 13 items covering 3, 8, 11, 12, 16, 17, 21, 23, 29, 34, 37, 44 and 48 questions. It determines the individual's life goals, individual self-development ability, and the extent to which he/she recognises and satisfies himself/herself. Health responsibility consists of a total of 10 items (2, 7, 15, 20, 20, 28, 32, 33, 42, 43 and 46). It determines the level of responsibility of the individual on his/her own health and the extent to which he/she participates in his/her health. Exercise; shows the level of exercise, which is an unchangeable element of healthy life, and consists of a total of 5 items (4, 13, 22, 30 and 38). Nutrition; It consists of a total of 6 items covering 1, 5, 14, 19, 26 and 35 questions. It determines the individual's values in choosing and organising meals and choosing food. Interpersonal support determines the communication and continuity level of the individual with his/her close environment and consists of 7 items (10, 18, 24, 25, 31, 39, and 47). Stress management consists of a total of 7 items (6, 9, 27, 36, 40, 41, and 45) that determine the individual's level of recognition of stress sources and stress control mechanisms.

Data Collection Process: The data will be collected by face-to-face interview method by the researchers. It will be done within the knowledge of the institutional staff within the time interval when they come to the community mental health centre. Pre-test applications will be made to individuals before psychoeducation is given. 6-week training will be given to individuals one by one. Each individual will be provided with 6 weeks of training. After the training, data collection tools will be applied again and post-tests will be created. 20 individuals will be included in the experimental group and 20 individuals will be included in the control group.

Conditions

Schizophrenia Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Awareness-Based Psychoeducation

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

Group Type: EXPERIMENTAL

awareness-based psychoeducation

Intervention Type: OTHER

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.

Interventions

awareness-based psychoeducation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Having been diagnosed with schizophrenia

2. TRSM registered and continuing

3. Acceptance to work and training

Exclusion Criteria

1. Have not been diagnosed with schizophrenia

2. If he/she does not agree to participate in the study

3. If not registered with TRSM

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kastamonu University

OTHER

Sponsor Role: lead

Responsible Party

Havva Kaçan

ASSOCIATE PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Havva K KAÇAN, ASSOCIATE PROFESSOR DOCTOR

Role: PRINCIPAL_INVESTIGATOR

Kastamonu University

Locations

Kastamonu Community Mental Health Centre

Kastamonu, Central, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Havva K KAÇAN, ASSOCIATE PROFESSOR DOCTOR

Role: CONTACT

hkacan@kastamonu.edu.tr

05057753893

Şevval Y YEYİT, Research Assistant

Role: CONTACT

syeyit@kastamonu.edu.tr

0546 542 0536

Other Identifiers

2024/20/4

Identifier Type: OTHER

Identifier Source: secondary_id

2024/20/4

Identifier Type: -

Identifier Source: org_study_id