- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06882538
The Effect of Mindfulness-Based Psychoeducation Programme Given Individually to Schizophrenia Patients on Internalised Stigma and Healthy Lifestyle Behaviours
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Havva K KAÇAN, ASSOCIATE PROFESSOR DOCTOR
- Phone Number: 05057753893
- Email: hkacan@kastamonu.edu.tr
Study Contact Backup
- Name: Şevval Y YEYİT, Research Assistant
- Phone Number: 0546 542 0536
- Email: syeyit@kastamonu.edu.tr
Study Locations
-
-
Central
-
Kastamonu, Central, Turkey, 37100
- Recruiting
- Kastamonu Community Mental Health Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having been diagnosed with schizophrenia
- TRSM registered and continuing
- Acceptance to work and training
Exclusion Criteria:
- Have not been diagnosed with schizophrenia
- If he/she does not agree to participate in the study
- If not registered with TRSM
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Awareness-Based Psychoeducation
Sessions
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The level of internalized stigma of schizophrenia patients
Time Frame: Four Week
|
In this study, the level of internalized stigma in schizophrenia patients will be measured with the internalized stigma scale.
|
Four Week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthy lifestyle behaviors of schizophrenia patients participating in psychoeducation will be evaluated.
Time Frame: Four Week
|
The frequency of healthy lifestyle behaviors of schizophrenia patients receiving psychoeducation will be measured.
|
Four Week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Havva K KAÇAN, ASSOCIATE PROFESSOR DOCTOR, Kastamonu University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/20/4 (Other Identifier: Kastamonu University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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