Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06368011 |
| Other study ID # |
MustafaKU-CINCINOGLU-001 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2023 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Mustafa Kemal University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of study is to determine the effect of acceptance and commitment therapy-based
psychoeducation on the level of stigmatization applied to relatives of schizophrenia
patients.
Type of study: This study was planned as a pretest-posttest quasi-experimental design with an
observation and control group.
Participants: The population of the study consisted of the relatives of schizophrenia
patients who were registered and actively attending the Community Mental Health Center in a
state hospital in Ankara.
Intervention: Before the psychoeducation process started, personal information form and
scales were applied to the relatives of the patients in the experimental and control groups.
An ACT-based psychoeducation program consisting of 8 sessions was applied to the experimental
group. each session lasted approximately 90 minutes. The control group did not receive any
intervention. After the psychoeducation, the scales were reapplied to the experimental and
control groups. In addition, the experimental group was asked to fill out the psychoeducation
evaluation form. The scales were reapplied to the experimental group after the 1-month
follow-up study and evaluated.
Description:
Aim The aim of this study is to determine the effect of Acceptance and Commitment Therapy
(ACT)-based psychoeducation on the level of stigmatization of mental illness in the relatives
of individuals diagnosed with schizophrenia.
Study Desing The design of the study is an experimental research with pretest-posttest,
follow-up measurement experiment and control group.
Hypotheses The reserach hypotheses are as follows; H0: acceptance and commitment therapy has
no effect on the level of stigmatization.
H1: Psychoeducation based on acceptance and commitment therapy is effective in reducing the
stigmatization levels of relatives of schizophrenia patients.
Variables of the study The study's dependent variable is stigma , and the independent
variable is ACT based psychoeducation.
Settings The research was conducted between April 2023 and July 2023 with the relatives of
patients diagnosed with schizophrenia who were followed up at the Ministry of Health Dr.
Nafiz Körez Sincan State Hospital Community Mental Health Center.
Participants The sample of this study consisted of relatives of patients diagnosed with
schizophrenia who were followed up in Dr. Nafiz Körez Sincan State Hospital Community Mental
Health Center. After determining the sufficient number of relatives for the sample,
randomization was performed. The relatives of the patients included in the study were
randomly assigned to the experimental and control groups. There was no loss of sample in both
groups during the psychoeducation period and the study was completed with 36 relatives of the
patients.
Information Form: the researcher prepared this form, consisting of questions about the
sociodemographic characteristics of relatives of schizophrenia patients, stigmatization scale
and stigma scale for relatives of schizophrenia patients.
Stigma Scale For Relatives of Schizophrenia Patients.The scale developed by Yıldırım et al.
was prepared as a 3-point Likert-type scale. Yes: 3, Sometimes: 2, No: 1 and scored as Yes:
3, Sometimes: 2, No: 1. The minimum score that can be obtained from the scale is 17 and the
maximum score is 51. There are no reverse scored items. The scale is interpreted on both the
total score and the subscale scores, and the higher the score obtained from the scale and
subscales, the more stigmatization is expressed. The stigmatization scale for relatives of
schizophrenia patients consists of 17 questions and 5 subscales. Social isolation and
inadequacy sub-dimension 1, 2, 3, 4, 9, 15 avoidance and deterioration in interpersonal
relationships sub-dimension: 5, 6, 7 social negative discrimination sub-dimension: 8, 10, 11
concealment and shame subscale: 12, 13, 14 negative internalization subscale: 16, 17 items.
In the reliability study, the Cronbach's Alpha coefficient of the scale was found to be 0.90.
The Cronbach's Alpha internal consistency coefficients of the Stigma Scale for Relatives of
Schizophrenia Patients were calculated as 0.87; 0.80; 0.76; 0.71; 0.69 for the sub-dimensions
of social isolation and inadequacy, avoidance and deterioration in interpersonal
relationships, social negative discrimination, concealment and shame, and negative
internalization, respectively. In the present study, the reliability of the CCPBS scale was
found to be high as Cronbach's Alpha=0.839.
Stigmatization Scale: The scale is a 5-point Likert-type. It is answered and scored as
Strongly Disagree: 1, Disagree: 2, Partially Agree: 3, Agree: 4, Strongly Agree: 5. The score
that can be obtained from the scale is between 22-110, and it can be said that individuals
who score below 55 points have a low stigmatization tendency, while individuals who score
above 55 points have a high stigmatization tendency. The Stigmatization Scale consists of 22
items and 4 dimensions and there are no reverse scored items. Discrimination and exclusion
sub-dimension 10,17,18,19,20,21 labeling sub-dimension 3,4,5,7,8,9 psychological health
sub-dimension 11,12,13,15,16, prejudice sub-dimension 1,2,6,14,22. In the reliability study,
Cronbach's Alpha coefficient of the scale was found to be 0.84. Cronbach's Alpha internal
consistency coefficients of the Stigma Scale were found to be 0.77, 0.68, 0.66, 0.54 for
discrimination and exclusion, labeling, psychological health, and prejudice sub-dimensions,
respectively. In this study, the reliability of the Stigmatization scale was found to be high
as Cronbach's Alpha=0.827.
Data Collection: Before the psychoeducation process started, personal information form and
scales were applied to the relatives of the patients in the experimental and control groups.
ACT-based psychoeducation program was applied to the experimental group. The psychoeducation
program was carried out in 8 sessions, each session lasting approximately 90 minutes. The
control group did not receive any intervention. After the psychoeducation program given to
the experimental group, the scales were reapplied to the experimental and control groups. In
addition, the experimental group was asked to fill out the psychoeducation evaluation form.
After 1 month of follow-up study, the scales were applied to the experimental group again and
evaluated.
Psychoeducation was provided to two separate groups of 8-10 individuals in the experimental
group in 8 sessions lasting 90 minutes. The group sessions were conducted once a week at the
TRSM under the leadership of the researcher. In total, the psychoeducation lasted 10 weeks
including make-up sessions. The sessions were held in the multi-purpose training hall of the
TRSM, which had appropriate conditions for psychoeducation (a table and enough chairs,
blackboard, computer, overhead projector).
Data Analysis The data obtained in the study were evaluated in computer environment through
SPSS 22.0 statistical program. Frequency and percentage analyses were used to determine the
descriptive characteristics of the employees participating in the study, and mean and
standard deviation statistics were used to examine the scale. Kurtosis and Skewness values
were analyzed to determine whether the research variables were normally distributed. It was
determined that the variables were normally distributed. Parametric methods were used to
analyze the data.Differences between the rates of categorical variables in independent groups
were analyzed with Chi-Square and Fisher exact tests. Independent groups t-test was used to
compare quantitative continuous data between two independent groups. Repeated measures anova
test and complementary bonferroni test were used to compare within-group measurements.
Funding No expenditure will be made on any item other than the consumables of the existing
forms for the research. the researcher will cover stationery and consumables.
