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StigmatizationNCT06368011

The Impact of Acceptance and Commitment Therapy on Stigmatization

A study testing acceptance and commitment therapy in people with Stigmatization, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 months and olderHealthy volunteers can take part
Conditions the study is for
Stigmatization
What is being tested?
acceptance and commitment therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Apr 2023to 30 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 months and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Being a relative of a patient diagnosed with schizophrenia according to DSM-V diagnostic criteria
  • Living with the patient (family member living with the patient for at least 35 hours or more per week)
  • Volunteering to participate in the research,
  • To be able to read and write
  • 18 years of age or older

Who cannot join

  • Not having attended any session of the eight-session training program and not having attended the make-up session
  • Not having participated in any of the pre-test, post-test and follow-up test

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hatay Mustafa Kemal Üniversitesi

    Hatay

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Acceptance and Commitment Therapy-Based Psychoeducation on Stigmatization Levels of Schizophrenia Patient Relatives

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.

Read more

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.

Read the detailed 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.

Conditions
Stigmatization
Being tested
acceptance and commitment therapy
Keywords
acceptance and commitment therapy, schizophrenia, family, stigma
Medical subject headings
Stereotyping, Schizophrenia, Social Stigma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • acceptance and commitment therapyBehavioural

    Psychoeducation was delivered in 8 sessions lasting 90 minutes to two separate groups of 8-10 individuals in the experimental group.Group sessions were conducted once a week at the community mental health center under the leadership of the researcher.In total, the psychoeducation lasted 10 weeks, including make-up sessions.

Study groups in NCT06368011
Study groupRoleWhat they receive
experimental group:relatives of schizophrenia patientsExperimentalThe population of the study consisted of the relatives of schizophrenia patients who were registered and actively attending the Ministry of Health Dr. Nafiz Körez Sincan State Hospital Community Mental Health Center.The sample size of the study was calculated at 95% confidence level according to the independent t test using 'G. Power-3.1.9.7' before the study was started.As a result of the analysis, the minimum sample size was calculated as 32, with 16 in the experimental group and 16 in the control group.
Receives: Behavioral: acceptance and commitment therapy
control group:relatives of schizophrenia patientsNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stigma Scale for Relatives of Patients with Schizophrenia

    It is a 3-point Likert-type scale. Yes: 3, Sometimes: 2, No: 1 and is scored as followsThe lowest score that can be obtained from the scale is 17 and the highest score is 51.

    Measured: Pre-test (before the intervention), post test (ten weeks after the intervention) and one month after follow up

  2. Stigma Scale for Relatives of Patients with Schizophrenia

    It is a 3-point Likert-type scale. Yes: 3, Sometimes: 2, No: 1 and is scored as followsThe lowest score that can be obtained from the scale is 17 and the highest score is 51.

    Measured: post test (ten weeks after the intervention)

  3. Stigma Scale for Relatives of Patients with Schizophrenia

    It is a 3-point Likert-type scale. Yes: 3, Sometimes: 2, No: 1 and is scored as followsThe lowest score that can be obtained from the scale is 17 and the highest score is 51.

    Measured: one month after follow up

Secondary outcomes (3)
  1. Stigmatization Scale

    It is a 5-point Likert-type scale. 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 tendency to stigmatize, while individuals who score above 55 points have a high tendency to stigmatize.

    Measured: Pre-test (before the intervention), post test (ten weeks after the intervention) and one month after follow up

  2. Stigmatization Scale

    It is a 5-point Likert-type scale. 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 tendency to stigmatize, while individuals who score above 55 points have a high tendency to stigmatize.

    Measured: post test (ten weeks after the intervention)

  3. Stigmatization Scale

    It is a 5-point Likert-type scale. 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 tendency to stigmatize, while individuals who score above 55 points have a high tendency to stigmatize.

    Measured: one month after follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2024
  2. Study start15 Apr 2023
  3. Primary completion31 Jul 2023
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06368011
Sponsor's protocol ID
MustafaKU-CINCINOGLU-001
Status last verified
Apr 2024
First submitted
18 Mar 2024
Last updated
16 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Pre-test and post-test scores of relatives of schizophrenia patients will be matched with coding. relatives of schizophrenia patients will be asked to code the codes consisting of the first letter of their surname, the last two digits of their

Questions about this trial

What is this clinical trial studying?

A study testing acceptance and commitment therapy in people with Stigmatization, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stigma Scale for Relatives of Patients with Schizophrenia (time frame: Pre-test (before the intervention), post test (ten weeks after the intervention) and one month after follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.

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