SchizophreniaNCT06347848
The Effect of Psychoeducation Focused on Reducing Internalized Stigma
A study testing Psychoeducation Focused on Reducing Internalized Stigma in people with Schizophrenia and Treatment Adherence, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
In the fight against stigma, the focus should be on the education of individuals diagnosed with mental illness. Psychoeducation has an important place in the treatment and rehabilitation of mental health problems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Treatment Adherence, Stigma, Social
- What is being tested?
- Psychoeducation Focused on Reducing Internalized Stigma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2024to 1 Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteer to participate in the research,
- Diagnosed with schizophrenia according to DSM-V TR diagnostic criteria,
- Over 18 years old,
- Being in remission for 2 months,
- At least primary school graduate,
- Residing in Edirne city center and its districts,
- Individuals without hearing or understanding problems.
Who cannot join
- Not meeting the inclusion criteria,
- Having a diagnosis of dementia or other organic mental disorder as an additional diagnosis,
- Individuals with a history of substance abuse (other than nicotine).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpasa (IUC)
Istanbul, Şişli
About this study
Official title: The Effect of Psychoeducation Focused on Reducing Internalized Stigma in Individuals Diagnosed With Schizophrenia on Treatment Adherence and Internalized Stigma
In the fight against stigma, the focus should be on the education of individuals diagnosed with mental illness. Psychoeducation has an important place in the treatment and rehabilitation of mental health problems. Psychoeducation is necessary for early recognition of signs and symptoms of diseases, ensuring compliance with treatment, improving coping skills, as well as combating stigma, preventing internalized stigma, and counteracting social stigma. If individuals with mental disorders have adequate knowledge about the causes of stigma, they may be less prone to internalized stigma.
Read the detailed description
The group most exposed to stigma among mental illnesses is individuals diagnosed with schizophrenia. These individuals avoid treatment due to fear of stigma, which creates a significant obstacle to ensuring their well-being. Internalization of stigma causes feelings of loneliness, anger, helplessness, deterioration in quality of life, and decrease in self-esteem, while at the same time creating a significant barrier to treatment compliance. Compliance problems with treatment: It causes impairments in functionality, relapses and exacerbations, repeated hospitalizations, adverse effects on quality of life and increased mortality rates. The fact that many patients who receive only medical treatment in the treatment of schizophrenia develop negative attitudes towards drug use due to drug side effects and recurrence of disease symptoms reveals that psychosocial approaches should also be given importance in addition to medical treatment. As a result, it is thought that internalized stigma is a significant obstacle to treatment compliance and practices implemented to reduce internalized stigma are effective in increasing treatment compliance.
- Conditions
- Schizophrenia, Treatment Adherence, Stigma, Social
- Being tested
- Psychoeducation Focused on Reducing Internalized Stigma
- Keywords
- Schizophrenia, Treatment Adherence, Internalized Stigma, Psychoeducation
- Medical subject headings
- Schizophrenia, Treatment Adherence and Compliance, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation Focused on Reducing Internalized StigmaOther
Participants will be randomized and divided into experimental and control groups. Initial measurements will be collected through a face-to-face meeting. While the control group will continue to receive routine Community Mental Health Center service, the experimental group will receive a psychoeducation program focused on reducing internalized stigma in addition to the routine Community Mental Health Center service. After the program is completed, final measurements of the experimental and control groups will be collected.
The program is planned to consist of 7 sessions, once a week, and approximately 60-90 minutes are expected to be allocated for each session. Sessions will be divided into two sessions: a 30-40 minute session and a 15 minute break.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Psyhcoeducation Group (Experimental) Psychoeducation focused on reducing internalized stigma will be applied to the experimental group. Receives: Other: Psychoeducation Focused on Reducing Internalized Stigma |
| No Intervention | No intervention | Controls (Control Group) No intervention will be applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internalized Stigma of Mental Illness Scale
It is a self-report scale consisting of 29 items and assessing internal stigma. The scale includes: 1. Alienation (6 items), 2. Endorsement of Stereotypes (7 items), 3. Perceived Discrimination (5 items), 4. Social Withdrawal (6 items) and 5. Resistance to Stigma (5 items). It has five subscales. The items in the scale are on a four-point Likert-type scale as "I strongly disagree" (1 point), "I disagree" (2 points), "I agree" (3 points), "I strongly agree" (4 points). is answered. Items of the "Resistance to stigma" subscale are scored reversely.
The total score obtained by summing the scores of the five subscales varies between 29 and 116 points. Higher scores from the scale mean that the person's internalized stigma is more severe in a negative way. While the internal consistency coefficient obtained for the entire scale was found to be 0.93, the split-half reliability of the scale was determined as 0.89.
Measured: 4 Month
Medication Adherence Reporting Scale
It is a 5-point Likert type scale consisting of 5 questions. The scale is used to evaluate medication compliance in many diseases such as blood pressure, diabetes, rheumatoid arthritis, inflammatory bowel disease, hyperlipidemia, chronic pain, and bipolar mood disorder. The total test score is obtained by adding the scores obtained from the items. Scores from the scale vary between 5 and 25. An increase in the scores obtained indicates compatibility, and a decrease in the scores indicates non-compliance. It was found that the scale was evaluated with a single factor structure and had good levels of criterion and discriminant validity and reliability (Cronbach Alpha = 0.85).
Measured: 4 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start30 Apr 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups randomized control study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadriye Atar, Istanbul University - Cerrahpasa
- Investigators
- Ozge SUKUT, PhD, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347848
- Sponsor's protocol ID
- IstanbulUCKA
- Status last verified
- Mar 2024
- First submitted
- 30 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Psychoeducation Focused on Reducing Internalized Stigma in Individuals Diagnosed With Schizophrenia on Treatment Adherence and Internalized Stigma
- ClinicalTrials.gov ID
- NCT06347848
- Acronym / sponsor ID
- IstanbulUCKA
- Conditions
- Schizophrenia, Treatment Adherence, Stigma, Social
- Keywords
- Schizophrenia, Treatment Adherence, Internalized Stigma, Psychoeducation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the fight against stigma, the focus should be on the education of individuals diagnosed with mental illness. Psychoeducation has an important place in the treatment and rehabilitation of mental health problems. Psychoeducation is necessary for early recognition of signs and symptoms of diseases, ensuring compliance with treatment, improving coping skills, as well as combating stigma, preventing internalized stigma, and counteracting social stigma. If individuals with mental disorders have adequate knowledge about the causes of stigma, they may be less prone to internalized stigma.
Detailed description
The group most exposed to stigma among mental illnesses is individuals diagnosed with schizophrenia. These individuals avoid treatment due to fear of stigma, which creates a significant obstacle to ensuring their well-being. Internalization of stigma causes feelings of loneliness, anger, helplessness, deterioration in quality of life, and decrease in self-esteem, while at the same time creating a significant barrier to treatment compliance. Compliance problems with treatment: It causes impairments in functionality, relapses and exacerbations, repeated hospitalizations, adverse effects on quality of life and increased mortality rates. The fact that many patients who receive only medical treatment in the treatment of schizophrenia develop negative attitudes towards drug use due to drug side effects and recurrence of disease symptoms reveals that psychosocial approaches should also be given importance in addition to medical treatment. As a result, it is thought that internalized stigma is a significant obstacle to treatment compliance and practices implemented to reduce internalized stigma are effective in increasing treatment compliance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups randomized control study
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Psychoeducation Focused on Reducing Internalized StigmaPsyhcoeducation Group (Experimental) Psychoeducation focused on reducing internalized stigma will be applied to the experimental group. |
| No Intervention | No intervention | –Controls (Control Group) No intervention will be applied to the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteer to participate in the research,
- Diagnosed with schizophrenia according to DSM-V TR diagnostic criteria,
- Over 18 years old,
- Being in remission for 2 months,
- At least primary school graduate,
Key exclusion criteria (3 listed)
- Not meeting the inclusion criteria,
- Having a diagnosis of dementia or other organic mental disorder as an additional diagnosis,
- Individuals with a history of substance abuse (other than nicotine).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducation Focused on Reducing Internalized StigmaParticipants will be randomized and divided into experimental and control groups. Initial measurements will be collected through a face-to-face meeting. While the control group will continue to receive routine Community Mental Health Center service, the experimental group will receive a psychoeducation program focused on reducing internalized stigma in addition to the routine Community Mental Health Center service. After the program is completed, final measurements of the experimental and control groups will be collected. The program is planned to consist of 7 sessions, once a week, and approximately 60-90 minutes are expected to be allocated for each session. Sessions will be divided into two sessions: a 30-40 minute session and a 15 minute break. | Other | Experimental |
Primary outcome
Internalized Stigma of Mental Illness Scale
Time frame: 4 Month
It is a self-report scale consisting of 29 items and assessing internal stigma. The scale includes: 1. Alienation (6 items), 2. Endorsement of Stereotypes (7 items), 3. Perceived Discrimination (5 items), 4. Social Withdrawal (6 items) and 5. Resistance to Stigma (5 items). It has five subscales. The items in the scale are on a four-point Likert-type scale as "I strongly disagree" (1 point), "I disagree" (2 points), "I agree" (3 points), "I strongly agree" (4 points). is answered. Items of the "Resistance to stigma" subscale are scored reversely. The total score obtained by summing the scores of the five subscales varies between 29 and 116 points. Higher scores from the scale mean that the person's internalized stigma is more severe in a negative way. While the internal consistency coefficient obtained for the entire scale was found to be 0.93, the split-half reliability of the scale was determined as 0.89.
Medication Adherence Reporting Scale
Time frame: 4 Month
It is a 5-point Likert type scale consisting of 5 questions. The scale is used to evaluate medication compliance in many diseases such as blood pressure, diabetes, rheumatoid arthritis, inflammatory bowel disease, hyperlipidemia, chronic pain, and bipolar mood disorder. The total test score is obtained by adding the scores obtained from the items. Scores from the scale vary between 5 and 25. An increase in the scores obtained indicates compatibility, and a decrease in the scores indicates non-compliance. It was found that the scale was evaluated with a single factor structure and had good levels of criterion and discriminant validity and reliability (Cronbach Alpha = 0.85).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozge SUKUT, PhD study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation Focused on Reducing Internalized Stigma in people with Schizophrenia and Treatment Adherence, run by Istanbul University - Cerrahpasa 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 7 inclusion and 3 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 4 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?
Contact Kadriye ATAR, MSc (5065595119 ext. +90, kadriye.atar@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internalized Stigma of Mental Illness Scale (time frame: 4 Month). The study lists 2 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 4 Apr 2024.