- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06347848
The Effect of Psychoeducation Focused on Reducing Internalized Stigma
The Effect of Psychoeducation Focused on Reducing Internalized Stigma in Individuals Diagnosed With Schizophrenia on Treatment Adherence and Internalized Stigma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kadriye ATAR, MSc
- Phone Number: +90 5065595119
- Email: kadriye.atar@ogr.iuc.edu.tr
Study Locations
-
-
Şişli
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Istanbul, Şişli, Turkey
- Istanbul University - Cerrahpasa (IUC)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Psyhcoeducation Group (Experimental) Psychoeducation focused on reducing internalized stigma will be applied to the experimental group.
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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. |
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No Intervention: No Intervention
Controls (Control Group) No intervention will be applied to the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
4 Month
|
|
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).
|
4 Month
|
Collaborators and Investigators
Investigators
- Study Director: Ozge SUKUT, PhD, Istanbul University - Cerrahpasa (IUC)
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
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
- IstanbulUCKA
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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