Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06347848
Other study ID # IstanbulUCKA
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 30, 2024
Est. completion date September 1, 2024

Study information

Verified date March 2024
Source Istanbul University - Cerrahpasa (IUC)
Contact Kadriye ATAR, MSc
Phone 5065595119
Email kadriye.atar@ogr.iuc.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date September 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Psychoeducation Focused on Reducing Internalized Stigma
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.

Locations

Country Name City State
Turkey Istanbul University - Cerrahpasa (IUC) Istanbul Sisli

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
4 Month
Primary 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). 4 Month
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A