NCT06347848

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

April 30, 2024

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 4, 2024

Status Verified

March 1, 2024

Enrollment Period

1 day

First QC Date

March 30, 2024

Last Update Submit

March 30, 2024

Conditions

Keywords

SchizophreniaTreatment AdherenceInternalized StigmaPsychoeducation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Experimental

EXPERIMENTAL

Psyhcoeducation Group (Experimental) Psychoeducation focused on reducing internalized stigma will be applied to the experimental group.

Other: Psychoeducation Focused on Reducing Internalized Stigma

No Intervention

NO INTERVENTION

Controls (Control Group) No intervention will be applied to the control group.

Interventions

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.

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Having a diagnosis of dementia or other organic mental disorder as an additional diagnosis,
  • Individuals with a history of substance abuse (other than nicotine).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University - Cerrahpasa (IUC)

Istanbul, Şişli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SchizophreniaTreatment Adherence and ComplianceSocial Stigma

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersHealth BehaviorBehaviorSocial Behavior

Study Officials

  • Ozge SUKUT, PhD

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two parallel groups randomized control study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2024

First Posted

April 4, 2024

Study Start

April 30, 2024

Primary Completion

May 1, 2024

Study Completion

September 1, 2024

Last Updated

April 4, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations