An interventional study of Integrated Psychoeducation Program in Schizophrenia, Schizoaffective Disorder and Internalized Stigma, sponsored by Dokuz Eylul University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Treatment
The goal of this pilot randomized controlled trial is to investigate whether the Integrated Psychoeducation Program reduces internalized stigma and improves related outcomes in adults with schizophrenia or schizoaffective disorder, and whether the program is feasible to deliver in a community mental health setting.
The main question it aims to answer is: Do participants who receive the program show a greater reduction in internalized stigma from pre-test to post-test than participants in a waitlist control group who continue treatment as usual? Researchers will also examine changes in self-esteem, hopelessness, and psychological flourishing, whether changes are maintained at 3-month follow-up, and attendance and retention rates.
Participants in the intervention group will attend 8 weekly group sessions that combine psychoeducation, an expressive writing exercise, and breathing/relaxation exercises. Participants in the waitlist control group will continue treatment as usual and will be offered the program after the study. All participants will complete questionnaires before the program (pre-tests), after the program (post-tests), and 3 months after the post-tests (3-month follow-up).
This study is conducted as part of the principal investigator's master's thesis in the Clinical Psychology Master's Program at Dokuz Eylul University, under the supervision of Dr. Elçin Yorulmaz.
Background: Internalized stigma is common among people with schizophrenia and is associated with lower self-esteem, reduced hope, and poorer well-being. This study tests a manualized group program designed to address internalized stigma and its related outcomes.
Intervention: The Integrated Psychoeducation Program consists of 8 weekly group sessions, each lasting approximately 80-90 minutes and divided into two parts separated by a 10-minute break. Each session includes thematic psychoeducation, a 10-minute expressive writing exercise with standardized instructions and a session-specific theme, group interaction, and a breathing/relaxation exercise (4-7-8 technique). The intervention is delivered in two cohorts starting in early November 2026.
Randomization and allocation concealment: After baseline assessment, participants are randomly assigned (1:1) to the intervention or waitlist control group using block randomization with randomly mixed block sizes of 4, 6, and 8, generated with the Sealed Envelope online randomiser, without stratification. Allocation is concealed using sequentially numbered, opaque, sealed envelopes, opened by a psychiatric nurse who is not involved in delivering the intervention or assessing outcomes.
Masking: The outcome assessor (the person who administers the questionnaires) is blinded to group allocation at all assessment points. The allocation list is held only by the nurse, the assessor has no contact with the sessions, and appointments are scheduled by another staff member.
Control condition: Participants in the waitlist control group continue treatment as usual at the Community Mental Health Center during the study period and are offered the same program after completing the 3-month follow-up assessment. Data from this delayed delivery will not be included in the primary analyses.
Sample size: As a pilot trial, the sample size is based on the recommended minimum of 12 participants per group for pilot studies (Julious, 2005), increased to 25 per group (total N = 50) to account for the high attrition expected in this population.
Analysis: Changes in clinical outcomes will be compared between groups across assessment points, and feasibility outcomes will be summarized descriptively. Texts produced in the expressive writing exercises may also be explored qualitatively.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 50 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Dokuz Eylul University is the lead sponsor of 261 studies on the registry; 35 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants attend the 8-session Integrated Psychoeducation Program (weekly group sessions of approximately 80-90 minutes) in addition to treatment as usual.
Behavioral: Integrated Psychoeducation Program
Participants continue treatment as usual at the Community Mental Health Center during the study period and are offered the "Integrated Psychoeducation Program" after completing the 3-month follow-up assessment.
A manualized 8-session group psychoeducation program designed to reduce internalized stigma and to improve self-esteem, hope, and psychological flourishing. Weekly sessions last approximately 80-90 minutes and combine thematic psychoeducation with group interaction, a 10-minute expressive writing exercise, and a breathing/relaxation exercise (4-7-8 technique).
Change in internalized stigma (ISMI total score)
Internalized stigma measured with the Internalized Stigma of Mental Illness (ISMI) scale, Turkish version (29 items, 4-point Likert scale). Higher scores indicate greater internalized stigma.
Time frame: Baseline (before randomization) and post-intervention (Week 8)
Change in self-esteem (RSES)
Self-esteem measured with the Rosenberg Self-Esteem Scale (RSES), Turkish version. Lower scores indicate higher self-esteem.
Time frame: Baseline and post-intervention (Week 8)
Change in hopelessness (BHS-7)
Hopelessness measured with the 7-item short form of the Beck Hopelessness Scale (BHS-7), Turkish version. Higher scores indicate greater hopelessness.
Time frame: Baseline and post-intervention (Week 8)
Change in psychological flourishing (Flourishing Scale)
Psychological flourishing measured with the Flourishing Scale (Diener et al., 2010), Turkish version (Psychological Well-Being Scale; Telef, 2013) (8 items, 7-point Likert scale; total score 8-56). Higher scores indicate greater psychological flourishing.
Time frame: Baseline and post-intervention (Week 8)
Internalized stigma at 3-month follow-up (ISMI)
ISMI total score at 3-month follow-up compared with baseline and post-intervention.
Time frame: Baseline, post-intervention (Week 8), and 3 months after the post-test
Self-esteem at 3-month follow-up (RSES)
RSES score at 3-month follow-up compared with baseline and post-intervention.
Time frame: Baseline, post-intervention (Week 8), and 3 months after the post-test
Hopelessness at 3-month follow-up (BHS-7)
BHS-7 score at 3-month follow-up compared with baseline and post-intervention.
Time frame: Baseline, post-intervention (Week 8), and 3 months after the post-test
Psychological flourishing at 3-month follow-up (Flourishing Scale)
Flourishing Scale score at 3-month follow-up compared with baseline and post-intervention.
Time frame: Baseline, post-intervention (Week 8), and 3 months after the post-test
Session attendance rate
Mean percentage of the 8 sessions attended by participants in the intervention group.
Time frame: Weeks 1-8
Program completion rate
Percentage of participants in the intervention group who attend at least 6 of the 8 sessions.
Time frame: Weeks 1-8
Assessment retention rate
Percentage of randomized participants in each group who complete the post-intervention and 3-month follow-up assessments.
Time frame: Post-intervention (Week 8) and 3-month follow-up
Plan to share: No — The informed consent form does not include permission to share individual participant data, and personal data are protected under Turkish Personal Data Protection Law
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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