SchizophreniaNCT07898852
Integrated Psychoeducation Program for Internalized Stigma in Schizophrenia
A study testing Integrated Psychoeducation Program in people with Schizophrenia and Schizoaffective Disorder, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Internalized Stigma
- What is being tested?
- Integrated Psychoeducation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Oct 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years
- Diagnosis of schizophrenia or schizoaffective disorder
- Literate in Turkish
- Receiving regular pharmacotherapy
- Informed consent from the participant (and from a legal guardian, where applicable)
Who cannot join
- Substance use disorder
- Neurological or organic brain disorder
- Acute exacerbation of psychotic symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ege University Hospital, Community Mental Health Center
Izmir, Bornova, 35100
Devran Turhan, +90 531 699 1916, turhandevran@gmail.com
About this study
Official title: The Effect of an Integrated Psychoeducation Program on Internalized Stigma, Self-Esteem, Hope, and Psychological Flourishing in Individuals Diagnosed With Schizophrenia: A Pilot Study
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).
Read the detailed description
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.
- Being tested
- Integrated Psychoeducation Program
- Keywords
- self-stigma, psychoeducation, expressive writing, self-esteem, hope, hopelessness, psychological well-being, group intervention, psychosis
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Social Stigma, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Psychoeducation ProgramBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Integrated Psychoeducation Program | Experimental | Participants attend the 8-session Integrated Psychoeducation Program (weekly group sessions of approximately 80-90 minutes) in addition to treatment as usual. Receives: Behavioral: Integrated Psychoeducation Program |
| Waitlist Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before randomization) and post-intervention (Week 8)
Secondary outcomes (10)
Change in self-esteem (RSES)
Self-esteem measured with the Rosenberg Self-Esteem Scale (RSES), Turkish version. Lower scores indicate higher self-esteem.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 1-8
Program completion rate
Percentage of participants in the intervention group who attend at least 6 of the 8 sessions.
Measured: Weeks 1-8
Assessment retention rate
Percentage of randomized participants in each group who complete the post-intervention and 3-month follow-up assessments.
Measured: Post-intervention (Week 8) and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start21 Oct 2026 (estimated)
- Primary completion25 Dec 2026 (estimated)
- Study completion31 Mar 2027 (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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Devran Turhan, Dokuz Eylul University
- Investigators
- Devran Turhan, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898852
- Sponsor's protocol ID
- SYL-2026-4326
- Other IDs
- SYL-2026-4326
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Integrated Psychoeducation Program on Internalized Stigma, Self-Esteem, Hope, and Psychological Flourishing in Individuals Diagnosed With Schizophrenia: A Pilot Study
- ClinicalTrials.gov ID
- NCT07898852
- Acronym / sponsor ID
- SYL-2026-4326
- Keywords
- self-stigma, psychoeducation, expressive writing, self-esteem, hope, hopelessness, psychological well-being, group intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 21 Oct 2026 (estimated)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Integrated Psychoeducation Program | Experimental | Behavioral: Integrated Psychoeducation ProgramParticipants attend the 8-session Integrated Psychoeducation Program (weekly group sessions of approximately 80-90 minutes) in addition to treatment as usual. |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 65 years
- Diagnosis of schizophrenia or schizoaffective disorder
- Literate in Turkish
- Receiving regular pharmacotherapy
- Informed consent from the participant (and from a legal guardian, where applicable)
Key exclusion criteria (3 listed)
- Substance use disorder
- Neurological or organic brain disorder
- Acute exacerbation of psychotic symptoms
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 |
|---|---|---|
| Integrated Psychoeducation ProgramA 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). | Behavioural | Integrated Psychoeducation Program |
Primary outcome
Change in internalized stigma (ISMI total score)
Time frame: Baseline (before randomization) and post-intervention (Week 8)
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.
10 secondary outcomes
Change in self-esteem (RSES)
Time frame: Baseline and post-intervention (Week 8)
Change in hopelessness (BHS-7)
Time frame: Baseline and post-intervention (Week 8)
Change in psychological flourishing (Flourishing Scale)
Time frame: Baseline and post-intervention (Week 8)
Internalized stigma at 3-month follow-up (ISMI)
Time frame: Baseline, post-intervention (Week 8), and 3 months after the post-test
Self-esteem at 3-month follow-up (RSES)
Time frame: Baseline, post-intervention (Week 8), and 3 months after the post-test
Hopelessness at 3-month follow-up (BHS-7)
Time frame: Baseline, post-intervention (Week 8), and 3 months after the post-test
Psychological flourishing at 3-month follow-up (Flourishing Scale)
Time frame: Baseline, post-intervention (Week 8), and 3 months after the post-test
Session attendance rate
Time frame: Weeks 1-8
Program completion rate
Time frame: Weeks 1-8
Assessment retention rate
Time frame: Post-intervention (Week 8) and 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: 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
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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.
Devran Turhan principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Psychoeducation Program in people with Schizophrenia and Schizoaffective Disorder, run by Dokuz Eylul University 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 5 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: opening soon, as of the sponsor's last update on 27 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Devran Turhan (+90 531 699 1916, turhandevran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in internalized stigma (ISMI total score) (time frame: Baseline (before randomization) and post-intervention (Week 8)). 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 27 Oct 2026.