NCT07733297

Brief Summary

Since ancient times, societies have exhibited negative, discriminatory, labeling, and stigmatizing attitudes toward mental disorders and individuals with psychiatric conditions. This situation has negatively affected individuals with mental disorders in many aspects. Over time, individuals with mental illness adopt the stigma they experience and subsequently begin to suffer from internalized stigma. Internalized stigma, or "self-stigmatization," is the adoption of society's negative perceptions-such as being dangerous or inadequate-by the individual with the mental illness themselves. The individual gradually internalizes the prejudices, discrimination, and exclusion present in society. For instance, the societal prejudice that "one cannot be friends with individuals with bipolar disorder" manifests in the patient as "this is true, I cannot be friends with anyone." Consequently, individuals diagnosed with bipolar disorder experience internalized stigma.Psychiatric patients must contend not only with the challenges brought by their illness but also with internalized stigma. Internalized stigma in individuals with mental disorders has detrimental effects on recovery. While experiencing feelings of guilt and shame, psychiatric patients suffering from internalized stigma particularly tend to hide their illness, avoid seeking help for treatment, and face adverse processes regarding treatment compliance. Furthermore, due to the impact of stigmatization, they withdraw from society, experiencing a reduction in social interaction and loneliness. It is well-documented that individuals diagnosed with bipolar disorder experience non-compliance with treatment due to the recurrent and chronic nature of the illness. This situation increases the risk of internalized stigma in patients. Studies demonstrate that patients diagnosed with bipolar disorder experience internalized stigma. Moreover, it stands out as one of the psychiatric illness groups that experiences the highest levels of stigmatization.The management of mental illnesses is a multidimensional framework that requires not only clinical interventions but also the active participation of the patient and social support systems. In this context, psychoeducation is defined as a systematic and evidence-based psychotherapeutic intervention method aimed at informing patients and their families about the disease process, strengthening coping mechanisms, and improving quality of life. Moving beyond traditional approaches, psychoeducation aims to transform the individual and their environment from passive recipients into competent stakeholders in illness management. The fundamental building blocks of psychoeducation comprise medical information regarding the illness, problem-solving strategies, effective communication skills, and the restoration of self-confidence. While these components enable individuals to gain insight into their illness, critical objectives such as managing potential crisis moments and minimizing suicide risk come to the forefront. The literature emphasizes that psychoeducation is one of the most effective supportive methods in preventing relapses and increasing adherence to treatment. Consequently, psychoeducation is a holistic approach aimed at empowering patients and their families by focusing on developing their skills to cope with psychosocial difficulties.Studies have shown that psychoeducation is effective in reducing internalized stigma in patients with bipolar disorder. A quasi-experimental study suggested that psychoeducation reduces internalized stigma and can be implemented in hospitals. A systematic review of individuals with bipolar disorder found that psychoeducation, as a complementary strategy to pharmacotherapy, reduced the frequency of new mood episodes, the duration of hospitalization, and non-compliance with medication. The unique value of this study within the Turkish sample lies in the scarcity of randomized controlled trials (RCTs) examining the specific effect of structured psychoeducation on internalized stigma in patients with bipolar disorder, alongside the inclusion of a three-month post-intervention follow-up test. The purpose of this study is to examine the effect of psychoeducation on the level of internalized stigma in individuals diagnosed with bipolar disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 18, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

PsychoeducationInternalized stigmaBipolar disorder

Outcome Measures

Primary Outcomes (1)

  • Internalized Stigma Level

    The Internalized Stigma of Mental Illness (ISMI) Scale is a 4-point Likert-type scale consisting of 29 items. The scale evaluates individuals' subjective experiences of stigma across five subscales: "Alienation", "Stereotype Endorsement", "Perceived Discrimination", "Social Withdrawal", and "Stigma Resistance". The items in the ISMI scale are scored as "strongly disagree" (1 point), "disagree" (2 points), "agree" (3 points), and "strongly agree" (4 points). Higher scores obtained from the scale indicate a higher level of internalized stigma. Total scores range from 29 to 116.

    Baseline, 8 weeks (immediately after the intervention), and 5 months (3 months after the intervention)

Secondary Outcomes (1)

  • Functioning Assessment Short Test

    Baseline, 8 weeks (immediately after the intervention), and 5 months (3 months after the intervention)

Study Arms (2)

Cognitive-Behavioral Psychoeducation Group

EXPERIMENTAL

This group receives an 8-week, structured, cognitive-behavioral theory-based psychoeducation program consisting of 8 sessions (90 minutes per session) to reduce internalized stigma and improve functioning.

Behavioral: Cognitive-behavioral based psychoeducation program

Routine Care Control Group

ACTIVE COMPARATOR

This group continues to receive standard routine follow-up, medical treatment, and psychosocial support care at the community mental health center without participating in the structured psychoeducation program.

Behavioral: Standard Care (in control arm)

Interventions

Cognitive-behavioral based psychoeducation program: The psychoeducation program consists of a total of eight sessions. The sessions will commence following the approvals of the ethics committee and the institution. Prior to the initiation of the psychoeducation program, patients will be informed about the study and requested to complete the pre-test form. Subsequently, an informative calendar regarding the psychoeducation schedule will be distributed to the experimental group. Each session is planned for 90 minutes. The sessions of the psychoeducation program will be conducted for approximately 90 minutes, with 10-minute breaks every 30 minutes. Techniques based on cognitive behavioral theory, such as Thought-Emotion-Behavior, Cognitive Restructuring, and homework assignments, will be utilized. A post-test will be administered after the sessions are completed.

Cognitive-Behavioral Psychoeducation Group

They will regularly participate in the routine "good morning meetings" and various activities at the Community Mental Health Center.

Routine Care Control Group

Eligibility Criteria

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

You may qualify if:

  • Being diagnosed with Bipolar Disorder according to the DSM-5 diagnostic criteria.Being between the ages of 18 and 65.Being followed with a diagnosis of bipolar disorder for at least six months.Being in remission.Being literate.Being open to communication and cooperation.Accepting to participate in the training and having given written informed consent

You may not qualify if:

  • Having previously participated in any training related to internalized stigma.Being in an acute exacerbation period.Using alcohol or psychoactive substances.Having a cognitive or mental problem that would prevent communication and cooperation.Having another comorbid psychiatric illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir Yunus Emre State Hospital Community Mental Health Center

Eskişehir, Yunus EMRE, 26000, Turkey (Türkiye)

Location

Related Publications (11)

  • Türkçapar, M. H., & Sargın, A. E. (2012). Bilişsel davranışçı psikoterapiler: tarihçe ve gelişim. Bilişsel Davranışçı Psikoterapi ve Araştırmalar Dergisi, 1(1), 7-14.

    BACKGROUND
  • Türk, A., & Uğurlu, N. B. (2023). Internalized stigma and the quality of life and self-esteem of individuals with bipolar disorder. Journal of Psychiatric Nursing, 14(1), 49.

    BACKGROUND
  • Rabelo JL, Cruz BF, Ferreira JDR, Viana BM, Barbosa IG. Psychoeducation in bipolar disorder: A systematic review. World J Psychiatry. 2021 Dec 19;11(12):1407-1424. doi: 10.5498/wjp.v11.i12.1407. eCollection 2021 Dec 19.

    PMID: 35070785BACKGROUND
  • Keshavarzpir Z, Seyedfatemi N, Mardani-Hamooleh M, Esmaeeli N, Boyd JE. The Effect of Psychoeducation on Internalized Stigma of the Hospitalized Patients with Bipolar Disorder: A Quasi-Experimental Study. Issues Ment Health Nurs. 2021 Jan;42(1):79-86. doi: 10.1080/01612840.2020.1779881. Epub 2020 Sep 3.

    PMID: 32881602BACKGROUND
  • Ersoy MA, Varan A. [Reliability and validity of the Turkish version of the internalized stigma of mental illness scale]. Turk Psikiyatri Derg. 2007 Summer;18(2):163-71. Turkish.

    PMID: 17566882BACKGROUND
  • Kök, H., & Demir, S. (2018). Şizofreni ve bipolar bozukluğu olan hastalarda içselleştirilmiş damgalanma, benlik saygısı ve algılanan sosyal destek. Cukurova Medical Journal, 43(1), 99- 106.

    RESULT
  • İlter, Z. Ç., Çetin, S. B., Özkorumak, E., & Tiryaki, A. (2023). The relationship between internalized stigma and coping strategies in bipolar disorder. Klinik Psikiyatri Dergisi, 26(1).

    RESULT
  • González-Sanguino, C., González-Domínguez, S., Castellanos, M. A., & Muñoz, M. (2022). Mental illness stigma. A comparative cross-sectional study of social stigma, internalized stigma and self-esteem. Clinical and Health, 33(2), 59-64.

    RESULT
  • Corrigan PW, Rao D. On the self-stigma of mental illness: stages, disclosure, and strategies for change. Can J Psychiatry. 2012 Aug;57(8):464-9. doi: 10.1177/070674371205700804.

  • Cam, O., & Bilge, A. (2007). Ruh hastaligina yönelik inanc ve tutumlar/Attitudes, beliefs toward mental illness. Anadolu Psikiyatri Dergisi, 8(3), 215.

    RESULT
  • Aydemir O, Uykur B. [Reliability and validity study of the Turkish version of functioning assessment short test in bipolar disorder]. Turk Psikiyatri Derg. 2012 Fall;23(3):193-200. Turkish.

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 18, 2026

First Posted

July 29, 2026

Study Start

January 1, 2026

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations