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Bipolar Disorder (BD)educationNCT07733297

The Effect of Cognitive Behavioral Psychoeducation on Internalized Stigma in Individuals With Bipolar Disorder

A study testing Cognitive-behavioral based psychoeducation program in people with Bipolar Disorder (BD) and Internalized Stigma, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Cognitive-behavioral based psychoeducation program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2026to 30 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

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

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Eskisehir Yunus Emre State Hospital Community Mental Health Center

    Eskişehir, Yunus EMRE, 26000

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Cognitive Behavioral Psychoeducation on Internalized Stigma in Individuals With Bipolar Disorder: A Randomized Controlled Trial

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.

Read the detailed description

This study is designed as a randomized controlled trial utilizing a true experimental design to evaluate the effects of a cognitive-behavioral theory-based psychoeducation program on internalized stigma among individuals diagnosed with bipolar disorder. The research is conducted at a local community mental health center.The intervention group receives a structured psychoeducation program specifically built upon the cognitive-behavioral approach. The program consists of eight sequential sessions, with each session designed to last approximately 90 minutes. To maintain participant engagement and prevent fatigue, sessions are conducted in 90-minute blocks that include 10-minute breaks every 30 minutes. The structured curriculum advances through specific therapeutic milestones across the eight weeks. The initial phase focuses on an introduction and program overview, followed by sessions dedicated to recognizing internalized stigma and identifying various cognitive distortions or cognitive processing types. Participants then transition to active therapeutic techniques, including challenging stigmatizing thoughts through Socratic questioning and developing alternative thoughts to combat stigma beliefs. Subsequent sessions address coping with stigma-related emotions, emotion regulation, and navigating social support and boundaries in personal relationships. The final stages of the program emphasize relapse prevention, coping strategies, and synthesizing the acquired skills into a comprehensive relapse prevention plan. Throughout these sessions, core cognitive-behavioral techniques such as the Thought-Emotion-Behavior framework, cognitive restructuring, and specific homework assignments are systematically utilized.Participants assigned to the control group do not receive this structured intervention during the study period but continue to receive their standard follow-up and routine care at the community mental health center. Content validity of the psychoeducation curriculum was rigorously established prior to implementation by obtaining expert consensus from faculty members specializing in cognitive behavioral therapy, achieving a flawless Content Validity Index (CVI) score after minor adjustments. Data collection points for evaluating the primary and secondary outcomes are scheduled at baseline, immediately following the completion of the eight-week program, and at a three-month post-intervention follow-up.

Being tested
Cognitive-behavioral based psychoeducation program, Standard Care (in control arm)
Keywords
Psychoeducation, Internalized stigma, Bipolar disorder
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive-behavioral based psychoeducation programBehavioural

    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.

  • Standard Care (in control arm)Behavioural

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

Study groups in NCT07733297
Study groupRoleWhat they receive
Cognitive-Behavioral Psychoeducation GroupExperimentalThis 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.
Receives: Behavioral: Cognitive-behavioral based psychoeducation program
Routine Care Control GroupActive comparatorThis 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.
Receives: Behavioral: Standard Care (in control arm)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. Functioning Assessment Short Test

    The Functioning Assessment Short Test (FAST) is a 24-item Likert-type scale designed to evaluate the functioning levels of patients. It assesses a total of six dimensions: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time activities. Each item is scored from 0 to 3. Total scores range from 0 to 72, where higher scores obtained from the scale indicate greater impairment in the participant's functioning.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2026
  2. Study start1 Jan 2026
  3. Primary completion30 Jun 2026
  4. Study completion30 Jun 2026

Resources

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
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07733297
Sponsor's protocol ID
30.01.2026-129743
Acronym
education
Status last verified
Jul 2026
First submitted
18 Jul 2026
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

  • 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.

  • 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.

    PubMed 35070785
  • 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.

    PubMed 32881602
  • 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.

    PubMed 17566882
  • 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.

  • 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).

  • 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.

  • 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.

    PubMed 22854028
  • Cam, O., & Bilge, A. (2007). Ruh hastaligina yönelik inanc ve tutumlar/Attitudes, beliefs toward mental illness. Anadolu Psikiyatri Dergisi, 8(3), 215.

  • 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.

    PubMed 22949289

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive-behavioral based psychoeducation program in people with Bipolar Disorder (BD) and Internalized Stigma, run by Eskisehir Osmangazi 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Jul 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Internalized Stigma Level (time frame: Baseline, 8 weeks (immediately after the intervention), and 5 months (3 months after the intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07733297, which also lists 11 linked publications.

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 29 Jul 2026.

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