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临床试验/NCT07733297
NCT07733297已完成不适用

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

Eskisehir Osmangazi University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2026年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
1
主要终点
Internalized Stigma Level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Internalized Stigma Level

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

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.

次要结局

  • Functioning Assessment Short Test(Baseline, 8 weeks (immediately after the intervention), and 5 months (3 months after the intervention))

研究者

发起方
Eskisehir Osmangazi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hülya Kök Eren

Associate Professor

Eskisehir Osmangazi University

研究点 (1)

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