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Идёт набор NCT02604277

Suicidal Behavior in Patients Diagnosed With Bipolar Disorder

Без фазы С лечением Depression Alcoholism Drug Abuse

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Interpersonal and Social Rhythm Therapy (ISRT), Bipolar-Specific Cognitive Behavioral Therapy (CBT), Mindfulness-Based Stress Reduction (MBSR), Psycho-education & Understanding Bipolar Medications Therapy.
Кому может быть актуально
Состояния в реестре: Depression, Alcoholism, Drug Abuse. Базовые параметры: 18 лет — 64 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Suicidal Behavior in Patients Diagnosed With Bipolar Disorder: The Roles of Biological and Childhood and Adult Environmental Risk Factors

Обзор

The purpose of this study is to learn the environmental and psychological factors that impact suicidality in patients diagnosed with Bipolar Disorder. Additionally, the study aims to identify treatments to reduce the suicidal behavior and improve quality of life through a 6-week group-based intervention program.

Подробное описание

Bipolar disorder (BD) is a severe, chronic, and relatively common psychiatric illness associated with significant premature mortality, including death by suicide. Given that suicidal behavior is a major public health problem and BD confers the highest risk of suicide among major mental disorders, it is important for clinical researchers to investigate why individuals with BD are at an increased risk for suicidal thoughts and behaviors. Among those diagnosed with BD, approximately 75% of patients experience suicidal ideation in their lifetime, 30% attempt suicide, and about 20% eventually die by suicide. Research has also demonstrated that suicidal acts in BD patients tend to be more lethal as indicated by a lower ratio of attempted suicide to death than in the general population. Given that BD patients use more dangerous suicide methods and die by suicide at an alarmingly high rate, early identification and appropriate treatment are critical. Thus, the proposed study should provide critical information and inform treatment efforts regarding suicide risk in low income BD patients.

Research has consistently demonstrated that childhood maltreatment, including abuse and neglect, are independently associated with increased risk for suicidal ideation/behavior in a variety of populations, including patients diagnosed with BD. Consequently, inquiring about past childhood abuse and neglect when assessing suicide risk in this vulnerable population is important. Moreover, childhood maltreatment has been shown to contribute to impulsive aggression and adult drug use, both of which have been shown to predict suicidal behavior in BD patients. Castroman and colleagues (2014) demonstrated that impulsive aggression was an intermediate factor linking childhood abuse with the severity of suicidal behavior in a large sample of suicide attempters. Similarly, Roy (2011) found that impulsive aggression was a significant mediator in the association between childhood abuse and suicidal behavior in substance-dependent patients. With regards to substance use, current evidence suggests that among individuals abused in childhood, the risk for drug use and subsequent suicidal behavior is increased. Further, among BD patients in particular, there appears to be significant additive effects of childhood maltreatment and drug abuse on suicide attempts.

The associations among these variables may be best explained by the interpersonal-psychological theory of suicide (IPTS), which provides a conceptual framework for understanding why individuals consider and engage in suicidal behavior. The theory differentiates between the desire for suicide and the capability of engaging in suicide behaviors among suicide attempters. Desire is characterized by two constructs, perceived burdensomeness (i.e., one's death is worth more than one's life to others) and thwarted belongingness (i.e., sense of alienation and disconnection). Suicide attempts and deaths are arguably related to the ability to use lethal means on one's self, and require pain tolerance and a developed sense of fearlessness in the face of death. Specifically, Joiner (2005) posits that the capability to initiate suicidal behavior is acquired via exposure to painful and fear-provoking events (e. g., childhood maltreatment) that habituate individuals to the pain and fear associated with death. Consequently, understanding pathways by which distal factors, such as childhood maltreatment, may influence suicidal capability is crucial. The proposed investigation of potential developmental pathways from childhood maltreatment to suicidal behaviors through the risk factors of impulsive aggression and drug use may elucidate the associations among these variables, and subsequently improve the assessment and treatment of suicidal BD patients. Thus, the proposed investigation will focus on the capability to engage in suicidal behaviors as examining all ITPS constructs is beyond the scope of this study. More specifically, the researchers propose to examine the relationships between these environmental and psychological factors in BP patients.

The purpose of this study is to learn the environmental and psychological factors that impact suicidality in patients with Bipolar Disorder. Additionally, the study aims to identify treatments to reduce the suicidal behavior and improve quality of life through a 6-week group-based intervention program. Groups will include topics such as interpersonal/social rhythm and mindfulness interventions, as well as interventions focused on understanding and changing thoughts to better cope with Bipolar Depression.

Вмешательства

  • Поведенческое Interpersonal and Social Rhythm Therapy (ISRT)
    Interpersonal and Social Rhythm Therapy (ISRT) will be given once a week over a six week period for 55-60 minutes. ISRT emphasizes identifying and maintaining a regular routine in daily life. It includes addressing sleep and solving interpersonal concerns and conflicts by focusing on daily routine.
  • Поведенческое Bipolar-Specific Cognitive Behavioral Therapy (CBT)
    Bipolar-Specific Cognitive Behavioral Therapy (CBT) will be given once a week over a six week period for 55-60 minutes.The therapy is directly focused on eliminating or managing specific problems experienced by people with Bipolar Disorder. As part of this intervention, participant's maladaptive thoughts, behaviors and emotions are identified followed by learning how to challenge negative thoughts and reframing into positive, more adaptive thoughts. Additionally, the intervention involves enhanc
  • Поведенческое Mindfulness-Based Stress Reduction (MBSR)
    Mindfulness-Based Stress Reduction (MBSR) will be given once a week over a six week period for 55-60 minutes. MBSR is a structured intervention that utilizes mindfulness meditation to reduce suffering associated with physical and psychiatric illnesses. MBSR is nonreligious in nature and aims to encourage an enhanced awareness of moment-to-moment experience of noticeable mental processes.
  • Поведенческое Psycho-education & Understanding Bipolar Medications Therapy
    Psycho-education \& Understanding Bipolar Medications Therapy will be given once a week over a six week period for 55-60 minutes. Psycho-education \& Understanding Bipolar Medications Therapy aims to provide psycho-education about Bipolar Depression as well as provide a platform for participants to address concerns about managing their illness. Issues such as managing symptoms, reducing relapses and hospitalizations as well as maintaining gains will be discussed

Первичные конечные точки

  • Columbia-Suicide Severity Rating Scale (C-SSRS) Score [Срок оценки: Pre-intervention, Post-intervention (Up to six weeks)]

Критерии участия

Критерии включения

  • English speaking
  • Diagnosis of Bipolar Disorder (BD)
  • Able to provide written informed consent

Критерии исключения

  • Cognitive impairments
  • Acutely psychotic
  • Medically unstable
  • History of schizophrenia spectrum disorder
  • History of mood incongruent psychotic symptoms
  • History of primary substance disorder
  • History of primary organic disease and/or dementia

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Grady Health System — Atlanta

Публикации

  • Au JS, Martinez de Andino A, Mekawi Y, Silverstein MW, Lamis DA. Latent class analysis of bipolar disorder symptoms and suicidal ideation and behaviors. Bipolar Disord. 2021 Mar;23(2):186-195. doi: 10.1111/bdi.12967. Epub 2020 Jul 8. PMID 32579284

Идентификаторы

NCT: NCT02604277 · IRB00084800 · 2025P010887

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗