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Набор скоро начнётся NCT07208721

The Key to Emotional Balance

Без фазы С лечением The Key to Emotional Balance

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: The Key to Emotional Balance.
Кому может быть актуально
Состояния в реестре: The Key to Emotional Balance. Базовые параметры: 18 лет — 65 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Key to Emotional Balance: The Effect of a Positive Psychotherapy-Based Balance Model on Emotion Regulation, Recovery, and Life Purpose in Bipolar Disorder

Обзор

This randomized controlled experimental study aimed to evaluate the effects of the Key to Emotional Balance (KBA) psychoeducational program, based on the Balance Model of Positive Psychotherapy (PPT), on indicators of emotion regulation difficulties, recovery, and purpose in life in adults with bipolar disorder. Intervention and control groups (n=37 each; total n=74) will be formed through simple random assignment. The intervention will consist of eight individual sessions, each lasting 40-50 minutes. Data will be collected using the Difficulty in Emotion Regulation, Recovery Assessment Scale, and the Life Goals Scale in the Context of PPT. Measurements will be conducted as a pretest and posttest.

Вмешательства

  • Поведенческое The Key to Emotional Balance
    The Key to Emotional Balance (KBA) program consists of eight sessions, each lasting 40-50 minutes, and aims to help participants develop emotional balance. The first session introduces the individual, introduces group rules, provides information about the program, and supports the client in identifying and expressing their emotions. The second session encourages the client to assess their energy-time intensity in their current and future balance models and, if deviations occur, to restructure th

Первичные конечные точки

  • Difficulty in Emotion Regulation [Срок оценки: Timeframe: Pre-test, 8 weeks later]
Вторичные конечные точки (2)
  • Recovery Assessment Scale: [Срок оценки: Timeframe: Pre-test, 8 weeks later]
  • Determining Life Goals in the Context of Positive Psychotherapy (PPBYABÖ): [Срок оценки: Timeframe: Pre-test, 8 weeks later]

Критерии участия

Критерии включения

  • Having a diagnosis of bipolar I or bipolar II disorder according to the DSM-5.
  • Being between 18 and 65 years of age.
  • Being literate and having the cognitive capacity to participate in written questionnaires.
  • Being in a stable mood/remission (neither severely manic nor severely depressed) at the start of the study.
  • Being on medication or willing and able to comply with treatment.
  • Voluntarily agreeing to participate in the study and signing the informed consent form.

Критерии исключения

  • Being in an episode of acute mania or severe depression.
  • Having a diagnosis of another serious psychiatric disorder such as schizophrenia, schizoaffective disorder, severe anxiety disorder, or obsessive-compulsive disorder (OCD).
  • Cognitive impairments, such as dementia, severe cognitive impairment, or mental retardation, that would prevent participation in the recommended therapy.
  • Individuals with a history of substance abuse within the last 6 months or ongoing active substance use.
  • Individuals who have attempted suicide within the last 6 months or who currently have suicidal thoughts (patients at high risk of suicide).
  • Refusal to attend regular therapy sessions or severe resistance to psychotherapy.
  • Individuals who are not compliant with recommended medication for bipolar disorder.
  • Serious medical problems or chronic conditions that would prevent recommended psychotherapy (e.g., uncontrolled epilepsy or serious cardiovascular disease).
  • Inability to speak Turkish sufficiently to understand the questionnaires and therapeutic interventions or difficulty communicating.

Критерии исключения

  • Not attending psychoeducation sessions more than three times or not completing any of the pretest and posttest measures of the data collection forms.
  • Relapse of disease during the study and inability to comply with the program.
  • Participating in any other program while the study is ongoing.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07208721 · The Key to Emotional Balance

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗