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Набор скоро начнётся NCT06882590

A Compassionate-focused Intervention for Older People with Bipolar Disorder

Без фазы С лечением Bipolar Disorder I or II

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: Compassionate-focused therapy.
Кому может быть актуально
Состояния в реестре: Bipolar Disorder I or II. Базовые параметры: 60 лет — 90 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
Великобритания
Следующий шаг
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Официальное название

A Brief Compassionate-focused Intervention for Older People with Bipolar Disorder

Обзор

The aim of this study is to determine whether it is feasible to deliver a 9-session compassionate-focused therapy for older people with bipolar disorder. Participants will be asked to complete baseline measures and at post-intervention follow-up (12 weeks and 24 weeks) to understand any potential clinical benefits of the therapy.

Подробное описание

The present study will evaluate the feasibility of a compassionate-focused intervention targeting rumination that is specifically tailored for older people with bipolar disorder. In addition to evaluating its feasibility, the study will also investigate whether there are any clinical benefits associated with the intervention, namely, any potential reductions in negative rumination and feelings of guilt and shame. To date, there has been no research evaluating the feasibility of this type of intervention.

Вмешательства

  • Другое Compassionate-focused therapy
    A 9-session therapy intervention targeting negative thinking, feelings of guilt and shame, and cultivating compassion for self and others.

Первичные конечные точки

  • Number of therapy sessions attended [Срок оценки: The timeframe for number of therapy sessions attended will span the length of intervention; from the first assessment session to final therapy session. The estimated period of time over which the event is assessed is up to 9 weeks.]
  • Number of participants who drop-out and at which stage of the intervention [Срок оценки: The time frame covers first therapy session to final therapy session. The estimated period of time over which the event is assessed is up to 9 weeks.]
Вторичные конечные точки (8)
  • The Altman Self-Rating Mania Scale [Срок оценки: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up]
  • The Bipolar Recovery Questionnaire [Срок оценки: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up]
  • The Quality of Life in Bipolar Disorder Questionnaire [Срок оценки: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up]
  • Other as Shamer Scale [Срок оценки: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up]
  • Guilt and Shame Questionnaire [Срок оценки: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up]
  • The Compassionate Engagement and Action Scale [Срок оценки: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up]
  • Generalised Anxiety Disorder Questionnaire (GAD-7) [Срок оценки: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up]
  • Center for Epidemiologic Studies Depression Scale (CES-D) [Срок оценки: Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up]

Критерии участия

Критерии включения

  • Adults aged 60 years and above.
  • Have a nominated healthcare professional (i.e. GP/Care Coordinator)
  • Meet the criteria for a diagnosis of bipolar disorder I or II according to the MINI.
  • Score of >57 on Ruminative Response Scale (RRS)
  • Be able to provide written informed consent.
  • Be able to speak sufficient English to engage in the assessments and intervention.

Критерии исключения

  • Currently in an episode of mania or hypomania according to the MINI.
  • Experiencing 'severe depression' according to the Hamilton Depression Rating Scale, which equates to a score of over 24.
  • MoCA score of <22 to exclude for moderate and severe cognitive impairment.
  • Currently receiving psychological therapy.

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
Другое

Центры проведения

Великобритания · 1 центр
  • Greater Manchester Mental Health NHS Foundation Trust — Greater Manchester

Идентификаторы

NCT: NCT06882590 · 348011

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗