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Идёт набор NCT04927533

The Ronnie Gardiner Method Effectiveness Study

Без фазы С лечением Psychiatric Disorder

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: Ronnie Gardiner Method.
Кому может быть актуально
Состояния в реестре: Psychiatric Disorder. Базовые параметры: от 60 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
Бельгия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Improving Cognitive and Emotional Processing in Older (Psychiatric) Patients: the Transdiagnostic Effectiveness of the Ronnie Gardiner Method (RGM).

Обзор

The investigators want to investigate the feasibility and transdiagnostic effectiveness of the Ronnie Gardiner Method (RGM) in a sample of Flemish psychogeriatric residential patients (≥60 years old) admitted to the Psychiatric Clinic of Alexianen Zorggroep Tienen. No control group will be used in this study, as every patient in the clinic is entitled to receive treatment. The investigators expect to observe significant improvements in the core executive functions (core EFs) by RGM participation. The investigators expect that the more sessions participants follow, the larger the effects will be. Given the strong connection between executive functions and emotion regulation, the investigators anticipate that strengthening the core EFs will in turn contribute to better emotion regulation. More specifically, the mediating role of core EFs in the relationship between the number of RGM sessions attended and improvement in emotion regulation is investigated. Given RGMs previously reported effects on quality of life, the investigators also expect to observe improved well-being. Additionally, the investigators want to examine to what extent positive experiences with RGM and temperament based personality types influence the effectiveness of the RGM training. The RGM training will be organised twice a week for a period of 12 weeks. The training sessions will be provided by trained RGM-practitioners in the Psychiatric Clinic of the Alexianen Zorggroep Tienen. Each session will last at least 45 minutes. Core EFs, emotion regulation and well-being are evaluated pre-, mid- and post-RGM (at 6-week intervals) using a number of relevant instruments (i.e. questionnaires and neuropsychological tests). At baseline, the information and consent forms will be delivered to the patient and exclusion criteria will be checked using the MMSE and the patient file. Experiences with RGM training will be evaluated midway and post-intervention by means of a brief questionnaire developed by the research team. Personality type questionnaires (The Behavioural Inhibition System (BIS)/Behavioural Activation System (BAS) scales and the Effortful Control (EC) scale), which allow us to study whether a particular temperament based personality type is predictive of RGMs success, are routinely administered in the psychiatric clinic upon admission.

Вмешательства

  • Другое Ronnie Gardiner Method
    The Ronnie Gardiner Method (RGM), developed in 1993 by Swedish jazz drummer Ronnie Gardiner, is a promising multimodal, music-based intervention with potential to stimulate and improve several cognitive functions, motor skills, reading and speech skills and social interaction. RGM participants are required to follow (what is known as) "choreoscores". This is a visual representation of the sequence of movements using four unique symbols. Each symbol represents a body half via color (red = left si

Первичные конечные точки

  • Change in Emotion Regulation using the Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij & Spinhoven, 2002) [Срок оценки: before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training]
  • Change in Core EFs (i.e. motor/response inhibition, cognitive flexibility and working memory) using four subtests of the Cambridge Neuropsychological Test Automated Battery (CANTAB® [Cognitive assessment software]). [Срок оценки: before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training]
  • Change in Core EFs (i.e. cognitive inhibition) using the California Older Adult Stroop Test (COAST) [Срок оценки: before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training]
  • Monitor mental well-being using the Dutch version of the 14-item Warwick-Edingburgh Mental Well-Being Scale (WEMWBS) [Срок оценки: before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training]
Вторичные конечные точки (3)
  • Defining the temperament based personality type using the Behavioural Inhibition System (BIS)/Behavioural Activation System (BAS) scale [Срок оценки: routinely administrated in the psychiatric clinic upon admission]
  • Experiences with RGM-training [Срок оценки: after 6 weeks of RGM-training and after 12 weeks of RGM-training]
  • Defining the temperament based personality type using the Effortful Control (EC) scale [Срок оценки: routinely administrated in the psychiatric clinic upon admission]

Критерии участия

Критерии включения

  • Psychogeriatric inpatients aged 60+

Критерии исключения

  • Checking for moderate to severe cognitive impairments (exclusion criterion) using the Mini-Mental State Examination (MMSE; Folstein, Folstein, \& McHugh, 1975; Dutch version: Kok and Verhey, 2002), following exclusion criterion applies: a score of less than 21 on the MMSE (excluding dementia or other moderate to severe cognitive impairment)
  • Not fluent in Dutch
  • Having undergone surgery and/or chemotherapy in the last three months.

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
Поддерживающая терапия

Центры проведения

Бельгия · 1 центр
  • Alexianen Zorggroep Tienen — Tienen

Публикации

  • Pohl P, Dizdar N, Hallert E. The Ronnie Gardiner Rhythm and Music Method - a feasibility study in Parkinson's disease. Disabil Rehabil. 2013;35(26):2197-204. doi: 10.3109/09638288.2013.774060. Epub 2013 Mar 12. PMID 23480646
  • Thornberg K, Josephsson S, Lindquist I. Experiences of participation in rhythm and movement therapy after stroke. Disabil Rehabil. 2014;36(22):1869-74. doi: 10.3109/09638288.2013.876107. Epub 2014 Jan 9. PMID 24400709
  • Bunketorp-Kall L, Lundgren-Nilsson A, Samuelsson H, Pekny T, Blomve K, Pekna M, Pekny M, Blomstrand C, Nilsson M. Long-Term Improvements After Multimodal Rehabilitation in Late Phase After Stroke: A Randomized Controlled Trial. Stroke. 2017 Jul;48(7):1916-1924. doi: 10.1161/STROKEAHA.116.016433. Epub 2017 Jun 15. PMID 28619985

Идентификаторы

NCT: NCT04927533 · B.U.N. 1432021000379

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗