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Идёт набор NCT07310147

Empower Your Mind to Embrace Your Life: an Online ACT Intervention for Young-Onset Parkinson's Disease

Без фазы С лечением Parkinson's Disease (PD)

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: Empower your mind to embrace your life.
Кому может быть актуально
Состояния в реестре: Parkinson's Disease (PD). Базовые параметры: 21 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
Португалия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Empower Your Mind to Embrace Your Life: Development and Efficacy Study of a Videoconference-delivered Group Intervention Based on Acceptance and Commitment Therapy for People With Young-onset Parkinson's Disease

Обзор

Parkinson's disease (PD) has a substantial impact on daily life and significantly affects functioning, mental health and quality of life. Although considered a disease of the elderly, an early diagnosis is also common. Non-pharmacological interventions have been increasingly recommended for PD, including psychotherapy, with emerging evidence suggesting that Acceptance and Commitment Therapy (ACT) may be suitable to support individuals living with PD. This project aims to expand the current evidence for ACT interventions in this population by developing, implementing, and investigating the preliminary efficacy of a novel online-delivered ACT intervention (Empower your mind to embrace your life) for individuals with a diagnosis of young-onset PD. For this purpose, a feasibility study will be conducted to assess the acceptability and preliminary efficacy of the intervention across two groups (control and ACT intervention). This group-based intervention consists of eight weekly sessions and will be delivered in an online format (via videoconferencing). Outcome measurement will be assessed at pre-intervention, post-intervention, and at 3-month follow-up. When comparing changes in outcome variables between the control and intervention groups at post-treatment, improvements are expected only in the intervention group. These improvements are also expected to be maintained over time (at 3-month follow-up). Lastly, changes in psychological (in)flexibility processes are expected to predict changes in outcome variables in the intervention group. This study will provide important insights to research and clinical practice by providing data on the feasibility and preliminary efficacy of this novel ACT-based intervention for the context of young-onset PD.

Подробное описание

Parkinson's disease (PD) is a complex, progressive neurodegenerative disease that predominantly affects movement. Although considered a disease of the elderly, an early diagnosis is also common and entails unique challenges that significantly affect several domains of life. PD is characterized by a multitude of motor (e.g., bradykinesia, resting tremor, rigidity) and non-motor symptoms (NMS, e.g., depression, pain, fatigue). Specifically, NMS have received increasing attention due to their detrimental impact on individuals' functioning, mental health outcomes and overall quality of life. In fact, NMS can be as disabling as motor PD manifestations, particularly in people with young-onset PD.

In recent years, non-pharmacological interventions have been developed with the aim of improving overall quality of life and managing NMS, including psychotherapy. In particular, third-wave psychological interventions have been applied in the context of PD with promising results, and literature has specifically highlighted Acceptance and Commitment Therapy (ACT) as a transdiagnostic model that appears to be well-suited for helping individuals with PD manage the challenges associated with their symptoms. The overarching goal of ACT is to increase psychological flexibility, a core process defined as the ability to be fully in contact with the present moment, with an accepting and nonjudgmental attitude, while behaving according to one's values. Evidence supports ACT's efficacy in several chronic physical illnesses, but few studies have implemented such interventions in adults diagnosed with PD. Despite promising results, current evidence remains limited and preliminary.

Additionally, literature highlighted the relevance of technology-supported psychological interventions in providing more cost-effective interventions for healthcare systems, especially in the context of chronic conditions. Notably, videoconferencing has been shown to be effective in overcoming face-to-face intervention-related barriers (e.g., mobility limitations, transport), which is particularly relevant in the context of PD.

Considering this background, the current project aims to contribute to the advance of ACT-based interventions in this field by developing, implementing, and examining the feasibility and preliminary efficacy of the "Empower your mind to embrace your life" intervention. This innovative ACT-based intervention was designed specifically to the context of young-onset PD and will be delivered online, in group format. The feasibility, acceptability and preliminary efficacy will be tested using a parallel-arm study, comparing the intervention with a control condition/waiting list (individuals with an early-onset PD diagnosis that will not receive any type of psychological intervention during the course of the study). Our hypothesis is that by targeting ACT core processes (e.g., acceptance, mindfulness, values), not only functioning and psychological outcomes will improve, but overall quality of life will be positively impacted. For this purpose, a longitudinal design will be implemented, including three assessment moments: baseline, post-intervention and 3-month follow-up (primary outcomes: health-related quality of life and psychopathology indicators -depression and anxiety symptoms; secondary outcomes: ACT core processes \[chronic illness-specific and general psychological flexibility, chronic illness-related cognitive fusion, mindfulness\], and other relevant outcomes, such as body functionality, shame). All procedures inherent to this research project were approved by the Ethics Committees of the Faculty of Psychology and Educational Sciences, University of Coimbra; Coimbra Local Health Unit (ULS Coimbra), and Hospital da Luz Coimbra. All participants provided their informed consent prior to data collection. The voluntary, confidential and pseudo-anonymized nature of the study was clearly explained. Participants were also informed about the option to decline participation or withdraw at any moment without any negative consequence. All participants will maintain their usual medical treatment, which includes medication for managing PD-related symptoms.

Вмешательства

  • Поведенческое Empower your mind to embrace your life
    An eight-session Acceptance and Commitment Therapy (ACT) for young-onset Parkinson's disease, applied in a group format and delivered online (via videoconferencing).

Первичные конечные точки

  • Parkinson's Disease Questionnaire - short form (PDQ-8) [Срок оценки: Baseline, Week 8, 3-month follow-up]
  • Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Baseline, Week 8, 3-month follow-up]
Вторичные конечные точки (7)
  • Psy-Flex for Chronic Illness (Psy-Flex-CI) [Срок оценки: Baseline, Week 8, 3-month follow-up]
  • Multidimensional Psychological Flexibility Inventory - 24 (MPFI-24) [Срок оценки: Baseline, Week 8, 3-month follow-up]
  • Cognitive Fusion Questionnaire - Chronic Illness (CFQ-CI) [Срок оценки: Baseline, Week 8, 3-month follow-up]
  • The Mindful Attention and Awareness Scale (MAAS) [Срок оценки: Baseline, Week 8, 3-month follow-up]
  • External and Internal Shame Scale (EISS) [Срок оценки: Baseline, Week 8, 3-month follow-up]
  • Functionality Appreciation Scale (FAS) [Срок оценки: Baseline, Week 8, 3-month follow-up]
  • The Work and Social Adjustment Scale (WSAS) [Срок оценки: Baseline, Week 8, 3-month follow-up]

Критерии участия

Критерии включения

  • Young-onset PD diagnosis confirmed by a neurologist
  • Classification between stages 1 and 2.5 according to the Hoehn \&Yahr scale
  • Aged between 21-65 years
  • Fluent Portuguese speakers

Критерии исключения

  • Currently undergoing any form of psychology intervention
  • Pregnancy
  • Current suicidal ideation
  • Diagnosis of severe psychiatric illness (e.g., severe depression, psychotic illness, bipolar disorder)
  • Cognitive impairment

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
Простое слепое
Основная цель
Лечение

Центры проведения

Португалия · 1 центр
  • CINEICC — Coimbra

Идентификаторы

NCT: NCT07310147 · 2022.12842.BD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗