Evaluating a Mindfulness Booster Course for Healthcare Staff
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: Mindfulness Booster Course, Usual Care.
- Кому может быть актуально
- Состояния в реестре: Occupational Stress or Workplace Stress. Базовые параметры: от 18 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Randomized Controlled Trial of an 8-Week Mindfulness "Booster" Course for Staff: Examining Effectiveness, Mediators of Impact, and Participant Experiences
Обзор
The goal of this clinical trial is to learn if a mindfulness booster course can reduce stress in healthcare staff who have previously attended a mindfulness course. The main questions it aims to answer are: * Is a mindfulness booster course for healthcare staff effective at reducing their stress levels? * Are any benefits maintained for 8 weeks? Researchers will compare a mindfulness booster course with usual care to see if it helps to reduce stress. Participants will take part in either a mindfulness booster course or do what they usually do to look after their wellbeing. They will complete questionnaires at the beginning, middle and end of the study.
Подробное описание
Aims:
1. To determine whether the mindfulness booster course for healthcare staff is effective in terms of the primary outcome (perceived stress) and secondary outcomes (wellbeing, depression, burnout, and compassion for others), and whether any benefits are maintained at follow-up. 2. To examine whether any effects on the above-mentioned outcomes are statistically mediated by changes in amount of mindfulness practice, rumination and worry, decentering, self-compassion, and trait mindfulness. 3. To develop an abbreviated grounded theory of the therapeutic process and outcomes of the mindfulness booster course.
Hypotheses:
1. a) The primary hypothesis is that we will see a significantly greater decrease in the primary outcome of perceived stress at post-intervention (the primary time-point of Weeks 11-12) relative to baseline (Weeks 0-1) for the 'mindfulness-booster course plus treatment as usual (TAU)' intervention group compared to the 'TAU-only' control group.
b) Our secondary hypothesis is that we will see significantly greater improvements in each of our secondary outcome measures at post-intervention (Weeks 11-12) relative to baseline for our intervention group compared to our control group. Improvements entail decreases in depression and burnout and increases in compassion for others and wellbeing.
c) Our third hypothesis is that we will also see the effects detailed in (1a) and (1b) above at the follow-up time-point (Weeks 19-20). 2. a) The relationship between group allocation (intervention vs. control) and reduction in perceived stress, from baseline to follow-up (Weeks 19-20), will be statistically mediated by changes from baseline to post-intervention in the following psychological constructs: i) increase in amount of mindfulness practice, both formal and informal; ii) reduction in rumination and worry, i.e., repetitive negative thinking; iii) increase in decentering; iv) increase in self-compassion; v) increase in trait mindfulness.
b) The relationships specified in Hypothesis 2a will also hold true for the secondary outcomes (i.e. change from baseline to follow-up \[Weeks 19-20\] in wellbeing, depression, burnout and compassion for others).
c) i) The relationship between group allocation and reduction in perceived stress will be serially statistically as follows: intervention group allocation predicts increased mindfulness practice (from baseline to post-intervention \[Weeks 11-12\]) which in turn predicts change in psychological mechanisms (i.e., rumination/worry, decentering, self-compassion and trait mindfulness; from baseline to post-intervention \[Weeks 11-12\]), which in turn predict reduced perceived stress (from baseline to follow-up \[Weeks 19-20\]).
ii) The relationships specified in Hypothesis 2c-i will also hold for the secondary outcomes (i.e. change from baseline to follow-up \[Weeks 19-20\] in wellbeing, depression, burnout and compassion for others).
Design Information Not Included Elsewhere in this Registration:
After Weeks 11-12, a subsample of intervention group participants will be invited to participate in a semi-structured individual interview, with the qualitative data being collected and analysed according to grounded theory principles. This aspect of the study has the following sub-aims: 1. To explore what processes occur during the mindfulness booster course, based on participants' experiences. 2. To explore how these processes interact with the participants' contexts, including, but not limited to, working in healthcare. 3. To explore how these processes and contexts interact with, and perhaps drive, any perceived impacts and outcomes of the course.
Вмешательства
- Поведенческое Mindfulness Booster Course
The mindfulness booster course will consist of eight 30-minute sessions, which participants will be asked to commit to. These will be online and usually occur weekly. Within these sessions, there will be a 15-minute mindfulness practice followed by a 15-minute discussion. This discussion time will involve reflecting on the mindfulness practice and speaking about between-session practice. Participants will be encouraged to practice mindfulness for home work between the sessions. - Поведенческое Usual Care
Participants will be encouraged to continue with whatever activities they usually undertake to manage their stress and support their wellbeing.
Первичные конечные точки
- Change in Perceived Stress Scale score from baseline (Weeks 0-1) at Weeks 11-12. [Срок оценки: Baseline (Weeks 0-1) and Weeks 11-12]
Вторичные конечные точки (9)
- Change in Perceived Stress Scale score from baseline (Weeks 0-1) at Weeks 19-20. [Срок оценки: Baseline (Weeks 0-1) and Weeks 19-20]
- Change in 8-item Patient Health Questionnaire score from baseline (Weeks 0-1) at Weeks 11-12. [Срок оценки: Baseline (Weeks 0-1) and Weeks 11-12.]
- Change in 8-item Patient Health Questionnaire score from baseline (Weeks 0-1) at Weeks 19-20. [Срок оценки: Baseline (Weeks 0-1) and Weeks 19-20]
- Change in Brief Sussex-Oxford Compassion for Others Scale score from baseline (Weeks 0-1) at Weeks 11-12. [Срок оценки: Baseline (Weeks 0-1) and Weeks 11-12.]
- Change in Brief Sussex-Oxford Compassion for Others Scale score from baseline (Weeks 0-1) at Weeks 19-20. [Срок оценки: Baseline (Weeks 0-1) and Weeks 19-20]
- Change in Short Warwick-Edinburgh Mental Wellbeing Scale score from baseline (Weeks 0-1) at Weeks 11-12. [Срок оценки: Baseline (Weeks 0-1) and Weeks 11-12.]
- Change in Short Warwick-Edinburgh Mental Wellbeing Scale score from baseline (Weeks 0-1) at Weeks 19-20. [Срок оценки: Baseline (Weeks 0-1) and Weeks 19-20.]
- Change in Sussex Burnout Scale score from baseline (Weeks 0-1) at Weeks 11-12. [Срок оценки: Baseline (Weeks 0-1) and Weeks 11-12.]
- Change in Sussex Burnout Scale score from baseline (Weeks 0-1) at Weeks 19-20. [Срок оценки: Baseline (Weeks 0-1) and Weeks 19-20.]
Критерии участия
Критерии включения
- UK National Health Service staff member.
- Has completed an 8-week mindfulness course (either MBCT, MBCT-L or MBSR). Individuals will be considered to have "completed" a mindfulness course if they attended four or more sessions.
- Is able to make one of the planned sets of times for the booster course sessions, in case they are randomly allocated to the intervention arm.
Критерии исключения
- Currently on sick leave.
- Planning on undertaking another 8-week mindfulness course.
- Previously participated in the mindfulness booster course in the feasibility study.
- Have previously found practising mindfulness distressing.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Великобритания · 1 центр
- Sussex Mindfulness Centre — Worthing
Идентификаторы
NCT: NCT07560371 · ETH2526-0057 · IRAS 366211