- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07686276
Brief Psychological Intervention to Reduce Alcohol Consumption
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
The research aims to test the role of self-incentivising implementation intentions for reductions/abstinence of alcohol consumption among people aged 18 and over, residing in the UK, and consuming 14 units of more of alcohol at the start of the study. The effectiveness of self-incentives has been successfully seen previously within health behaviour change, has not been tested in reduction/abstinence of alcohol consumption. Therefore, this research will build on what is known about the effectiveness of self-incentives used for increasing fruit and vegetable consumption, and smoking cessation.
This study is a randomised controlled trial with the between participants factor of condition which has two levels:
1. Control (plan) or 2. Weekly self-incentivising implementation intention.
The within participants' factor will be time which has three levels:
Baseline (T1) Follow-up (T2) (1-week following baseline) Follow-up (T3) (1-month following baseline)
An ethical concern is that participants in the control condition may struggle more to reduce/abstain from alcohol consumption as they will not have the additional benefits of being within an experimental condition which uses self-incentives to aid their attempt. A control condition is needed to monitor if changes to alcohol consumption is due to the use of self-incentives or another behaviour change technique.
The recruitment process will recruit participants to complete an online questionnaire (via Qualtrics), from Prolific. Prolific is an online recruitment platform, which allows screeners to be set (e.g., age, residency, consumption level) prior to contacting potential participants. Prolific then contacts the participants to which the screeners apply, and the participants can decide if they would like to take part. The researcher can then set restrictions to only allow completion of the follow-up questionnaires, based on those participants who completed the online questionnaire at baseline.
All participants who are able to provide informed consent, are over the age of 18 years old, resident in the UK (due to discrepancies in the safe recommended alcohol consumption rates across countries), are eligible to take part in the study. Unfortunately, the study does not cater for people who cannot understand English at the present time, although this will be monitored for amendments in future studies.
The participant information sheet included prior to the online questionnaire includes details about the study, costs and benefits of taking part in the study, and the right to consent and withdraw at any point throughout the study. There are no risks involved in taking part in the study. Participants are reimbursed via Prolific based on the expected time to complete each questionnaire (i.e., £3.55 per questionnaire completed, which equates to more than the current UK living wage). There is a minimal burden in time taken to complete the questionnaires, which should take no longer than 15 minutes per time point, though this time estimation is considered generous.
In terms of confidentiality, participants will not provide any identifier other than their Prolific ID. This ensures that no identifying information is available to the research team, but that the participant can be added to the screener for completion of the baseline questionnaires, and that all questionnaires (baseline, 1-week follow-up, and 1-month follow-up) can be matched.
There are no conflicts of interest. Participants are provided with contact details of the research team, should they like to contact for a summary of the results.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
-
Lancaster, Соединенное Королевство
- Lancaster University
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Aged 18 years or over
- Able to understand written English
- Competent to provide informed consent
- Residing in the UK
- Regularly consuming 14 units of alcohol or more at baseline
Exclusion Criteria:
- Note aged 18 years old or over
- Not able to understand written English
- Not competent to provide informed consent
- Not residing in the UK
- Not regularly consuming 14 units of alcohol or more at baseline
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Behavioural: Self-incentive
Weekly self-incentivising
|
Participants read a brief statement designed to encourage them to reduce/abstain from alcohol consumption (we would like you to plan to reduce/abstain your alcohol consumption).
Participants are then asked to specify a self-incentive on which they could implement at the end of each week which they have been successful.
|
|
Активный компаратор: Plan
Control
|
Participants read a brief statement designed to encourage them to reduce/abstain from alcohol consumption (we would like you to plan to reduce/abstain your alcohol consumption).
Participants are then asked to form their plan.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Alcohol consumption
Временное ограничение: Up to 1-month
|
Total units of alcohol consumed in last week
|
Up to 1-month
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Alcohol use disorders identification test (AUDIT)
Временное ограничение: Up to 1- month
|
Changes in AUDIT scores
|
Up to 1- month
|
|
Compliance to self-incentivise
Временное ограничение: Up to 1-month
|
Whether participants allocated to the intervention self-incentives
|
Up to 1-month
|
|
Frequency of self-incentivisation
Временное ограничение: Up to 1-month
|
How frequently participants allocated to the intervention condition use self-incentives
|
Up to 1-month
|
|
Self-incentives used
Временное ограничение: Up to 1-month
|
What self-incentives are chosen by participants (monetary, BCT etc)
|
Up to 1-month
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- FHM-2024-4354-RECR-4
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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