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Self-help App and Wellbeing

24 июля 2022 г. обновлено: VTan

Does Using a Self-help App to Improve Wellbeing Work? - An Experimental Follow-up Study

Anxiety and worry are amongst the most common mental health difficulties. The Second Mental Health Study found a significant increase in the lifetime prevalence for GAD, from 0.9% to 1.6%. In addition, the Organisation for Economic Cooperation and Development found that among Singaporean students, 86% experienced anxiety levels that were significantly higher than the OECD average.

Past research revealed that individuals who worried more experienced decreases in life satisfaction. It was also found that worry and anxiety are significant predictors of one's psychological wellbeing .

In line with this trend, the market for wellbeing apps have been one of the fastest growing categories of apps ever since; with more than 10,000 on the market. Studies have shown that the use of wellbeing apps has been correlated with an improvement in mental wellbeing. However, due to the lack of research that focuses on disorder-specific evidence, there still exists debates around the effectiveness of wellbeing apps on anxiety and worry. In addition, the lack of research on the mediating factor of psychological mindedness in the relationship between the use of wellbeing apps and mental well-being, could be pivotal to the effectiveness of wellbeing apps.

To show the effectiveness of evidence-based wellbeing apps in targeting anxiety and worry, this study will employ the engagement of participants with a wellbeing app for a controlled period of 2 weeks before recording their mental wellbeing outcomes.This paradigm has been replicated extensively through multiple studies.

This study will use a between-groups experimental study design whereby participants will be block randomised into 2 conditions: Active control condition, and Anxiety condition. Each condition will be given a restricted version of the wellbeing app according to their treatment groups. Follow-up data will be collected at 2-weeks post intervention to establish efficacy of the intervention.

Objective 1: To evaluate the effectiveness of a wellbeing app self-help programme for reducing anxiety and worry.

Objective 2: To examine if psychological mindedness moderates hypothesised effects of wellbeing app usage and anxiety and worry.

Hypothesis 1: Participants in the intervention group will report significantly lower anxiety and worry than participants in the control group.

Hypothesis 2: Psychological mindedness will moderate the effect of the wellbeing app's self-help programme on anxiety and worry: Participants high in psychological mindedness will benefit more from the wellbeing apps than those with lower scores on psychological mindedness.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

492

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Сингапур
      • Singapore, Сингапур, 119077
        • National University of Singapore

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • At least 18 years old for NUS students, or 21 for non NUS students

Exclusion Criteria:

  • Participants who do not meet the age requirement

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Поддерживающая терапия
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Тройной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Anxiety Group
Participants will download the anxiety application to their own handphones, and will complete the programme subsequently in their own time over the course of 2 weeks. The expected duration participants will spend on the anxiety application daily is estimated to be around 5 to 10 minutes, amounting to a total of around 140 minutes (2 hours and 10 minutes) during the 2 weeks intervention. Participants in the anxiety group are asked to complete daily brief exercises. For example, they will practice noticing worry thoughts and journal them down.
Поведенческий: Anxiety Application
The Intellect mobile app (containing the anxiety application) can be freely downloaded from the App store and Google Play store for free. The app provides access to the different programmes. The mobile app has been pilot tested by Intellect before the release on the App and Google Play store. However, for this research project Intellect is going to provide the the programmes as stand alone applications exclusively for the participants of this research.
Активный компаратор: Procrastination Group
Participants will download the procrastination application to their own handphones, and will complete the programme subsequently in their own time over the course of 2 weeks. The expected duration participants will spend on the procrastination application daily is estimated to be around 5 to 10 minutes, amounting to a total of around 140 minutes (2 hours and 10 minutes) during the 2 weeks intervention. Participants in the procrastination group are asked to complete daily brief exercises. For example, they will practice to reduce procrastination-related thoughts.
Поведенческий: Procrastination Application
The Intellect mobile app (containing the procrastination application) can be freely downloaded from the App store and Google Play store for free. The app provides access to the different programmes. The mobile app has been pilot tested by Intellect before the release on the App and Google Play store. However, for this research project Intellect is going to provide the the programmes as stand alone applications exclusively for the participants of this research.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
General Anxiety Disorder - 7 (GAD-7)
Временное ограничение: Measured before the intervention
General Anxiety Disorder- 7 (GAD-7) is a 7 item self report instrument that measures anxiety and is widely used in research in clinical and nonclinical practices anxiety as a continuum (Siddaway, Taylor & Wood, 2018) and is a reliable and valid instrument for assessing anxiety in a general population (Löwe et al., 2008). Items are scored on a 4-point scale, ranging from "not at all (0)", "several days (1)", "more than half the days (2)" and "nearly everyday (3)". GAD-7 produced an excellent internal consistency of α=0.92 in a sample of 2982 participants (Spitzer, Kroenke, Williams, & Löwe, 2006).
Measured before the intervention
General Anxiety Disorder - 7 (GAD-7)
Временное ограничение: 1-2 days after completing the intervention (2 weeks)
General Anxiety Disorder- 7 (GAD-7) is a 7 item self report instrument that measures anxiety and is widely used in research in clinical and nonclinical practices anxiety as a continuum (Siddaway, Taylor & Wood, 2018) and is a reliable and valid instrument for assessing anxiety in a general population (Löwe et al., 2008). Items are scored on a 4-point scale, ranging from "not at all (0)", "several days (1)", "more than half the days (2)" and "nearly everyday (3)". GAD-7 produced an excellent internal consistency of α=0.92 in a sample of 2982 participants (Spitzer, Kroenke, Williams, & Löwe, 2006).
1-2 days after completing the intervention (2 weeks)
General Anxiety Disorder - 7 (GAD-7)
Временное ограничение: 2 weeks after the completion of the intervention
General Anxiety Disorder- 7 (GAD-7) is a 7 item self report instrument that measures anxiety and is widely used in research in clinical and nonclinical practices anxiety as a continuum (Siddaway, Taylor & Wood, 2018) and is a reliable and valid instrument for assessing anxiety in a general population (Löwe et al., 2008). Items are scored on a 4-point scale, ranging from "not at all (0)", "several days (1)", "more than half the days (2)" and "nearly everyday (3)". GAD-7 produced an excellent internal consistency of α=0.92 in a sample of 2982 participants (Spitzer, Kroenke, Williams, & Löwe, 2006).
2 weeks after the completion of the intervention
Patient Health Questionnaire - 9 (PHQ-9)
Временное ограничение: Measured before the intervention
Patient Health Questionnaire (PHQ-9) i s a 9 item self report instrument that measures depression. Items are scored on a 4-point scale, ranging from "not at all (0)", "several days (1)", "more than half the days (2)" and "nearly everyday (3)". In a sample of 3000 patients in the PHQ Primary Care Study, PHQ-9 achieved an excellent internal consistency of α=0.89 (Kroenke, Spitzer, & Williams, 2001).
Measured before the intervention
Patient Health Questionnaire - 9 (PHQ-9)
Временное ограничение: 1-2 days after completing the intervention (2 weeks)
Patient Health Questionnaire (PHQ-9) i s a 9 item self report instrument that measures depression. Items are scored on a 4-point scale, ranging from "not at all (0)", "several days (1)", "more than half the days (2)" and "nearly everyday (3)". In a sample of 3000 patients in the PHQ Primary Care Study, PHQ-9 achieved an excellent internal consistency of α=0.89 (Kroenke, Spitzer, & Williams, 2001).
1-2 days after completing the intervention (2 weeks)
Patient Health Questionnaire - 9 (PHQ-9)
Временное ограничение: 2 weeks after the completion of the intervention
Patient Health Questionnaire (PHQ-9) i s a 9 item self report instrument that measures depression. Items are scored on a 4-point scale, ranging from "not at all (0)", "several days (1)", "more than half the days (2)" and "nearly everyday (3)". In a sample of 3000 patients in the PHQ Primary Care Study, PHQ-9 achieved an excellent internal consistency of α=0.89 (Kroenke, Spitzer, & Williams, 2001).
2 weeks after the completion of the intervention

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Psychological Mindedness Scale
Временное ограничение: Measured before the intervention
Psychological Mindedness Scale (PM): 45 item self report instrument that measures an individual's ability to be reflective about interpersonal relationships, psychological processes and meanings across both intellectual and emotional dimensions. Items are scored on a 4 point-scale ranging from "strongly agree (4)" to "strongly disagree (1)". The PM has a good internal consistency of α= 0.86 and recomputed to 0.87 in a study of 256 patients (Conte et al., 1990).
Measured before the intervention
App Engagement Scale
Временное ограничение: Measured 1-2 days after completing the intervention (2 weeks)
App Engagement Scale (AES): 7 item self report feedback instrument that indicates the degree to which an individual engages with an app. Items are scored on a 5 point-scale ranging from "strongly agree (5)" to "strongly disagree (1)". This App Engagement Scale had good internal reliability, Cronbach's α = .839 in a study of 1349 app user (Rickard & Bakker, 2019).
Measured 1-2 days after completing the intervention (2 weeks)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

VTan

Соавторы

The Intellect Company

Следователи

  • Главный следователь: Oliver Suendermann, National University of Singapore

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

8 июня 2021 г.

Первичное завершение (Действительный)

8 февраля 2022 г.

Завершение исследования (Действительный)

8 апреля 2022 г.

Даты регистрации исследования

Первый отправленный

26 мая 2021 г.

Впервые представлено, что соответствует критериям контроля качества

30 мая 2021 г.

Первый опубликованный (Действительный)

3 июня 2021 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

26 июля 2022 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

24 июля 2022 г.

Последняя проверка

1 июля 2022 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

  • NUS-IRB-2021-266

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

Research data will be stored in an encrypted NUS nbox folder with viewing-only permissions set and restricted to the PI and co-investigator. Primary data will be kept secured in electronic form by the PI and co-investigator in a format that precludes subsequent alteration. Research data files (e.g Excel sheets) will only be accessible by PI and Co-PI. Survey data will be collected on Qualtrics secured with an account password and 2FA verification. Upon completion of the data collection, personal identifiable information(e.g. matric number from RP pool students) will be removed from the Qualtrics file, and the MS Excelsheet containing the data will be encrypted and stored in an encrypted NUS nbox folder, accessible only by the PI and Co-investigator. App data will be linked to a participant code given to participants. However, no personal identifiable data will be collected through the wellbeing app programs. Personal data will be only be shared with PI and Co-I as mentioned above.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Anxiety and Worry

Клинические исследования Anxiety Application

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