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Self-help App and Wellbeing

24 de julio de 2022 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

492

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Singapur
      • Singapore, Singapur, 119077
        • National University of Singapore

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Conductual: 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.
Comparador activo: 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.
Conductual: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
General Anxiety Disorder - 7 (GAD-7)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Psychological Mindedness Scale
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

VTan

Colaboradores

The Intellect Company

Investigadores

  • Investigador principal: Oliver Suendermann, National University of Singapore

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

8 de junio de 2021

Finalización primaria (Actual)

8 de febrero de 2022

Finalización del estudio (Actual)

8 de abril de 2022

Fechas de registro del estudio

Enviado por primera vez

26 de mayo de 2021

Primero enviado que cumplió con los criterios de control de calidad

30 de mayo de 2021

Publicado por primera vez (Actual)

3 de junio de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de julio de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

24 de julio de 2022

Última verificación

1 de julio de 2022

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • NUS-IRB-2021-266

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Anxiety and Worry

  • Bambino Gesù Hospital and Research Institute
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    Obalon en niños con obesidad severa (Obalon)
    Obesidad Pediátrica Severa (IMC > 97° pc -Según Centers for Disease Control and Prevention IMC Charts-) | Pruebas de función hepática alterada | Intolerancia glucémica
    Italia

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