Self-help App and Wellbeing

Sponsor
VTan (Other)
Overall Status
Completed
CT.gov ID
NCT04911803
Collaborator
The Intellect Company (Other)
492
1
2
10
49.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Anxiety Application
  • Behavioral: Procrastination Application
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
492 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Does Using a Self-help App to Improve Wellbeing Work? - An Experimental Follow-up Study
Actual Study Start Date :
Jun 8, 2021
Actual Primary Completion Date :
Feb 8, 2022
Actual Study Completion Date :
Apr 8, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Behavioral: 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.

Active Comparator: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. General Anxiety Disorder - 7 (GAD-7) [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).

  2. General Anxiety Disorder - 7 (GAD-7) [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).

  3. General Anxiety Disorder - 7 (GAD-7) [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).

  4. Patient Health Questionnaire - 9 (PHQ-9) [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).

  5. Patient Health Questionnaire - 9 (PHQ-9) [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).

  6. Patient Health Questionnaire - 9 (PHQ-9) [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).

Secondary Outcome Measures

  1. Psychological Mindedness Scale [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).

  2. App Engagement Scale [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National University of Singapore Singapore Singapore 119077

Sponsors and Collaborators

  • VTan
  • The Intellect Company

Investigators

  • Principal Investigator: Oliver Suendermann, National University, Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VTan, Co-Investigator, National University, Singapore
ClinicalTrials.gov Identifier:
NCT04911803
Other Study ID Numbers:
  • NUS-IRB-2021-266
First Posted:
Jun 3, 2021
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by VTan, Co-Investigator, National University, Singapore

Study Results

No Results Posted as of Jul 26, 2022