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Clinical Trials/NCT04911803
NCT04911803
Completed
Not Applicable

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

VTan1 site in 1 country492 target enrollmentJune 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety and Worry
Sponsor
VTan
Enrollment
492
Locations
1
Primary Endpoint
Patient Health Questionnaire - 9 (PHQ-9)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 8, 2021
End Date
April 8, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
VTan
Responsible Party
Sponsor Investigator
Principal Investigator

VTan

Co-Investigator

National University of Singapore

Eligibility Criteria

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

Outcomes

Primary Outcomes

Patient Health Questionnaire - 9 (PHQ-9)

Time Frame: 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).

General Anxiety Disorder - 7 (GAD-7)

Time Frame: 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).

Secondary Outcomes

  • Psychological Mindedness Scale(Measured before the intervention)
  • App Engagement Scale(Measured 1-2 days after completing the intervention (2 weeks))

Study Sites (1)

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