Clinical trial NCT04911803: Self-help App and Wellbeing
Official title: Does Using a Self-help App to Improve Wellbeing Work? - An Experimental Follow-up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety and Worry
Keywords: Self-help
App
Wellbeing
Experimental
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: The Intellect Company
First posted: 2021-06-03
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: General Anxiety Disorder - 7 (GAD-7)
timeFrame: Measured before the intervention
measure: General Anxiety Disorder - 7 (GAD-7)
timeFrame: 1-2 days after completing the intervention (2 weeks)
measure: General Anxiety Disorder - 7 (GAD-7)
timeFrame: 2 weeks after the completion of the intervention
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: Measured before the intervention
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: 1-2 days after completing the intervention (2 weeks)
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: 2 weeks after the completion of the intervention
Secondary outcomes:
measure: Psychological Mindedness Scale
timeFrame: Measured before the intervention
measure: App Engagement Scale
timeFrame: Measured 1-2 days after completing the intervention (2 weeks)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore
Study officials:
affiliation: National University of Singapore
name: Oliver Suendermann
role: PRINCIPAL_INVESTIGATOR
References: