Anxiety and WorryNCT04911803
Self-help App and Wellbeing
A study testing Anxiety Application and Procrastination Application in people with Anxiety and Worry, run by VTan at 1 site in Singapore.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety and Worry
- What is being tested?
- Anxiety Application and Procrastination Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 492 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Jun 2021to 8 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old for NUS students, or 21 for non NUS students
Who cannot join
- Participants who do not meet the age requirement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read more
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.
- Conditions
- Anxiety and Worry
- Being tested
- Anxiety Application, Procrastination Application
- Keywords
- Self-help, App, Wellbeing, Experimental
- Medical subject headings
- Anxiety Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety ApplicationBehavioural
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.
Procrastination ApplicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Anxiety Group | Experimental | 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. Receives: Behavioral: Anxiety Application |
| Procrastination Group | Active comparator | 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. Receives: Behavioral: Procrastination Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Anxiety Disorder - 7 (GAD-7)
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: Measured before the intervention
General Anxiety Disorder - 7 (GAD-7)
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: 1-2 days after completing the intervention (2 weeks)
General Anxiety Disorder - 7 (GAD-7)
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: 2 weeks after the completion of the intervention
Patient Health Questionnaire - 9 (PHQ-9)
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: Measured before the intervention
Patient Health Questionnaire - 9 (PHQ-9)
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: 1-2 days after completing the intervention (2 weeks)
Patient Health Questionnaire - 9 (PHQ-9)
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: 2 weeks after the completion of the intervention
Secondary outcomes (2)
Psychological Mindedness Scale
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: Measured before the intervention
App Engagement Scale
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: Measured 1-2 days after completing the intervention (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start8 Jun 2021
- Primary completion8 Feb 2022
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and WorryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- VTan
- Sponsor type
- University, hospital or other
- Collaborators
- The Intellect Company
- Responsible party
- Sponsor-investigator, VTan, National University of Singapore
- Investigators
- Oliver Suendermann, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911803
- Sponsor's protocol ID
- NUS-IRB-2021-266
- Status last verified
- Jul 2022
- First submitted
- 26 May 2021
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Using a Self-help App to Improve Wellbeing Work? - An Experimental Follow-up Study
- ClinicalTrials.gov ID
- NCT04911803
- Acronym / sponsor ID
- NUS-IRB-2021-266
- Conditions
- Anxiety and Worry
- Keywords
- Self-help, App, Wellbeing, Experimental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- VTanUniversity, hospital or other
- Collaborators
- The Intellect Company
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anxiety Group | Experimental | Behavioral: Anxiety ApplicationParticipants 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. |
| Procrastination Group | Active comparator | Behavioral: Procrastination ApplicationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least 18 years old for NUS students, or 21 for non NUS students
Key exclusion criteria (1 listed)
- Participants who do not meet the age requirement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anxiety ApplicationThe 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. | Behavioural | Anxiety Group |
| Procrastination ApplicationThe 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. | Behavioural | Procrastination Group |
Primary outcome
General Anxiety Disorder - 7 (GAD-7)
Time frame: 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).
General Anxiety Disorder - 7 (GAD-7)
Time frame: 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).
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).
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: 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).
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: 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).
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).
2 secondary outcomes
Psychological Mindedness Scale
Time frame: Measured before the intervention
App Engagement Scale
Time frame: Measured 1-2 days after completing the intervention (2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Suendermann principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anxiety Application and Procrastination Application in people with Anxiety and Worry, run by VTan at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Anxiety Disorder - 7 (GAD-7) (time frame: Measured before the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022; AzTrials last refreshed its copy on 27 Oct 2026.