Depressive SymptomsNCT06099301
Mental Health Mobile Apps for Adults
A study testing Brief advice of a list of mobile apps in people with Depressive Symptoms and Anxiety, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
Trial summary
In Hong Kong, the shortage of mental health professionals has been a public health concern for many decades. The World Health Organization (WHO) recommends self-care intervention as one of the most promising and exciting new approaches to improve health and well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Symptoms, Anxiety, Well-Being, Psychological
- What is being tested?
- Brief advice of a list of mobile apps
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2023to 31 Oct 2024
- 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
- Adults aged 18 years or above
- Have mild to moderate depression (Patient Health Questionnaire (PHQ) - 9, score 5-14) and/or anxiety (General Anxiety Disorder (GAD) - 7, score 5-14)
- Hong Kong residents who can communicate in Chinese (Cantonese)
- Own a smart phone
Who cannot join
- Physically or mentally unable to communicate
- Currently taking antidepressant or anxiolytic medication or receiving active psychotherapy in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Advice of a List of Mental Health Mobile Apps for Reducing Depressive Symptoms and Anxiety in Adults: a Pilot Randomised Controlled Trial
In Hong Kong, the shortage of mental health professionals has been a public health concern for many decades. The World Health Organization (WHO) recommends self-care intervention as one of the most promising and exciting new approaches to improve health and well-being. Rapid development in digital technologies is making population-based self-care interventions possible. The goal of this pilot randomised controlled trial is to provide brief advice of a list of mental health mobile apps for reducing depressive symptoms and anxiety in adults. Participants will be instructed to use four mobile apps for 10 min each day for 30 days. They have freedom to choose which one app to use, or a mix of two or three apps. The Waitlist control group will not receive treatment from the research team during the assessment period. But they will be notified their evaluation results (mild to moderate depression) after they complete the baseline assessment. They will receive the information about mental health hotline services for general public. The hypothesis is that the interventions show preliminary effectiveness in reducing adults' depressive and/or anxiety symptoms.
Read the detailed description
Over 10,000 mental health mobile apps are commercially available and counting. Only a small number of apps are regularly downloaded and used, which is in stark contrast with the surge of depression and anxiety apps on the marketplace. Most commercial apps were released without any supportive data. It is costly to develop a brand-new app, which requires a professional team to maintain. The reach and impact are questionable. Some apps include rich contents, yet the public or patients may find them not useful. The preferences of mobile apps may vary in different populations. A list of the high-quality mobile apps will be formed, then conduct a pilot randomized controlled trial (RCT) to evaluate whether a brief advice to provide these apps is feasible for adult populations with mild to moderate depressive symptoms. The assumption is that digital-based self-help interventions are effective methods to improve wellbeing and promote mental health, and their impact could be extended at the population level with a minimal cost and time if proved to be effective. In this feasibility trial, the research aim was to explore trial design, subject acceptability of the interventions and preliminary effectiveness of the interventions, and to provide data to estimate the parameters required to design a definitive RCT.
A parallel-group pilot RCT with an equal randomization of 1:1, (1) Intervention group: brief advice of a list of mobile apps (LMA) and (2) Waitlist control (WL) group. A total of 234 participants (117 in each group) who have mild to moderate depression or anxiety symptoms will be recruited. Participants will be approached through mass email, public posters or active approach in community centres. The randomisation will be conducted after the participants give consent and complete the baseline assessments (T1) (via Qualtrics). The individuals will be randomised into intervention and control groups. The randomized list will be generated using an Excel spreadsheet by a statistician who is not involved in any part of the study. The recruitment staff will be blinded in the allocation process. The randomisation number will not be decoded to the participants until they get assigned a group. Considering the nature of the intervention, participants and research staff cannot be blinded in the process. As the recruitment will be mainly conducted online and through telephone, contamination between groups is expected to be minimal. Potential contamination will be checked at the T1 assessment by asking whether any participants they know have attended the other group. In the final assessment, the participants in the control group will be asked whether they have used any of the recommended apps in the past 3 months.
A 2-hour instruction session of the mobile apps will be delivered to all the participants via Zoom or other online platforms. Participants will be introduced to the concept of self-care and presented with a list of four high-quality and suitable mobile apps along with their main functions. Participants will be instructed to use at least one of the apps for 10 minutes daily over a period of 30 days. They can choose one app or a combination of two or three apps. Participants will create their own user accounts for the chosen app(s), with a reminder to prioritize privacy. Two reminders will be sent during the second and third weeks, emphasizing app usage, the concept of self-care, and providing tips for using the apps. If participants encounter any difficulties accessing the apps, the project coordinator will discuss the issues and collaborate with them to find solutions. Participants will complete the process evaluation (intervention group only) immediately after the intervention (T2), complete the process evaluation (intervention group only) and outcome assessment at 3-month (T3). A fidelity checks on adherence and competence will be conducted.
The feasibility outcomes, including the recruitment rate and duration, retention rate, and adverse events, will be reported descriptively and narratively. For the clinical endpoints, descriptive statistics, mean (standard deviation) for continuous outcomes, will be reported. After adjusting the baseline covariates, mean differences in the outcomes will be compared between the two groups. Multiple imputation approach will be used to deal with missing data (mice package in R). Three sensitivity analyses will be carried out to assess the effect of three factors on the outcomes (retention, choice of mobile apps, effective features). For the in-depth telephone interview, content analysis method will be used following the framework method analysis procedure (e.g., coding). It is expected that the intervention group show more significant improvements in the measured outcomes than the control group, indicating preliminary evidence of effectiveness.
- Conditions
- Depressive Symptoms, Anxiety, Well-Being, Psychological
- Being tested
- Brief advice of a list of mobile apps
- Keywords
- Apps, Depressive Symptoms, Anxiety, Mental Health, Coping Self-efficacy
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief advice of a list of mobile appsBehavioural
Also called mobile apps
The mobile apps in the list should: (1) focus primarily on anxiety/depression/stress, (2) be available for free download; (3) be available in English or Chinese; and (4) have a user star rating in the app store.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist control (WC) | No intervention | The WC group will not receive treatment from the research team during the assessment period. But they will be notified their evaluation results (mild to moderate depression) after they complete the baseline assessment. They will receive the information about mental health hotline services for general public (e.g. Social Welfare Department: 2343 2255; Caritas Family Crisis Support Centre: 18288; Joyful Mental Health Foundation: 2301 2303). The intervention group will receive the hotline information as well. If they want to consult a family doctor, information about the primary care provider/directory for mental health care and counselling services will be provided in their preferred district. Their treatment or help-seeking of the formal mental health services will not be intervened. The mobile app list will be provided to the WC group after the assessment period. The instruction session will be delivered to the WC group and provide necessary assistance. |
| Brief advice of a list of mobile apps | Experimental | In the instruction session, the participants will be introduced with the concept of self-care, a list of four mobile apps with high quality and suitability, and the main functions of these apps. Participants will be instructed to use at least one of the apps for 10 min each day for 30 days. They have freedom to choose which one app to use, or a mix of two or three apps. For each app they choose, they will create user accounts by themselves but be reminded to protect privacy. Two reminders will be sent to the participants at the 2nd and 3rd week. The message will include reminders to use the suggested mobile apps, self-care concept, and tips of using the provided apps. If they have not accessed to any of the mobile apps, the project coordinator will discuss the reasons and work together with the participants to overcome the problems. Receives: Behavioral: Brief advice of a list of mobile apps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in depressive symptoms
The Patient Health Questionnaire (PHQ)-9 will be used to measure depressive symptoms. Participants rate the frequency of nine symptoms over the past two weeks on a 4-point Likert scale (from 0=not at all to 3=nearly every day). The total score ranges from 0 to 27, with higher scores indicating a greater severity of depressive symptoms.
Measured: T1: baseline; T2: immediate post-intervention (1-month after baseline); T3: 3-month after the intervention
Changes in anxiety symptoms
The Generalized Anxiety Disorder (GAD)-7 will be used to measure anxiety symptoms. Participants rate the frequency of seven symptoms over the past two weeks on a 4-point Likert scale (from 0=not at all to 3=nearly every day). The total score ranges from 0 to 21, with a higher score indicating a higher level of anxiety.
Measured: T1: baseline; T2: immediate post-intervention (1-month after baseline); T3: 3-month after the intervention
Secondary outcomes (3)
Changes in well-being
The 7-item Short Warwick-Edinburgh Mental Well-being Scale with the 5-point Likert scale (1=none of the time, 5=all the time) will be used to measure well-being. The score is calculated by summing all seven items with a range of 7 to 35. A higher score indicates a higher level of well-being.
Measured: T1: baseline; T2: immediate post-intervention (1-month after baseline); T3: 3-month after the intervention
Changes in coping self-efficacy (CSE)
The Coping Efficacy Questionnaire (CEQ) with the 4-point Likert scale (1 = totally disagree, 4 = strongly agree) will be used to assess CSE. Scores are calculated from the sum of the reverse score of items 1-3, and the remaining 4-17 item scores, ranging from 17 to 68. Higher scores indicate greater CSE.
Measured: T1: baseline; T2: immediate post-intervention (1-month after baseline); T3: 3-month after the intervention
Changes in psychological stress
The Chinese version of the Perceived Stress Scale-10 (CPSS-10) will be used to measure psychological stress during the past month. It consists of six positive and four negative items, with each item scored on a 5-point Likert scale from 0 (never) to 4 (very often). The positive items will be reverse scored. The total score ranges from 0 to 40, and a higher score indicates a higher perceived psychological stress.
Measured: T1: baseline; T2: immediate post-intervention (1-month after baseline); T3: 3-month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Aug 2023
- Primary completion26 Aug 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund
- Responsible party
- Principal investigator, Dr Grace SUN Yuying, Hong Kong Metropolitan University
- Investigators
- Yuying Sun, PhD, Principal investigator, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099301
- Sponsor's protocol ID
- HE-HMRF2023/09
- Status last verified
- Mar 2025
- First submitted
- 16 Oct 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Advice of a List of Mental Health Mobile Apps for Reducing Depressive Symptoms and Anxiety in Adults: a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06099301
- Acronym / sponsor ID
- HE-HMRF2023/09
- Conditions
- Depressive Symptoms, Anxiety, Well-Being, Psychological
- Keywords
- Apps, Depressive Symptoms, Anxiety, Mental Health, Coping Self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 25 Oct 2023 (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.
In Hong Kong, the shortage of mental health professionals has been a public health concern for many decades. The World Health Organization (WHO) recommends self-care intervention as one of the most promising and exciting new approaches to improve health and well-being. Rapid development in digital technologies is making population-based self-care interventions possible. The goal of this pilot randomised controlled trial is to provide brief advice of a list of mental health mobile apps for reducing depressive symptoms and anxiety in adults. Participants will be instructed to use four mobile apps for 10 min each day for 30 days. They have freedom to choose which one app to use, or a mix of two or three apps. The Waitlist control group will not receive treatment from the research team during the assessment period. But they will be notified their evaluation results (mild to moderate depression) after they complete the baseline assessment. They will receive the information about mental health hotline services for general public. The hypothesis is that the interventions show preliminary effectiveness in reducing adults' depressive and/or anxiety symptoms.
Detailed description
Over 10,000 mental health mobile apps are commercially available and counting. Only a small number of apps are regularly downloaded and used, which is in stark contrast with the surge of depression and anxiety apps on the marketplace. Most commercial apps were released without any supportive data. It is costly to develop a brand-new app, which requires a professional team to maintain. The reach and impact are questionable. Some apps include rich contents, yet the public or patients may find them not useful. The preferences of mobile apps may vary in different populations. A list of the high-quality mobile apps will be formed, then conduct a pilot randomized controlled trial (RCT) to evaluate whether a brief advice to provide these apps is feasible for adult populations with mild to moderate depressive symptoms. The assumption is that digital-based self-help interventions are effective methods to improve wellbeing and promote mental health, and their impact could be extended at the population level with a minimal cost and time if proved to be effective. In this feasibility trial, the research aim was to explore trial design, subject acceptability of the interventions and preliminary effectiveness of the interventions, and to provide data to estimate the parameters required to design a definitive RCT.
A parallel-group pilot RCT with an equal randomization of 1:1, (1) Intervention group: brief advice of a list of mobile apps (LMA) and (2) Waitlist control (WL) group. A total of 234 participants (117 in each group) who have mild to moderate depression or anxiety symptoms will be recruited. Participants will be approached through mass email, public posters or active approach in community centres. The randomisation will be conducted after the participants give consent and complete the baseline assessments (T1) (via Qualtrics). The individuals will be randomised into intervention and control groups. The randomized list will be generated using an Excel spreadsheet by a statistician who is not involved in any part of the study. The recruitment staff will be blinded in the allocation process. The randomisation number will not be decoded to the participants until they get assigned a group. Considering the nature of the intervention, participants and research staff cannot be blinded in the process. As the recruitment will be mainly conducted online and through telephone, contamination between groups is expected to be minimal. Potential contamination will be checked at the T1 assessment by asking whether any participants they know have attended the other group. In the final assessment, the participants in the control group will be asked whether they have used any of the recommended apps in the past 3 months.
A 2-hour instruction session of the mobile apps will be delivered to all the participants via Zoom or other online platforms. Participants will be introduced to the concept of self-care and presented with a list of four high-quality and suitable mobile apps along with their main functions. Participants will be instructed to use at least one of the apps for 10 minutes daily over a period of 30 days. They can choose one app or a combination of two or three apps. Participants will create their own user accounts for the chosen app(s), with a reminder to prioritize privacy. Two reminders will be sent during the second and third weeks, emphasizing app usage, the concept of self-care, and providing tips for using the apps. If participants encounter any difficulties accessing the apps, the project coordinator will discuss the issues and collaborate with them to find solutions. Participants will complete the process evaluation (intervention group only) immediately after the intervention (T2), complete the process evaluation (intervention group only) and outcome assessment at 3-month (T3). A fidelity checks on adherence and competence will be conducted.
The feasibility outcomes, including the recruitment rate and duration, retention rate, and adverse events, will be reported descriptively and narratively. For the clinical endpoints, descriptive statistics, mean (standard deviation) for continuous outcomes, will be reported. After adjusting the baseline covariates, mean differences in the outcomes will be compared between the two groups. Multiple imputation approach will be used to deal with missing data (mice package in R). Three sensitivity analyses will be carried out to assess the effect of three factors on the outcomes (retention, choice of mobile apps, effective features). For the in-depth telephone interview, content analysis method will be used following the framework method analysis procedure (e.g., coding). It is expected that the intervention group show more significant improvements in the measured outcomes than the control group, indicating preliminary evidence of effectiveness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist control (WC) | No intervention | –The WC group will not receive treatment from the research team during the assessment period. But they will be notified their evaluation results (mild to moderate depression) after they complete the baseline assessment. They will receive the information about mental health hotline services for general public (e.g. Social Welfare Department: 2343 2255; Caritas Family Crisis Support Centre: 18288; Joyful Mental Health Foundation: 2301 2303). The intervention group will receive the hotline information as well. If they want to consult a family doctor, information about the primary care provider/directory for mental health care and counselling services will be provided in their preferred district. Their treatment or help-seeking of the formal mental health services will not be intervened. The mobile app list will be provided to the WC group after the assessment period. The instruction session will be delivered to the WC group and provide necessary assistance. |
| Brief advice of a list of mobile apps | Experimental | Behavioral: Brief advice of a list of mobile appsIn the instruction session, the participants will be introduced with the concept of self-care, a list of four mobile apps with high quality and suitability, and the main functions of these apps. Participants will be instructed to use at least one of the apps for 10 min each day for 30 days. They have freedom to choose which one app to use, or a mix of two or three apps. For each app they choose, they will create user accounts by themselves but be reminded to protect privacy. Two reminders will be sent to the participants at the 2nd and 3rd week. The message will include reminders to use the suggested mobile apps, self-care concept, and tips of using the provided apps. If they have not accessed to any of the mobile apps, the project coordinator will discuss the reasons and work together with the participants to overcome the problems. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or above
- Have mild to moderate depression (Patient Health Questionnaire (PHQ) - 9, score 5-14) and/or anxiety (General Anxiety Disorder (GAD) - 7, score 5-14)
- Hong Kong residents who can communicate in Chinese (Cantonese)
- Own a smart phone
Key exclusion criteria (2 listed)
- Physically or mentally unable to communicate
- Currently taking antidepressant or anxiolytic medication or receiving active psychotherapy in the past 3 months
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 |
|---|---|---|
| Brief advice of a list of mobile appsAlso: mobile appsThe mobile apps in the list should: (1) focus primarily on anxiety/depression/stress, (2) be available for free download; (3) be available in English or Chinese; and (4) have a user star rating in the app store. | Behavioural | Brief advice of a list of mobile apps |
Primary outcome
Changes in depressive symptoms
Time frame: T1: baseline; T2: immediate post-intervention (1-month after baseline); T3: 3-month after the intervention
The Patient Health Questionnaire (PHQ)-9 will be used to measure depressive symptoms. Participants rate the frequency of nine symptoms over the past two weeks on a 4-point Likert scale (from 0=not at all to 3=nearly every day). The total score ranges from 0 to 27, with higher scores indicating a greater severity of depressive symptoms.
Changes in anxiety symptoms
Time frame: T1: baseline; T2: immediate post-intervention (1-month after baseline); T3: 3-month after the intervention
The Generalized Anxiety Disorder (GAD)-7 will be used to measure anxiety symptoms. Participants rate the frequency of seven symptoms over the past two weeks on a 4-point Likert scale (from 0=not at all to 3=nearly every day). The total score ranges from 0 to 21, with a higher score indicating a higher level of anxiety.
3 secondary outcomes
Changes in well-being
Time frame: T1: baseline; T2: immediate post-intervention (1-month after baseline); T3: 3-month after the intervention
Changes in coping self-efficacy (CSE)
Time frame: T1: baseline; T2: immediate post-intervention (1-month after baseline); T3: 3-month after the intervention
Changes in psychological stress
Time frame: T1: baseline; T2: immediate post-intervention (1-month after baseline); T3: 3-month after the intervention
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 1 Apr 2025.
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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.
Yuying Sun, PhD principal investigator
Hong Kong Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief advice of a list of mobile apps in people with Depressive Symptoms and Anxiety, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
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 4 inclusion and 2 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 1 Apr 2025. 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 Hong Kong. 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?
Changes in depressive symptoms (time frame: T1: baseline; T2: immediate post-intervention (1-month after baseline); T3: 3-month after the intervention). The study lists 2 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 1 Apr 2025.