NCT06099301

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

October 16, 2023

Last Update Submit

March 26, 2025

Conditions

Keywords

AppsDepressive SymptomsAnxietyMental HealthCoping Self-efficacy

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    T1: baseline; T2: immediate post-intervention (1-month after baseline); T3: 3-month after the intervention

Secondary Outcomes (3)

  • Changes in well-being

    T1: baseline; T2: immediate post-intervention (1-month after baseline); T3: 3-month after the intervention

  • Changes in coping self-efficacy (CSE)

    T1: baseline; T2: immediate post-intervention (1-month after baseline); T3: 3-month after the intervention

  • Changes in psychological stress

    T1: baseline; T2: immediate post-intervention (1-month after baseline); T3: 3-month after the intervention

Other Outcomes (2)

  • Utility assessment during application use

    T2: immediate post-intervention (1-month after baseline); T3: 3-month after the intervention

  • The overall satisfaction with the program and subjective changes

    After completing all quantitative outcome assessments (3-month after the intervention)

Study Arms (2)

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.

Behavioral: Brief advice of a list of mobile apps

Interventions

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.

Also known as: mobile apps
Brief advice of a list of mobile apps

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Physically or mentally unable to communicate
  • Currently taking antidepressant or anxiolytic medication or receiving active psychotherapy in the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Metropolitan University

Hong Kong, 000000, Hong Kong

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Study Officials

  • Yuying Sun, PhD

    Hong Kong Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 25, 2023

Study Start

August 1, 2023

Primary Completion

August 26, 2024

Study Completion

October 31, 2024

Last Updated

April 1, 2025

Record last verified: 2025-03

Locations