跳至主要内容
临床试验/NCT07209904
NCT07209904已完成不适用

Study on Understanding the Overall Effectiveness of Mindline.sg on Improving Mental Health Literacy, Quality of Life and Economic Outcomes

Centre for Evidence and Implementation Singapore Ltd1 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2025年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
242
试验地点
1
主要终点
Mental health symptoms by 21-item Depression, Anxiety and Stress Scale (DASS-21)

研究概览

简要总结

This study aims to evaluate the effectiveness of mindline.sg, a digital mental health platform, in improving mental health literacy, emotional wellbeing, quality of life, and economic outcomes among adults in Singapore. We will conduct a randomized controlled trial (RCT) with two phases: an initial screening and a 1-month intervention. Eligible participants, identified based on mental health symptom scores, will be randomly assigned to either an intervention group using mindline.sg or a control group receiving standard mental health information.

The intervention group will receive weekly prompts to engage with key features of the platform, including psychoeducation, positive psychology tools, emotion regulation exercises, and access to digital navigation for mental health services. Participants in both groups will complete surveys at baseline, post-intervention, and two months post-intervention, measuring outcomes such as mental health symptoms, resilience, wellbeing, emotion regulation, mental health literacy, and work performance. We expect mindline.sg users to show greater improvements across mental health and quality of life indicators, increased mental health literacy, and better work productivity compared to controls. This study will provide evidence on the utility of digital mental health tools in supporting population mental wellbeing and inform future digital mental health strategies in Singapore and similar contexts.

详细描述

The primary hypothesis is:

- Participants in the intervention group using mindline.sg will show significantly greater improvements in mental health outcomes, quality of life, and work productivity at post-intervention (T1) and 3-month follow-up (T2), compared to the control group.

Secondary hypotheses include:

  • Intervention participants will demonstrate increased resilience, better emotion regulation, and more positive attitudes and behaviors toward mental health help-seeking compared to the control group.
  • Participants in the intervention group will show higher usage and engagement with digital mental health features and report higher perceived helpfulness of tools.
  • The mindline.sg intervention will be cost-effective compared to the control condition, considering improvements in mental health and productivity outcomes relative to platform costs.

The study will use a randomized controllled trial design. Participants will be assigned to either: (1) A control group (receiving a mental health information pamphlet), or (2) An intervention group (using mindline.sg). Primary outcomes include mental health status, quality of life, economic and productivity measures, and user engagement metrics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Aged at least 21 years or at least 18 years old if National of University student
  • •Have lived in Singapore for at least 2 years
  • •Have not received a formal diagnosis of a psychiatric disorder
  • •Not currently receiving any form of mental health treatment (e.g., counselling)
  • •Fluent in English
  • •Participants from screening whose DASS-21 scores are mild or moderate for any one of the sub scales.

排除标准

  • •- Those who do not meet the inclusion criteria will be screened and excluded.

研究组 & 干预措施

Intervention

Experimental

In the intervention group, participants will be encouraged to use Mindline.sg for four weeks. Each week, participants will receive a reminder to complete certain activities on the website and a quiz to measure completion of activities.

干预措施: mindline.sg (Behavioral)

Control

No Intervention

In the control group, participants will receive mental health literacy materials based on standard materials given out in Singapore. At the end-of-study debrief, control group participants will be directed to the mindline.sg website so they can benefit from it.

结局指标

主要结局

Mental health symptoms by 21-item Depression, Anxiety and Stress Scale (DASS-21)

时间窗: Screening, baseline, 4 weeks after baseline, 12 weeks after baseline

The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items. Higher scores indicate higher severity of symptoms.

Quality of Life by 6-item EQ-5D-5L scale

时间窗: Baseline, 4 weeks after baseline, 12 weeks after baseline

The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group in 2009 to improve the instrument's sensitivity and to reduce ceiling effects, as compared to the EQ-5D-3L. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

Work productivity by WHO-HPQ measure of absenteeism and presenteeism

时间窗: 4 weeks after baseline, 12 weeks after baseline

Absenteeism questions included both sickness absence and non-sickness absence. The questions asked about the number of days in the past 1 year that participants were absent due to health-related problem and non-health-related conditions separately. The questions about presenteeism asked the number of days in the past 1 year that participants had come to work while sick, felt they should take sick leave or were incapable of working with full performance.

Mental health symptoms by 21-item Depression, Anxiety and Stress Scale (DASS-21)

时间窗: Screening, baseline, 4 weeks after baseline, 12 weeks after baseline

The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items. Higher scores indicate higher severity of symptoms.

Quality of Life by 6-item EQ-5D-5L scale

时间窗: Baseline, 4 weeks after baseline, 12 weeks after baseline

The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group in 2009 to improve the instrument's sensitivity and to reduce ceiling effects, as compared to the EQ-5D-3L. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

Work productivity by WHO-HPQ measure of absenteeism and presenteeism

时间窗: 4 weeks after baseline, 12 weeks after baseline

Absenteeism questions included both sickness absence and non-sickness absence. The questions asked about the number of days in the past 1 year that participants were absent due to health-related problem and non-health-related conditions separately. The questions about presenteeism asked the number of days in the past 1 year that participants had come to work while sick, felt they should take sick leave or were incapable of working with full performance.

次要结局

  • Attitudes, knowledge and behaviours regarding mental health and help-seeking by the Mental Help Seeking Attitudes Scale (MHSAS)(Baseline, 4 weeks after baseline, 12 weeks after baseline)
  • Positive psychology by the Cantril Ladder and the WHO-5 Wellbeing Index(Baseline, 4 weeks after baseline, 12 weeks after baseline)
  • Emotion regulation by DERS-18(Baseline, 4 weeks after baseline, 12 weeks after baseline)
  • Self-reported usage patterns of mindline.sg(Baseline, during intervention, 4 weeks after baseline, 12 weeks after baseline)
  • Cost-effectiveness of mindline.sg(Baseline, 4 weeks after baseline, 12 weeks after baseline)
  • Self-reported usage patterns of mindline.sg(Baseline, during intervention, 4 weeks after baseline, 12 weeks after baseline)
  • Resilience by 10-item Connor-Davidson Resilience Scale(Baseline, 4 weeks after baseline, 12 weeks after baseline)
  • Attitudes, knowledge and behaviours regarding mental health and help-seeking by the Mental Help Seeking Attitudes Scale (MHSAS)(Baseline, 4 weeks after baseline, 12 weeks after baseline)
  • Positive psychology by the Cantril Ladder and the WHO-5 Wellbeing Index(Baseline, 4 weeks after baseline, 12 weeks after baseline)
  • Emotion regulation by DERS-18(Baseline, 4 weeks after baseline, 12 weeks after baseline)
  • Cost-effectiveness of mindline.sg(Baseline, 4 weeks after baseline, 12 weeks after baseline)

研究者

发起方
Centre for Evidence and Implementation Singapore Ltd
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean Liu

Associate Director

Centre for Evidence and Implementation Singapore Ltd

研究点 (1)

Loading locations...

相似试验