Actively Recruiting
Ecological Momentary Assessment Combined mHealth-based Psychosocial Intervention to Prevent Postpartum Depression in Pregnant Women: a Pilot Randomized Controlled Trial
Led by The University of Hong Kong · Updated on 2025-01-16
60
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying pregnant women between 20 and 28 weeks of gestation who have a total EPDS-10 score of 7 or higher, indicating potential distress symptoms. The purpose is to evaluate a proactive intervention combining brief psychological counselling, Ecological Momentary Assessment (EMA), mobile health (mHealth) psychological support, and cognitive-behavioral therapy (CBT)-guided telephone counselling to help prevent postpartum depression (PPD). This pilot randomized controlled trial aims to assess the feasibility, acceptability, and preliminary effectiveness of this combined intervention compared to other approaches. Participants will be randomly assigned into one of three groups. The first group receives a comprehensive intervention including brief psychological counselling and health education, 2-week EMA, 10 weeks of mHealth psychological support via instant messages, and a CBT-guided telephone counselling session. The second group receives brief counselling and health education plus the 2-week EMA. The control group receives only brief psychological counselling and health education. Follow-ups occur at 2, 4, 6, and 8 weeks after enrollment to monitor progress. During the study, participants will complete EMA surveys via smartphone notifications five times daily over two weeks, providing real-time data on emotions and lifestyle factors. Researchers will collect survey data by telephone after childbirth and conduct interviews with intervention group participants to understand their experiences. The main outcome measured is the difference in postpartum depression scores at 2 weeks postpartum, with additional assessments of anxiety, stress, insomnia symptoms, self-rated health, family functioning, and happiness over 8 weeks. The study is sponsored by The University of Hong Kong and lasts through August 2025.
CONDITIONS
Brief Title
EMA and mHealth in Preventing Postpartum Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women between 20 and 28 weeks of gestation
- Receiving regular antenatal care service in Hong Kong
- Total EPDS-10 score of 7 or higher, suggesting potential distress symptoms
- Able to read and understand Chinese
- Able to use an instant messaging app weekly
You will not qualify if you...
- Currently undergoing psychiatric or psychological treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session at enrollment
Participants receive brief 1-on-1 psychological counselling including information on mood fluctuations during pregnancy, potential prepartum depressive symptoms, and available psychiatric consultation and medication in Hong Kong, along with self-help psychoeducational materials.
1 visit (in-person)
Duration - 2 weeks
Participants answer questions about emotions and lifestyle triggers via smartphone notifications 5 times daily within a 2-hour window during a 2-week period starting the day after enrollment.
Daily assessments through smartphone notification for 2 weeks
Duration - 10 weeks
Participants receive 20 personalized instant messages over 10 weeks via WhatsApp, providing psychological support based on baseline characteristics and EMA results.
Messages sent periodically over 10 weeks
Duration - Single session during the intervention period
Participants receive a 45-minute telephone counselling session based on cognitive behavioral therapy (CBT) as a booster guided by comprehensive assessment.
1 telephone counselling session
Duration - 8 weeks postpartum
Participants complete surveys via telephone after childbirth at 2, 4, 6, and 8 weeks postpartum to assess depression, anxiety, stress, and other health measures.
4 telephone survey visits at 2, 4, 6, and 8 weeks postpartum
Trial Site Locations
Total: 2 locations
1
School of Nursing, The University of Hong Kong
Hong Kong, Pokfulam, Hong Kong, 999077
Actively Recruiting
2
The Queen Mary Hospital
Hong Kong, Pokfulam, Hong Kong, 999077
Actively Recruiting
Research Team
S
Shengzhi Zhao, PhD
M
Mengyao Li, Mphil
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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