EMA and mHealth in Preventing Postpartum Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brief psychological counselling and health education, 2 Weeks of Ecological Momentary Assessment (EMA), 10 weeks of mobile health psychological support, CBT-guided telephone counselling booster.
- Who it may be relevant to
- Registry conditions: Postpartum Depression (PPD), Ecological Momentary Assessment, mHealth Intervention. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ecological Momentary Assessment Combined mHealth-based Psychosocial Intervention to Prevent Postpartum Depression in Pregnant Women: a Pilot Randomized Controlled Trial
Overview
This proposed study aims to develop and examine the feasibility, acceptability, and preliminary effectiveness of a proactive intervention model that combines brief psychological counselling, Ecological Momentary Assessment (EMA), mHealth-based psychological support, and CBT-guided telephone counselling to prevent postpartum depression (PPD).
Detailed description
The target participants are pregnant women between 20 and 28 weeks of gestation with a total EPDS-10 score of ≥7. Sixty participants will be actively recruited from the Department of Obstetrics and Gynaecology at Queen Mary Hospital (QMH), a major acute hospital in Hong Kong. Recruitment will extend to other public hospitals if needed.
This study will be a three-arm (allocation ratio:1:1:1; permutated block size of 3, 6, and 9), single-blinded, parallel, pilot randomised controlled trial (RCT) with follow-ups at 2, 4, 6, and 8 weeks post-enrollment using standard methodology (CONSORT) to evaluate the effectiveness of the intervention. The EMA+IM group (group A) will receive an evidence-based intervention composed of brief psychological counselling and health education, 2-week EMA, mHealth-based psychological support, and CBT-guided telephone counselling, guided by comprehensive assessment. The EMA group (Group B) will only receive a 2-week EMA, and the control group (group C) will receive only brief psychological counselling and health education. Surveys will be collected via telephone after childbirth. Semi-structured individual interviews will be conducted with the participants in the intervention group to understand the experience and the perceptions towards the EMA data collection and mHealth-based intervention on mental health.
The primary clinical outcome of this study will be the difference in the EPDS scores between the two groups at 2 weeks postpartum. Secondary clinical outcomes will include differences in anxiety levels, stress levels, and insomnia symptoms at 2, 4, 6 and 8 weeks postpartum. Differences in participants' self-rated health, family functioning, family well-being and perceived happiness will also be analyzed.
Interventions
- Behavioral Brief psychological counselling and health education
This is a brief 1-on-1 psychological counselling, including potential mood fluctuation during pregnancy, possible prepartum depressive symptoms, and available psychiatric consultation and medication in Hong Kong with self-help psychoeducational materials. - Behavioral 2 Weeks of Ecological Momentary Assessment (EMA)
The 2-week EMA period will start the next day. Participants will be prompted to answer questions about emotion (e.g. worry, enjoyment, anxiety, etc.) and other lifestyle and environmental triggers through the smartphone notification function. There will be a 2-hour window for each assessment before expiration and total 5 assessments a day. - Behavioral 10 weeks of mobile health psychological support
A total of 20 regular instant messages (e.g., via WhatsApp) personalised by baseline demographic characteristics (current pregnancy details, history of postpartum mental illness) and results of EMA will be sent to the participants in multi-media formats. - Behavioral CBT-guided telephone counselling booster
A 45-minute telephone counselling based on CBT.
Primary outcome measures
- Postpartum depression [Time frame: 2-week postpartum]
Secondary outcome measures (4)
- Postpartum depression [Time frame: 4, 6, 8 weeks postpartum]
- Anxiety [Time frame: 2, 4, 6, 8 weeks postpartum]
- Depression [Time frame: 2, 4, 6, 8 weeks postpartum]
- Stress [Time frame: 2, 4, 6, 8 weeks postpartum]
Eligibility criteria
Inclusion criteria
- Pregnant women who are in their 20 to 28 weeks of gestation,
- Receiving regular antenatal care service in Hong Kong,
- Had a total score ≥7 in EPDS-10 (suggesting potential distress symptoms),
- Able to read and understand Chinese and use an instant messaging app weekly
Exclusion criteria
1\) Pregnant women who are undergoing psychiatric/psychological treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Hong Kong · 2 centers
- School of Nursing, The University of Hong Kong — Hong Kong
- The Queen Mary Hospital — Hong Kong
Identifiers
NCT: NCT06777563 · PPD prevention