Ecological Momentary Assessment Combined mHealth-based Psychosocial Intervention to Prevent Postpartum Depression in Pregnant Women: a Pilot Randomized Controlled Trial
| Registry | NCT06777563 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, prevention |
| Enrollment | 60 (Estimated) |
| Sponsor | The University of Hong Kong (Other) |
| Conditions | Postpartum Depression (PPD), Ecological Momentary Assessment, mHealth Intervention |
| Interventions | 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 (Behavioral) |
| Dates | start 2024-08-25, primary completion 2025-06-30 (estimated), completion 2025-08-31 (estimated), first posted 2025-01-16, last updated 2025-01-16 |
| Locations | 2 sites in Hong Kong |
Related Papers Related Patents Related Grants Related Experts
All trials for Postpartum Depression (PPD) All trials for Ecological Momentary Assessment All trials of Brief psychological counselling and health education All trials of 2 Weeks of Ecological Momentary Assessment (EMA)
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).
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention group (EMA + IM) | Experimental | Behavioral: Brief psychological counselling and health education; Behavioral: 2 Weeks of Ecological Momentary Assessment (EMA); Behavioral: 10 weeks of mobile health psychological support; Behavioral: CBT-guided telephone counselling booster | The EMA+IM group (group A) will receive an evidence-based intervention composed of brief psychological counselling and health education, 2-week EMA, 10-week mHealth-based psychological support, and CBT-guided telephone counselling, guided by comprehensive assessment. |
| EMA group | Experimental | Behavioral: Brief psychological counselling and health education; Behavioral: 2 Weeks of Ecological Momentary Assessment (EMA) | The EMA group (Group B) will receive brief psychological counselling and health education and 2-week EMA. |
| Control group | Active comparator | Behavioral: Brief psychological counselling and health education | The control group (group C) will receive only brief psychological counselling and health education. |
Sex: Female, ages: 18 Years to any
Inclusion Criteria: 1. Pregnant women who are in their 20 to 28 weeks of gestation, 2. Receiving regular antenatal care service in Hong Kong, 3. Had a total score ≥7 in EPDS-10 (suggesting potential distress symptoms), 4. Able to read and understand Chinese and use an instant messaging app weekly Exclusion Criteria: 1\) Pregnant women who are undergoing psychiatric/psychological treatment.
| Facility | City | Country | Status |
|---|---|---|---|
| School of Nursing, The University of Hong Kong | Hong Kong, Pokfulam | Hong Kong | Recruiting |
| The Queen Mary Hospital | Hong Kong, Pokfulam | Hong Kong | Recruiting |