Clinical trial NCT06777563: EMA and mHealth in Preventing Postpartum Depression
Official title: Ecological Momentary Assessment Combined mHealth-based Psychosocial Intervention to Prevent Postpartum Depression in Pregnant Women: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Depression (PPD)
Ecological Momentary Assessment
mHealth Intervention
Keywords: postpartum depression
ecological momentary assessment
mHealth-based intervention
pregnant women
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postpartum depression
timeFrame: 2-week postpartum
Secondary outcomes:
measure: Postpartum depression
timeFrame: 4, 6, 8 weeks postpartum
measure: Anxiety
timeFrame: 2, 4, 6, 8 weeks postpartum
measure: Depression
timeFrame: 2, 4, 6, 8 weeks postpartum
measure: Stress
timeFrame: 2, 4, 6, 8 weeks postpartum
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The University of Hong Kong
state: Pokfulam
city: Hong Kong
country: Hong Kong
facility: The Queen Mary Hospital
state: Pokfulam
Study officials:
References: