EMA and mHealth in Preventing Postpartum Depression

Ecological Momentary Assessment Combined mHealth-based Psychosocial Intervention to Prevent Postpartum Depression in Pregnant Women: a Pilot Randomized Controlled Trial

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).

Study Overview

• Status: Recruiting
• Conditions: Ecological Momentary Assessment; mHealth Intervention; Postpartum Depression (PPD)
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shengzhi Zhao, PhD; Phone Number: +852 6561 4500; Email: lubabezz@connect.hku.hk
• Study Contact Backup: Name: Mengyao Li, Mphil; Phone Number: +852 6851 8462; Email: lmy0814@connect.hku.hk

Study Locations

• Hong Kong
  • Pokfulam
    • Hong Kong, Pokfulam, Hong Kong, 999077
      • Recruiting
      • School of nursing, The University of Hong Kong
      • Sub-Investigator: Man Ping Wang, PhD
      • Sub-Investigator: Tzu Tsun Luk, PhD
      • Contact: Shengzhi Zhao, PhD; Phone Number: +852 6561 4500; Email: lubabezz@connect.hku.hk
      • Contact: Mengyao Li, Mphil; Phone Number: +852 6851 8462; Email: lmy0814@connect.hku.hk
      • Principal Investigator: Shengzhi Zhao, PhD
      • Sub-Investigator: Yi Nam Sun, PhD
      • Sub-Investigator: Ka Wang Cheung, PhD
    • Hong Kong, Pokfulam, Hong Kong, 999077
      • Recruiting
      • The Queen Mary Hospital
      • Contact: Shengzhi Zhao, PhD; Phone Number: +852 6561 4500; Email: lubabezz@connect.hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group (EMA + IM); 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.	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.
Experimental: EMA group; The EMA group (Group B) will receive brief psychological counselling and health education and 2-week EMA.	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.
Active Comparator: Control group; The control group (group C) will receive only brief psychological counselling and health education.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum depression	Postpartum depression will be measured by Edinburgh Postnatal Depression Scale (EPDS-10). The score ranges from 0-30. 0-9 indicates minimal or no depressive symptoms.10-12 suggests mild depressive symptoms and further monitoring may be recommended.13-14 indicates moderate depressive symptoms and a potential need for further assessment.15-30 suggests significant depressive symptoms and likely clinical depression, requiring further evaluation and intervention.	2-week postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum depression	Postpartum depression will be measured by the Edinburgh Postnatal Depression Scale (EPDS-10). The score ranges from 0-30. 0-9 indicates minimal or no depressive symptoms.10-12 suggests mild depressive symptoms and further monitoring may be recommended.13-14 indicates moderate depressive symptoms and a potential need for further assessment.15-30 suggests significant depressive symptoms and likely clinical depression, requiring further evaluation and intervention.	4, 6, 8 weeks postpartum
Anxiety	Anxiety will be measured by the 7-item Generalized Anxiety Disorder (GAD-7). The total score ranges from 0 to 21. A higher score on the GAD-7 indicates greater severity of anxiety symptoms.	2, 4, 6, 8 weeks postpartum
Depression	Depression will be measured by the 9-item Patient Health Questionnaire (PHQ-9). The total score ranges from 0 to 27. A higher score on the PHQ-9 indicates greater severity of depressive symptoms.	2, 4, 6, 8 weeks postpartum
Stress	Self-perceived stress will be measured by the 10-item Perceived Stress Scale (PSS-10). The total score ranges from 0 to 40. A higher score on the PSS-10 indicates greater perceived stress, reflecting a higher level of distress or difficulty in managing life's challenges.	2, 4, 6, 8 weeks postpartum

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: pregnant women; postpartum depression; ecological momentary assessment; mHealth-based intervention
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Behavioral Symptoms; Mood Disorders; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: PPD prevention

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No